🇭🇰 港交所GRAND PHARMAQwen · 实盘不做把握 3/10不做原因:风险收益比不佳
北京时间·🕒 发布 08-26 21:38:00时区推断·⟳ 抓取 08-26 21:56:11·⚡ 决策 08-27 01:07:15 +3h11m·62.1 天前
远大医药2026年中期业绩:收入增3.2%至63.9亿港元,经调整经营性纯利下降6.6%,核药板块高增55%但五官科及急救板块大幅下滑
中期业绩方向混合:核药+55%和氨基酸+31%高增长被五官科-25%、急救-12%和整体利润下滑-6.6%抵消;毛利率从59%压缩至52.7%显示结构性压力;无法获取市场一致预期判断是否超预期;股价已处52周低位附近(-45%),缺乏明确方向性edge
📄 原文GRAND PHARMA↗ 原文
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the con…
不做 远大医药集团(00512.HK)
中期业绩方向混合:核药(+55%)和氨基酸(+31%)高增长被五官科(-25%)和急救(-12%)大幅下滑抵消,整体经调整经营性纯利同比-6.6%;毛利率从59%压缩至52.7%显示结构性压力;无法获取一致预期判断是否超预期;未派中期股息;缺乏明确单边方向性edge,不满足ENTER条件
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
结论摘要
远大医药2026中期业绩呈混合特征:核药抗肿瘤板块(+55.4%)和氨基酸板块(+30.9%)展现强劲增长,但五官科(-25.4%)和心脑血管急救(-12.4%)因'销售策略调整'大幅下滑,导致整体经调整经营性纯利同比下降6.6%至9.73亿港元。毛利率从59.0%压缩至52.7%是重要负面信号。公司股价已较52周高位下跌45%,近期在5.2-5.5港元区间震荡,无事件前异动。由于无法获取市场一致预期数据,且业绩方向混合、利润下滑,缺乏明确的方向性交易edge。
🔎 新鲜度:最早出现 2026-08-26 · 扩散 low · price-in 风险 low ↗
消息传播链
- 远大医药2026中期业绩公告于港股收盘后发布,属一手法定披露市场反应:尚未有市场反应(次日开盘前)
主要风险
- 整体经调整经营性纯利同比下降6.6%,五官科和急救板块大幅下滑反映竞争压力
- 毛利率从59.0%压缩至52.7%,显示收入结构变化或定价压力
反向证据
- 做多前查反向 · 来源 kb_search · 影响 none
内部KB检索降级且无命中,无法获取券商预期或近期研报观点
检索:远大医药 2026 中期业绩 市场预期
先例如何影响了这次决策
对本次决策的影响:无先例可用,不影响AVOID结论(本身因方向混合、缺乏edge而AVOID)
方向:无法确定
涨幅量级:无可用先例
形态:无法判断
工具调用 · 历史记录,结果未知(6 种)
- fetch_decision_experience · 结果未知
- search_processed_events · 结果未知
- stock_quote · 结果未知
- search_case_library · 结果未知
- web_search · 结果未知
- kb_search · 结果未知
原文全文
展开原文 · 229,956 字
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no
responsibility for the contents of this announcement, make no representation as to its accuracy or
completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in
reliance upon the whole or any part of the contents of this announcement.
GRAND PHARMACEUTICAL GROUP LIMITED
遠 大 醫 藥 集 團 有 限 公 司*
(Incorporated in Bermuda with limited liability)
(Stock Code: 00512)
2026 INTERIM RESULTS ANNOUNCEMENT
Financial Highlights
-
For the six months ended 30 June 2026, the Group’s business grew steadily, with revenue of
approximately HK$6,388.91 million (restated for the same period last year1: HK$6,189.20
million), representing an increase of approximately 3.2% as compared to the corresponding
period of last year. Revenue from innovative and barrier products2 accounted for approximately
50% of total revenue.
-
For the six months ended 30 June 2026, the profit for the period attributable to owners of the
Company amounted to approximately HK$1,061.54 million (restated for the same period last
year: HK$1,193.17 million). During the period, the Group’s fair value change gain and disposal
gain on Telix investment amounted to approximately HK$88.78 million (same period last year:
HK$151.72 million), representing a decrease of HK$62.94 million compared to the same period
last year. If the impact of Telix investment on profit is excluded, the adjusted net operating
profit attributable to owners of the Company3 was approximately HK$972.76 million (restated
for the same period last year: HK$1,041.44 million).
-
For the six months ended 30 June 2026, the Group’s nuclear medicine anti-tumor diagnosis and
treatment segment recorded revenue of approximately HK$655.24 million, representing an
increase of approximately 55.4% compared to the corresponding period in 2025 (approximately
HK$421.78 million). This increase was primarily attributable to revenue growth driven by the
rapid rise in clinical demand for core products and the rapid scaling-up of sales volumes for new
products.
—1—
–
The Group is firmly committed to implementing an innovation-driven strategy, and “Go Global”
strategies, optimizing the allocation of R&D resources, and focusing on high-barrier sectors such
as nuclear medicine for anticancer therapy and anti-infective treatments for critical illnesses,
whilst also expanding into cutting-edge fields such as innovative mRNA medicines and
innovative ophthalmic drugs. Leveraging its end-to-end R&D platform, the Group has built a
tiered innovation pipeline spanning the short, medium, and long term, resulting in continuous
improvements in R&D-to-commercialization efficiency. The Group has established a mature
global clinical trial and “simultaneous China-U.S. filing” registration system, with multiple
products having received clinical trial approvals from international regulatory authorities.
Clinical results for core products have been published in top-tier international journals and
successively incorporated into authoritative domestic and international diagnostic and treatment
guidelines, providing strong support for the commercialization process. The Group currently has
more than 30 high-value projects in development, with a concentration of R&D milestones
expected to be achieved in 2027–2028. This robust pipeline will provide growth momentum for
long-term development.
Note:
1.
In the first half of 2026, the Company successfully acquired 100% of the equity interests in Hebei Yuanda
Jiufu Biotechnology Co., Ltd. (“Hebei Jiufu”) and Baoding Jiahe Fine Chemicals Co., Ltd. (“Baoding
Jiahe”). At the time of the acquisition, China Grand Enterprises Incorporation (“China Grand”) was the
controlling shareholder of both Hebei Jiufu and Baoding Jiahe, and was also the controlling shareholder of
the Company. Therefore, the acquisition was treated as a business combination involving entities under
common control and accounted for using the merger accounting method. Consequently, the comparative
condensed consolidated statements of income and other comprehensive income for the six months ended 30
June 2025, as well as the condensed consolidated statements of financial position as of 31 December 2025,
and 1 January 2025, have been restated to incorporate the assets, liabilities, profits, and cash flows of the
combined entity from the date on which it first came under common control. For details, please refer to
Note 2 to the condensed consolidated financial statements.
2.
Innovative and barrier products refer to the Company’s original research products, products with exclusive
market positions, products with exclusive commercialization rights, and first-to-market generic products
that break foreign monopolies.
3.
Adjusted net operating profit attributable to owners of the Company is defined as the profit attributable to
owners of the Group for the period which excludes the impact of fair value changes and disposal gains on
the Telix investment.
—2—
MANAGEMENT DISCUSSION AND ANALYSIS
GROUP POSITIONING
The Group is an international pharmaceutical company of technological innovation. Its core businesses
cover three major areas, namely nuclear medicine anti-tumor diagnosis and treatment and
cerebrocardiovascular precision interventional diagnosis and treatment technology, pharmaceutical
technology and biotechnology. Based on the pharmaceutical and biological industries, the Group focuses
on the needs of patients, and takes technological innovation as the driving force. In response to the
unmet clinical needs, the Group will increase its investment in global innovative products and advanced
technologies, enrich and improve its product pipelines, consolidate and strengthen its industrial chain
layout, and fully leverage the Group’s industrial strengths and R&D capabilities to provide more
advanced and diverse treatment solutions to patients worldwide.
With unremitting efforts in recent years, the Group has laid a more solid foundation for development,
consolidated its operation scale, gradually optimized its business structure, continued to improve its
operation mode, accelerated its pace of transformation and upgrading, and made various achievements in
innovative layout. The Group’s profitability continues to improve and help facilitate R&D and
innovation; its good ability in mergers and acquisitions and integration continues to consolidate the scale
of development; the integration of raw materials and preparations improves the structure of the industrial
chain; and the diversification of business and entities has effectively enhanced the comprehensive
advantages.
“Maintain stable growth, strive in innovation and strategic planning”, the Group will stick with the
development concept of “comprehensive strengths, innovation leading and global expansion” and the
strategy of “dual-wheel driving development of independent R&D, global expansion and dual-cycle
operation”. The Group has formed a new pattern of domestic and international cycles that synergize with
each other, and is committed to becoming an international pharmaceutical company of technological
innovation, delivering on its promises for doctors and patients, and making significant contribution to
the society.
BUSINESS REVIEW AND PROSPECTS
During 2026 up to the date of this report, the Group had a total of 18 significant milestones, including 8
innovative products, 6 generic products, 3 API products and 1 major collaboration. Meanwhile, the
continued rapid scale-up of the Group’s innovative and barrier products, such as Yttrium-90 microsphere
injections, liquid embolic agent Lava™, together with the simultaneous growth in both volume and price
of core products within the biotechnology segment, has successfully contributed to the Group’s steady
growth in performance.
—3—
Innovative products
Nuclear medicine anti-tumor diagnosis and treatment:
–
–
–
The New Drug Application (NDA) for the global innovative radiopharmaceutical TLX591-CDx for
the diagnosis of prostate cancer has been accepted for review by the National Medical Products
Administration of the People’s Republic of China (“NMPA”);
A clinical trial conducted in the United States with the globally innovative radioactive product
SIR-Spheres ® Y-90 resin microsphere injection for the treatment of primary hepatocellular
carcinoma (HCC) has met its clinical endpoints;
The global innovative radionuclide-drug conjugate (“RDC”) GPN01530-2 for the diagnosis of
solid tumors, has been granted Fast Track Designation (“FTD”) by the U.S. Food and Drug
Administration (“FDA”).
Cerebrocardiovascular precision interventional diagnosis and treatment:
–
The innovative device GPG04862 for intravascular imaging has been approved for marketing by
the NMPA.
Respiratory and critical and severe disease:
–
The class 1 innovative chemical drug GPN01411 for the treatment of infections, has received
approval from the NMPA to conduct a Phase I clinical trial;
ENT:
–
–
–
TP-03, a globally innovative ophthalmic drug for the treatment of demodicosis blepharitis, has
been approved for commercialization by the NMPA;
GPN01360, a Class 1.1 innovative TCM for the treatment of depression, has completed the
enrollment and administration of the first patient in its Phase III clinical trial in China;
GPN01020, a Class 1.1 innovative TCM drug intended for the prophylactic treatment of migraine,
has received approval from the NMPA to conduct a Phase II clinical trial in China.
Generic products
There were 6 products that have been approved for marketing by the NMPA.
API products
There were 3 API products approved for commercialization by the NMPA.
—4—
Key Partnership
The Group has entered into a strategic partnership with the University of Hong Kong and its whollyowned subsidiary, University of Hong Kong Versitech Limited (“HKU Versitech”). The two parties will
engage in in-depth collaboration in areas such as academic research, resource sharing, talent
development, and product development, and will work together to advance the research and development
of innovative drugs in the field of anti-infective therapy and the commercialization of research
outcomes.
BUSINESS INTRODUCTION
The Group has strong technological innovation strength, outstanding internationalization strength, solid
industrial foundation, complete industrial chain and significant comprehensive advantages in the
integration of raw materials and preparations. The Group has more than 130 products included in the
National Essential Drug List (2026 version) 「
( 國家基本藥物目錄」
(2026年版)) and more than 260
products included in the National Reimbursement Drug List for Basic Medical Insurance, Work-Related
Injury Insurance and Maternity Insurance (2025 version) 「
( 國家基本醫療保險、工傷保險和生育保險
藥品目錄(2025年版)」).
Nuclear Medicine Anti-tumor Diagnosis and Treatment as well as Cerebro-cardiovascular
Precision Interventional Diagnosis and Treatment Technology
By fully capitalizing “accurate and stable business development capabilities at home and abroad, the
introduction and digestion of international leading technologies, excellent marketing and sales
capabilities”, the Group is aiming at the frontier areas of technological innovation and focusing on the
layout of the “nuclear medicine anti-tumor diagnosis and treatment” and “cerebro-cardiovascular
precision interventional diagnosis and treatment” segments. It has become a leading enterprise in nuclear
medicine anti-tumor diagnosis and treatment in China, and a comprehensive cerebro-cardiovascular
precision interventional diagnosis and treatment technology platform with international cutting-edge
technologies.
Nuclear Medicine Anti-tumor Diagnosis and Treatment Segment
In the nuclear medicine anti-tumor diagnosis and treatment segment, the Group has achieved a
comprehensive layout in the fields of R&D, production, distribution, and sales, with over 1,200
employees worldwide. The Group has established a global nuclear medicine industry chain layout based
on its R&D centers in Boston and Chengdu, production facilities in Boston, Frankfurt, Singapore, and
Chengdu, and a sales network covering over 50 countries and regions worldwide.
—5—
As the Group’s core domestic R&D and production facility within its global nuclear pharmaceuticals
industry layout, Grand Pharmaceutical’s Radiopharmaceutical R&D and Production Base(遠大醫藥放
射性藥物研發及生產基地), located in Chengdu was completed and accepted in April 2025, obtained a
Class A Radiation Safety Licence issued by the Ministry of Ecology and Environment in May of the
same year, and officially commenced operations at the end of June. This facility is the world’s first fully
integrated closed-loop nuclear medicine supply chain platform, covering the entire value chain from
“isotope production – nuclear medicine R&D – manufacturing – clinical trials – commercialization”. It
has established end-to-end management capabilities spanning the entire lifecycle from early-stage R&D
to clinical translation to commercialization, with R&D efficiency leading globally. It addresses the
‘bottleneck’ challenges in nuclear medicine, achieving 100% domestic production to break free from
reliance on imports. Fourteen high-standard GMP production lines meet the demand for multi-product,
large-scale production. Established a fully intelligent management system, featuring nuclear-grade safety
and unmanned intelligent manufacturing, achieving “zero radiation leakage”, “zero pollution discharge”,
and “zero occupational exposure exceeding standards”, meeting the standards of the world’s top nuclear
facilities. We have established a world-class research, production, quality, and operational system,
making it one of the most comprehensive and highly automated intelligent factories in the world in
terms of isotope variety and automation levels. This R&D and production base will further solidify the
foundation of the Group’s nuclear pharmaceutical industry, accelerate the implementation of global
innovative R&D pipelines, drive the Group’s high-quality development in the nuclear pharmaceutical
sector, cultivate high-value blockbuster products, and lay a solid foundation for the domestic production
of the Group’s radioactive drugs.
The Group, together with Sirtex, cooperated with Telix Pharmaceutical Limited (“Telix”) and ITM
Isotope Technologies Munich SE (“ITM”) to establish a world-class tumor intervention technology
platform and a RDC technology platform. The Group adheres to the treatment concept of integrated
oncology diagnosis and treatment. Currently, the Group has 14 innovative products in the pipeline at the
R&D registration stage, covering five radionuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr as well as
seven cancers including liver cancer, prostate cancer and brain cancer. The early stages of R&D focused
primarily on RDC drugs, with a product pipeline now comprising more than 10 products. In terms of
product types, it covers two types of radionuclide drugs for diagnosis and therapy, providing patients
with global leading anti-tumor solutions with multi-indication treatment options, multi-means and
integrated diagnosis and treatment.
Global R&D efforts for innovative products within the segment are progressing smoothly. In China,
YiGanTai ® Yttrium-90 microsphere injection was successfully launched in January 2022 for the
treatment of liver metastases from colorectal cancer (“mCRC”), and in May 2025, it received approval
from the NMPA to conduct a Phase II registrational clinical trial for the treatment of unresectable
hepatocellular carcinoma (“HCC”); The global innovative temperature-sensitive embolization agent
GPN00289 completed the enrollment of all patients in its registrational clinical study in October 2025.
Overseas registration-wise, SIR-Spheres® Yttrium-90 microsphere injection was formally approved in
the United States for a new indication, used to treat unresectable HCC. The Group’s independently
developed and globally innovative GPN01530, is a small molecule radionuclide-drug conjugate (“RDC”)
drug that targets fibroblast activating protein (“FAP”). It has been approved in the United States to
—6—
conduct a Phase I/II clinical study for the diagnosis of solid tumors and has been granted FTD by the
FDA, which is the Group’s first self-developed RDC product that receives FDA approval for clinical
trials. The successful approval of the GPN01530 clinical trial provides an important paradigm for the
international development of the Group’s nuclear medicine product pipeline. At the same time, it fully
demonstrates the Group’s comprehensive strength in the construction of cutting-edge nuclear medicine
technology platforms, international clinical development, and registration applications, etc. To date, the
Group has six RDC drugs approved for clinical studies worldwide. Among them, TLX591-CDx for
diagnosing prostate cancer, has entered the NDA stage, while three have entered Phase III clinical trials,
including TLX591 for treating prostate cancer, TLX250-CDx for diagnosing clear cell renal cell
carcinoma, and ITM-11 for treating GEP-NETs. In the future, the Group will continue to strengthen the
R&D in and establishment of the nuclear medicine anti-tumor diagnosis and treatment segment, as well
as enrich and improve the product pipeline and industrial layout, forming a nuclear medicine anti-tumor
diagnosis and treatment product cluster with the core of YiGanTai® Yttrium-90 microsphere injections,
which continuously consolidates the Group’s global leading position in the field of nuclear medicine
anti-tumor diagnosis and treatment.
Core products
YiGanTai® Yttrium-90 microsphere injections, the global innovative product:
The Group’s global blockbuster innovative product, YiGanTai® Yttrium-90 microsphere injections,
received marketing approval from the NMPA in January 2022 for the treatment of patients with
unresectable colorectal cancer liver metastases who have failed standard therapy. In July 2025, based on
the breakthrough interim results of the DOORwaY90 clinical trial, the FDA granted accelerated approval
for the new indication of treating unresectable hepatocellular carcinoma (HCC). In April 2026, all
clinical studies were completed, and the clinical endpoints were successfully met. YiGanTai® Yttrium-90
microsphere injections is the first and currently the only FDA-approved selective internal radiation
therapy (“SIRT”) product for the dual indications of unresectable HCC and liver metastases from
colorectal cancer. It has been used by more than 150,000 people in over 50 countries and regions around
the world. It is also recommended by the treatment guidelines issued by different international
authoritative organizations such as Barcelona Clinic Liver Cancer Guidelines (BCLC), National
Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO) Clinical
Practice Guideline for diagnosis, treatment and follow-up of hepatocellular carcinoma (2025 edition),
European Association for the Study of the Liver EASL Guideline on hepatocellular carcinoma (2025
Edition) European Association for the Study of the Liver (EASL), National Institute for Health and Care
Excellence (NICE), etc. And it has been included in several authoritative clinical practice guidelines in
China, including the “Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2026 Edition)”
《
( 原發性肝癌診療指南(2026版)》), “CSCO Guidelines for Diagnosis and Treatment of Primary Liver
Cancer (2024 Edition)” (《 CSCO原 發 性 肝 癌 診 療 指 南( 2024版)》), Guidelines for Diagnosis and
Comprehensive Treatment of Colorectal Cancer Liver Metastases (2025 Edition)” 《
( 結直腸癌肝轉移診
斷 和 綜 合 治 療 指 南( 2025版)》), “Clinical Practice Guidelines for Liver Cancer and Liver
Transplantation in China (2021 Edition)” 《
( 中國肝癌肝移植臨床實踐指南(2021版)》), etc.
—7—
In May 2022, YiGanTai® Yttrium-90 microsphere injections was officially commercialized in China.
The treatment of liver malignancies in China has entered a new “Y-90 era”. Since the official
commercialization of YiGanTai®, over 110 hospitals have completed the nuclide transfer procedures, its
official surgeries have been carried out in over 70 hospitals in 22 provinces and cities in China. In order
to speed up the implementation and popularization of YiGanTai ® microsphere injections precise
interventional therapy in China, the Group, based on the surgeon supervision and training system
approved by the Chinese NMPA and the U.S. FDA, concentrated global resources to provide
comprehensive training to surgeons in China on patient screening knowledge, surgical operation skills,
and prognosis assessment methods, helping doctors to master and accumulate clinical experience to
ensure a wider, safe and effective applications of the product, and assisted domestic doctors in
conducting multiple personalized practical trainings by well-known overseas clinical experts. At present,
9 surgery, treatment and training centers have been established. The Group has trained more than 1,200
doctors in 80 hospitals on the surgery theory or skills of YiGanTai®, more than 340 doctors have
obtained the surgeon registration for YiGanTai®. Among which, 161 doctors have obtained the operation
qualification of independent surgery through strict one-to-one training by international and domestic
renowned experts, and 120 doctors have been qualified as assistants in surgical operation. Another 32
experts have obtained the qualification of training instructor, which will further accelerate the clinical
popularization of YiGanTai® radioactive interventional operation.
Since its commercialization, YiGanTai® Yttrium-90 microsphere injection has been included in over 50
inclusive insurances such as Beijing Puhui Health Insurance(北京普惠健康保), Shanghai Hu Hui Bao
(上海滬惠保), Wuhan Fuhankang(武漢福漢康), Chongqing Yukuaibao(重慶渝快保), Nanjing Ning
Hui Bao(南京寧惠保)and 1 special medical insurances, which covers more than 30 provincial-level
administrative regions and over 100 cities with a significant increase in the accessibility of such product
to patients with liver cancer.
In terms of academic research,, researchers in mainland China published a wealth of high-value realworld data on Yigantai ® Yttrium-90 Microspheres Injection: at the American Society of Clinical
Oncology Gastrointestinal Cancers (ASCO GI) Symposium, the American Society of Clinical Oncology
(ASCO) Annual Meeting, the European Society for Medical Oncology (ESMO Asia) Annual Meeting,
the Asia-Pacific Primary Liver Cancer Experts Alliance (APPLE) Conference, the Annual Meeting of
the Asia-Pacific HepatoPancreato-Biliary Association (A-PHPBA), the Annual Meeting of the Asian
Oncology Society (AOS), the Annual Meeting of the Asia-Pacific Association for the Study of the Liver
(APASL), and the Annual Meeting of the International Hepato-Pancreato Biliary Association (IHPBA)
among other leading international academic conferences in the fields of oncology and hepatology, with a
cumulative total of 100 poster presentations and 7 oral presentations. Concurrently, related research
findings have been consistently published in internationally renowned journals. Among these, a study
comparing Transcatheter Arterial Chemoembolization (TACE) in patients with high tumor burden was
published in the International Journal of Surgery; a retrospective study systematically evaluating the
dual effects of Yttrium-90 (Y-90) resin microspheres on tumor shrinkage and contralateral hepatic lobe
—8—
hyperplasia was published in EJNMMI Research. Dozens of other research papers, including case
studies and reviews, have also been published subsequently. The above cover the treatment of liver
cancer patients at all stages, for early-stage patients, it can undergo radioactive liver segment ablation;
for intermediate-stage patients, helps downstaging to liver transplantation/hepatectomy,demonstrating
potent tumor shrinkage effects even for tumors larger than 10 cm or 15 cm; for advanced patients,
combination therapy with systemic treatment/, TACE, Hepatic Artery Infusion Chemotherapy (HAIC),
etc. Compared to traditional treatments, which require longer treatment durations, this approach offers
comprehensive care for patients with complex conditions. The “Chinese Protocol” for Yttrium-90 (Y-90)
resin microsphere therapy is gaining increasing attention and recognition from the international
academic community, thanks to its consecutive appearances at top-tier international academic
conferences and in authoritative journals, as well as the presentation of its significant findings.
LavaTM, a global innovative liquid embolic agent
LavaTM is the first innovative liquid embolic agent approved for the treatment of peripheral vascular
arterial hemorrhage in the United States. Its radiopacity makes the product less prone to artifacts during
the imaging process, thus giving a better imaging effect. LavaTM can be easily prepared in 2 minutes,
while it takes about 20 minutes to prepare similar products, saving doctors’ preparation time in
emergency situations and increasing the probability of patient survival; the solid embolization upon
conversion offers two viscosities which can be used flexibly for patients with different conditions.
LavaTM can create synergies with radioisotopes brachytherapy and interventional therapies. The product
was approved for commercialization in the United States in April 2023 and its formal commercialization
commenced in October of the same year.
The early detection product for urothelial carcinoma, AcornMed • UI-SEEK®
This product employs a dual-target design combining methylation and gene mutations. According to data
from a registrational clinical study involving over 1,000 cases, UI-SEEK® demonstrates a sensitivity of
92.5% and a specificity of 95.8%. The clinical results are excellent, and the test is non-invasive,
unaffected by external factors such as haematuria or stones, thereby aiding in the early detection,
diagnosis, treatment, and benefits for patients with urothelial carcinoma. The product has been approved
for market launch by the NMPA and achieved its first commercial prescription in April 2025. It is
currently the only approved product in China with a dual mechanism of methylation and gene mutation
for early detection of urothelial carcinoma. Additionally, it is the only product recommended in
authoritative guidelines such as CSCO Urothelial Carcinoma Diagnosis and Treatment Guidelines (2025
Edition) 《(CSCO尿路上皮癌診療指南(2025版)》), the Expert Consensus on Early Detection and
Treatment of Bladder Cancer (2024 Edition) (《膀 胱 癌 早 診 早 治 專 家 共 識( 2024版)》), and the
Technical Expert Consensus of the China Cancer Screening Center 《
( 中國癌症篩查中心技術專家共
®
識》). UI-SEEK achieves precise, non-invasive early diagnosis of urothelial carcinoma patients with ‘a
single urine sample’.
—9—
Innovative R&D pipeline
The products of the nuclear medicine anti-tumor diagnosis and treatment segment are mainly divided
into two categories: interventional therapy and RDC.
Interventional therapy:
GPN00289, a global innovative temperature sensitive embolic agent:
GPN00289 is an NMPA innovative medical device approved temperature sensitive embolic material for
the treatment of vascular–rich benign and malignant tumors. At room temperature, the gel has good
flowability and is delivered to the vasculature of the diseased tissue through a microcatheter. The gel is
then solidified in situ at body temperature from the peripheral vessels to the main donor vessel to
achieve embolization of the diseased tissue. It is suitable for the embolization of various vascular-rich
solid organ tumors, especially benign and moderate malignant tumors in the liver. The product
completed the enrollment of all patients in the registration clinical study in October 2025. Currently,
clinical study and regulatory submissions for this product are is progressing smoothly.
KonaTM, a global innovative liquid embolic agent
The product, for the treatment of preoperative embolization of cerebral arteriovenous malformations, is
developed with a transient radiopacity that diminishes over time, which can present clear post-operative
organ visualization. In addition, with its drug loading potential, KonaTM can load other chemical or
radiopharmaceuticals to develop new drug-device combination products, so as to provide more
diversified treatment options for the treatment of other tumors or vascular diseases. Currently, an
application for Premarket Approval (PMA) has been submitted to the FDA for KonaTM.
AuroLase®, a global innovative solid tumor ablation therapy
AuroLase® is a global innovative therapeutic technology for prostate cancer tissue ablation that uses a
new type of optically tunable nanoparticle, delivered intravenously and enriched in the tumor, to
selectively absorb laser energy and convert light into heat, thereby precisely destroying the tumor and
the blood vessels supplying it without severely damaging the surrounding healthy tissue. AuroLase®
therapy can maximize treatment outcomes while minimizing the side effects associated with surgery,
radiation and alternative focal therapies compared to surgery, radiation or traditional alternative focal
therapies. Currently, an application for PMA has been submitted to the FDA for the product.
RDC drugs:
There are currently 8 product candidates under research, and a number of products have made important
progress during the period.
— 10 —
TLX591/TLX591CDx, global innovative products for prostate cancer diagnosis and treatment:
TLX591 is a therapeutic RDC drug targeting prostate-specific membrane antigen (PSMA), and its early
overseas clinical studies have shown positive treatment outcomes, with a median imaging progressionfree survival (rPFS) of 8.8 months and a good safety profile. The product has undergone international
multi-center Phase III clinical trials overseas, and in April 2025, an application to join the international
multi-center Phase III clinical trials was submitted to the NMPA. The application was formally approved
by the NMPA in July of the same year. TLX591-CDx is diagnostic RDC drugs targeting PSMA, which
could form an integrated radiotherapy portfolio with TLX591 for prostate cancer. TLX591-CDx was
approved for commercialization in Australia in November 2021 and in the United States in December of
the same year.In March 2023, it was approved in the United States for an expanded indication for
screening prostate cancer patients eligible for PSMA-targeted radiopharmaceutical therapy. In 2025, the
TLX591-CDx was approved for commercialization in more than 20 countries, including those in Europe
and the Americas. The phase III study in China of TLX591-CDx has successfully achieved the clinical
endpoint in December 2025. According to top-line clinical results, the overall positive predictive value
(“PPV”) was 94.8% for detection of tumors with TLX591-CDx (confidence intervals, CI: 85.9%98.2%). The PPV was 100.0% in the prostate bed and in extra-pelvic soft tissue, lymph nodes, and organ
metastases (non-bone); 94.7% in the pelvic region outside of the prostate bed, including lymph nodes;
and 87.0% in bone metastases. At the same time, patients with suspected biochemical recurrence (BCR)
were assigned to groups according to their baseline prostate specific antigen (“PSA”) level in this trial.
TLX591-CDx PET imaging demonstrated high PPV in all patient groups, including at very low PSA
levels, in the subgroup of participants with extremely low PSA levels, the PPV remained above 90%.
This suggests that PET imaging detection of TLX591-CDx has very positive clinical significance for the
early diagnosis of prostate cancer patients with suspected biochemical recurrence. In addition, more than
two-thirds (67.2%) of patients experienced a change in their treatment plan following TLX591-CDx
PET/CT or PET/MRI compared with the initial plan at baseline. This indicates that PET imaging with
TLX591-CDx had a meaningful impact on clinical decision-making, potentially leading to improved
treatment strategies for participants with BCR. At present, the marketing application for TLX591-CDx
has been officially accepted by the NMPA.
TLX250/TLX250CDx, global innovative products for the treatment of clear cell renal cell carcinoma:
TLX250 and TLX250-CDx form an integrated radiotherapy portfolio for clear cell renal cell carcinoma
(ccRCC). TLX250-CDx was granted a breakthrough therapy by the FDA in July 2020, and the overseas
phase III clinical study successfully met clinical endpoints in November 2022. According to the study
results, for the patients with renal masses suggested by computerized tomography (CT) or magnetic
resonance imaging (MRI) but unable to determine whether it is ccRCC, the sensitivity and specificity of
positron emission tomography (PET) imaging with TLX250-CDx in the diagnosis of ccRCC reached
86% and 87% respectively, which far exceeded the preset threshold required by the FDA (both
sensitivity and specificity higher than or equal to 70%). Its positive predictive value has reached 93%.
For early ccRCC in stage T1a, which is currently difficult to diagnose (the tumor is confined to the
kidney with the largest tumor diameter smaller than or equal to 4 cm), the sensitivity and specificity of
TLX250-CDx diagnosis reached 85% and 89% respectively. These breakthrough clinical results
demonstrate that TLX250-CDx is expected to rovide a highly accurate and non-invasive diagnostic
— 11 —
solution for ccRCC, and has the potential to become a new clinical diagnostic standard for ccRCC.
Moreover, clinical studies of TLX250-CDx on a number of extended indications such as CAIX-positive
solid cancer, bladder and Urothelial carcinoma are progressing worldwide. In terms of registration in
China, the product completed the first patient enrollment and dosing in Phase III clinical trials in
November 2024. TLX250 is undergoing phase II clinical study overseas.
ITM-11, a global innovative product for the treatment of gastroenteropancreatic neuroendocrine tumors
(“GEP-NETs”):
ITM-11 is an RDC product that uses radionuclide-drug conjugate technology to target and destroy GEPNETs. This product consists of carrier-free 177Lu conjugated to a somatostatin analog, which kills
tumor cells by binding to the somatostatin receptor (SSTR) highly expressed on the surface of GEPNETs. This product has received an orphan drug status from FDA and European Medicines Agency
(“EMA”), and its Phase III clinical study (COMPETE) overseas has reached its primary clinical
endpoint in January 2025, and its NDA in the United States was formally accepted by the FDA in
December 2025. For the registration in China, the product was approved by the Chinese NMPA in April
2023 for use in the treatment of unresectable, progressive, SSTR+ GEP-NETs. In March 2024, it was
approved by the NMPA to join an international multi-center Phase III clinical study (COMPOSE
International Multi-center Study) targeting high-grade invasive Grade 2 and Grade 3, SSTR+ GEPNETs, and the first patient was enrolled and dosed in March 2025; Additionally, the product received
approval from the Chinese NMPA in December 2024 to initiate a Phase III bridging clinical trial for the
treatment of well-differentiated Grade 1 or 2, SSTR+ GEP-NETs. The product is expected to achieve
comprehensive coverage of all stages of GEP-NET disease progression.
TLX101, a global innovative product for glioblastoma treatment:
TLX101 is a RDC drug for the treatment of glioblastoma multiforme. It can pass through the bloodbrain barrier entering the brain freely, and targets the overexpressed L-type amino acid transporter 1
(LAT–1) in glioblastoma to precisely irradiate cancer cells, and promote their apoptosis to achieve
therapeutic effect. The product has been granted orphan drug designation by the FDA. Preliminary
results from an earlier overseas Phase II clinical trial of TLX101 (the IPAX-Linz study) have confirmed
patient benefits. These results indicate that TLX101 was well tolerated, with no serious adverse events
observed, and that the median overall survival (OS) for patients treated with TLX101 was approximately
11.9 months (approximately 32.2 months from initial diagnosis). In contrast, the median survival for
patients with recurrent glioblastoma receiving external beam radiation therapy (EBRT) alone was only
9.9 months. In May 2026, the Phase I clinical trial of TLX101 (the IPAX-2 study), conducted in
Australia, Austria, and the Netherlands, completed patient enrollment and dosing. In addition, TLX101
is currently being evaluated in another pivotal clinical trial (IPAX BrIGHT) to compare the safety and
efficacy of TLX101 in combination with chemotherapy versus chemotherapy alone (lomustine) in
patients with recurrent glioblastoma (last-line treatment). IPAX BrIGHT is actively enrolling patients
and administering treatment in Australia and the Netherlands; the trial has also been approved in Austria
and Belgium, where patient enrollment is set to begin shortly. This marks TLX101 as the first
radiopharmaceutical therapy to enter Phase 3 development for glioblastoma. Currently, this product has
been approved for clinical trials in China.
— 12 —
GPN01530-2, a global innovative solid tumors diagnostic product
GPN01530-2 is a small molecule RDC drug that targets fibroblast activating protein (“FAP”). FAP is
one of the important markers of cancer-associated fibroblasts (“CAFs”), participating in processes such
as extracellular matrix remodeling, regulation of tumor cell proliferation, and tumor immunosuppression,
thus promoting tumor growth and invasion. It is a novel and specific target for tumor diagnosis and
treatment. Studies have shown that FAP is not expressed or is expressed at low levels in normal tissues,
but is highly expressed in 90% of epithelial tumor tissues and CAFs in various tumor
microenvironments. GPN01530-2 optimizes the structure of the FAP ligand, improving its uptake in
tumor tissues, while reducing its uptake in normal tissues. Preclinical studies have shown that this
product, compared to other FAP-targeted ligands, exhibits rapid tumor targeting, higher tumor uptake,
and superior pharmacokinetic properties. Furthermore, ongoing IIT human studies have demonstrated a
favorable safety profile for GPN01530-2, rapid background clearance, strong and sustained lesion
uptake, and superior clinical image contrast and accurate detection rate of positive lesions compared to
18F-FDG. Based on these preclinical and clinical results, this product significantly improves the
diagnostic efficacy of FAP-targeted RDC drugs, and provide a brand-new tumor diagnosis solution for a
large number of solid tumor patients. At present, the product has been approved by the FDA in
December 2025 to conduct a Phase I/II clinical study for the diagnosis of solid tumors, and was granted
FTD by the FDA in August 2026..
GPN02006, a global innovative hepatocellular carcinoma diagnostic product
GPN02006 is a globally innovative diagnostic radiopharmaceutical based on radiopharmaceuticalantibody conjugation technology, targeting phosphoinositide glycoprotein 3 (“GPC-3”). It exhibits high
specificity and affinity for the GPC-3 target, with good safety profiles, making it suitable for precise
diagnosis of hepatocellular carcinoma (HCC). Currently, drug development targeting the GPC-3 target is
still in the early stages of research and development globally, with no drugs targeting this target yet
available on the market. The investigator-initiated clinical study (IIT clinical study) of GPN02006
conducted in China achieved breakthrough progress in April 2025, and the clinical results were
presented at the Chengdu 2025 Future XDC New Drug Conference and the North American Society of
Nuclear Medicine and Molecular Imaging Annual Meeting. The clinical study data demonstrated that
GPN02006 exhibits excellent safety and imaging efficacy: No drug-related adverse reactions were
reported in any of the participants after administration, demonstrating excellent safety and tolerability;
high-quality imaging can be achieved within 30 minutes after administration, fully meeting the clinical
demand for rapid diagnosis of hepatocellular carcinoma. The drug has three significant advantages in
terms of imaging quality: 1) extremely low background signal; 2) high specificity of uptake in HCC
lesions; and 3) superior diagnostic contrast. Based on its unique molecular targeting mechanism, the
drug can achieve: 1) early precise localization of HCC lesions; 2) dynamic assessment of treatment
— 13 —
response; and 3) Early warning of recurrence and metastasis, providing robust molecular imaging
evidence for clinicians to develop personalized treatment plans; Compared to current HCC diagnostic
protocols, GPN02006 demonstrates superior diagnostic efficacy in detecting early-stage, small HCC
lesions. This product has the potential to improve the current clinical challenges of low early diagnosis
rates and difficulties in monitoring recurrence and metastasis in HCC patients. Currently, the clinical
registration development of this product is being actively advanced.
Cerebro-cardiovascular Precision Interventional Diagnosis and Treatment Segment
The Group adheres to the treatment concept of “precision treatment” and conducts comprehensive layout
in multiple directions, namely channel management, chronic disease management, structural heart
disease and heart failure, to build a high-end medical device product cluster. At present, the segment has
reserved over 30 products, of which 23 products in channel management have been approved for
commercialization in China. 1 product in the chronic disease management category has been approved
for commercialization in China, and 3 products in the field of structural heart disease has been approved
for commercialization in China. Additionally, clinical registration efforts in China are actively underway
for other innovative products currently in development. Furthermore, in July 2026, the Group formally
entered into a comprehensive commercialization strategic partnership with Siemens Healthineers System
Co., Ltd. (“Siemens Healthineers”), under which Grand Pharma is responsible for the exclusive
commercialization and promotion in China of Siemens Healthineers’ AcuNav LumosTM 4D ICE real-time
3D intracardiac echocardiography catheter, a product that has already been approved for marketing by
the NMPA; the transcatheter mitral valve clip system NeoBlazar®, developed in collaboration between
the Group and Jiangsu Zhenyi Medical Technology Co., Ltd., received marketing approval from the
NMPA in July 2026. The Group will continue to expand its innovative product pipeline to drive steady
growth in this business segment.
The Group has completed the comprehensive construction of the “active + passive” innovative device
platform in this segment. Among them, the Active Equipment R&D and Production Base in Optics
Valley, Wuhan and the Passive Equipment R&D and Production Base in Changzhou have been put into
use. At present, the Group has carried out technology cooperation with clinical centers or R&D
platforms in the Unites States, Canada, Germany, Italy and Switzerland, and gradually started a new
process of globalized R&D. The Group is committed to developing this segment into a leading “cerebrocardiovascular precision interventional therapy platform” in China and worldwide.
— 14 —
Core Products
RESTORE DEB®, a coronary drug-coating balloon:
RESTORE DEB® is the first drug-coating balloon with the dual indications of original coronary artery
disease mutation and stent restenosis in China. Its clinical research results were published in the
important journal JACC (Journal of the American College of Cardiology) Cardiovascular Interventions
in the field of cardiovascular disease. The unique SAFEPAX patented technology ensures a uniform and
stable drug coating with a low shedding rate. Since its launch, it has been recognized by a large number
of clinicians and patients and has a good market reputation, and its clinical status was also affirmed in
the guidelines and expert consensus such as the “Expert Consensus on the Clinical Application of Drugcoated Balloons Guided by Intravascular Imaging (2026 Edition)(冠狀動脈腔內影像學指導藥物塗層
球囊臨床應用專家共識(2026版))”, and the “Guidelines for Treatment of Percutaneous Coronary
Intervention (2025 Edition)”(中國經皮冠狀動脈介入治療指南(2025版)).
APERTO® OTW, a drug coated balloon for dialysis access:
APERTO® OTW is the first drug-coating balloon for the indication of arteriovenous fistula stenosis in
dialysis patients. This product has the dual characteristics of high pressure resistance and drug coating.
Compared with ordinary high pressure balloon, APERTO® OTW has a significant advantage in the
passing rate of target lesions for six months after surgery, which will greatly contribute to the extension
of the life time of fistula and the improvement of the quality of life of dialysis patients. Its clinical
research results are published in “American Journal of Kidney Diseases”, an important journal in the
field of kidney disease treatment.
Lu Ci®, the first domestically produced adjustable intracranial thrombectomy stent product:
Lu Ci ® features a circular wire braided structure design, allowing manual adjustment to the ideal
diameter outside the body to match the target vessel. During stent implantation, the entire process is
visible and radiopaque, enabling surgeons to better adjust the stent based on the location and total length
of the thrombus to better adapt to the occluded vessel, thereby achieving a higher vascular recanalization
rate. The adjustable characteristics of Lu Ci® enhance the stent’s ability to engage with the thrombus,
improving surgical efficacy, while also reducing vascular damage and enhancing surgical safety.
Additionally, Lu Ci ® is fully radiopaque, facilitating precise manipulation by physicians. The
commercialization of Lu Ci® provides a new option for thrombus removal therapy in acute ischemic
stroke.
— 15 —
Multi-polar renal artery radiofrequency ablation system Platinum Wisdom IberisTM
Utilizing advanced renal nerve ablation technology, the system delivers the ablation catheter precisely to
the renal artery via minimally invasive intervention. Radiofrequency energy is then used to ablate the
renal sympathetic nerves, effectively blocking the transmission of overly excited renal sympathetic nerve
signals, thereby achieving stable blood pressure regulation. IberisTM has demonstrated excellent clinical
efficacy in the treatment of patients with uncontrolled primary hypertension. and related research
findings have been published in full in the top-tier international cardiovascular academic journal
Circulation (Impact Factor: 35.5), receiving high recognition from the international academic
community. It is currently the only renal artery denervation ablation (RDN) product globally that has
obtained EU CE certification and features a dual-access design via the radial and femoral arteries.
AcuNav LumosTM 4D ICE Catheter: Real-Time 3D Intracardiac Echocardiography Catheter
The AcuNav LumosTM 4D ICE Catheter represents a significant leap forward in imaging capabilities,
advancing from 2D and 3D to real-time 3D imaging. It is suitable for a wide range of complex
interventional procedures for structural heart disease, including mitral valve repair, left atrial appendage
closure, and congenital heart defect closure. This product features technical enhancements in imaging
capabilities, intraoperative guidance, and procedural adaptability: equipped with an improved multiplane reconstruction and dual-plane imaging function, it outputs real-time 4D volumetric imaging with
clear and smooth dynamic visuals, providing surgeons with high-resolution visual references for
intraoperative anatomical assessment and device guidance; The catheter can penetrate deep into the
cardiac chambers, minimizing obstruction by tissue structures, and is suitable for use throughout
complex procedures such as transcatheter edge-to-edge repair (TEER). Additionally, the catheter
features 180º bending capability in four directions, offering flexible maneuverability to facilitate
exploration of different regions within the heart. During TEER procedures, the AcuNav LumosTM 4D
ICE Catheter supports the entire process, from preoperative assessment to intraoperative instrument
manipulation and postoperative outcome verification. During the valve assessment phase, it clearly
visualizes valve morphology, the degree of regurgitation, and leaflet prolapse, assisting the surgeon in
developing a tailored surgical plan; during surgery, it provides real-time tracking of the position and
orientation of instruments such as clamps, assisting the surgeon in performing critical procedures such
as valve leaflet grasping and clamp release; during the postoperative assessment phase, it rapidly detects
residual regurgitation, allowing for timely evaluation of surgical outcomes and helping physicians
optimize clinical decisions.
— 16 —
Domestic Transcatheter Mitral Valve Clip System NeoNova®
This product enables edge-to-edge mitral valve repair for patients with mitral regurgitation via an
interventional approach, improving cardiac function, reducing surgical trauma, and shortening recovery
time. The product is easy to operate and has good safety. It uses an elastic self-locking mechanism that
allows the clamp arms to automatically adapt to the valve strength and lock automatically, ensuring
stable clamping while maximizing the avoidance of the risk of valve tears during and after surgery; The
‘I-shaped’ clamp design allows flexible adaptation to complex scenarios such as chordal entanglement
and transvalvular crossing at the commissure; it offers stable bending control with a smaller radius,
reducing the surgical space required within the atrium and providing greater operational flexibility. This
product could offer a new treatment option for patients with mitral regurgitation.
NeoBlazar® Domestic Transcatheter Tricuspid Valve Clip System
It is China’s first domestically produced transcatheter tricuspid valve clip system. It performs edge-toedge tricuspid valve repair via an interventional approach for patients with tricuspid regurgitation,
improving cardiac function and enhancing patients’ quality of life. The product features several core
design advantages. Its unique “I-shaped” design is structurally minimalist and easy to operate,
effectively mitigating the risk of chordal entanglement during surgery. It supports rapid device release
and allows for multiple precise adjustments, retrieval, and repositioning during the procedure, enabling
physicians to confidently handle various complex intraoperative situations. This significantly lowers the
procedural barrier, shortens the physician’s learning curve, and markedly enhances procedural
controllability and safety; The innovative elastic self-locking mechanism delivers a stable and sustained
clamping force on the valve leaflets while effectively cushioning intraoperative and postoperative
stresses. This maximizes protection of the patient’s fragile valve leaflets and myocardial tissue, prevents
secondary damage, and ensures long-term surgical efficacy. This product offers a new treatment option
for patients with tricuspid regurgitation.
First Domestically Produced Braided Intracranial Aneurysm Co-embolization Stent Blue WhaleTM
Suitable for intracranial aneurysms patients aged 18 and older. This device consists of a delivery system,
and a nickel-titanium braided self-expanding stent. With its innovative structural and performance
design, it overcomes the limitations of existing products, better adapts to complex anatomical structures,
and meets diverse clinical needs. Utilizing a 16-strand nickel-titanium monofilament braiding process, it
balances robust radial support with excellent flexibility and conformability. The V-shaped occlusion
design at both the proximal and distal ends ensures secure anchoring within the vessel and prevents
displacement; Leveraging unique winding and radiopaque technology, four radiopaque wires are
uniformly wound around the stent. Four radiopaque markers at the proximal end, combined with
V-shaped reinforcement at the distal end, ensure clear tracking throughout the procedure, providing the
operator with precise visualization. In terms of manipulation and delivery, the stent offers excellent
controllability and can be retrieved even after 80% deployment, enabling precise implantation. Stents
— 17 —
with a diameter of 3 mm or less can be delivered and deployed via a 17-gauge microcatheter,
significantly enhancing maneuverability and delivery performance; Compared to laser-cut stents, its
metal coverage has been increased to 18%, enabling moderate blood flow diversion. The angiographic
aneurysm occlusion rate exceeds 95%, optimizing treatment outcomes. This product is expected to offer
a new treatment option for patients with intracranial aneurysms.
Innovative and R&D pipeline
aXess, a global innovative endogenous tissue repair product:
aXess is a global innovative endogenous tissue repair product for end-stage renal disease (ESRD)
patients with arteriovenous graft (AVGs) for hemodialysis treatment. The product is expected to provide
safer and more effective blood access for dialysis patients by providing a basic structural framework for
autologous tissue repair of patients, accelerating the establishment of dialysis access, and reducing the
incidence of thrombosis and related complications. aXess can further synergize with APERTO® OTW in
the field of hemodialysis. The product received Breakthrough Device designation from the FDA in
November 2024, and enrolled its first patient in a pivotal clinical trial approved for conduct in the
United States that same month, while the pivotal clinical trial conducted in Europe successfully met its
clinical endpoints in October 2025. Specific results show that, compared to standard therapy, aXess
achieved significant improvements across all key clinical metrics. Compared to other arteriovenous
grafts, aXess demonstrated superior patency rates for both primary and secondary endpoints, with fewer
interventions. Compared to autologous arteriovenous fistulas (AVFs), aXess had a lower reintervention
rate and exhibited high resistance to infection; Regarding safety, among all 120 patients, only one case
of (partial) graft removal related to puncture site infection occurred, indicating that aXess possesses
extremely high resistance to infection; aXess enables near-immediate puncture, with a bleeding
complication rate of less than 0.02% across more than 15,000 dialysis treatments. These data
demonstrate that aXess possesses excellent safety and efficacy profiles, outperforming current standard
therapies in all aspects. This product received CE certification in April 2026. Regarding registration in
China, the product is currently in the preclinical development stage.
Saturn, a global innovative mitral valve replacement system:
Saturn is a global innovative medical device for mitral valve replacement. The product is implanted in
an interventional manner via a room septum to minimize surgical trauma and shorten post-operative
recovery time, and innovatively combines annular reconstruction technology with valve replacement
technology to enhance device adaptability and suitability for all common mitral valve structures. The
product underwent a clinical study using the transcatheter approach in Europe in 2020 and completed
patient enrollment in 2022. The five-year follow-up has now been completed, and the results are in line
with expectations. In May 2024, the first patient enrollment for clinical study using the femoral vein
approach was completed in Europe. The follow-up results are in line with expectations, and the
product’s safety and efficacy have been preliminarily validated. Meanwhile, the registration of the
product in China is also under active progress.
— 18 —
CoRISMA, a global innovative ventricular assisted device:
CoRISMA is a fully implanted transcatheter ventricular assisted medical device for the treatment of
class III and end-stage heart failure. By adopting the world’s most advanced energy transmission
technology for wireless power supply, it provides a minimally invasive, safe, power-line infection-free
and complication-free treatment for patients with end-stage heart failure through minimally invasive
surgery. Currently, the Group is working with an innovative medical device company incubated by Yale
University on product development.
PHARMACEUTICAL TECHNOLOGY
With years of experience in the respiratory and critical and severe disease, ENT and cerebrocardiovascular emergency fields, the Group currently has a number of products with high entry barrier
and exclusive products with leading market shares, a strong brand name and a solid market position, and
also reserves a number of innovative products.
Through an innovation model combining global technology cooperation and independent R&D, the
Group has established the International R&D Center in Optics Valley, Wuhan, the Glycomics R&D
Center in Australia and the mRNA R&D Center in Aoluo, Nanjing in the field of pharmaceutical
technology. These R&D centers and technology platforms will continue to work in concert to empower
the Group, providing cutting-edge technological resources and sustained R&D momentum for innovation
in the field of pharmaceutical technology.
Respiratory and Critical and Severe Disease Segment
The Group’s products on sale in the respiratory and critical and severe disease segment covers a wide
range of indications such as rhinitis, bronchitis, pneumonia, asthma and chronic obstructive pulmonary
disease, etc. The core products, Qie Nuo (Eucalyptol, Limonene and Pinene Enteric Soft Capsules),
Compound Nasal Spray Ryaltris ®, Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® are exclusive
products nationwide, which are in the leading position in their respective segments.
The innovative strategic plan in this field focuses on the unmet significant clinical needs, with a number
of products under research, covering sepsis and Acute Respiratory Distress Syndrome (“ARDS”) etc. In
the future, the Group will continue to adopt the R&D concept of independent R&D and global expansion
to create a full-cycle management product cluster for chronic airway diseases and a pipeline of products
for critical and severe diseases, so as to continuously strengthen the Group’s industry position in this
field.
— 19 —
Respiratory products
The main products include Qie Nuo®, Enerzair®, Breezhaler® and Atectura®, Breezhaler®, new compound
nasal spray Ryaltris®, Budesonide Nasal Spray, Fluticasone propionate Nasal Spray etc.
Qie Nuo®:
It is a soluble and phlegm-free drug for viscosity, and is suitable for acute and chronic rhinosinusitis as
well as respiratory diseases such as acute and chronic bronchitis, pneumonia, bronchial dilation,
pulmonary abscess, chronic obstructive pulmonary disease, bacterial infection in the lungs, tuberculosis,
and silica lungs. It can also be used for bronchoscopic angiography to facilitate the discharge of contrast
medium. It is an exclusive product in China independently developed by the Group with two separate
types of drugs for adult and children’s use and was included in both the China’s National
Reimbursement Drug List and China’s National Essential Drug List, and was listed in the Top Brands of
the Health Industry in 2025(二零二五年健康產業品牌榜), Potential Brands in China’s Pharmaceutical
Retail Market 2024(2024年度中國藥品零售市場潛力品牌), top Brands of Family Medicine in China
2022-2023(2022-2023年中國家庭常備藥上榜品牌). Currently, there are dozens of guidelines and
expert consensus recommending the use of viscosity dissolving promotors for clinical use. Among them,
more than 10 guidelines and expert consensus explicitly recommend eucalyptol, limonene and pinene
enteric soft capsules or its active ingredients for clinical treatment, such as Guidelines for the diagnosis,
treatment and management of cough in China (2024 Edition)《中國咳嗽基層診療與管理指南((2024年
版)》), the Expert Consensus on the Diagnosis and Treatment of Adult Bronchiectasis in China (2021
Edition)(《中國成人支氣管擴張症診斷與治療專家共識(2021版)》), Guidelines for the Diagnosis and
Treatment of Secretory Otitis Media in Children (2021 Edition) 《
( 兒童分泌性中耳炎診斷和治療指南
(2021版)》), the Guidelines for Rational Use of Drugs for Chronic COPD in Primary Care (2020
Edition) 《
( 慢性阻塞性肺疾病基層合理用藥指南(2020版)》), Chinese Guidelines for Perioperative
Airway Management in Thoracic Surgery (2020 Edition)(《中國胸外科圍手術期氣道管理指南(2020
版)》), Expert Consensus on Classification and Diagnosis of Rhinitis and Nasal Medication Regimen
(《鼻 炎 分 類 和 診 斷 及 鼻 腔 用 藥 方 案 的 專 家 共 識》)and Expert Consensus on Childhood Recurrent
Respiratory Infections(《兒童反復呼吸道感染專家共識》), etc. Its clinical status is prominent, and the
level of recognition among doctors and patients is high, continuing to lead the market of oral cough
relieving and phlegm relieving drugs.
— 20 —
Enerzair® Breezhaler® (indacaterol acetate, glycopyrronium bromide and mometasone furoate powder for
inhalation II) and Atectura ® Breezhaler ® (indacaterol acetate and mometasone furoate powder for
inhalation II, III):
Enerzair ® Breezhaler ® is the first triple combination inhalation preparation for asthma indications
approved in China for the maintenance treatment of asthma in adults not adequately controlled with the
maintenance combination treatment of long-acting beta2 adrenergic agonist (LABA) and inhaled
corticosteroid (ICS). The product has clear efficacy, is convenient to use, and has achieved
breakthroughs in three aspects: (1) using an optimized drug combination of ICS, LABA and long-acting
muscarinic receptor antagonist (LAMA) (i.e. mometasone furoate/indacaterol acetate/glycopyrronium
bromide), the three effective ingredients can provide synergy benefit, and compared with the
conventional high dose ICS-LABA and high dose ICS-LABA combined with LAMA opened triple
combination, Enerzair® Breezhaler® can effectively improve the clinical symptoms and lung function of
patients with moderate to severe asthma, and significantly reduce the risk of acute attacks; (2) dosing
once a day, which significantly facilitates the patient and is expected to improve the compliance; (3)
using the advanced Breezhaler® inhalation device, which is easy to operate, and provides patients with
triple confirmation of dosing as audible, tasteable, and visible, enhancing patients’ confidence that the
complete dose has been taken. The ARGON phase III clinical study of the product shows that, compared
with high dose Salmeterol-Fluticasone powder for inhalation combined with Tiotropium Bromide Spray
opened triple combination, Enerzair® Breezhaler® significantly reduce the annualized rate of moderate
exacerbations (based on 24 weeks data) by 43%. Atectura® Breezhaler® is an innovative combination of
ICS mometasone furoate and LABA indacaterol acetate for the maintenance treatment of adult and
12years old above adolescent patients with asthma. Atectura® Breezhaler® also has the characteristics
including “visible and controllable, precise inhalation, once a day” etc. It can significantly improve the
lung function of patients and reduce the risk of acute attacks, and is a new choice for optimal treatment
of asthma patients. The phase III clinical study of the product shows that, compared with the
conventional high dose Salmeterol-Fluticasone powder for inhalation, Atectura ® Breezhaler ® can
significantly improve the risk of acute attack in patients, and the risk of severe, moderately severe and
all acute attack categories is reduced by approximately 26%, 22% and 19% respectively. Both products
have been included in the Chinese Expert Consensus on the Standardized Application of Inhalation
Devices for Stable Chronic Airway Diseases (2023 Edition) 《
( 穩定期慢性氣道疾病吸入裝置規範應
用中國專家共識(2023版)》), Chinese Expert Consensus on the Diagnosis and Management of Severe
Asthma (2024 Edition) (《重 度 哮 喘 診 斷 與 處 理 中 國 專 家 共 識( 2024版)》), Guidelines for the
Prevention and Treatment of Bronchial Asthma (2024 Edition) 《
( 支氣管哮喘防治指南(2024年版)》),
the Global Strategy for Asthma Management and Prevention (2025 Edition) 《
( 全球哮喘管理和預防策
略( 2025版)》) and other authoritative clinical guidelines and expert consensus documents both
domestically and internationally. Additionally, both products have been officially included in the
Category B drug management scope of China’s National Basic Medical Insurance, Work Injury
Insurance, and Maternity Insurance Drug Directory 《
( 國家基本醫療保險、工傷保險和生育保險藥品
目錄》), providing new treatment options for individuals undergoing long-term asthma therapy.
— 21 —
New Compound Nasal Spray Ryaltris®:
Ryaltris® is a novel antihistamine and corticosteroid combination nasal spray for the treatment of
moderate to severe seasonal AR in adult and pediatric patients 6 years of age and older, and moderate to
severe perennial AR in adult and pediatric patients 12 years of age and older. Authoritative clinical
guidelines and expert consensus documents both domestically and internationally, such as Chinese
Guideline for Diagnosis and Treatment of Allergic Rhinitis (2022 Edition) 《
( 中國變性鼻炎診斷與治療
指引(2022版)》), Clinical Consensus on Classification and Diagnosis of Rhinitis and Nasal Medication
Regimen (2019 Edition) 《
( 鼻炎分類及診斷及鼻腔用藥方案(2019版)》), ARIA Clinical Pathway for
Allergen Immunotherapy (2019 Edition),《(ARIA變應原免疫治療的醫療路徑(2019版)》), recommend
intranasal antihistamines and intranasal corticosteroids as the first-line treatments for allergic rhinitis.
As a combination formulation, Ryaltris offers patients a more convenient and effective treatment option,
improves patient adherence, and provides a new therapeutic option for AR patients in China. The
product received FDA approval in January 2022 and was approved by the NMPA in November 2025.
Budesonide Nasal Spray:
It is a nasal corticosteroid medication with potent local anti-inflammatory and anti-allergic effects,
which can directly act on the nasal mucosa to relieve rhinitis symptoms. It is used for the treatment of
seasonal and perennial allergic rhinitis, perennial non-allergic rhinitis; it can also be used to prevent the
recurrence of nasal polyps after nasal polyp removal and for symptomatic treatment of nasal polyps. As
a first-line medication for allergic rhinitis, it has been included in multiple clinical guidelines and expert
consensus documents such as the product has been included in clinical guidelines such as Guidelines for
the Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2024 Edition) 《
( 中國慢性
鼻竇炎診斷與治療指南(2024版)》), Chinese Guidelines for the Diagnosis and Treatment of Allergic
Rhinitis (2022 Revised Edition) 《
( 中國變應性鼻炎診斷和治療指南(2022年,修訂版)》), Chinese
Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition)
《
( 兒童變應性鼻炎診斷和治療指南(2022年,修訂版)》), the Expert Consensus on the Treatment of
Allergic Rhinitis with Nasal Corticosteroids 《
( 鼻用糖皮質激素治療變應性鼻炎專家共識》), and the
Expert Consensus on the Classification, Diagnosis, and Nasal Medication Regimens for Rhinitis 《
( 鼻炎
分類和診斷及鼻腔用藥方案的專家共識》). This product is the first generic in China and is expected
to alter the competitive landscape in the market for products with the same generic name, which has
been dominated by foreign companies.
Fluticasone propionate Nasal Spray:
It is a nasal corticosteroid medication with potent local anti-inflammatory and anti-allergic effects, it
directly acts on the nasal mucosa to alleviate nasal inflammation symptoms. It is indicated for the
prevention and treatment of seasonal allergic rhinitis (including hay fever) and perennial allergic
rhinitis. It is a first-line treatment for allergic rhinitis and is included in the Chinese Guidelines for the
Diagnosis and Treatment of Chronic Sinusitis (2024 Edition) 《
( 中國慢性鼻竇炎診斷與治療指南(2024
版)), Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)
《
( 中國變應性鼻炎診斷和治療指南(2022年,修訂版)》), Chinese Guidelines for the Diagnosis and
— 22 —
Treatment of Allergic Rhinitis in Children (2022 Revised Edition) 《
( 兒童變應性鼻炎診斷和治療指南(
2022年,修 訂 版)), the Expert Consensus on the Treatment of Allergic Rhinitis with Nasal
Corticosteroids (《鼻用糖皮質激素治療變應性鼻炎專家共識》), and the Expert Consensus on the
Classification, Diagnosis, and Nasal Medication Regimens for Rhinitis 《
( 鼻炎分類和診斷及鼻腔用藥
方案的專家共識》). This product is the first generic in China and is expected to alter the competitive
landscape in the market for products with the same generic name, which has been dominated by foreign
companies.
Innovative R&D pipeline
Based on unmet clinical needs, the Group has reserved a number of global innovative drugs for the
indications of sepsis, ARDS, etc.
STC3141, a global innovative drug for the treatment of severe diseases:
STC3141 is a small molecule compound with a novel mechanism of action independently developed by
the Group, which can be used to reverse organ damage caused by excessive immune responses by
neutralizing extracellular free histones and neutrophil traps and is applicable to multiple severe disease
indications. STC3141 is the world’s first sepsis treatment solution centered on rebuilding immune
homeostasis, representing a major upgrade in treatment dimensions. Building on existing symptomatic
supportive treatments such as anti-infection, fluid resuscitation and organ function maintenance, it
precisely regulates the core cause of the disease, which is immune dysregulation, to help the body
restore balance. This is expected to fill the current clinical gap in sepsis treatment targeting the
underlying cause. The product has a novel mechanism, and the results of related preclinical research
have been published in “Nature Communications” and “Critical Care”, both top academic journals with
far-reaching academic influence, in February 2020 and November 2023, respectively. At present, the
product has been granted 7 clinical approvals in four indications of sepsis, ARDS, severe COVID-19
infection (“COVID-19”), and ARDS caused by COVID-19 in five countries around three continents
including China, Australia, Belgium, United Kingdom and Poland. Four patient-specific clinical studies
were completed and have successfully met the clinical endpoints. Previous Phase Ib clinical studies
conducted in Australia and Belgium for the treatment of sepsis, a Phase Ib clinical study conducted in
China targeting acute respiratory distress syndrome (ARDS), and a Phase IIa clinical study conducted in
Europe for the treatment of severe COVID-19 infection have all demonstrated that STC3141 exhibits
good safety and tolerability. Additionally, it has shown positive signals in helping patients wean off
ventilators, discontinuing vasopressors, and shortening ICU hospitalization duration. The Phase II
clinical study targeting sepsis conducted in China successfully achieved its primary clinical endpoint in
May 2025. Clinical results showed that the SOFA scores of the drug treatment group on day 7 were
significantly lower than baseline, particularly in the high-dose group, with a reduction significantly
greater than that of the placebo group, and the difference was statistically significant and clinically
meaningful; the trends for secondary endpoints were consistent with the primary endpoint and met
expectations. Additionally, STC3141 demonstrated good safety and tolerability, with pharmacokinetic
characteristics also in line with expectations. These study results confirm the efficacy and safety of
STC3141 in the treatment of sepsis, marking a new breakthrough in critical care medicine. Currently,
the product’s subsequent clinical development and regulatory filing are actively underway.
— 23 —
ENT segment
The ENT segment adheres to a development strategy combining traditional Chinese and Western
medicine with integrated pharmaceutical and medical device therapies, continue to refine our portfolio
of product clusters that promote the coordinated development of traditional Chinese patent medicines,
innovative ophthalmic drugs, and OTC retail products. In the traditional Chinese patent medicine sector,
the Group leverages the core strengths of traditional Chinese medicine in the treatment of chronic
diseases and continues to deepen its expertise. Building upon the consolidation and enhancement of our
otolaryngology product portfolio, we have successfully expanded our business into therapeutic areas
such as cardiovascular and cerebrovascular chronic diseases and neurology through strategic initiatives
involving several TCM products with significant competitive advantages, we have successfully expanded
our business into therapeutic areas such as cardiovascular and cerebrovascular chronic diseases and
neurology. This has enabled a strategic transformation of our TCM business from a single focus on ENT
to a comprehensive approach to chronic disease treatment; In the OTC retail sector, the Group is
actively building China’s leading eye health consumer brand, providing professional, safe, and
convenient eye health solutions; In the field of innovative ophthalmic drugs,through a combination of
collaborative introductions and independent R&D, the Group has developed a portfolio of globally
innovative products for the treatment of “dry eye syndrome”, “demodicosis blepharitis”, “post-surgical
anti-inflammatory” and “analgesic therapy” in ophthalmology, “pterygium”, and “myopia”, establishing
a differentiated competitive advantage. These products are expected to provide patients with more
treatment options and improve their quality of life. At the same time, by continuously strengthening the
development of our clinical evidence-based medicine framework and professional academic promotion
system, we provide clinical experts with comprehensive disease management protocols and detailed
product service solutions. Moving forward, this division will continue to focus on cutting-edge
innovation areas, further enhance its industry influence, and achieve new breakthroughs in its business
domains.
ENT products
The ENT core products of the Group include He Xue Ming Mu tablets, Jinsang Series (Jinsang Kaiyin
Tablet/Capsule/Pill/Granules, Jinsang Qingyin Tablet/Capsule/Pill/Granules, Jinsang Liyan Tablet/
Capsule/Pill/Granules, Jinsang Sanjie Tablet/Capsule/Pill/Granules), Maixuekang (Maixuekang capsules
and Maixuekang enteric-coated tablets), Rui Zhu (polyvinyl alcohol eye drop, sodium hyaluronate eye
drop) and Nuo Tong (Xylometazoline Hydrochloride), Dan Zhen Headache Capsules, Valinic acid
tartrate nasal spray etc.
He Xue Ming Mu tablets:
Which is produced by three classical formulae, namely the Siwutang(四物湯), Erzhiwan(二至丸)and
Shengpuhuangtang(生蒲黃湯), has the functions of cooling blood hemostasis, moisturising dryness and
removing blood stasis, and nourishing liver and eye-brightening, and is mainly used for the treatment of
retinal disease caused by the cloudy liver and the heat-burn winding. Since He Xue Ming Mu tablets
have been the exclusive product in China, the State Protected Chinese Medicine, the National
— 24 —
Reimbursement Drug List and the National Essential Drug List for the last 30 years since its
commercialization, the Group has accumulated a large number of clinical research data and application
experience in the field of retinal hemorrhage, which has been included in a number of guidelines/
consensus such as Guidelines for the Prevention and Treatment of Type 2 Diabetes in Traditional
Chinese Medicine (2024 Edition)《(2型糖尿病中醫防治指南(2024版)), Guidelines for the Diagnosis
and Treatment of Pathological Myopia with Macular Hemorrhage in Traditional Chinese Medicine (2022
Edition) (《病理性近視眼底病變黃斑出血中醫診療指南(2022版)), and the Expert Consensus on
Clinical Application of He Xue Ming Mu Tablets for the Treatment of Wet Age-related Macular
Degeneration (《和 血 明 目 片 治 療 濕 性 年 齡 相 關 性 黃 斑 變 性 臨 床 應 用 專 家 共 識》) and provides
valuable literature support for clinical use of the products.
Jinsang Series Products:
They are exclusive products nationwide, covering all the diseases of the throat, among which, Jinsang
Sanjie Capsule is used for the treatment of chronic hoarseness disease caused by heat and poisoning
storage and airtight blood stasis (vocal nodules, polyp of vocal cords, thickening of mucosa of vocal
cords) and the resulting hoarseness. Jinsang Sanjie Capsule has been widely used in clinical application
for more than 30 years since its commercialization. Jinsang Liyan Capsule is the only Chinese patent
medicine for the treatment of throat diseases caused by intraocular obstruction of liver depression and
phlegm and humidification. It is also an ideal medicine for the treatment of pharyngeal symptoms in
clinical operation, gastroesophageal reflux pharyngitis, and chronic and thick pharyngitis. Jinsang
Kaiyin Capsule is designed for the rapid effect of acute pharyngitis as well as throat redness, swelling,
heat, pain and hoarning caused by acute pharyngitis. This series of product has received widespread
clinical recognition. Guidelines for the Diagnosis and Treatment of Common Diseases in
Otorhinolaryngology of Traditional Chinese Medicine (《中 醫 耳 鼻 咽 喉 科 常 見 病 診 療 指 南》),
Guidelines for the Rational Use of Traditional Chinese Medicines for Promoting Blood Circulation and
Removing Blood Stasis 《
( 活血化瘀類中成藥合理用藥指南》), the Clinical Drug Guidelines 《
( 臨床用
藥指南》) for the diagnosis and treatment of clinicians, he authoritative monographs of the Manual for
Common Traditional Chinese Medicine of Otorhinolaryngology 《
( 常見眼耳鼻咽喉科中成藥手冊》)
and the Practical Otorhinolaryngology Head and Neck Surgery 《
( 實用耳鼻咽喉頭頸外科學》), etc.,
has been included in numerous clinical pathways and expert treatment guidelines. In January 2022 and
August 2024, the Expert Consensus on the Clinical Application of Jinsang Sanjie Capsules for the
Treatment of Vocal Nodules and Polyp of Vocal Cords 《
( 金嗓散結膠囊治療聲帶小結、聲帶息肉臨
床應用專家共識》) and the Expert Consensus on the Clinical Application of Jinshao Kaiyin Capsules
(Pills/Tablets/Granules)(《金 嗓 開 音 膠 囊(丸/片/顆 粒)臨 床 應 用 專 家 共 識》) were issued by the
Chinese Association of Traditional Chinese Medicine, which has also provided new support for the
evidence-based development of Jinsang Sanjie and Jinsang Kaiyin products. Jinsang Sanjie and Jinsang
Kaiyin Capsules are products on the National Reimbursement Drug List. Jinsang Kaiyin and Qingyin are
dual cross-over products with both prescription and over-the-counter drugs.
— 25 —
Duoputai®, Maixuekang capsules and Maixuekang enteric-coated tablets:
It has the effects of anticoagulation, antithrombosis, antifibrosis, and improvement of blood circulation,
and can be used in the treatment of cerebro-cardiovascular diseases such as coronary heart disease, acute
cerebral infarction, ischemic stroke, and unstable angina. It is included in the National Reimbursement
Drug List and the Essential Drug List, and is currently the only Chinese patent medicine that is labeled
with antithrombin activity units in China (each capsule/tablet is equivalent to 14 units of antithrombin
activity). It has been included in many authoritative clinical guidelines, such as the Clinical EvidenceBased Practice Guidelines for Integrated Traditional Chinese and Western Medicine Rehabilitation for
Stroke, Guidelines for Integrated Traditional Chinese and Western Medicine Prevention and Treatment
of Stroke, Guideline for the Diagnosis and Treatment of Cerebral Infarction with the Integrated
Traditional Chinese and Western Medicine, the Clinical Practice Guideline for Chinese Medicine in the
Treatment of Idiopathic Membranous Nephropathy, and the Expert Consensus on the Use of Maixuekang
Capsule (Enteric-coated Tablet) for Patients with Cardiovascular and Cerebrovascular diseases in
Clinical Practice.
Dan Zhen Headache Capsules:
Formulated from classic prescriptions such as Si Wu Tang, Tian Ma Gou Teng Yin, and Tong Qiao Huo
Xue Tang, these capsules have the effects of calming the liver and subduing wind, dispersing blood
stasis and unblocking meridians, and relieving spasms and pain. They are indicated for the treatment of
headaches, back pain, neck stiffness, irritability, and anger caused by liver yang hyperactivity and blood
stasis obstructing the meridians. This product has a clear clinical indication and is supported by robust
evidence-based research. Its therapeutic scope encompasses primary headaches, secondary headaches,
and headache prevention, offering broad clinical application prospects. It is a nationally exclusive
product listed in the National Medical Insurance Directory and the National Essential Medicines List,
and has been included in clinical guidelines and expert consensus such as the Chinese Guidelines for the
Chinese Expert Consensus on the Integrated Traditional Chinese and Western Medicine Diagnosis and
Treatment of Primary Headaches (2026 Edition)(《原發性頭痛中西醫結合診療中國專家共識(2026
版)》) and the Integrated Traditional and Western Medicine Prevention and Treatment of Migraine (2022
Edition) 《
( 中國偏頭痛中西醫結合防治指南(2022年版)》).
Rui Zhu® (polyvinyl alcohol eye drop, sodium hyaluronate eye drop):
It is a single-piece preservative-free artificial tear and currently the first-line drug for the treatment of
dry eye. It is recommended by experts such as the Chinese Expert Consensus on the Clinical Diagnosis
and Treatment of Dry Eye (2024 Edition)(《中 國 乾 眼 臨 床 診 療 專 家 共 識( 2024版)》), the Expert
Consensus on Prevention and Control of Cataract Surgery in China (2021 Edition) 《
( 中國白內障圍手
術 期 乾 眼 防 治 專 家 共 識( 2021年 版)》), the Expert Consensus on Sterily Surgery in China (2020
Edition) 《
( 中國乾眼專家共識(2020年版)》), the Expert Consensus on Refractive Surgery in Laser
Corneal Surgery in China (2019 Edition) 《
( 中國激光角膜屈光手術圍手術期用藥專家共識(2019年
版)》), and the Expert Consensus on Diagnosis and Treatment of Functional Disorder of Bleacne in
China (2017 Edition) 《
( 我國瞼板腺功能障礙診斷與治療專家共識(2017年版)》). Rui Zhu has good
brand recognition and was awarded the China Well-known Trademark in 2017; and was awarded the
CPEO Gold Award for nine consecutive years from 2016 to 2024, namely the “Healthy Industry Brand
List”.
— 26 —
Nuo Tong (xylometazoline hydrochloride nasal spray/nasal drops):
It is a nasal decongestant to relieve nasal congestion, and is suitable for relieving nasal congestion
caused by acute and chronic rhinitis, sinusitis, allergic rhinitis, hypertrophic rhinitis and other nasal
disorders. It does not contain hormones or ephedrine and is suitable for both adults and children. Nuo
Tong is divided into two dosage forms: nasal drops and nasal spray, of which the nasal spray is the
exclusive domestic dosage form and is the leading product among its generic counterparts. The product
has been included in clinical guidelines such as Chinese Expert Consensus on the Diagnosis and
Treatment of Chronic Sinusitis in Children (Hangzhou, 2024) 《
( 兒童慢性鼻竇炎的診斷和治療中國專
家共識(杭州,2024)》), Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China
(Revised Edition 2022) 《
( 中國變應性鼻炎診斷和治療指南(2022年,修訂版)》), Guidelines for the
Diagnosis and Treatment of Allergic Rhinitis in Children (Revised Edition 2022) 《
( 兒童變應性鼻炎診
斷和治療指南(2022年,修訂版)》).
Valinic acid tartrate nasal spray (“OC-01”):
It is a highly selective acetylcholine receptor agonist that activates the trigeminal nerve parasympathetic
pathway to increase natural tear secretion, thereby achieving the therapeutic effect for dry eye syndrome.
According to the results of the Phase III clinical study of OC-01, compared with the control group, OC01 demonstrated statistically and clinically significant improvements in tear secretion in patients with
dry eye syndrome. with a significant increase in natural tear secretion compared to baseline (a higher
proportion of participants showed an increase of 10 millimetres or more in Schirmer scores compared to
baseline), and demonstrated good safety and tolerability. The product was approved for marketing in the
United States in October 2021 and is currently the first and only preservative-free, multi-dose, sterilepackaged nasal spray approved for the treatment of mild, moderate, and severe dry eye syndrome
globally; In terms of registration in China, the product was approved for marketing in the Macau Special
Administrative Region of China in February 2023; In April 2023, it was introduced as an imported
clinically urgent medication in the Hainan Lecheng Medical Pilot Zone; in December 2023, the first
prescription was issued in the Guangdong-Hong Kong-Macao Greater Bay Area at the University of
Hong Kong-Shenzhen Hospital; in November 2024, it was approved for commercialization by the
Chinese NMPA; and in the same month, it was approved for market launch in Taiwan, China; In July
2025, the first commercial prescriptions were issued in mainland China following formal approval.
Currently, the product is included in authoritative clinical guidelines and consensus documents such as
the Guidelines for the Diagnosis and Treatment of Dry Eye Associated with Myopia in Children and
Adolescents (2026 Edition) 《
( 兒童青少年近視相關干眼診療指南(2026版)》), the Chinese Expert
Consensus on the Clinical Diagnosis and Treatment of Dry Eye (2024 Edition) 《
( 中國乾眼臨床診療專
家共識(2024版)》), the 2025 Edition of TFOS DEWS III: Management and Therapy (2025版《TFOS
DEWS III:管理與治療報告》) published by the Tear Film & Ocular Surface Society and the 2023
Edition of the Clinical Practice Guidelines for Dry Eye (2023版《乾眼臨床實踐指南》) published by the
American Academy of Ophthalmology.
— 27 —
TP-03, a globally innovative ophthalmic formulation for the treatment of demodex blepharitis TP-03
(lotilaner ophthalmic solution 0.25%):
Is a non-competitive antagonist selective for gamma-aminobutyric acid-gated chloride channels
(“GABA-Cl”). By selectively inhibiting GABA-Cl in Demodex mites, TP-03 paralyzes and kills the
mites, which are the root cause of Demodex blepharitis. The product is highly lipophilic, which
promotes its absorption into the oils of eyelash follicles where mites reside. Currently the product has
completed two pivotal clinical studies in the United States, both trials met the primary endpoint and all
secondary endpoints, with statistical significance and no serious treatment-related adverse events. and
was approved for commercialization by the United States Food and Drug Administration (“FDA”) in
July 2023. It is the first and only drug approved by the FDA for Demodex blepharitis. It was approved
for marketing by the Macau Medicines and Healthcare Products Regulatory Authority in May 2025 and
approved for marketing by NMPA in March 2026. Currently, this product is included in the 2025
Edition of TFOS DEWS III: Management and Therapy (2025版《TFOS DEWS III:管理與治療報告》)
published by the Tear Film & Ocular Surface Society, the 2025 Edition of the DEPTH Expert Consensus
issued by the Demodex Expert Panel on Treatment and Eyelid Health 《
( DEPTH專家共識》), the 2023
Edition of the Clinical Practice Guidelines for Dry Eye (2023版《乾眼臨床實踐指南》) published by the
American Academy of Ophthalmology, the Chinese Expert Consensus on the Diagnosis and Treatment
of Meibomian Gland Dysfunction (2023 Edition)(《中國瞼板腺功能障礙專家共識:診斷和治療(2023
版)》), among other authoritative domestic and international clinical guidelines and consensus
documents.
Innovative R&D pipeline
The Group reserved three innovative drugs in the direction of clear clinical needs for anti-inflammatory
and pain relief after ophthalmology surgery, pterygium and myopia etc.:
GPN00833, an improved new drug hormone nano-suspension eye drops for anti-inflammatory and pain
relief after ophthalmology surgery:
Its main active ingredient, clobetasol propionate, is a potent glucocorticoid, and has efficient local antiinflammatory and strong capillary contraction effect. Its unique nano-preparation technique effectively
eliminates the low bioavailability and safety risks caused by low water solubility of hormones products.
This product received marketing approval from the US FDA in March 2024. Regarding its registration in
China, the product completed its Phase III clinical study in November 2024 and successfully achieved
clinical endpoints. Compared to the control group, the product demonstrated statistically significant and
clinically meaningful differences in anti-inflammatory and analgesic effects. The product also
demonstrated good safety and tolerability, and its pharmacokinetic profile met expectations. Currently,
the product is in the New Drug Application (NDA) preparation stage.
— 28 —
GPN00153, an improved new drug for the treatment of pterygium (CBT-001):
It is an innovative and improved product, Nintedanib, which is used for the treatment of pulmonary
fibrosis. It inhibits neovascularization and tissue fibrosis. Currently, the phase II clinical trial has been
completed in the United States with high safety and significant clinical efficacy, which can inhibit the
growth of pterygium and control the aggravation of the disease. The global phase III clinical trial for
CBT-001 has conducted in June 2022 and it has been approved to conduct phase III clinical trial in
China by the NMPA in March 2023, and all patients were enrolled in June 2025.
Novel ophthalmic preparation GPN00884 for delaying the progression of myopia in children:
It is an innovative drug with a new mechanism jointly developed by the Group and the Eye Hospital of
Wenzhou Medical University (“WMU”). Compared with low-concentration atropine eye drops,
GPN00884 eye drops have no mydriasis effect, no adverse reactions such as photophobia and decreased
accommodation, and the dosing period is not limited, which can improve patient compliance. The
product has been approved to conduct phase I clinical study in China in March 2024, which was
accepted by the NMPA, completed the Phase I clinical study in March 2025, and completed the
enrollment of the first patient in Phase IIa clinical trial conducted in China in October 2025.
In addition, the Group’s traditional Chinese medicine division has also developed two Class 1 innovative
TCM drugs for use in chronic disease management:
An Innovative Traditional Chinese Medicine for the Treatment of Depression GPN01360:
This is a Class 1.1 innovative TCM for the treatment of depression (liver stagnation and spleen
deficiency syndrome). Based on the ancient classic formula “Xiaoyaosan(逍遙散)”, it was developed
and optimized through modern pharmacological and clinical research. The prescription consists of 12
TCM herbs, including Bupleurum, Turmeric Root Tuber, and Finger Citron, with the effects of soothing
the liver and strengthening the spleen, relieving depression, and calming the mind. This TCM is mainly
used to treat depression of the liver stagnation and spleen deficiency type, of which the typical
symptoms include low mood, slow thinking, decreased willpower, irritability, anxiety, insomnia,
forgetfulness, poor appetite, and fatigue. Preliminary human clinical studies involving nearly 100 people
have shown that GPN01360 demonstrates favorable efficacy and safety in improving depressive
symptoms, relieving anxiety and insomnia, and regulating spleen and stomach function. In December
2025, this TCM reached its clinical endpoint in Phase II clinical trials conducted in China. Research
findings indicate that GPN01360 demonstrates good safety and efficacy in the treatment of depression,
and shows significant improvement in symptoms such as anxiety and insomnia associated with
depression. Currently, the registration process for further studies of this product is proceeding smoothly.
In July 2026, the first patient was enrolled and dosed in the Phase III clinical trial in China.
— 29 —
An Innovative Traditional Chinese Medicine for the Preventive Treatment of Migraines GPN01020:
This is a Class 1.1 innovative TCM drug intended for the prophylactic treatment of migraine
(characterized by blood stasis obstruction). Derived from an in-house formulation developed at a Grade
A Level 3 medical institution, it has been in clinical use for over 30 years. Its primary functions and
indications include promoting blood circulation and removing blood stasis, as well as regulating qi and
tonifying deficiency. It is suitable for vascular-neurogenic headaches, traumatic headaches,
hypertension, and cerebral arteriosclerosis associated with qi deficiency and blood stasis. The product’s
primary historical clinical applications have included primary headaches (such as tension-type headaches
and migraines) and secondary headaches (such as vascular headaches and neurovascular headaches).
Results from preliminary human experience studies involving hundreds of participants indicate that
GPN01020 demonstrates good efficacy and safety in reducing the number of migraine attack days and
attack frequency, as well as in improving migraine-related symptoms. In March 2026, the product was
approved by the NMPA to proceed with Phase II clinical trials.
Cerebro-cardiovascular emergency segment
The Group’s cerebro-cardiovascular emergency segment specializes in both emergency care and chronic
disease management. In terms of emergency care, the Group is listed as a “national essential drug
production base”, an “emergency medicines manufacturer for national ready reserve” and a “national
centralized production base and construction unit for minority-variety medicines (drugs in short
supply)”, etc. with over 30 varieties, 14 of which are included in the national emergency drugs catalogue
of China, while 16 of which are included in the shortage drugs catalogue, which has ranked the top in
the industry in terms of product pipeline. Our products cover three major emergency scenarios, namely
in-hospital emergency care, pre-hospital emergency care and civilian emergency care. Through this, we
continue to provide cerebro-cardiovascular emergency patients in China with a portfolio of safe and
effective products with application in multiple scenarios and various choices. In terms of chronic disease
management, core products such as Nengqilang, Limetone® eplerenone tablets, Herbesser(合貝爽®及合
心爽®)continue to lead the segmented market. Currently, the Group will continue to invest in and
develop products in the fields of cerebro-cardiovascular emergency and chronic disease treatment that
are in urgent clinical need through a combination of independent innovation and research and
development and making breakthroughs in difficult generic technologies.
Cerebro-cardiovascular emergency products
The products mainly cover the fields of blood pressure control, vascular active drugs, myocardial
metabolism, heart failure and anticoagulation. The main products include Li Shu An (norepinephrine
bitartrate injection, epinephrine hydrochloride injection), Herbesser (Diltiazem Hydrochloride Tablets/
Diltiazem Hydrochloride Sustained-Release Capsules, Diltiazem Hydrochloride Injection), Nengqilang
(coenzyme Q10 tablets), Limetone® eplerenone tablets, etc.
— 30 —
Herbesser(合 貝 爽®及 合 心 爽® ), diltiazem hydrochloride tablets/diltiazem hydrochloride extendedrelease capsule, diltiazem hydrochloride injection):
As a classic calcium channel blocker with proven clinical efficacy and high safety, it is available in oral,
sustained-release, and injectable formulations, effectively meeting the clinical needs of patients with
cardiovascular and cerebrovascular diseases such as hypertension and coronary artery disease. It has
been included in numerous authoritative clinical guidelines and domestic and international expert
consensus, including Clinical Management Guidelines for Antihypertensive Drugs in the Perinatal
Period (2025 Edition) (《圍 產 期 降 血 壓 藥 物 臨 床 應 用 管 理 指 引( 2025版)》), Comprehensive
Management Guidelines for Cardiomyopathy in China (2025 Edition) 《
( 中國心肌病變綜合管理指引
(2025版)》), Comprehensive Management Guidelines for Chronic Kidney Disease in the Elderly (2025
Edition) 《
( 老年慢性腎臟病綜合管理指引(2025版)》), Chinese Expert Consensus on the Diagnosis,
Treatment, and Management of Hypertrophic Cardiomyopathy in Children (2025 Edition) 《
( 中國兒童
肥 厚 型 心 肌 病 變 診 斷 治 療 與 管 理 專 家 共 識( 2025版)》), Expert Consensus on Intra-procedural
Coronary Artery Thrombolysis During Percutaneous Coronary Intervention for Acute ST-Elevation
Myocardial Infarction (2025 Edition) 《
( 急性ST段上升型心肌梗塞經皮冠狀動脈介入治療術中冠狀
動 脈 內 溶 栓 專 家 共 識( 2025版)》), British Renal Association Clinical Practice Guidelines: Blood
Pressure Management in Adult, Paediatric, and Adolescent Dialysis Patients (2025 Edition) 《
( 英國腎臟
病 協 會 臨 床 實 務 指 引:成 人、兒 童 及 青 少 年 透 析 病 患 的 血 壓 管 理(2025版)》), ACC/AHA/ACEP/
NAEMSP/SCAI Guidelines for the Management of Patients with Acute Coronary Syndrome (2025
Edition)《(ACC/AHA/ACEP/NAEMSP/SCAI急性冠狀動脈症候群病患管理指引(2025版)》).
Nengqilang® (Coenzyme Q10 Tablets):
It is used to improve myocardial metabolism and energy supply, promoting oxidative phosphorylation
and protecting the structural integrity of biological membranes. For patients with chronic heart failure,
this drug can significantly improve symptoms of shortness of breath and fatigue, effectively combining
with conventional treatment to improve patient prognosis and quality of life. Over the past 30 years
since its launch, it has been included in numerous authoritative guidelines and domestic and
international expert consensus documents, including the Global Andrology Forum Clinical Guidelines on
Antioxidant Use in the Treatment of Male Infertility (2026 Edition) 《
( 全球男性學論壇(GAF)抗氧化
劑治療男性不育臨床指南(2026版)》), the Expert Recommendations for the Diagnosis and Treatment
of Fulminant Myocarditis in Children (2025 Edition) 《
( 兒童暴發性心肌炎診治專家建議(2025版)》),),
Comprehensive Management Guidelines for Cardiomyopathy in China (2025 Edition) 《
( 中國心肌病變
綜合管理指引(2025版)》), Expert Consensus on the Comprehensive Prevention and Treatment of PostTraumatic Stress Disorder Following Traumatic Brain Injury (2025 Edition) 《
( 顱腦衝擊傷後創傷後應
激障礙綜合防治專家共識(2025版)》), Chinese Expert Consensus on the Diagnosis, Treatment, and
— 31 —
Management of Hypertrophic Cardiomyopathy in Children (2025 Edition) 《
( 中國兒童肥厚型心肌病變
診斷治療與管理專家共識(2025版)》), Guidelines for the Management of Cyclic Vomiting Syndrome
in Children (2025 Edition) 《
( 兒童週期性嘔吐症候群治療指引(2025版)》), Expert Consensus on the
Diagnosis and Treatment of Severe Fever with Thrombocytopenia Syndrome (2025 Edition) 《
( 重症發燒
伴血小板減少症候群診治專家共識(2025版)》), Chinese Guidelines for the Clinical Diagnosis and
Treatment of Myocarditis in Adults (2024) 《
( 中國成人心肌炎臨床診斷與治療指引2024》), Chinese
Guidelines for the Diagnosis and Treatment of Chronic Alcohol-Related Brain Damage (2024 Edition)
《
( 慢性酒精相關性腦損傷的中國診療指引(2024版)》), Chinese Expert Consensus on the Diagnosis
and Treatment of Hereditary Ataxia (2024 Edition) 《
( 中國遺傳性共濟失調診治專家共識(2024版)》),
Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2024 Edition) 《
( 中國心力衰竭診
斷和治療指南(2024版)》), etc.
Limetone® eplerenone tablets(力美通®依普利酮片):
It is a new MRA drug. It can block heart disease and vascular damage caused by excessive activation of
mineralocorticoid receptor (“MR”) by binding to the MR. ESC Guidelines: Management of
Cardiovascular Disease and Pregnancy (2025 Edition)《(ESC指南:心血管疾病和妊娠的管理(2025
版)》), ACC/AHA/ACEP/NAEMSP/SCAI Guidelines for the Management of Patients with Acute
Coronary Syndrome (2025 Edition) 《(ACC/AHA/ACEP/NAEMSP/SCAI急性冠狀動脈綜合症患者管
理指引(2025版)》), TES Clinical Practice Guidelines: Primary Aldosteronism (2025 Edition)《(TES臨
床實務指引:原發性醛固酮增多症(2025版)》), AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/
AMA/ASPC/NMA/PCNA/SGIM Guidelines for the Prevention, Detection, Evaluation, and Management
of Hypertension in Adults (2025 Edition),《(AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/
ASPC/NMA/PCNA/SGIM成人高血壓預防、檢測、評估與管理指引(2025版)》), Expert Consensus
on the Evaluation and Management of High-Volume Loads in Patients with Hypertension (2025 Edition)
(《高 血 壓 患 者 高 容 量 負 荷 的 評 估 與 管 理 專 家 共 識( 2025版)》), Guidelines for Prevention and
Treatment of Hypertension in China (2024 Edition) 《
( 中國高血壓防治指南(2024版)》), the Guidelines
for Diagnosis and Treatment of Heart Failure in China (2024 Edition) 《
( 中國心力衰竭診斷和治療指
南)
(2024版)》, Chinese Expert Consensus on Blood Pressure Management of Refractory Hypertension
(《難 治 性 高 血 壓 血 壓 管 理 中 國 專 家 共 識》), the Multidisciplinary Expert Consensus for Clinical
Application of Mineralocorticoid Receptor Antagonists in China (2022 Edition) 《
( 鹽皮質激素受體拮
抗劑臨床應用多學科中國專家共識(2022版)》) and many other well-known clinical guidelines and
expert consensus at home and abroad recommend the clinical use of MRA drugs in the treatment of
cardiovascular diseases such as heart failure and hypertension. Compared with the first-generation MRA
drug Spironolactone, Eplerenone has higher MR selectivity and lower affinity for androgen receptor and
progesterone receptor, so it has fewer side effects and is a safe and effective new generation of MRA
drug. This product was approved for commercialization by the NMPA in August 2023, bridging the gap
of second-generation selective mineralocorticoid receptor antagonist drugs in China. In May 2024, the
first prescription was completed, and the commercialization was officially realized in China. In
November 2024, it was officially included in China’s National Basic Medical Insurance, Work-related
Injury Insurance and Maternity Insurance Drug List (2024 Edition) 《
( 國家基本醫療保險、工傷保險和
生育保險藥品目錄(2024版)》).
— 32 —
Neffy® Adrenaline Nasal Spray:
Neffy® is the first non-injectable treatment product approved by FDA for the treatment of type I allergic
reactions (including severe allergic reactions). It uses an innovative nasal spray delivery method, which
is convenient to use, compact and easy to carry, and can be administered by the patient or others in the
event of an allergic reaction The product has a shelf life of up to 30 months, which can significantly
reduce waste caused by expired medicines, and alleviate the economic and medication burden on
patients. Its pivotal clinical study results show that subjects treated with Neffy® or approved adrenaline
injection products had comparable blood concentrations of adrenaline, and Neffy® has been shown to
have a rapid onset of action and provide short-term symptom relief in patients with allergic reactions.
With its unique portability and user-friendly operation, Neffy® is expected to quickly penetrate various
out-of-hospital scenarios, including homes, schools, and travel, and fill the gap in the availability of
emergency medications for severe allergic reactions in out-of-hospital settings.
Runmodelin® Treprostinil Injection:
This is a rare disease drug for the treatment of pulmonary arterial hypertension. It is a synthetic
analogue of endogenous prostacyclin. By acting on specific prostaglandin receptors and antagonizing
thromboxane A2, it promotes vascular smooth muscle relaxation, reduces thrombosis, inhibits vascular
wall cell proliferation, and thereby increases blood flow and reduces cardiac stress. This product, when
used in combination with existing treatments, can significantly improve patients’ long-term survival. Its
use is recommended by authoritative domestic and international guidelines, including the Guidelines for
the Diagnosis and Treatment of Pulmonary Arterial Hypertension Associated with Congenital Heart
Disease in Adults (2026 Edition) 《
( 成人先天性心臟病相關肺動脉高壓診斷與治療指南(2026版)》),
the ESC Guidelines: Management of Cardiovascular Disease and Pregnancy (2025 Edition)《(ESC指南:
心血管疾病和妊娠的管理(2025版)》), the Expert Consensus on Joint Management of Targeted Drug
Therapy for Pulmonary Arterial Hypertension (2025 Edition) 《
( 動脈性肺動脈高壓標靶藥物治療醫學
共 管 專 家 共 識( 2025版)》), the Guidelines for the Diagnosis and Treatment of Acute Pulmonary
Embolism (2025 Edition) 《
( 急性肺栓塞診斷與治療指南(2025版)》), the Guidelines for the Diagnosis
and Treatment of Chronic Thromboembolic Pulmonary Hypertension (2024 Edition) 《
( 慢性血栓栓塞性
肺動脈高壓診斷與治療指南(2024版)》), the ESC/ERS Guidelines for the Diagnosis and Treatment of
Pulmonary Hypertension (2022 Edition) 《 (ESC/ERS肺 動 脈 高 壓 診 斷 與 治 療 指 南( 2022版)》), the
Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension (2021 Edition) in China 《
( 中國
®
肺 動 脈 高 壓 診 斷 與 治 療 指 南( 2021版)》). Runmodelin is one of only two treprostinil products
currently approved for marketing in China. In January 2023, it was officially included in China’s
“National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List
(2022 Edition)”, significantly improving patient accessibility and reducing the treatment burden,
benefiting a large number of patients with pulmonary arterial hypertension.
— 33 —
Pharmaceutical Raw Materials Segment
The Group’s pharmaceutical raw materials segment has a rich product pipeline and significant
advantages in terms of product concentration. Our bulk APIs and specialty APIs are sold in parallel,
with sales channels spread all over the world. As an important link in the front-end of the integrated
supply chain of raw materials and preparations, the Group now owns several modernized production
bases of pharmaceutical raw materials with complete equipment, superb technique, outstanding
industrialization capability and standardized quality control. The Group focuses on the R&D of API
production in five major areas, namely cerebro-cardiovascular, anti-infection, antipyretic analgesic, the
digestive system and anti-tumor, and fully supports the production of preparations and R&D work in the
field of pharmaceutical technology, so as to ensure high quality standard and consistency of the
Company’s preparations at the source, and truly realize the integration of upstream and downstream
industrial advantages.
mRNA platform
The Group has established a world-leading mRNA technology platform centered on Nanjing AuroRNA
Biotech Co., Ltd. (“AuroRNA Biotech”). As the Group’s global mRNA innovation technology platform,
AuroRNA Biotech possesses two core underlying mRNA technologies–the development of mRNA
nucleic acid therapeutics and lipid nanoparticle (LNP) delivery–both of which are protected by its own
intellectual property rights. These technologies address a number of key industry challenges, including
vaccine antigen design, in vivo targeted delivery via LNPs, and process development. The technological
foundation is capable of cross-project reuse and is highly scalable, enabling the development of a
diverse range of mRNA drug candidates. AuroRNA Biotech’s research and development is primarily
focused on areas of significant clinical and public health importance, such as cancer treatment and the
prevention and control of infectious diseases. The platform is currently prioritizing the development of
two therapeutic mRNA vaccines–one for HPV-16-related cervical cancer and the other for HSV-2related genital herpes–whilst also conducting proof-of-concept studies for several early-stage research
projects based on its proprietary platform technology.
— 34 —
Biotechnology
The Group pursues the concept of green, low-carbon and sustainable development and promotes highquality development of the segment with the world’s leading innovative technology in synthetic
biotechnology. The amino acid products are the core business in the field of biotechnology, and it is
positioned as a global premium service provider of high-quality amino acids. The Group’s development
in the biological field focuses on technological innovation and the construction of high-quality systems.
We are comprehensively advancing the international registration process by establishing technical and
quality barriers, thereby strengthening the Group’s overall competitiveness in the international market.
Currently, the Group holds approximately 350 invention patents and has led and participated in the
formulation of more than 70 national, industrial and group standards, with approximately 50 standards
published. We have a complete domestic and international quality system certification, and have won
many honors such as National Green Factory(國家級綠色工廠), the National Manufacturing Individual
Champion Demonstration Enterprise(國家製造業單項冠軍示範企業), National-level “Little Giant”
Enterprises(國 家 級 專 精 特 新「小 巨 人」企 業), the National Intellectual Property Demonstration
Enterprise(國 家 知 識 產 權 示 範 企 業), the China Light Industry Green Manufacturing Engineering
Technology Research Centers for Sulfur-containing Amino Acids(中國輕工業含硫氨基酸綠色製造工
程技術研究中心), and the Advanced Enterprise in China’s Bio-fermentation Industry(中國生物發酵
行業先進企業).
Amino acids segment
The Group has been cultivating in the field of amino acids for more than 20 years and has always
adhered to the spirit of technological innovation, taking synthetic biology as the core, it pioneered a
world’s leading innovative technology in China based on biotechnology method to produce various
amino acids by biological method, which filled the gap in the industry. The Group has undertaken the
project for national industrial strong foundation engineering and the industrial foundation transformation
project of the PRC, and is the first company in China to be approved for the “Same production line,
same standard, same quality” three-in-one certification for amino acids, to ensure the safety and stability
of the supply chain and industrial chain of high-quality amino acids in China.
The Group has always adhered to the core business philosophy of “new technology, high quality,
industrial chain, and internationalization” and has continued to strengthen the expansion of the amino
acid industry. Based on pharmaceutical-grade amino acids and by leveraging our industrial advantages,
the Group continues to expand into diversified amino acids.
— 35 —
New technology:
Focusing closely on the field of synthetic biology and after years of scientific research, at present, we
have built eight technology platforms, including synthetic biology, enzyme engineering, fermentation
engineering, process optimization, quality research and application transformation, while taking
initiatives in construction of cell factory, fine control of fermentation processes, and research of the full
technology chain of separation and purification. Through the innovation and integration of several
technology areas, we have had an integrated synergistic system with new product development, new
technology engineering, industrialization and application solutions, which provides strong support for
continuous innovation and industrial implementation, and some of the technologies have filled the
domestic gaps in China. Currently, the Group has established long-term deep cooperation relationship
with a number of scientific research institutions such as Wuhan University, Huazhong University of
Science and Technology, Tianjin University of Science and Technology and Huazhong Agricultural
University, under which, a new amino acid fermentation technology and an enzyme expression system
were developed. Meanwhile, the technological development of cell culture media-level amino acid has
been further deepened, providing raw material guarantee for the research of self-produced cell culture
medium. We have applied the technologies of molecular biology and proteomics to modify the structure
of biological enzymes, thus effectively improving the activity of biological enzymes and the yield and
quality of the products. Among them, the fermentation process with strain construction optimization as
the core and the enzyme conversion process with immobilized enzymes as the core can not only replaces
the traditional chemical synthesis process, improving process safety and production convenience, but
also significantly reduces carbon dioxide emissions during the production process, which fully
demonstrates the development concept of energy saving, emission reduction and green environment
protection of emission peak and carbon neutrality, generating great economic and environmental
benefits. The industrial technology highway built by the Group in the amino acid segment is beginning
to take shape, which has laid a solid foundation for Original technological innovation and product
industrialization.
The Group attaches great importance to the construction of R&D team and the close integration of
production and research. At present, the amino acid segment has a core technical team led by talents
from the 100 Talents Plan of Hubei Province(湖北省百人計劃). The innovative model of combining
production, academia, research and application in this segment, as well as the echelon of technical
innovation talents with clear division of labor and complementary strengths, has yielded fruitful results
with the number of granted invention patents ranking at the leading level in the same industry.
— 36 —
High quality:
The Group’s amino acid products have a complete quality certification system at home and abroad.
Many core products have passed the drug/food system certification and registration in Europe, the
United States, Japan, Southeast Asia, China and other countries and regions, including European Union
GMP certification, EU REACH registration, Export to European Union WC certification, the US FDA
certification, KFDA Registration in Korea, the ISO quality management system certification, the
FSSC22000 food system certification, FAMI-QS feed certification, IP non-GMO certification, the
HALAL certification, the KOSHER certification, etc, not only ensuring the compliance of overseas
operations of core products, but also laying the foundation for the subsequent expansion of new market
applications of products. Meanwhile, the Group has also made efforts to increase registration in new
economies such as South America, paving the way for the globalization of the Group’s core products.
Our comprehensive system certification and registration have demonstrated the Group’s strong
competitiveness for business expansion in overseas markets.
Industry chain:
The Group has nearly 50 types of various amino acids and their derivatives. It has 26 registered amino
acid APIs and is the pharmaceutical company with the largest number of registered amino acid APIs in
China. At the same time, the Group has also added a number of food-grade and feed-grade amino acid
products, opening up growth space through differentiated paths and demonstrating the dual-wheel drive
effectiveness of market breakthroughs and product innovation. The rich amino acid product cluster can
better meet the customized needs of the downstream market, provide one-stop services of multiple
varieties and specifications, and enhance customer adhesion in high-end application scenarios. In
addition to raw material products, the Group is also actively expanding its pharmaceutical products. Two
of the self-developed functional dietary supplements, have obtained the U.S. FDA approval and have
been commercialized in the United States. The Group already has over 10 independently developed
functional foods approved for commercialization in China.
Internationalization:
The sales network of the Group’s amino acid segment covers more than 140 countries and regions
worldwide, including mainstream markets in Europe, the United States, Japan, Southeast Asia and
China, with overseas business accounting for about 40% of the total. Among which, some of our amino
acid varieties ranking among the top three in terms of market share. Relying on technological
breakthroughs and cost advantages, the core products have long served domestic and international highquality customers including Fortune 500 companies, and established long-term and stable cooperative
relationships with customers in the upstream and downstream of the industrial chain as well as a high
brand awareness and market reputation worldwide, which has laid a solid customer base for the
continuous and rapid growth of the segment’s performance.
— 37 —
In the future, the Group will continue to rely on its world-leading new bio-method manufacturing
technology in the field of high-quality amino acids, solid industrial base and industrial accumulation,
rich amino acid product clusters, high-standard quality certification systems, strong international
registration and commercialization capabilities, with a focus on high-end parenteral nutrition
preparations, innovative peptide drugs, cell culture base and other pharmaceutical-related high valueadded fields, as well as functional dietary supplements such as sports protection, special medical and
infant food, beauty and pet food and other large health consumer areas. The extensive market space and
huge development potential of the downstream segment will provide the Group’s amino acid segment
with strong and sustainable development momentum.
FINANCIAL REVIEW
Revenue and profit
For the six months ended 30 June 2026, the business of the Group grew steadily and recorded a revenue
of approximately HK$6,388.91 million (same period last year (restated) 1: HK$6,189.20 million),
representing a year-on-year increase of approximately 3.2%. Revenue from innovative and barrier
products2 accounted for approximately 50% of total revenue. During the current period under review, the
profit for the period attributable to the owners of the Company was approximately HK$1,061.54 million
(same period last year (restated): HK$1,193.17 million). During the period, the Group’s fair value
changes and disposal gains from its investment in Telix totaled approximately HK$88.78 million (same
period last year (restated): HK$151.72 million), a decrease of HK$62.94 million compared to the same
period last year. If the impact of the Telix investment on profits is excluded, the adjusted operating net
profit for the period attributable to the owners of the Company3 was approximately HK$972.76 million
(same period last year (restated): HK$1,041.44 million), which was mainly due to the short-term impact
of adjusting sales strategies in response to market competition.
During the current period, the Group recorded a revenue of HK$745.13 million from the nuclear
medicine anti-tumor diagnosis and treatment and cerebro-cardiovascular precision interventional
diagnosis and treatment technology products, representing an increase of approximately 29%, as
compared with the same period of 2025 (approximately HK$577.74 million). In particular, we recorded
a revenue of HK$655.24 million from the nuclear medicine anti-tumor sector, representing an increase
of approximately 55.4%, as compared with the same period of 2025 (approximately HK$421.78 million),
due to revenue growth as a result of the rapid growth in clinical demand for core products and the rapid
release of new products; and a revenue of HK$89.89 million from the cerebro-cardiovascular precision
interventional diagnosis and treatment sector.
During the current period, the Group recorded a revenue of approximately HK$3,274.08 million from
pharmaceutical technology products, representing a decrease of 14.9% as compared with the
corresponding period in 2025 (approximately HK$3,845.19 million). In particular, we recorded a
revenue of approximately HK$1,041.73 million from the respiratory and critical and severe disease
segment, remaining almost the same as compared with the corresponding period in 2025 (approximately
HK$1,047.35 million); a revenue of approximately HK$1,115.51 million from the ENT segment,
— 38 —
representing a decrease of approximately 25.4% as compared with the corresponding period in 2025
(approximately HK$1,494.71 million); and a revenue of approximately HK$792.30 million from the
cerebro-cardiovascular emergency segment, representing a decrease of approximately 12.4% as
compared with the corresponding period in 2025 (approximately HK$904.41 million). The revenue in
the ENT segment and cardiovascular emergency care segment declined, was primarily due to the shortterm impact of sales strategy adjustments made in response to market competition.
During the current period, the Group recorded a revenue of approximately HK$2,369.70 million from
biotechnology products, representing an increase of approximately 34.2% as compared with the restated
result of corresponding period in 2025 (approximately HK$1,766.26 million). In particular, we recorded
a revenue of approximately HK$1,870.28 million from the amino acid segment (including taurine),
representing an increase of approximately 30.9% as compared with the restated result of corresponding
period in 2025 (approximately HK$1,428.49 million), which was mainly driven by higher sales prices
for core products and expanding demand in downstream markets, driving business growth in scale.
Notes:
1
In the first half of 2026, the Company successfully acquired 100% of the equity interests in Hebei Jiufu and
Baoding Jiahe. At the time of the acquisition, China Grand was the controlling shareholder of both Hebei
Jiufu and Baoding Jiahe, and was also the controlling shareholder of the Company. Therefore, the
acquisition was treated as a business combination involving entities under common control and accounted
for using the merger accounting method. Consequently, the comparative condensed consolidated statements
of income and other comprehensive income for the six months ended 30 June 2025, as well as the
condensed consolidated statements of financial position as of 31 December 2025, and 1 January 2025, have
been restated to incorporate the assets, liabilities, profits, and cash flows of the combined entity from the
date on which it first came under common control. For details, please refer to Note 2 to the condensed
consolidated financial statements.
2
Innovative and barrier products refer to the Company’s original research products, products with exclusive
market position, products with exclusive commercialization rights, and first-to-market generic products that
break foreign monopolies.
3
The Group’s adjusted operating profit attributable to owners of the Company is defined as the profit for the
period attributable to owners of the Company, excluding the impact of fair value changes and disposal gains
on the Telix investment.
— 39 —
Distribution costs and administrative expenses
For the six months ended 30 June 2026, the Group’s distribution costs and administrative expenses were
approximately HK$1,582.34 million and HK$668.10 million respectively as compared to the restated
amounts of approximately HK$1,919.44 million and HK$705.47 respectively for the corresponding
period in 2025. The distribution costs during the current period decreased by approximately HK$337.10
million, which was mainly due to the optimisation of the marketing organisation and the adjustment of
sales strategies during the current period. The administrative expenses also decreased by approximately
HK$37.38 million as compared to the restated result of corresponding period of last year mainly due to
the organisational restructuring and refined operational management during the current period.
Finance costs
For the six months ended 30 June 2026, the Group’s finance costs were approximately HK$76.76 million
as compared to the restated amount of approximately HK$82.00 million for the corresponding period in
2025. The decrease in finance costs was due to a decrease in the overall interest rate as a result of loan
replacement.
R&D and project investment
For the six months ended 30 June 2026, the Group continuously invested resources in the stages of
research project and introduction of innovative projects. If including the R&D expenses and also the
capitalized R&D expenses, prepayments for new projects and other investments, the Group’s investment
in R&D and various projects is approximately HK$764 million.
Receivables and payables
As of 30 June 2026, trade and other receivables of the Group amounted to approximately HK$5,397.24
million, representing an increase of approximately HK$664.65 million as compared to the restated
balance in 2025, mainly due to the increase in trade and bills receivables of approximately HK$898.52
million as compared to the closing balance of last year. This is mainly a result of the increase in
business during the current period, and also as general market practise it will put more force to collect
receivables at the year end and thus the trade receivable year-end balances always recorded
comparatively lower.
As of 30 June 2026, the Group’s trade and other payables amounted to approximately HK$4,002.71
million, substantially remaining the same as compared to the restated balance in 2025, mainly due to the
increase in trade and bills payables of approximately HK$110.28 million as a result of the increase in
business during the period. Furthermore, due to the optimisation of the marketing organisation and the
adjustment of sales strategies during the year, we accrued reduced selling and operating expenses such
as salaries, marketing and promotion expenses and R&D expenses amounted to approximately
HK$159.16 million.
— 40 —
Significant investments
The Group’s investments with value over 5% of value of its total assets are considered as significant
investments. As at 30 June 2026, our significant investments include (i) Grand Pharma Sphere Pte
Limited (“Grand Pharma Sphere”) and (ii) Shanghai Xudong Haipu Pharmaceutical Company Limited
(“Xudong Haipu”).
Grand Pharma Sphere is the holding company of a group of companies principally engaged in the
research and development, manufacturing and sales of nuclear medicine and tumor intervention
products. The Group effectively owned approximately 57.98% equity interests of it. For the six months
ended 30 June 2026, the Group’s share of profit in Grand Pharma Sphere was approximately HK$40.48
million (for the six months ended 30 June 2025: profit attributable to the Company approximately
HK$39.3 million).
Xudong Haipu and its subsidiaries is a group of companies principally engaged in the manufacturing and
sales of pharmaceutical injections of various volumes. The Group effectively owned 55% equity
interests of it. For the six months ended 30 June 2026, the Group’s share of profit in Xudong Haipu was
approximately HK$38.11 million (for the six months ended 30 June 2025: approximately: HK$42.82
million).
The quote fair value of significant investments in associates is not available, since the significant
associates are private entities and do not have quoted market price. The results and assets and liabilities
of associates are incorporated in the consolidated financial statements of the Group using the equity
method of accounting.
The Group may consider to make investments in these associates due to different criteria, mainly
including:
1.
Looking for opportunities to enter into new markets and expand product pools. For instance, the
investment in Grand Pharma Sphere offered an opportunity for the Group to venture into the field
of nuclear drug anti-tumor, and investment in other associates may help the Group get into other
markets like grasp advanced technology and step into the global market of cardiovascular
interventional medical devices;
2.
Looking for synergy effect to the Group’s existing products and markets. For example, Xudong
Haipu’s core product line may create synergy with the Group’s preparation products, and enrich
the Group’s core product pool in the areas of emergency medications and cerebro-cardiovascular
and respiratory products. It can also strengthen the Group’s product quality, market share and
brand in those areas; and
3.
Seeking opportunities to cooperate with companies in early R&D stage and obtain the commercial
rights for products with strong potentials.
— 41 —
For further details of the product research and development and business prospects of these associates,
please refer to the section with heading “Business Review and Prospects” above.
Research and development
The Group has sufficient innovation pipeline. During the period, there were 34 innovation projects,
which were in different stages from preclinical to new drug commercialization application. The pipeline
layout was reasonable, forming a good echelon effect.
R&D Pipeline
Field
Sector
Direction
Radionuclide-drug conjugate (RDC)
Technologies on nuclear medicine
and anti-tumor diagnosis and
treatment
as well as cerebrocardiovascular
precision interventional diagnosis
and treatment
Nuclear medicine and
anti-tumor diagnosis and
treatment
Product
Indication
TLX591
(177Lu-rosapatumab)
Prostate cancer
TLX591-CDx
(68Ga-PSMA-11)
Prostate cancer – diagnosis
TLX250
(177Lu-girentuximab)
Clear cell renal cell carcinoma
TLX250-CDx
(89Zr-girentuximab)
Clear cell renal cell carcinoma
– diagnosis
TLX101
(131I-IPA)
Glioblastoma
ITM-11
Gastroenteropancreatic
neuroendocrine tumor
GPN01530-2
Solid tumor - diagnosis
GPN02006
Hepatocellular carcinoma diagnosis
Y-90 microsphere injection
Primary liver cancer
Thermosensitive embolic agent
Vascular-rich solid organ tumors
product
Interventional treatment
Cerebrocardiovascular
precision
interventional
diagnosis
and treatment
Cerebral arteriovenous
malformations
AuroLase
Prostate cancer
UPro-SEEK
Prostate cancer
UI-MRD
Urothelial carcinoma
Vascular intervention
aXess
Hemodialysis
Neurointervention
GPN01037
Intracranial stenosisss
Structural heart disease
and heart failure
Structural heart
disease
Saturn
Mitral regurgitation
Heart failure
Heart failure
CoRisma
HPV-16-positive solid tumors
Access management
Ophthalmology
ENT
Pharmaceutical Technology
Kona
Traditional Chinese Medicine
GPN00153(CBT-001)
Pterygium
GPN00833
Anti-inflammatory and analgesic
GPN00884
Myopia prevention and control
GPN01360
Depression
GPN01020
Neurological Disorders
Anti-infection
Respiratory and
severe disease
Respiratory
GPN01411
Severe disease
STC3141
Sepsis
mRNA platform
Tumor
ARC01 (A002)
HPV-16 positive solid tumors
Mainland China
Overseas
— 42 —
R&D progress
Preclinical
IND/Model
Inspection
Phase I
Phase II
Phase III
NDA/
Registration
Launch
R&D center
Currently, the Group is involved in and has established a number of R&D technology platforms and
R&D centers around the world:
In the field of pharmaceutical technology, the International R&D Center in Optics Valley (光谷國際研
發中心) in Wuhan, China is the main R&D body of the Group in the pharmaceutical technology field in
China, providing technical support for the R&D of the Group’s high-end preparation products; the
Glycomics technology platform is located at the R&D center in Australia, focusing on the development
of antiviral drugs; the mRNA technology platform is located in Nanjing, China, focusing on the
development of anti-tumor and anti-infective mRNA drugs, and will further expand into the fields of
rare disease and protein replacement therapy in the future.
In the segment of nuclear medicine anti-tumor diagnosis and treatment, the tumor intervention
technology platform and the RDC technology platform involve the Boston R&D Center in the United
States and the Chengdu Radiopharmaceutical Research and Development Center in China, respectively.
In the cerebro-cardiovascular precision interventional diagnosis and treatment sector, the Group’s highend medical device R&D technology platform comprises the International R&D Center in Optics Valley
in Wuhan and the Changzhou Device R&D Center.
Development of generic drugs
During the period under review, the Company obtained drug registration certificates from the NMPA for
its products of metronidazole gel, icatibant acetate injection, amorolfine hydrochloride liniment and
acetylcysteine solution for inhalation.
Consistency Evaluation
During the period under review, metronidazole gel, icatibant acetate injection, amorolfine hydrochloride
liniment, acetylcysteine solution for inhalation, diazepam injection and amikacin sulfate injection were
approved or deemed to have passed the consistency evaluation. New applications were submitted for
teneligliptin hydrobromide tablets, nalmefene hydrochloride injection, bisoprolol fumarate tablets, and
acetylcysteine effervescent tablets. Currently, the Group has a total of 70 products approved or deemed
to have passed the consistency evaluation, with another 19 products under review.
— 43 —
Intellectual Property Protection
During the period under review, the Group had an addition of 55 applications. There were 33 new
patents being granted, of which 17 were invention patents, accounting for 52%, and 1 new foreign patent
being granted. The Group has accumulated 1,028 valid patents, of which 599 are valid invention patents.
The Group attaches great importance to the protection of intellectual property rights in independent
innovation projects, with 274 patents in the field of innovation. It has filed 23 new patent applications in
innovative fields such as anti-infection, oncology, medical devices, and mRNA technology platforms,
accounting for 42% of the group’s total new applications. Among them, core patents in the anti-infection
field have been authorized in China, the United States, Europe, Japan, South Korea, Israel, Singapore,
Australia, and other regions.
Commercialization Capability
The Group’s performance continued to improve, and the continuous commercialization of innovative
products and profit contribution cannot be separated from the continuous improvement of
commercialization capabilities. As at the date of this announcement, the Group had approximately 5,000
sales personnel, of which more than 4,000 were in the pharmaceutical area (including OTC), covering
more than 50,000 hospitals and primary medical and healthcare institutions in China, of which more
than 13,000 were ranked hospitals. In the OTC area, we had over 1,000 sales personnel with a reach of
more than 500,000 pharmacies in China. The cerebro-cardiovascular precision interventional diagnosis
and treatment segment had a sales team comprising approximately 150 staff covering nearly 1,800
hospitals. The nuclear medicine anti-tumor diagnosis and treatment segment has over 900 sales
personnel worldwide, with its global sales network covering more than 50 countries and regions. It has
also actively carried out the hospital admission and academic promotion of YiGanTai® Yttrium-90
microsphere injections in China.
International Standard
The Group continues to accelerate the pace of globalization and has a number of independently
operating overseas companies in the fields of nuclear medicine anti-tumor diagnosis and treatment,
cerebro-cardiovascular precision interventional diagnosis and treatment, and critical and severe diseases,
etc. The Group has advanced overseas clinical trials of a number of global innovative products and
obtained 8 clinical approvals in five countries, including the United States, Australia, Belgium, Poland
and the United Kingdom, involving a number of indications such as primary liver cancer, solid tumor
and sepsis. Currently, the Group and its associates have over 350 employees overseas.
— 44 —
Material Investment, M&A and Cooperation
The Group continued to implement the development strategy of “self-development + global expansion”,
further exploring high– quality innovative projects around the world to expand the Group’s product
pipeline and enhance the Group’s comprehensive strengths and putting vigorous efforts in transformation
towards innovation and internationalization. During the reporting period, the Group has carried out the
following material investment, M&A and cooperation:
•
Strategic Collaboration with The University of Hong Kong
In April 2026, the Group entered into a strategic collaboration with The University of Hong Kong
and its wholly-owned subsidiary, Versitech Limited (“HKU Versitech”). The parties will engage
in in-depth collaboration in areas including academic research, resource sharing, talent
development and product development, jointly advancing innovative drug R&D and
industrialisation of research outcomes in the anti-infection field. This collaboration will commence
with the development of innovative antibacterial agents. The relevant projects will be undertaken
by the research team of professor Li Xuechen(李學臣), aiming to develop novel therapeutic
solutions with improved efficacy and safety profiles to address the unmet clinical needs in the
antibacterial treatment landscape. Subsequently, The University of Hong Kong will grant the
Group an exclusive license to the relevant intellectual property rights it owns, and the Group will
be fully responsible for the subsequent development, registration and commercialisation, thereby
efficiently translating cutting-edge scientific research outcomes into industrial applications. This
collaboration marks another pivotal step for the Group in engaging with world-class universities
and deeply integrating frontier academic research with industrial translation and application.
INVESTOR RELATIONS
The Group has been committing to improving its corporate governance to ensure the long-term
development. During the period, the Group published annual reports, annual results announcements, and
other announcements and circulars on the websites of the Company and the Hong Kong Exchanges and
Clearing Limited, and issued voluntary announcements, so as to disclose the latest business
developments of the Group to shareholders and investors.
At the same time, the Group actively maintains close communication with investors through various
channels, including securities company roadshows, large-scale telephone conferences, one-on-one
meetings and other diversified communication methods, to introduce the Group’s business situation,
development progress and overseas member companies’ businesses to investors, and simultaneously
releases the latest business updates through different media channels, aiming to build an open, two-way,
transparent and sincere communication platform, so that investors can keep abreast of the Group’s
business progress and development prospects. During the period, the Group actively communicated with
— 45 —
the capital market and investors through promotional activities such as results announcements and
investor site visit, and participated in a number of summits, forums, strategy conferences and special
roadshows held by large investment banks and securities companies, attracting hundreds of institutional
investors and analysts. Through communication with investors, the Group hopes to listen to more
valuable opinions and extensively collect feedback from investors by establishing an active and efficient
information and communication mechanism, so as to further enhance its corporate governance.
The Group’s investor relations management efforts have helped establish a high-quality corporate image
and communicate its core strategy of technological innovation, earning widespread recognition within
the industry across multiple dimensions. In January 2026, the Company was honored on the 12th “Top
100 Hong Kong Stocks” Annual Pharmaceutical and Healthcare Innovation Pioneer List, as well as the
2nd JuDongmi “Top 100 IRM Companies (Top 20)” and the 2nd JuDongmi “Top 100 ESG Companies
(Top 20)”.
Other Significant Matters
SHARE OPTION SCHEME
As at 30 June 2026, the Company did not adopt any share option scheme and no outstanding share
options.
No share options were granted or exercised under any share option scheme, and there were no
outstanding share options as at 30 June 2026.
Share Award Scheme
On 1 September 2021, the Company has adopted the Share Award Scheme (“Scheme”) in which the
Group’s employees, directors or consultants will be entitled to participate. Details of the Scheme are set
out in the Company’s announcement dated 1 September 2021.
The Group has paid to the trust established for the Scheme approximately HK$278.56 million, and
including the dividend belongs to the shares acquired previously, the trustee used approximately
HK$268.5 million to purchase 47,761,500 shares of the Company (“Shares”) as part of the trust fund,
and such Shares are held by the trustee for the benefit of the eligible participants under the trust and are
the total number of award shares available for grant under the Scheme, representing approximately
1.35% of the issued Shares of the Company. Where the trustee has received instructions from the Group
to acquire Shares and necessary funds, the trustee shall acquire such number of Shares on-market at the
prevailing market price as soon as reasonably practicable.
— 46 —
Save for the aforesaid, as at 30 June 2026, the Group did not grand any awards nor caused to pay the
trustee the trust fund for purchase nor subscription of Shares. When any awards were granted later, the
number of Shares to be awarded, award price, vesting criteria and vesting schedule of awards of each
participant will be subject to the applicable Listing Rules and other applicable regulations by that time,
and will inform the participants in the form of an award letter. The Board shall not make any award of
Shares which will result in the aggregate number of the Shares awarded by the Board under the Scheme
exceeding 5% of the number of issued Shares of the Company as at the adoption date of the Scheme (i.e.
177,478,557 Shares), and the maximum entitlement of each participant under the Scheme in every
12-months in aggregate shall not exceed 1% of the issued Shares as at the adoption date of the Scheme
(i.e. 35,495,711 Shares).
Purpose of the Scheme
The purpose of the Scheme is to recognise the contributions of the Selected Participants and provide
them with incentives in order to retain them for the continual operation, growth and development of the
Group.
Remaining Term of the Scheme
Subject to any early termination as may be determined by the Board pursuant to the Scheme Rules, the
Scheme shall be valid and effective for the Scheme Period, i.e. a term of 10 years commencing on the
Effective Date. As of 30 June 2026, the Scheme has approximately 5.5 years remaining in force.
Purchase, Sale or Redemption of Shares
During the period ended 30 June 2026, neither the Company nor any of its subsidiaries has purchased,
sold or redeemed any of the Company’s listed securities.
Employees and Remuneration Policy
As at 30 June 2026, the Group employed about 12,326 staff and workers in Hong Kong and the PRC (31
December 2025: about 12,614). The Group remunerates its employees based on their performance and
experience and their remuneration package will be reviewed periodically by the management. Other
employee benefits include medical insurance, retirement scheme, appropriate training program and share
option scheme.
Competing Interest
No Directors or the management shareholders of the Company (as defined in the Listing Rules) had an
interest in a business which competes or may compete with the business of the Group.
— 47 —
Directors’ Interests in Transaction, Arrangements or Contracts
No transaction, arrangement or contract of significance to which the Company, or any of its holding
company, subsidiaries or fellow subsidiaries was a party, and in which a director of the company had a
material interest, subsisted at the end of the year or at any time during the year.
Model Code for Securities Transactions
The Company has adopted the Model Code for Securities Transactions by Directors of Listed Issuers
(the “Model Code”) as set out in Appendix C3 of the Listing Rules as its own code of conduct for
securities transactions by directors. Having made specific enquiry of the Company’s directors, all
directors have confirmed their compliance with all the relevant requirements as set out in the Model
Code during the period ended 30 June 2026.
Independence of Independent Non-executive Directors
The Company has received from each independent non-executive director an annual confirmation for
independence pursuant to Rule 3.13 of the Listing Rules. The independent non-executive directors have
confirmed that they are independent.
Code of Corporate Governance Practices
The Company has complied with all of the code provisions of the Corporate Governance Code and
Corporate Governance Report (the “CG Code”) as set out in Appendix C1 of the Listing Rules during
the six months ended 30 June 2026.
Audit Committee
The Company has established the audit committee for the purpose of monitoring the integrity of the
financial statements and overseeing the financial reporting process and the internal control system of the
Group. Currently, the audit committee is chaired by independent non-executive director Ms. So Tosi
Wan, Winnie and other members include the three independent non-executive directors Mr. Hu Yebi,
Dr. Pei Geng and Dr. Xing Li Na. Ms. So Tosi Wan, Winnie, has appropriate professional qualifications
as required by Rules 3.10(2) and 3.21 of the Listing Rules.
The Group’s condensed interim financial statements for the period ended 30 June 2026 are unaudited but
have been reviewed by the audit committee.
— 48 —
Remuneration Committee
The Company has established the remuneration committee to consider the remuneration of all directors
and senior management of the Company. Currently, the remuneration committee is chaired by
independent non-executive Director Ms. So Tosi Wan, Winnie and other members including the
executive Director Dr. Tang Weikun, Ms. Lam Chit Yee Jessica and independent non-executive Director
Mr. Hu Yebi.
Nomination Committee
The Company has established the nomination committee to assist the Board in the overall management
of the director nomination systems of the Company. Currently, the nomination committee is chaired by
independent non-executive Director Ms. So Tosi Wan, Winnie and other members including the
executive Director Mr. Zhou Chao and independent non-executive Director Mr. Hu Yebi.
By order of the Board
Grand Pharmaceutical Group Limited
Chairman
Dr. Tang Weikun
Hong Kong, 26 August 2026
As at the date of this announcement, the Board comprises four executive directors, namely, Dr. Tang
Weikun, Mr. Zhou Chao, Mr. Yang Guang and Ms. Lam Chit Yee Jessica, and four independent nonexecutive directors, namely, Ms. So Tosi Wan, Winnie, Dr. Xing Li Na, Dr. Pei Geng and Mr. Hu Yebi.
*
For identification purpose only
— 49 —
INTERIM RESULTS
The board (the “Board”) of directors (the “Directors”) of Grand Pharmaceutical Group Limited (the
“Company”) is pleased to announce the unaudited consolidated interim results for the six months ended
30 June 2026 of the Company and its subsidiaries (collectively the “Group”), together with comparative
figures for the previous period.
CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME
For the Six Months Ended 30 June 2026
Note
4
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
6,388,913
(3,021,240)
6,189,196
(2,536,157)
Gross profit
Other gains and losses, net
Distribution costs
Administrative expenses
Changes in fair value of financial assets at fair value through
profit or loss
Share of results of associates
Finance costs
3,367,673
44,914
(1,582,343)
(668,097)
3,653,039
205,405
(1,919,443)
(705,473)
114,376
58,314
(76,756)
174,593
57,944
(81,995)
Profit before tax
Income tax expense
5
1,258,081
(189,475)
1,384,070
(180,769)
Profit for the period
6
1,068,606
1,203,301
Revenue
Cost of sales
— 50 —
Note
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Other comprehensive income/(loss), net of income tax
Items that will not be reclassified subsequently to profit or loss:
Changes in fair value of equity investments recognised in
other comprehensive income at fair value
Share of other comprehensive loss of associates
(31,875)
(34,353)
24,155
(29,212)
Items that may be reclassified subsequently to profit or loss:
Exchange difference on translation of foreign operations
350,507
423,642
Other comprehensive income for the period,
net of income tax
284,279
418,585
Total comprehensive income for the period,
net of income tax
1,352,885
1,621,886
Profit for the period attributable to:
– Owners of the Company
– Non-controlling interests
1,061,538
7,068
1,193,167
10,134
1,068,606
1,203,301
1,352,196
689
1,615,402
6,484
1,352,885
1,621,886
Total comprehensive profit for the period attributable to:
– Owners of the Company
– Non-controlling interests
Dividend
7
–
–
Earnings per share
– Basic and diluted (HK cents)
8
30.31
34.07
— 51 —
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
As at 30 June 2026
Note
Non-current assets
Property, plant and equipment
Right-of-use assets
Investment properties
Interests in associates
Equity instruments at fair value through other
comprehensive income
Goodwill
Intangible assets
Deferred tax assets
Prepayments
Current assets
Inventories
Trade and other receivables
Amounts due from related companies
Financial assets at fair value through profit
or loss
Pledged bank deposits
Cash and cash equivalents
Current liabilities
Trade and other payables
Contract liabilities
Bank and other borrowings
Lease liabilities
Amounts due to related companies
Amounts due to immediate holding company
Income tax payable
9
9
10
10
— 52 —
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
1 January
2025
HK$’000
(Unaudited)
(Restated)
4,567,707
504,875
183,832
7,916,349
4,407,175
500,955
176,694
7,604,716
3,864,305
490,340
174,356
7,791,030
178,733
1,801,648
3,323,751
110,508
1,328,248
209,656
1,731,688
3,270,771
70,639
1,028,713
247,724
1,352,345
2,089,911
33,463
1,073,670
19,915,651
19,001,007
17,117,144
1,479,251
5,397,239
48,814
1,517,638
4,732,590
52,775
1,434,231
3,519,769
51,534
602,504
43,632
623,081
924,169
22,588
1,182,397
1,799,961
–
1,351,086
8,194,521
8,432,157
8,156,581
4,002,710
200,406
1,666,244
11,708
4,671
2,331
220,710
4,003,962
337,802
2,893,036
14,841
46,496
2,331
198,018
3,046,160
242,719
3,216,102
20,422
13,151
2,331
243,978
6,108,780
7,496,486
6,784,863
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
1 January
2025
HK$’000
(Unaudited)
(Restated)
Net current assets
2,085,741
935,671
1,371,718
Total assets less current liabilities
22,001,392
19,936,678
18,488,862
Non-current liabilities
Bank and other borrowings
Lease liabilities
Deferred tax liabilities
Other payables
Deferred income
3,331,121
42,036
366,622
569,068
333,186
1,840,763
40,277
367,265
224,671
321,149
1,256,280
40,604
300,351
–
299,843
4,642,033
2,794,125
1,897,078
Net assets
17,359,359
17,142,553
16,591,784
Share capital and reserves attributable to
owners of the Company
Share capital
Reserves
35,496
17,223,941
35,496
16,953,391
35,496
16,493,123
Equity attributable to owners of the
Company
Non-controlling interests
17,259,437
99,922
16,988,887
153,666
16,528,619
63,165
Total equity
17,359,359
17,142,553
16,591,784
Note
10
— 53 —
Notes:
1.
BASIS OF PREPARATION
This condensed consolidated interim financial report has been prepared in accordance with Hong Kong
Accounting Standard 34 (“HKAS 34”) “Interim Financial Reporting” issued by the Hong Kong Institute
of Certified Public Accountants (the “HKICPA”) and the applicable disclosure requirements of the Rules
Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the “Listing Rules”).
This condensed consolidated interim financial report contains consolidated financial results and selected
explanatory notes. The notes include an explanation of events and transactions that are significant to an
understanding of the changes in financial position and performance of the Group since the 2025 annual
financial statements. Upon approval of the condensed consolidated financial statements, the directors of the
Company have a reasonable expectation that the Group has adequate resources to continue in operational
existence for the foreseeable future. Accordingly, they continue to adopt the going concern basis of
accounting in preparing the condensed consolidated financial statements.
The financial information relating to the financial year ended 31 December 2025 included in this
consolidated interim financial report as being previously reported information does not constitute the
Company’s statutory financial statements for that financial year but is derived from those financial
statements. Statutory financial statements for the year ended 31 December 2025 are available from the
Company’s registered office. The auditor has expressed an unqualified opinion on those financial statements
in their report dated 26 March 2026.
2.
MERGER ACCOUNTING FOR BUSINESS COMBINATION INVOLVING ENTITIES UNDER
COMMON CONTROL
On 31 December 2025, the Company, as the purchaser, entered into an agreement with China Grand and
Wuhan Jiuxiang Biotechnology Partnership (Limited Partnership) in relation to the acquisition of the entire
100% equity interests in Hebei Jiufu and Baoding Jiahe, for a total consideration of RMB316 million. Hebei
Jiufu and its subsidiaries are principally engaged in the production and sales of amino acid products, while
Baoding Jiahe is principally engaged in the processing, manufacturing and sales of mercaptan products.
At the time of the acquisition, China Grand was the controlling shareholder of Hebei Jiufu and Baoding
Jiahe, holding 81.3217% equity interest in Hebei Jiufu and 81.3217% equity interest in Baoding Jiahe. In
respect of the acquisition, since China Grand is also the controlling shareholder of the Company, indirectly
holding approximately 53.42% of the total issued share capital of the Company, the acquisition is regarded
as a business combination involving entities under common control and is accounted for using the principles
of merger accounting.
Accordingly, the comparative condensed consolidated statement of profit or loss and other comprehensive
income for the six months ended 30 June 2025, and the condensed consolidated statement of financial
position as at 31 December 2025 and 1 January 2025 have been restated to include the assets and liabilities,
profits and cash flows of the combined entities from the date when they first came under common control.
The application of merger accounting for the Acquisition resulted in an increase in total comprehensive
income attributable to owners of the Company and profit attributable to owners of the Company for the six
months ended 30 June 2025 by HKD26.18 million and HKD24.15 million, respectively.
— 54 —
The effects of the merger accounting restatement on each item in the condensed consolidated statement of
profit or loss and other comprehensive income for the six months ended 30 June 2025 are as follows:
For the six
months ended
30 June
2025
HK$’000
(Unaudited)
(As originally
presented)
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
For the six
months ended
30 June
2025
HK$’000
(Unaudited)
(Restated)
Revenue
Cost of sales
6,107,323
(2,507,159)
81,873
(28,998)
6,189,196
(2,536,157)
Gross profit
Other income and losses, net
Distribution costs
Administrative expenses
Fair value change on financial assets at fair value
through profit or loss
Share of results of associates
Finance costs
3,600,164
203,578
(1,916,285)
(691,751)
52,875
1,827
(3,158)
(13,722)
3,653,039
205,405
(1,919,443)
(705,473)
174,593
57,944
(80,350)
–
–
(1,645)
174,593
57,944
(81,995)
Profit before tax
Income tax expense
1,347,893
(174,023)
36,177
(6,746)
1,384,070
(180,769)
Profit for the period
1,173,870
29,431
1,203,301
Other comprehensive income/(loss), net of income
tax
Items that will not be reclassified to profit or loss:
Changes in fair value of equity investments recognised
in other comprehensive income at fair value
Share of other comprehensive income associates
Item that may be reclassified subsequently to profit or
loss:
Exchange difference on translating foreign operations
24,155
(29,212)
–
–
24,155
(29,212)
421,201
2,441
423,642
Other comprehensive income for the period, net of
income tax
416,144
2,441
418,585
Total comprehensive income for the period, net of
income tax
1,590,014
31,872
1,621,886
Profit for the period attributable to:
-Owners of the Company
-Non-controlling interests
1,169,019
4,851
24,148
5,283
1,193,167
10,134
1,173,870
29,431
1,203,301
1,589,226
788
26,176
5,696
1,615,402
6,484
1,590,014
31,872
1,621,886
0.69
34.07
Total comprehensive profit for the period
attributable to:
-Owners of the Company
-Non-controlling interests
Dividends
–
Earnings per share
-Basic and diluted (HK cents)
33.38
— 55 —
The effects of the merger accounting restatement in respect of the above acquisition on each item in the
condensed consolidated statement of financial position as at 31 December 2025 are as follows:
As at
31 December
2025
HK$’000
(Unaudited)
(As originally
presented)
Non-current assets
Property, plant and equipment
Right-of-use assets
Investment properties
Interests in associates
Equity instruments at fair value through other
comprehensive income
Goodwill
Intangible assets
Deferred tax assets
Prepayments
Current assets
Inventories
Trade and other receivables
Amounts due from related companies
Financial assets at fair value through profit or loss
Pledged bank deposits
Cash and cash equivalents
Current liabilities
Trade and other payables
Contract liabilities
Bank and other borrowings
Lease liabilities
Amounts due to related companies
Amount due to the immediate holding company
Income tax payable
Net current assets
Total assets less current liabilities
— 56 —
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
As at
31 December
2025
HK$’000
(Unaudited)
(Restated)
4,332,283
492,214
176,694
7,604,716
74,892
8,741
–
–
4,407,175
500,955
176,694
7,604,716
209,656
1,676,875
3,269,431
70,632
1,026,776
–
54,813
1,340
7
1,937
209,656
1,731,688
3,270,771
70,639
1,028,713
18,859,277
141,730
19,001,007
1,484,191
4,679,486
54,723
924,169
22,588
1,142,370
33,447
53,104
(1,948)
–
–
40,027
1,517,638
4,732,590
52,775
924,169
22,588
1,182,397
8,307,527
124,630
8,432,157
3,936,683
323,926
2,828,720
12,646
16,778
2,331
195,627
67,279
13,876
64,316
2,195
29,718
–
2,391
4,003,962
337,802
2,893,036
14,841
46,496
2,331
198,018
7,316,711
179,775
7,496,486
990,816
(55,145)
935,671
19,850,093
86,585
19,936,678
As at
31 December
2025
HK$’000
(Unaudited)
(As originally
presented)
Non-current liabilities
Bank and other borrowings
Lease liabilities
Deferred tax liabilities
Other payables
Deferred income
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
As at
31 December
2025
HK$’000
(Unaudited)
(Restated)
1,840,763
40,277
367,265
105,798
316,305
–
–
–
118,873
4,844
1,840,763
40,277
367,265
224,671
321,149
2,670,408
123,717
2,794,125
Net assets
17,179,685
(37,132)
17,142,553
Capital and reserves attributable to owners of
the Company
Share capital
Reserves
35,496
16,981,543
–
(28,152)
35,496
16,953,391
Equity attributable to owners of the Company
Non-controlling interests
17,017,039
162,646
(28,152)
(8,980)
16,988,887
153,666
Total equity
17,179,685
(37,132)
17,142,553
— 57 —
The effects of the merger accounting restatement in respect of the above acquisition on each item in the
condensed consolidated statement of financial position as at 1 January 2025 are as follows:
As at
1 January
2025
HK$’000
(Unaudited)
(As originally
presented)
Non-current assets
Property, plant and equipment
Right-of-use assets
Investment properties
Interests in associates
Equity instruments at fair value through other
comprehensive income
Goodwill
Intangible assets
Deferred tax assets
Prepayments
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
As at
1 January
2025
HK$’000
(Unaudited)
(Restated)
3,784,285
481,783
174,356
7,791,030
80,020
8,557
–
–
3,864,305
490,340
174,356
7,791,030
247,724
1,299,741
2,082,728
33,456
1,070,540
–
52,604
7,183
7
3,130
247,724
1,352,345
2,089,911
33,463
1,073,670
16,965,643
151,501
17,117,144
1,370,582
3,454,589
59,411
1,799,961
1,340,979
63,649
65,180
(7,877)
–
10,107
1,434,231
3,519,769
51,534
1,799,961
1,351,086
8,025,522
131,059
8,156,581
2,928,087
242,719
3,127,347
18,315
13,151
2,331
241,273
118,073
–
88,755
2,107
–
–
2,705
3,046,160
242,719
3,216,102
20,422
13,151
2,331
243,978
6,573,223
211,640
6,784,863
Net current assets
1,452,299
(80,581)
1,371,718
Total assets less current liabilities
18,417,942
70,920
18,488,862
Current assets
Inventories
Trade and other receivables
Amounts due from related companies
Financial assets at fair value through profit or loss
Cash and cash equivalents
Current liabilities
Trade and other payables
Contract liabilities
Bank and other borrowings
Lease liabilities
Amounts due to related companies
Amount due to the immediate holding company
Income tax payable
— 58 —
As at
1 January
2025
HK$’000
(Unaudited)
(As originally
presented)
Non-current liabilities
Bank and other borrowings
Lease liabilities
Deferred tax liabilities
Deferred income
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
As at
1 January
2025
HK$’000
(Unaudited)
(Restated)
1,256,280
40,604
300,351
295,369
–
–
–
4,474
1,256,280
40,604
300,351
299,843
1,892,604
4,474
1,897,078
Net assets
16,525,338
66,446
16,591,784
Capital and reserves attributable to owners of
the Company
Share capital
Reserves
35,496
16,437,714
–
55,409
35,496
16,493,123
Equity attributable to owners of the Company
Non-controlling interests
16,473,210
52,128
55,409
11,037
16,528,619
63,165
Total equity
16,525,338
66,446
16,591,784
— 59 —
3.
CHANGES IN ACCOUNTING POLICIES
This condensed consolidated financial report has been prepared on the historical cost basis, except for
certain financial instruments that are measured at fair value, where applicable.
Except for other accounting policies/changes in accounting policies resulting from the application of
amendments to HKFRS Accounting Standards, the accounting policies and methods of computation used in
the condensed consolidated financial statements for the six months ended 30 June 2026 are consistent with
those presented in the Group’s annual consolidated financial statements for the year ended 31 December
2025.
Application of amendments to HKFRS Accounting Standards
In the current interim period, the Group has applied the following amendments to HKFRS Accounting
Standards issued by the HKICPA for the first time, which are mandatorily effective for the annual periods
beginning on or after 1 January 2026 for the preparation of the Group’s condensed consolidated financial
statements:
Amendments to HKFRS 9 and HKFRS 7
Amendments to HKFRS 9 and HKFRS 7
Amendments to HKFRS Accounting
Standards
Classification and Measurement of Financial Instruments
Contracts Referencing Nature-dependent Electricity
Annual Improvements to HKFRS Accounting Standards –
Volume 11
The application of the amendments to HKFRS Accounting Standards in the current period has had no
material impact on the Group’s financial positions and performance for the current and prior periods and/or
on the disclosures set out in these condensed consolidated financial statements.
4.
REVENUE AND SEGMENT INFORMATION
For the six months ended 30 June 2026, the Group’s operations consistently constitute only one single
reportable segment, namely the manufacture and sales of pharmaceutical technology products,
biotechnology products and nuclear medicine anti-tumor diagnosis and treatment and cerebro-cardiovascular
precision interventional diagnosis and treatment technology products. The Board, being the chief operating
decision maker of the Group, reviews the operating results of the Group as a whole to make decisions about
resource allocation. The operation of the Group constitutes one single reportable segment under HKFRS 8
and accordingly, no separate segment information is prepared.
The Group’s revenue represents the invoiced value of goods sold, net of discounts and sales related taxes.
— 60 —
Geographical information
The Group’s operations are mainly located in the People’s Republic of China (the “PRC”) (country of
domicile) and it also derives revenue from America, Europe and Asia.
Information about the Group’s revenue from external customers is presented based on geographical location
of the customers and information about the Group’s non-current assets is presented based on geographical
location of the assets are detailed below:
Revenue from external customers
Six months ended 30 June
Non-current assets
30 June
31 December
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
2026
HK$’000
(Unaudited)
2025
HK$’000
(Unaudited)
(Restated)
The PRC
Americas
Europe
Asia, other than the PRC
Others
5,295,014
565,770
242,358
253,941
31,830
5,370,813
373,186
229,197
184,721
31,279
13,759,994
250,827
–
106,922
–
13,079,416
261,327
–
103,689
–
Total
6,388,913
6,189,196
14,117,743
13,444,432
Note:
Non-current assets excluded equity instruments at fair value through other income, deferred tax
assets and a part of interests in associates.
Information about major customers
For the six months ended 30 June 2026 and 2025, none of the Group’s revenue from a single customer
amounted to 10% or more of the Group’s total revenue.
— 61 —
Revenue
Revenue from contracts with customers
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Type of goods and services
Manufacture and sales of pharmaceutical technology products
Sales of biotechnology products
Sales of nuclear medicine anti-tumor diagnosis and treatment and
cerebro-cardiovascular precision interventional diagnosis and
treatment technology products
3,274,083
2,369,701
3,845,193
1,766,260
745,129
577,743
Revenue recognised at point in time
6,388,913
6,189,196
Revenue disclosed in segment information
External customers
6,388,913
6,189,196
Timing of revenue recognition
At a point in time
6,388,913
6,189,196
All of the Group’s revenue are recognised at point in time upon arrival of carrier designated by the
customers, or after the customer’s acceptance or upon transfer of control of the goods to customer. All
revenue contracts are for period of one year or less, as permitted by practical expedient under HKFRS 15,
the transaction price allocated to these unsatisfied contacts is not disclosed.
5.
INCOME TAX EXPENSES
Taxation in the condensed consolidated statement of profit or loss and other comprehensive income
represents:
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Current tax
Deferred tax
— 62 —
245,202
(55,727)
189,434
(8,665)
189,475
180,769
Under the two-tiered profits tax rates regime, the first HK$2,000,000 of assessable profits of the qualifying
group entity will be taxed at 8.25% and assessable profits above HK$2,000,000 wIll be taxed at 16.5%. The
assessable profits of group entity not qualifying for the two-tiered profits tax rates regime will continue to
be taxed at a flat rate of 16.5%.
Under the Law of the People’s Republic of China on Enterprise Income Tax (the “EIT Law”) and
Implementation Regulation of the EIT Law, the tax rate of the PRC subsidiaries is 25% from 1 January
2008 onwards.
According to the relevant PRC tax regulations, High-New Technology Enterprise (the “HNTE”) being
assessed by relevant government authorities are entitled to a reduced Enterprise Income Tax (the “EIT”)
rate of 15%. Certain subsidiaries are recognised as HNTE and accordingly, are subject to EIT at 15%. The
recognition as a HNTE is subject to review on every three years by the relevant government bodies.
6.
PROFIT FOR THE PERIOD
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Profit for the year is stated after charging:
Staff costs comprises:
– Wages and salaries
– Retirement benefits schemes contributions
1,084,957
92,334
1,095,557
89,955
1,177,291
1,185,512
Depreciation of property, plant and equipment
Depreciation of right-of-use assets
Amortisation of intangible assets
194,336
16,603
138,556
185,847
24,875
84,278
Total depreciation and amortisation
349,495
295,000
3,011,784
2,487
263,179
2,536,157
3,574
280,611
Cost of inventories recognised as an expense
Operating leases rentals in respect of land and buildings
Research and development costs
7.
INTERIM DIVIDEND
During the six months ended 30 June 2026, the Board declared and paid HK$0.169 per share or
approximately HK$591.81 million in aggregate as final dividend for the year ended 31 December 2025
(2025: HK$0.26 per share or approximately HK$910.471 million in aggregate).
No interim dividend has been paid or declared by the Company for the six months ended 30 June 2026 (six
months ended 30 June 2025: Nil).
— 63 —
8.
EARNINGS PER SHARE
Basic earnings per share is calculated by dividing the profit attributable to equity owners of the Company
by the weighted average number of ordinary shares outstanding during the period, excluding ordinary shares
purchased by the Group and held as treasury shares.
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Earnings:
Earnings for the purpose of basic earnings per share calculation
Number of shares:
Weighted average number of ordinary shares for the purpose of basic
earnings per share calculation (Note)
1,061,538
1,193,167
’000
(Unaudited)
’000
(Unaudited)
(Restated)
3,501,810
3,501,810
Note:
As at 30 June 2026 and 30 June 2025, treasury shares are deducted from total shares in issue for the
purpose of calculating earnings per share.
Diluted earnings per share is the same as the basic earnings per share for the six months ended 30 June
2026 and 2025 as there were no potential dilutive ordinary shares in issue.
9.
TRADE AND OTHER RECEIVABLES
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
Trade receivables, net
Bills receivables
Deposits and prepayments
Other tax receivables
Other receivables, net
3,919,472
505,508
2,041,189
160,090
99,228
1,798,997
1,727,468
1,869,788
167,440
197,610
Less: non-current portion of prepayments
6,725,487
(1,328,248)
5,761,303
(1,028,713)
5,397,239
4,732,590
— 64 —
The Group generally allows a credit period of 30 – 180 days to its trade customers. The Group does not
hold any collaterals over the trade and other receivables. The following is an aged analysis of trade
receivables presented based on the invoice date at the reporting date. The bills receivables were all with
maturity within 180 days from the reporting date.
The ageing analysis of the trade receivables is as follows:
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
2,375,923
802,277
741,272
1,413,503
247,698
137,796
3,919,472
1,798,997
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
Trade payables
Bills payables
Accruals and other payables
Other tax payables
1,191,717
791,297
2,412,858
175,906
903,878
968,855
2,227,621
128,279
Less: non-current portion of other payables
4,571,778
(569,068)
4,228,633
(224,671)
4,002,710
4,003,962
200,406
337,802
Within 90 days
91-180 days
181-365 days
10.
TRADE AND OTHER PAYABLES
Contract liabilities (note (a))
— 65 —
Notes:
(a)
Contract liabilities in relation to sales of finished goods are expected to be settled within one year.
The following is an aged analysis of trade payables presented based on the invoice date at the end of the
reporting period:
Within 90 days
Over 90 days
11.
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
479,298
712,419
506,493
397,385
1,191,717
903,878
CONTINGENT LIABILITIES
The Group has no significant contingent liabilities as at 30 June 2026 (31 December 2025: Nil).
— 66 —
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其
準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而
產生或因倚賴該等內容而引致的任何損失承擔任何責任。
GRAND PHARMACEUTICAL GROUP LIMITED
遠 大 醫 藥 集 團 有 限 公 司*
(於百慕達註冊成立之有限公司)
(股份代號: 00512)
二零二六年中期業績公佈
財務摘要
-
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 集 團 的 業 務 穩 健 增 長,收 益 約 港 幣
6,388,910,000元(去 年 同 期 重 述1:港幣6,189,200,000元),同 比 上 漲 約3.2%。創新和
壁壘產品2收益佔總收益的比例約50%。
-
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 公 司 擁 有 人 應 佔 期 內 溢 利 約 為 港 幣
1,061,540,000元(去 年 同 期 重 述:港 幣1,193,170,000元)。期 內,本 集 團 對Telix投 資
的 公 允 價 值 變 動 和 處 置 合 計 收 益 約 港 幣88,780,000元(去 年 同 期 收 益:港 幣
151,720,000元),與去年同期相比減少了港幣62,940,000元,如果撇除Telix投資對利
潤的影響,本期的本公司擁有人應佔經調整的經營性純利3約為港幣972,760,000元(去
年同期重述:港幣1,041,440,000元)。
-
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 集 團 核 藥 抗 腫 瘤 板 塊 錄 得 收 益 約 港 幣
655,240,000元,較 二 零 二 五 年 同 期(約 港 幣421,780,000元)比 較 上 漲 約55.4%,其 上
漲主要因為核心產品的臨床需求快速增長以及新產品快速放量所帶來的收入增長。
—1—
-
本集團堅定落實創新驅動和Go Global戰略,優化研發資源配置,聚焦核藥抗腫瘤、
重症抗感染等高壁壘賽道,同時佈局mRNA創新葯、眼科創新葯等前沿領域,依托
全鏈條研發平台打造短中長期階梯式創新管線,研發轉化效率持續改善。本集團全
球 化 臨 床 及「中 美 雙 報」註 冊 體 系 成 熟,多 款 產 品 獲 國 際 藥 監 機 構 臨 床 許 可;核 心
產品臨床成果登上國際頂級期刊,相繼納入國內外權威診療指南,有力支撐商業化
進 程。本 集 團 現 擁 有30餘 項 高 價 值 在 研 創 新 項 目,2027-2028年 迎 來 研 發 里 程 碑 集
中兌現,充足的管線儲備將為長期發展帶來增長動能。
附註:
1.
於二零二六年上半年,本公司成功收購河北遠大九孚生物科技有限公司(「河北九孚」)和保定加合精
細化工有限公司(「保定加合」)100%股權。於收購時點,中國遠大集團有限責任公司(「中國遠大」)為
河北九孚和保定加合的控股股東,且同時為本公司的控股股東,故此收購事項被視為涉及受共同控
制實體之業務合併,並採用合併會計法原則入賬。因此,截至二零二五年六月三十日止六個月之比
較簡明綜合損益及其他全面收益表以及於二零二五年十二月三十一日及二零二五年一月一日之簡明
綜合財務狀況表已重列,藉此納入合併實體自其首次受共同控制之日起計之資產及負債、溢利以及
現金流量。具體請參見簡明綜合財務報表附註2。
2.
創新和壁壘產品指公司原研產品、獨家市場地位產品、擁有獨家商業化權益的產品以及打破外資壟
斷的首仿產品。
3.
本公司擁有人應佔經調整的經營性純利界定為本公司擁有人應佔期內溢利但不包括Telix投資的公允
價值變動和處置收益的影響。
—2—
管理層討論及分析
企業定位
本集團是一家科技創新型國際化醫藥企業,核心業務橫跨核藥抗腫瘤診療及心腦血管精
準介入診療科技、製藥科技、生物科技三大領域。本集團以醫藥及生物工業為基礎,以患
者 需 求 為 核 心,以 科 技 創 新 為 源 動 力,針 對 尚 未 滿 足 的 臨 床 需 求,加 大 對 全 球 創 新 產 品
和 先 進 技 術 的 投 入,豐 富 和 完 善 產 品 管 線,鞏 固 和 強 化 產 業 鏈 佈 局,充 分 發 揮 本 集 團 的
產業優勢和研發實力,為全球患者提供更先進更多樣的治療方案。
經過近年的不懈努力,本集團發展基礎更加穩健,經營規模更加鞏固,業務結構逐步優化,
經營方式持續提升,轉型升級步伐加快,創新佈局多點開花。本集團盈利能力持續增強,
助力研發創新;良好的併購與整合能力,繼續鞏固發展規模;原料製劑一體化,完善產業
鏈結構;業務與實體多元化,有效加強綜合優勢。
「穩 增 長、強 創 新、謀 佈 局」,本 集 團 將 繼 續 秉 承「綜 合 優 勢、創 新 引 領 和 全 球 拓 展」的 發
展理念,採用「自主研發和全球拓展雙輪驅動,全球化運營佈局和雙循環經營發展」策略,
形成國內國外雙循環聯動發展並相互促進的新格局,致力於成為一家受醫生和患者尊重
並還原於社會的科技創新型國際化醫藥企業。
業務回顧及前景
於二零二六年至本公告日期止,本集團共有18項重要里程碑進展,其中創新產品8項,仿
製產品6項;原料藥產品3項;重要合作1項。同時,本集團易甘泰®釔[90Y]微球注射液、液
體栓塞劑LavaTM等創新和壁壘產品的持續快速放量以及生物科技板塊核心產品的量價齊升,
成功助力本集團業績的穩健增長。
—3—
創新產品
核藥抗腫瘤診療:
-
-
-
用 於 診 斷 前 列 腺 癌 的 全 球 創 新RDC產 品TLX591-CDx的 新 藥 上 市 申 請(NDA)獲 得 中
華人民共和國國家藥品監督管理局(「中國藥監局」)受理;
全 球 創 新 放 射 性 產 品SIR-Spheres ®釔[90Y]微 球 注 射 液 在 美 國 開 展 的 治 療 原 發 性 肝 細
胞癌(HCC)臨床研究達到了臨床終點;
用於診斷實體瘤的全球創新放射性核素偶聯藥物(「RDC」)GPN01530-2獲得美國食品
藥品監督管理局(「FDA」)授予的快速通道資格(Fast Track Designation,「FTD」)。
心腦血管精準介入診療:
-
用於腔內影像診斷的創新器械GPG04862獲中國藥監局批准上市。
呼吸及危重症:
-
用於抗感染的化藥1類創新藥物GPN01411獲得中國藥監局批准開展I期臨床研究;
五官科:
-
-
-
用於治療蠕形蟎瞼緣炎的全球創新眼科藥物TP-03獲得中國藥監局批准上市;
治療抑鬱症的中藥1.1類創新藥GPN01360在中國開展的III期臨床研究完成首例患者入
組給藥;
用於預防性治療偏頭痛的中藥1.1類創新藥GPN01020獲中國藥監局批准在中國開展II
期臨床研究。
仿製產品
有6款產品獲得中國藥監局批准上市。
原料產品
有3款原料藥產品獲得中國藥監局批准上市。
—4—
重要合作
本集團與香港大學及其全資子公司港大科橋有限公司(「港大科橋」)達成戰略合作。雙方
將 於 學 術 研 究、資 源 分 享、人 才 培 養 以 及 產 品 開 發 等 方 面 展 開 深 度 合 作,合 力 推 進 抗 感
染領域的創新藥物研發與成果產業化落地。
業務介紹
本集團科技創新實力強勁、國際化實力突出、工業基礎雄厚,產業鏈完整,原料製劑一體
化綜合優勢顯著。本集團有超過130款產品列入「國家基本藥物目錄」
(2026年版),有超過
260款產品入選「國家基本醫療保險、工傷保險和生育保險藥品目錄(2025年版)」。
核藥抗腫瘤診療及心腦血管精準介入診療科技
本集團充分發揮「精準和穩健的海內外業務拓展能力,國際領先技術的引進消化落地能力
和優秀的市場推廣銷售能力」,瞄準科技創新前沿領域,重點佈局「核藥抗腫瘤診療」以及
「心腦血管精準介入診療」板塊,已成為中國核藥抗腫瘤診療的龍頭企業和具備國際前沿
技術的全方位心腦血管精準介入診療科技平台。
核藥抗腫瘤診療板塊
本集團在核藥抗腫瘤診療板塊已實現了研發、生產、配送、銷售等多個環節的全方位佈局,
板塊全球員工超過1200人,以波士頓、成都為核心的研發基地,波士頓、法蘭克福、新加
坡、成 都 所 在 的 生 產 基 地 以 及 覆 蓋 全 球50多 個 國 家 和 地 區 的 銷 售 網 絡 為 基 礎,本 集 團 已
實現了全球化的核藥產業鏈佈局。
—5—
作為本集團核藥全球化產業佈局的國內核心研發及生產載體,位於成都的遠大醫藥放射
性藥物研發及生產基地於二零二五年四月竣工驗收,同年五月獲得國家生態環境部頒發
的甲級《輻射安全許可證》,並於六月底正式投入運營。該基地為全球首個核藥全產業鏈
閉環平台,覆蓋「同位素製備-核藥研發-生產-臨床-商業化」全鏈條,形成從早期研發
到臨床轉化到上市銷售的全生命周期管理能力,研發效率國際領先;解決了核藥「卡脖子」
難 題,100%自主 生 產 破 解 進 口 依 賴 困 局,14條 高 標 準GMP生 產 線 實 現 多 品 種、規模化製
備 需 求;建 立 全 流 程 智 能 管 理 體 系,核 電 級 安 全 與 無 人 化 智 造,可 實 現 輻 射「零 泄 漏」,
污染「零外排」,職業照射「零超標」,達到全球頂尖核設施標準;建立世界一流研發生產
質 量 與 運 營 體 系,是 目 前 國 際 範 圍 內 核 素 種 類 最 全、自 動 化 程 度 最 高 的 智 能 工 廠 之 一。
該研發及生產基地將進一步夯實本集團核藥產業的基礎,加速全球創新研發管線的落地,
推 動 本 集 團 實 現 核 藥 產 業 的 高 質 量 發 展,培 育 高 價 值 重 磅 品 種,為 本 集 團 放 射 性 藥 物 的
國產化落地奠定堅實的基礎。
本集團聯合Sirtex並與Telix Pharmaceutical Limited(「Telix」)和ITM Isotope Technologies
Munich SE(「ITM」)合作,搭建了具有國際化一流水平的腫瘤介入技術平台和RDC技術平
台。圍 繞 腫 瘤 診 療 一 體 化 的 治 療 理 念,目 前 在 研 發 註 冊 階 段 已 儲 備14款 創 新 產 品,涵 蓋
68
Ga、177Lu、131I、90Y、89Zr在 內 的5種 放 射 性 核 素,覆 蓋 了 肝 癌、前 列 腺 癌、腦 癌 等 在 內
的7個 癌 種;早 期 研 發 階 段 以RDC藥 物 為 主,產 品 儲 備10餘 款。在 產 品 種 類 方 面,涵 蓋 診
斷 和 治 療 兩 類 核 素 藥 物,為 患 者 提 供 多 適 應 症 治 療 選 擇、多 手 段 且 診 療 一 體 化 的 全 球 領
先的抗腫瘤方案。
板 塊 內 創 新 產 品 全 球 研 發 工 作 順 利 推 進。中 國 方 面,易 甘 泰®釔[90Y]微 球 注 射 液 於 二 零
二二年一月順利上市,用於治療結直腸癌肝轉移(「mCRC」),並於二零二五年五月獲得
中國藥監局批准開展治療不可切除肝細胞癌(「HCC」)的II期註冊性臨床試驗;全球創新
溫度敏感性栓塞劑GPN00289於二零二五年十月完成了註冊性臨床研究的全部患者入組。
海外註冊方面,SIR-Spheres ®釔[90Y]微球注射液在美國提前正式獲批新適應證,用於治療
不可切除HCC;本集團自主研發的全球創新靶向FAP的小分子放射性核素偶聯藥物(「RDC」)
GPN01530-2在美國獲批開展用於診斷實體瘤的I/II期臨床研究並獲得FDA授予的快速通道
資格,該產品是本集團首款獲得FDA批准開展臨床研究的自研RDC產品,其臨床研究的成
功獲批為本集團核藥產品管線的國際化開發提供了重要範式,同時也充分體現了本集團
在 前 沿 核 藥 技 術 平 台 建 設、國 際 化 臨 床 開 發 與 註 冊 申 報 等 方 面 的 綜 合 實 力。截 止 到 目 前
為 止,本 集 團 在 全 球 範 圍 內 共 有 六 款 創 新RDC藥 物 獲 批 開 展 註 冊 性 臨 床 研 究,其 中 診 斷
前列腺癌的產品TLX591-CDx已進入NDA階段,三款進入III期臨床階段,包括治療前列腺
癌 的 產 品TLX591、診 斷 透 明 細 胞 腎 細 胞 癌 產 品TLX250-CDx以 及 治 療GEP-NETs的 產 品
ITM-11。未 來,本 集 團 將 持 續 加 強 核 藥 抗 腫 瘤 診 療 板 塊 的 研 發 和 建 設,豐 富 和 完 善 產 品
管線及產業佈局,形成以易甘泰 ®釔[90Y]微球注射液為核心的核藥抗腫瘤診療產品集群,
持續夯實本集團在全球核藥抗腫瘤診療領域領軍企業地位。
—6—
核心產品
全球創新產品易甘泰®釔[90Y]微球注射液:
本 集 團 重 磅 全 球 創 新 產 品 易 甘 泰®釔[90Y]微 球 注 射 液 於 二 零 二 二 年 一 月 獲 得 中 國 藥 監 局
的上市許可,批准用於經標準治療失敗的不可手術切除的mCRC患者的治療,於二零二五
年七月,基於DOORwaY90臨床試驗的突破性中期結果,FDA提前正式批准用於治療不可
切 除HCC的 新 增 適 應 症,於 二 零 二 六 年 四 月 完 成 全 部 臨 床 研 究 並 成 功 達 到 臨 床 終 點。易
甘 泰 ®釔[90Y]微 球 注 射 液 是 全 球 首 個 且 目 前 唯 一 獲FDA批 准 用 於 治 療 不 可 切 除HCC和
mCRC雙重適應症 的 選 擇 性 內 放 射 治 療「SIRT」產 品,在 全 球 共 有50多 個 國 家 和 地區超過
了15萬人次使用,並被巴賽羅那臨床肝癌指南(BCLC)、美國國立綜合癌症網絡(NCCN)、
歐洲腫瘤內科學會(ESMO)肝 細 胞 癌 診 斷、治 療 和 隨 訪 臨 床 實 踐 指 南(2025版)、歐 洲 肝
臟研究學會(European Association for the Study of the Liver,EASL)肝細胞癌指南(2025
版)、英國國家健康照護專業組織(National Institute for Health and Care Excellence,NICE)
等多個國際權威機構的治療指南推薦,並進入了《原發性肝癌診療指南(2026版)》、《CSCO
原發性肝癌診療指南(2024版)》、《結直腸癌肝轉移診斷和綜合治療指南(2025版)》、《中
國肝癌肝移植臨床實踐指南(2021版)》等多項中國權威的臨床實踐指南當中。
—7—
二零二二年五月,易甘泰®釔[90Y]微球注射液在中國正式投入應用,中國肝部惡性腫瘤治
療 邁 入 了 全 新 的「釔 時 代」。自 易 甘 泰®正 式 上 市 後,中 國 已 有 超 過110家 醫 院 完 成 了 核 素
轉 讓 手 續,正 式 手 術 已 在22個 省、直 轄 市 的70餘 家 醫 院 展 開。為 加 快 易 甘 泰®微 球 注 射 液
精 準 介 入 治 療 手 段 在 中 國 的 落 地 與 普 及,本 集 團 依 據 中 國 藥 監 局 及 美 國FDA批 准 的 術 者
督 導 培 訓 體 系,集 中 全 球 資 源 對 中 國 國 內 術 者 提 供 患 者 篩 選 知 識、手 術 操 作 技 巧、預 後
評估方法等全方位培訓,幫助醫生掌握和積累臨床經驗以保證產品更加廣泛安全有效的
應 用,通 過 海 外 知 名 臨 床 專 家 協 助 國 內 醫 師 進 行 了 多 次 特 性 化 的 實 操 培 訓。目 前,已 建
立9個 手 術、治 療 及 培 訓 中 心,並 對80家 醫 院 超 過1,200名 醫 生 進 行 了 易 甘 泰®手 術 理 論 或
技能培訓,已有超過340名醫師獲得易甘泰®手術醫師登記。其中161名醫師通過了國際和
國內著名專家一對一的嚴格培訓,獲取了獨立手術的操作資格,120名醫師具備助理手術
操作資質。另外有32位專家已經獲得培訓導師的資格,將進一步加快易甘泰 ®放射性介入
操作的臨床普及。
自上市以來,易甘泰®釔[90Y]微球注射液已進入北京普惠健康保、上海滬惠保、武漢福漢
康、重 慶 渝 快 保、南 京 甯 惠 保 等50多 個 惠 民 保 和1個 特 藥 險,覆 蓋 超 過30個 省 級 行 政 區,
100餘個城市,大大增加肝癌患者對該產品的可及性。
學術研究方面,中國大陸研究者發表了大量易甘泰®釔[90Y]微球注射液的高價值真實世界
數據:在美國臨床腫瘤學會胃腸道腫瘤(ASCO GI)研討會、美國臨床腫瘤學會(ASCO)年
會、歐洲腫瘤內科學會亞洲(ESMO Asia)年會、亞太原發性肝癌專家聯盟(APPLE)會議、
亞太肝膽胰協會(A-PHPBA)年會、亞洲腫瘤學會(AOS)年會、亞太肝病研究協會(APASL)
年會、國際肝膽胰協會(IHPBA)年會等國際頂級腫瘤及肝病領域學術會議上,累計發佈
海報展示100篇、口頭報告7篇。同時,相關研究成果持續登上國際權威期刊,其中高腫瘤
負荷患者對比肝動脈化療栓塞治療(Transcatheter Arterial Chemoembolization,TACE)的研
究發表於International Journal of Surgery;系統評估釔[90Y]樹脂微球在縮瘤及對側肝葉增
生方面雙重作用的回顧性研究發表於EJNMMI research,另有典型病例、綜述等數十篇成
果相繼見刊。上述研究覆蓋了肝癌全分期治療,針對早期患者,可開展放射性肝段消融術;
針 對 中 期 患 者,可 助 力 降 期 轉 化 至 肝 移 植 術╱肝 切 除 術,對 於10cm乃 至15cm的 巨 塊 肝 癌
展現出強效縮瘤效果;針對晚期患者,可聯合系統治療、TACE、肝動脈灌注化療(Hepatic
Artery Infusion Chemotherapy,HAIC)等治療方案,相較傳統治療為患者帶來更長生存獲
益,也 為 綜 合 治 療 經 治 的 患 者 提 供 了 通 向 治 愈 的 可 能。釔[90Y]樹 脂 微 球 治 療 的「中 國 方
案」,憑藉在國際頂級學術盛會與權威期刊的接連亮相和重磅成果展示,正日益獲得國際
學術界的廣泛關注與認可。
—8—
全球創新的液體栓塞劑LavaTM
Lava TM為 美 國 首 款 獲 批 用 於 治 療 外 周 血 管 動 脈 出 血 的 創 新 液 體 栓 塞 劑,該 產 品 具 有 不 透
射線屬性,成像過程中不易出現僞影,體現出更優的成像效果。Lava TM使用便捷,製備過
程只需2分鐘(同類產品製備過程約需要20分鐘),在緊急狀況下為醫生節省準備時間提高
患者生存概率;轉化後的固體栓塞提供兩種粘度選擇,針對不同情況的患者可靈活使用。
Lava TM可 以 與 放 射 性 同 位 素 的 近 距 離 放 射 療 法 和 介 入 療 法 產 生 協 同 作 用。該 產 品 已 於 二
零二三年四月在美國獲批上市並於同年十月正式實現商業化。
尿路上皮癌早檢產品橡鑫 • 優愛®
採用甲基化+基因突變雙靶點設計,根據超過1,000例的註冊性臨床研究的資料顯示,優愛
®
的 敏 感 性 達 到92.5%,特 異 性 達 到95.8%,臨 床 結 果 優 異,而 且 無 創,不 受 血 尿、結 石 等
外界因素干擾,有助於實現對尿路上皮癌患者的早發現、早診斷、早治療與早獲益。目前
該產品已經獲得了中國藥監局批准上市,並於二零二五年四月實現了首張商業化處方落地,
是 中 國 目 前 唯 一 獲 批 上 市 的 甲 基 化+基 因 突 變 雙 機 制 的 尿 路 上 皮 癌 早 檢 產 品,同 時 作 為
《CSCO尿路上皮癌診療指南(2025版)》、《膀胱癌早診早治專家共識(2024版)》、《中國癌
症篩查中心技術專家共識》等權威指南共識唯一推薦的產品,優愛®以「一管尿」,精準無
創的實現尿路上皮癌患者的早期診斷。
—9—
創新研發管線
核藥抗腫瘤診療板塊產品主要分為介入治療和RDC兩大類別。
介入治療:
全球創新溫度敏感性栓塞劑GPN00289:
GPN00289是一款獲得中國藥監局創新型醫療器械資質認定的溫度敏感性栓塞材料,用於
治 療 富 血 管 的 良 性 及 惡 性 腫 瘤。於 常 溫 下,凝 膠 具 有 良 好 的 流 動 性,通 過 微 導 管 輸 送 到
病 變 組 織 的 血 管 後,在 人 體 溫 度 下 凝 膠 形 成 從 末 梢 血 管 到 主 供 血 管 的 原 位 固 化,實 現 病
變 組 織 血 管 的 栓 塞,適 用 於 各 種 富 血 管 性 實 質 臟 器 腫 瘤,特 別 是 肝 臟 富 血 管 的 良 性 及 中
惡性腫瘤的栓塞治療。該產品已於二零二五年十月完成了註冊性臨床研究的全部患者入組,
目前,該產品的臨床研究與註冊申報工作正在順利推進中。
全球創新的液體栓塞劑KonaTM
適 用 於 腦 動 靜 脈 畸 形 的 術 前 栓 塞,該 產 品 具 有 短 暫 不 透 射 線 屬 性,射 線 不 透 性 將 隨 時 間
而遞減,可達成清晰的術後器官可視化效果。此外,Kona TM具有載藥特性潛力,有望裝載
其 他 化 藥 或 放 射 性 藥 物,開 發 全 新 的 藥 械 組 合 產 品,可 為 其 他 腫 瘤 或 血 管 疾 病 治 療 領 域
提供更為豐富的治療方案。目前Kona TM已向FDA遞交了上市前審批(Premarket Approval,
PMA)申請。
全球創新的實體瘤消融治療技術AuroLase®
AuroLase ®是一款用於前列腺癌組織消融的全球創新治療技術,利用一種具有光學可調性
的新型納米顆粒,通過靜脈遞送並富集在腫瘤中,選擇性地吸收鐳射能量,將光轉換成熱,
從 而 精 準 地 破 壞 腫 瘤 以 及 為 腫 瘤 供 血 的 血 管,而 不 會 嚴 重 破 壞 周 圍 的 健 康 組 織。與 外 科
手術、放射療法或傳統的替代性局灶療法相比,AuroLase ®療法可以最大程度地提高治療
效 果,同 時 最 大 程 度 地 減 少 與 手 術、放 射 線 和 替 代 性 局 灶 療 法 相 關 的 副 作 用。目 前 該 產
品已向FDA遞交了PMA申請。
RDC藥物:
目前有8款在研產品,多款產品於期內取得了重要進展。
— 10 —
全球創新型前列腺癌診療產品TLX591/TLX591-CDx:
TLX591是一款靶向前列腺特異性膜抗原(PSMA)的治療性RDC藥物,其海外早期臨床研究
顯示出了積極治療結果,影像學無進展生存期(rPFS)中位數為8.8個月,且安全性良好,該
產品已在海外開展了國際多中心III期臨床研究,並於二零二五年四月向中國藥監局遞交
了 加 入 國 際 多 中 心III期 臨 床 研 究 申 請,於 同 年 七 月 獲 得 中 國 藥 監 局 正 式 批 准。TLX591–
CDx是 靶 向PSMA的 診 斷RDC藥 物,可 與TLX591形 成 前 列 腺 癌 的 放 射 診 療 一 體 化 組 合。
TLX591-CDx於二零二一年十一月在澳大利亞獲批上市,同年十二月在美國獲批上市;於
二零二三年三月在美國批准擴展適應症,用於篩選可接受PSMA靶向放射性核素治療的前
列 腺 癌 患 者;二 零 二 五 年,TLX591-CDx在 歐 洲、美 洲 等 二 十 余 個 國 家 獲 批 商 業 化。
TLX591-CDx在中國開展的III期臨床研究已於二零二五年十二月成功達到臨床終點,根據
臨床頂線結果顯示,TLX591-CDx檢測腫瘤的總體陽性預測值(「PPV」)達94.8%(置信區間,
CI: 85.9%-98.2%)。對於復發在前列腺床區和轉移到盆腔外的軟組織、淋巴結和器官(非
骨轉移)的腫瘤,PPV為100.0%;對於復發在前列腺床區以外的盆腔區域(含淋巴結)的腫
瘤,PPV為94.7%;對 於 骨 轉 移,PPV為87.0%。同 時,該 試 驗 根 據 受 試 者 不 同 的 前列腺特
異 性 抗 原(「PSA」)基 線 水 平 進 行 分 組,TLX591-CDx在 所 有 的 分 組 中 均 顯 示 出 了 較 高 的
PPV,即 使 在 極 低 的PSA水 平 的 受 試 者 亞 組 中,PPV依 然 超 過 了90%,這 提 示 了TLX591CDx的PET成像檢測對於疑似生化復發的前列腺癌患者的早期診斷有著非常積極的臨床意
義。此外,超過三分之二(67.2%)的患者在TLX591-CDx的PET成像檢測後,其治療方案較
基線時的初始方案發生了調整。這表明TLX591-CDx的PET成像檢測對臨床決策具有重要
影響,可優化疑似生化復發的前列腺癌患者的臨床治療策略。目前,TLX591-CDx的上市
申請已獲中國藥監局受理。
全球創新型透明細胞腎細胞癌診療產品TLX250/TLX250-CDx:
TLX250與TLX250-CDx形 成 了 透 明 細 胞 腎 細 胞 癌(「 ccRCC 」)的 放 射 診 療 一 體 化 組 合。
TLX250-CDx在 二 零 二 零 年 七 月 獲FDA授 予 的 突 破 性 療 法,其 海 外III期 臨 床 研 究 在 二 零
二 二 年 十 一 月 成 功 達 到 臨 床 終 點。根 據 試 驗 結 果 顯 示,對 於 通 過 目 前 臨 床 常 用 診 斷 方 法
電 子 掃 瞄(CT)或 磁 力 共 振(MRI)提 示 存 在 腎 臟 腫 塊 但 無 法 判 斷 是 否 為ccRCC的 患 者,
TLX250-CDx正電子發射斷層成像(PET)在診斷ccRCC的敏感性和特異性上分別達到86%和
87%,遠超過FDA要求的預設閾值(敏感性和特異性均大於或等於70%),陽性預測值可達
93%,針對目前難以診斷的處於T1a期的早期ccRCC(即腫瘤局限於腎內,腫瘤最大徑少於
— 11 —
或等於4cm),TLX250-CDx診斷的敏感性和特異性分別達到85%和89%。這些突破性的臨
床結果表明,TLX250-CDx將有望為臨床提供一種準確性高且無創的ccRCC診斷方案,並
有潛力成為全新的ccRCC臨床診斷標準;此外,TLX250-CDx用於CAIX陽性實體瘤、膀胱
及尿路上皮癌的多項拓展適應症臨床研究也在全球範圍內同步推進中;中國註冊方面,
該產品已於二零二四年十一月完成了III期臨床研究的首例入患者入組給藥;TLX250正在
海外開展II期臨床研究。
全球創新型胃腸胰腺神經內分泌瘤(「GEP-NETs」)治療產品ITM-11:
ITM-11是一款基於放射性核素偶聯技術靶向殺傷治療GEP-NETs 的 RDC 產品,該產品是
將 無 載 體177Lu與 生 長 抑 素 類 似 物 偶 聯,通 過 與GEP-NETs表 面 高 水 平 表 達 的 生 長 抑 素 受
體(SSTR)結合殺傷腫瘤細胞。該產品獲得FDA和歐洲藥品管理局(「EMA」)的孤兒藥資格,
海外開展的III期臨床研究(COMPETE)已於二零二五年一月達到主要臨床終點,其在美國
的 新 藥 上 市 申 請 於 二 零 二 五 年 十 二 月 獲 得FDA正 式 受 理。中 國 註 冊 方 面,該 產 品 於 二 零
二三年四月獲得中國藥監局批准開展用於治療不可手術、進展性、SSTR+的GEP-NETs的I
期 臨 床 研 究,於 二 零 二 四 年 三 月 獲 得 中 國 藥 監 局 批 准 加 入 針 對 高 分 化 侵 襲 性2級 和3級、
SSTR+的GEP– NETs的國際多中心III期臨床研究(COMPOSE研究),並於二零二五年三月
完 成 了 首 例 患 者 入 組 給 藥;此 外,該 產 品 於 二 零 二 四 年 十 二 月 獲 得 中 國 藥 監 局 批 准 開 展
用 於 治 療 高 分 化1級 或2級、SSTR+的GEP-NETs的III期 橋 接 臨 床 研 究。該 產 品 有 望 實 現 對
GEP-NETs各階段病程的全方位覆蓋。
全球創新型膠質母細胞瘤治療產品TLX101:
TLX101是一款用於治療多形性膠質母細胞瘤的RDC藥物,可自由通過血腦屏障進入大腦,
並靶向膠質母細胞瘤過度表達的L型氨基酸轉運蛋白1(LAT-1)精準輻射癌細胞,促使其
雕亡以達到治療效果。該產品已獲FDA孤兒藥認定。早前TLX101的一項海外II期臨床試驗
(IPAX-Linz研究)的初步結果已證實了患者的獲益,該臨床結果表明,TLX101治療耐受性
良好,未發現嚴重不良事件,接受TLX101治療的患者中位總生存期(OS)約為11.9個月(自
初次診斷起約32.2個月)。相比之下,僅接受體外放射治療(EBRT)的復發性膠質母細胞瘤
患者的中位生存期僅為9.9個月,二零二六年五月,TLX101在澳大利亞、奧地利和荷蘭開
展的I期臨床研究(IPAX-2研究),完成了全部患者入組給藥,此外,TLX101目前還在另一
項關鍵性臨床試驗(IPAX BrIGHT)中進行評估,以對比單用化療(洛莫司汀)與TLX101聯
合化療在復發性膠質母細胞瘤(末線)患者中的安全性和有效性。IPAX BrIGHT正在澳大
利 亞 和 荷 蘭 積 極 入 組 患 者 並 給 藥,該 實 驗 同 時 已 在 奧 地 利 和 比 利 時 獲 批,即 將 開 始 患 者
入組。這標誌著TLX101將成為首個進入膠質母細胞瘤3期研發的放射性藥物療法。目前,
該產品已獲批在中國開展臨床研究。
— 12 —
全球創新型實體瘤診斷產品GPN01530-2
GPN01530-2是 一 款 靶 向 成 纖 維 細 胞 活 化 蛋 白(「FAP」)的 小 分 子RDC藥 物。FAP是 腫 瘤 相
關成纖維細胞(cancer associated fibroblasts,「CAFs」)的重要標誌物之一,參與細胞外基質
重 塑、腫 瘤 細 胞 增 殖 調 節 和 腫 瘤 免 疫 抑 制 等 過 程 促 進 腫 瘤 的 生 長 和 侵 襲,是 腫 瘤 診 療 的
新型特異性靶點。研究表明,FAP在正常組織中不表達或低表達,但在90%的上皮性腫瘤
組 織 和 多 種 腫 瘤 微 環 境 的CAFs中 高 表 達。GPN01530-2優 化 了FAP配 體 的 結 構,提 高 了 其
在 腫 瘤 組 織 中 的 攝 取,同 時 降 低 其 在 正 常 組 織 中 的 攝 取。臨 床 前 研 究 結 果 表 明,本 產 品
與其它FAP配體相比,表現出快速的腫瘤靶向、更高的腫瘤攝取和更優的藥代動力學特性。
此外,在已開展的IIT人體研究中顯示,GPN01530-2安全性良好,具備快速的背景清除、
強而持久的病灶攝取,與18F-FDG相比表現出更優的臨床圖像對比度和陽性病灶的準確檢
出率。基於已有臨床前及臨床研究結果,本產品顯著提升了FAP靶點類的RDC藥物的診斷
效 能,並 有 望 為 廣 大 的 實 體 瘤 患 者 提 供 一 款 全 新 的 腫 瘤 診 斷 方 案。目 前,該 產 品 於 二 零
二五年十二月獲得FDA批准開展用於診斷實體瘤的I/II期臨床研究,並於二零二六年八月
獲得FDA授予的快速通道資格。
全球創新型肝細胞癌診斷產品GPN02006
GPN02006是一款全球創新、基於放射性核素-抗體偶聯技術的靶向磷脂醯肌醇蛋白聚糖3
(「GPC-3」)的診斷型放射性藥物,其對GPC-3靶點具有高特異性和高親和力,且安全性好,
適用對HCC的精準診斷。目前,全球範圍內針對GPC-3靶點的藥物開發尚處於早期研發階
段,尚未有該靶點的藥物上市,GPN02006在中國開展的IIT臨床研究於二零二五年四月取
得 了 突 破 性 進 展,並 於 成 都2025未 來XDC新 藥 大 會 和 北 美 核 醫 學 與 分 子 影 像 學 會 年 會 中
公佈了臨床結果,臨床研究數據表明,GPN02006展現出卓越的安全性和顯像效能:所有
受 試 者 給 藥 後 均 未 報 告 任 何 藥 物 相 關 不 良 反 應,安 全 耐 受 性 表 現 優 異;給 藥 後30分 鐘 即
可 實 現 高 質 量 顯 像,充 分 滿 足 肝 細 胞 癌 臨 床 快 速 診 斷 需 求。該 藥 物 在 顯 像 質 量 方 面 具 有
三大顯著優勢:1)極低的背景信號;2)HCC病灶特異性高攝取;3)優異的診斷對比度。
基於其獨特的分子靶向機制,該藥物能夠實現:1)HCC病灶的早期精準定位;2)治療反
應的動態評估;3)復發轉移的早期預警,為臨床醫生制定個體化診療方案提供強有力的
分子影像學依據;相較於現行的HCC診斷方案,GPN02006在早期微小HCC病灶檢測中展
示出更優異的診 斷 效 能,該 產 品 有 望 改 善 當 前HCC患 者 早 期 診 斷 率 不 足 及 復 發 轉 移監測
困難的臨床現狀。目前,該產品的註冊性臨床研發工作正在積極推進中。
— 13 —
心腦血管精準介入診療板塊
本 集 團 秉 承「精 準 治 療」的 治 療 理 念,圍 繞 通 路 管 理、慢 病 管 理、結 構 性 心 臟 病 及 心 衰 多
個方向進行全方位佈局,搭建高端醫療器械產品集群,目前該板塊已佈局超過30款產品,
其中通路管理方向已有23款產品在中國獲批上市,慢病管理方向已有1款產品在中國獲批
上市,結構性心臟病方向已有3款產品在中國獲批上市,其他在研創新產品也在積極推進
中國臨床註冊工作。此外,二零二六年七月,本集團與西門子醫療系統有限公司(下稱「西
門子醫療」)正式達成全面商業化戰略合作,由遠大醫藥負責西門子醫療實時三維心腔內
超聲導管AcuNav Lumos™ 4D ICE導管在中國的獨家商業化推廣工作,該產品已獲得中國
藥 監 局 批 准 上 市;本 集 團 與 江 蘇 臻 億 醫 療 科 技 有 限 公 司 合 作 的 經 導 管 三 尖 瓣 夾 系 統
NeoBlazar ®於二零二六年七月獲中國藥監局批准上市。本集團將持續豐富創新產品管線,
帶動該板塊業務穩定增長。
本集團在該板塊已實現「無源+有源」創新器械平台的全面建設,其中,武漢光谷有源器械
研發生產基地和常州無源器械研發生產基地已投入使用。目前已經和美國、加拿大、德國、
義 大 利、瑞 士 等 多 國 臨 床 中 心 或 者 研 發 平 台 進 行 技 術 合 作,逐 步 開 啓 邁 向 全 球 化 研 發 新
進程,致力於將該板塊打造成為中國乃至全球領先的「心腦血管精準介入診療平台」。
— 14 —
核心產品
冠脈藥塗球囊RESTORE DEB®:
RESTORE DEB®是中國首款具有原發冠脈血管病變和支架內再狹窄雙重適應症的藥塗球囊,
其臨床研究結果發佈於心血管疾病領域重要期刊「JACC(Journal of the American College of
Cardiology)Cardiovascular Interventions」,獨有的SAFEPAX專利技術,藥物塗層均一穩定,
且 脫 落 率 小,上 市 以 來 獲 得 了 廣 大 臨 床 醫 生 和 患 者 的 認 可 和 良 好 的 市 場 口 碑。其 臨 床 地
位也在「冠狀動脈腔內影像學指導藥物涂層球囊臨床應用專家共識(2026版)」、「中國經皮
冠狀動脈介入治療指南(2025版)」等指南和專家共識中得以肯定。
透析通路藥塗球囊APERTO® OTW:
APERTO® OTW為首款針對透析患者動靜脈內瘻狹窄適應症的藥塗球囊,這款產品具有耐
高壓和藥物塗層雙重特性,與普通高壓球囊相比,APERTO® OTW在術後六個月靶病變通
暢 率 具 有 顯 著 優 勢,對 於 延 長 內 瘺 的 使 用 時 間、改 善 透 析 患 者 的 生 活 質 量 都 會 起 到 重 大
貢 獻,其 臨 床 研 究 成 果 發 佈 於 腎 病 治 療 領 域 重 要 期 刊「 American Journal of Kidney
Diseases」。
首款國產可調節顱內取栓支架產品鸕鷀®:
鸕鷀®採用圓絲編織結構設計,可在體外進行手動調控至理想直徑以匹配目標血管,同時
支 架 植 入 過 程 中 全 程 可 視、全 程 顯 影,能 夠 更 好 的 輔 助 術 者 根 據 血 栓 部 位 與 總 長 度,來
調節支架以更好的適應閉塞血管,實現更高的血管再通率。鸕鷀®的可調節特性,一方面
提 高 了 支 架 與 血 栓 嵌 合 能 力,提 高 了 手 術 的 有 效 性,另 一 方 面 減 少 了 對 血 管 的 損 傷,提
高了手術的安全性。此外,鸕鷀®為全支架顯影,更便於醫生精準操作,鸕鷀®的上市可為
急性缺血性卒中取栓治療提供了新的選擇。
— 15 —
多極腎動脈射頻消融系統鉑睿時IberisTM
依 托 先 進 的 腎 神 經 消 融 技 術,通 過 微 創 介 入 操 作,將 消 融 導 管 精 準 送 達 腎 動 脈 血 管,利
用 射 頻 能 量 對 腎 交 感 神 經 進 行 消 融,有 效 阻 斷 過 度 興 奮 的 腎 交 感 神 經 信 號 傳 導,從 而 實
現血壓的穩定調控。IberisTM在控制不佳的原發性高血壓患者的治療中展現出優秀臨床療效,
相關研究成果已在國際心血管頂級學術期刊Circulation(影響因數:35.5)上全文發表,獲
得了國際學術界的高度認可,是目前全球範圍內唯一獲得歐盟CE認證且具備橈動脈與股
動脈雙入路設計的腎動脈去交感神經消融術(RDN)產品。
實時三維心腔內超聲導管AcuNav Lumos™ 4D ICE導管
AcuNav Lumos™ 4D ICE導管實現了從二維、三維到實時三維成像的跨越式升級可適配二
尖 瓣 修 復、左 心 耳 封 堵、先 天 性 心 臟 病 封 堵 等 多 種 復 雜 結 構 性 心 臟 病 介 入 場 景。該 產 品
在 成 像 能 力、術 中 引 導 及 操 作 適 配 層 面 進 行 了 技 術 迭 代 優 化:配 備 改 進 型 多 平 面 重 建 雙
平 面 成 像 功 能,可 輸 出 實 時4D容 積 成 像,動 態 畫 面 清 晰 流 暢,為 術 者 術 中 解 剖 評 估 與 器
械 引 導 提 供 清 晰 影 像 參 考;該 導 管 可 深 入 心 腔 內 部,減 少 組 織 結 構 遮 擋,適 配 經 導 管 瓣
膜緣對緣修復術(TEER)等復雜手術全程使用。此外,該導管可實現四向180º的打彎角度,
活動靈活,便於探查心臟內部不同區域結構。在TEER手術中,AcuNav Lumos™ 4D ICE導
管 可 覆 蓋 術 前 評 估、術 中 器 械 操 作 及 術 後 結 果 核 查 全 流 程。在 瓣 膜 評 估 階 段,能 清 晰 可
視 化 瓣 膜 形 態、反 流 程 度 及 瓣 葉 脫 垂 情 況,輔 助 術 者 制 定 適 配 手 術 方 案;術 中 可 實 時 追
蹤 夾 合 器 等 器 械 的 位 置 與 姿 態,輔 助 術 者 完 成 瓣 葉 抓 取、夾 合 器 釋 放 等 關 鍵 操 作;在 術
後評估階段,能快速檢測術後殘余反流情況,及時判斷手術效果,助力醫生優化診療決策。
— 16 —
國產經導管二尖瓣夾系統NeoNova®
通 過 介 入 方 式 對 二 尖 瓣 反 流 患 者 進 行 緣 對 緣 二 尖 瓣 修 復,提 高 心 臟 功 能,減 小 患 者 手 術
創 傷,縮 短 恢 復 時 間。該 產 品 操 作 便 捷 且 安 全 性 好,採 用 彈 性 自 鎖 機 制 可 以 讓 夾 臂 自 動
適 應 瓣 膜 強 度 並 自 動 鎖 定,在 保 證 夾 合 穩 定 的 同 時,最 大 限 度 規 避 了 術 中 和 術 後 遠 期 瓣
膜被撕裂風險;使用「一字型」夾合器,可靈活應對腱索纏繞和交界區域跨瓣等複雜情況;
控彎穩定,半徑更小,節省了手術在心房內所需的操作空間,手術操作餘地更大。該產品
可為二尖瓣反流患者提供全新的治療選擇。
國產經導管三尖瓣夾系統NeoBlazar®
是中國首款國產的經導管三尖瓣夾系統,通過介入方式對三尖瓣反流患者進行緣對緣三
尖瓣修復,改善患者心臟功能,提升患者生活質量。該產品搭載多項核心優勢設計,採用
獨 特「一 字 型」設 計,結 構 極 簡、操 作 便 捷,可 有 效 規 避 術 中 腱 索 纏 繞 風 險,支 持 器 械 快
速解脫,允許術中多次精準調整、回收重定位,助力醫生從容應對各類復雜術中情況,大
幅 降 低 手 術 操 作 門 檻、縮 短 醫 師 學 習 曲 線,顯 著 提 升 手 術 的 可 控 性 與 安 全 性;創 新 的 彈
性 自 鎖 機 制,可 在 輸 出 穩 固 持 久 的 瓣 葉 夾 持 力 的 同 時,有 效 緩 衝 術 中 及 術 後 應 力,最 大
程 度 保 護 患 者 脆 弱 的 瓣 葉 與 心 肌 組 織,規 避 二 次 損 傷,保 障 手 術 遠 期 療 效。該 產 品 可 為
三尖瓣反流患者提供全新的治療選擇。
首款國產編織型顱內動脈瘤輔助栓塞支架藍鯨™
適 用 於18歲 以 上 顱 內 動 脈 瘤 患 者,由 輸 送 系 統 及 鎳 鈦 絲 編 織 自 膨 式 支 架 構 成,憑 藉 結 構
與性能的創新設計,突破現有產品局限,可更好適配複雜解剖結構,滿足多樣化臨床需求。
採用鎳鈦單絲16頭編織工藝,兼顧強勁徑向支撐力與優異柔順貼壁性,遠近端V形封閉設
計可穩固錨定血管,防止移位;依托獨特纏繞顯影技術,4根顯影絲均勻纏繞,近端4個顯
影點搭配遠端V形加強顯影,全程清晰示蹤,為術者提供精準視野;操控與輸送方面,其
可控性出色,釋放至80%仍可回收,實現精準植入,直徑3mm以內支架可經17微導管輸送
釋放,操控及輸送性能顯著提升;相較於激光切割型支架,其金屬覆蓋率提升至18%,可
實現適度血流分流,血管造影動脈瘤閉塞率超95%,優化治療預後。該產品有望為顱內動
脈瘤患者提供全新的治療選擇。
— 17 —
創新研發管線
全球創新型內源性組織修復產品aXess:
aXess是一款用於對終末期腎臟病(ESRD)患者建立移植物血管內瘻(AVG)開展血液透析
治療的全球創新內源性組織修復產品,該產品可以為患者自體組織修復提供基礎結構框架,
加 快 透 析 通 路 的 建 立,降 低 血 栓 以 及 相 關 並 發 症 的 發 生,有 望 為 透 析 患 者 提 供 一 種 更 為
安全且有效的血液通路。aXess可進一步與APERTO ®OTW在血液透析領域形成協同。該產
品 於 二 零 二 四 年 十 一 月 獲 得FDA突 破 性 醫 療 器 械 認 定,並 於 同 月 完 成 在 美 國 獲 批 開 展 的
關鍵性臨床研究的首例患者入組,在歐洲開展的關鍵性臨床研究於二零二五年十月成功
達到臨床終點,具體結果顯示,與標準療法相比,aXess在所有關鍵臨床指標上均實現重
大提升,與其他動靜脈移植物相比,aXess在主要和次要終點均展現出優異的通暢率,且
干預次數更少,與自體動靜脈內瘻(AVF)相比,aXess的再干預率更低且具有高抗感染性;
安全性方面,在全部120名患者中,僅出現一例因穿刺感染相關的(部分)人工血管取出事
件,表明aXess具有極高抗感染性;aXess可實現近乎即時的穿刺操作,在超過1.5萬次透析
治療中出血並發症發生率低於0.02%,這些數據證明aXess擁有優秀的安全性和有效性特徵,
在各方面均優於現行標準療法。該產品於二零二六年四月獲得CE認證。中國註冊方面,
該產品尚處於臨床前開發階段。
全球創新型二尖瓣置換系統Saturn:
Saturn是一款用於二尖瓣置換的全球創新醫療器械,該產品用經房間隔的介入方式植入,
最 大 程 度 避 免 手 術 創 傷,縮 短 術 後 恢 復 時 間,創 新 性 地 將 瓣 環 重 建 技 術 與 瓣 膜 置 換 技 術
相 結 合,提 升 器 械 適 配 性,適 合 各 種 常 見 的 二 尖 瓣 結 構。該 產 品 於 二 零 二 零 年 在 歐 洲 開
展了經心間入路的臨床研究,並於二零二二年完成全部患者入組,目前五年隨訪工作完成,
隨訪結果符合預期;於二零二四年五月在歐洲完成了經股靜脈入路的臨床研究的首例患
者 入 組,隨 訪 結 果 符 合 預 期,產 品 安 全 有 效 性 得 到 初 步 驗 證。該 產 品 在 中 國 的 註 冊 工 作
也在積極地推進中。
— 18 —
全球創新型心室輔助器械CoRISMA:
CoRISMA是一款治療三級和終末期心衰的經導管完全植入的心室輔助醫療器械,採用世
界先進的能量傳輸技術無線供電,通過微創手術為心衰終末期患者提供了具有創傷小、
安全性高、無電源線感染、並發症少的治療方法。目前,本集團正在與耶魯大學孵化的創
新性醫療器械公司進行產品的合作開發工作。
製藥科技
本 集 團 在 呼 吸 及 危 重 症、五 官 科、心 腦 血 管 急 救 等 領 域 深 耕 多 年,現 有 多 款 市 場 份 額 領
先 的 高 壁 壘 產 品 和 獨 家 品 種,具 備 良 好 的 品 牌 優 勢 和 穩 固 的 市 場 地 位,亦 儲 備 多 款 創 新
產品。
通過全球技術合作與自主研發相結合的創新模式,本集團在製藥科技領域建立了武漢光
谷國際研發中心、澳洲糖組學研發中心以及南京奧羅mRNA研發中心。各研發中心及技術
平台將持續協同賦能,為本集團在製藥科技領域的研發創新輸送前沿技術儲備與長效研
發動能。
呼吸及危重症板塊
本集團呼吸及危重症板塊在售產品覆蓋鼻炎、支氣管炎、肺炎、哮喘、慢性阻塞性肺部疾
患等多個適應症。核心產品切諾®(桉檸蒎腸溶膠囊)、新型複方鼻噴劑萊特靈®、恩卓潤®
比斯海樂®和恩明潤®比斯海樂®均為全國獨家品種,處於細分領域的領先地位。
該 板 塊 針 對 未 被 滿 足 的 重 大 臨 床 需 求 進 行 創 新 佈 局,在 研 產 品 覆 蓋 膿 毒 症、呼 吸 窘 迫 綜
合征(「ARDS」)等適應症。未來,本集團將繼續採用自主研發與全球拓展的研發理念,打
造氣道慢病全周期管理產品集群和危重症產品管線,不斷鞏固本集團在該領域的行業地位。
— 19 —
呼吸科產品
主要產品包括切諾®、恩卓潤®比斯海樂®和恩明潤®比斯海樂®、新型複方鼻噴劑萊特靈®、
布地奈德鼻噴霧劑、丙酸氟替卡松鼻噴霧劑等。
切諾®(桉檸蒎腸溶膠囊):
為一款粘液溶解性祛痰藥。適用於急、慢性鼻竇炎;急慢性支氣管炎、肺炎、支氣管擴張、
肺膿腫、慢性阻塞性肺部疾患、肺部真菌感染、肺結核和硅肺等呼吸道疾病;亦可用於支
氣 管 造 影 術 後,促 進 造 影 劑 的 排 出。為 本 集 團 自 主 研 發 的 中 國 獨 家 品 種,有 成 人 裝 和 兒
童裝分別適用於成年人和兒童使用,為中國國家醫保目錄和中國國家基藥目錄收錄品種,
並榮登「二零二五年健康產業品牌榜」、「2024年度中國藥品零售市場潛力品牌」、「2022-2023
年中國家庭常備藥上榜品牌」。目前已有數十項指南和專家共識推薦使用粘液溶解促排劑
用於臨床,其中十餘項指南和專家共識均明確推薦桉檸蒎腸溶膠囊或其活性成分用於臨
床治療,如《中國咳嗽基層診療與管理指南(2024版)》、《中國成人支氣管擴張症診斷與治
療專家共識(2021版)》、《兒童分泌性中耳炎診斷和治療指南(2021版)》、《慢性阻塞性肺
疾病基層合理用藥指南(2020版)》、《中國胸外科圍手術期氣道管理指南(2020版)》、《鼻
炎分類和診斷及鼻腔用藥方案的專家共識》、《兒童反復呼吸道感染專家共識》等,臨床地
位突出,醫生及患者認可程度高,持續領跑口服止咳祛痰藥物市場。
— 20 —
恩卓潤®比斯海樂®(茚達格莫吸入粉霧劑II)和恩明潤®比斯海樂®(茚達特羅莫米松吸入粉
霧劑II、III):
恩 卓 潤®比 斯 海 樂®是 中 國 國 內 首 款 獲 批 哮 喘 適 應 症 的 三 聯 複 方 吸 入 製 劑,適 用 於 使 用 長
效β2受體激動劑(LABA)和吸入性糖皮質激素(ICS)聯合維持治療未能充分控制的成年
哮 喘 患 者 的 維 持 治 療。產 品 療 效 明 確,使 用 便 捷,並 實 現 了 三 方 面 的 突 破:(1)採 用 了 優
化的ICS、LABA和 長 效 乙 醯 膽 鹼 受 體 拮 抗 劑(LAMA)藥 物 組 合,即 糠 酸 莫 米 松╱醋酸茚
達 特 羅╱格 隆 溴 銨,三 種 有 效 成 分 協 同 增 益,對 比 常 規 高 劑 量ICS-LABA和 高 劑 量ICS–
LABA聯合LAMA開放三聯,恩卓潤®比斯海樂®可有效改善中重度哮喘患者臨床症狀和肺
功能,並顯著降低急性發作風險;(2)每日一次給藥,極大程度便利患者並有望改善依從性;
(3)採用先進的比斯海樂®吸入裝置,裝置操作簡易,為患者提供可聽、可嘗、可視的三重
給藥確認,增強患者完整劑量用藥的信心。該產品III期臨床研究ARGON顯示,相較於高
劑 量 沙 美 特 羅 替 卡 松 吸 入 粉 霧 劑 聯 合 噻 托 溴 銨 吸 入 噴 霧 劑 開 放 三 聯,恩 卓 潤®比 斯 海 樂®
可顯著降低急性發作風險,特別是24周中度急性發作風險的年化發生率降低了43%。恩明
潤®比 斯 海 樂®為 創 新 型ICS糠 酸 莫 米 松 和LABA醋 酸 印 達 特 羅 的 二 聯 複 方 製 劑,適 用 於 成
人及12歲以上青少年哮喘患者的維持治療。恩明潤®比斯海樂®同樣具備「可視可控、精準
吸入、一天一次」等特點,可顯著改善患者肺功能並減少急性發作風險,是哮喘患者優化
治療的新選擇。該產品III期臨床研究顯示,對比常規高劑量沙美特羅替卡松吸入粉霧劑,
恩明潤®比斯海樂®可顯著改善患者急性發作風險,重度、中重度和所有急性發作類別風險
分 別 降 低 約26%、22%和19%。這 兩 款 產 品 已 被 納 入《穩 定 期 慢 性 氣 道 疾 病 吸 入 裝 置 規 範
應用中國專家共識(2023版)》、《重度哮喘診斷與處理中國專家共識(2024版)》、《支氣管
哮喘防治指南(2024版)》、《全球哮喘管理和預防策略(2025版)》等國內外權威臨床指南和
專家共識中,此外,這兩款產品均已正式納入中國的《國家基本醫療保險、工傷保險和生
育保險藥品目錄》乙類藥品管理範圍,為長期接受哮喘治療的人群提供新的治療方案。
— 21 —
新型複方鼻噴劑萊特靈®:
萊 特 靈®是 一 種 新 型 的 抗 組 胺 藥 和 皮 質 類 固 醇 的 複 方 鼻 噴 劑,用 於 成 人 和6歲 及 以 上 兒 童
的中度至重度季 節 性 過 敏 性 鼻 炎 的 對症 治 療,及 成 人 和12歲 及 以 上 兒 童 的 中 度 至重度常
年性過敏性鼻炎的對症治療。《中國變應性鼻炎診斷和治療指南(2022版)》、《鼻炎分類和
診斷及鼻腔用藥 方 案 臨 床 共 識(2019版)》、《ARIA變 應 原 免 疫 治 療 的 醫 療 路 徑(2019版)》
等國內外權威臨床指南和專家共識均推薦鼻用抗組胺藥和鼻用皮質類固醇藥作為過敏性
鼻炎的首選用藥,萊特靈®作為複方製劑,能給患者帶來更便捷和有效的治療方式,提高
患者的依從性,為中國的AR患者帶來新的治療手段。該產品於二零二二年一月獲FDA批
准上市,於二零二五年十一月獲得中國藥監局批准上市。
布地奈德鼻噴霧劑:
是一種鼻用皮質類固醇藥物,具有強效的局部抗炎與抗過敏作用,可直接作用於鼻粘膜,
緩 解 鼻 炎 症 狀。適 用 於 治 療 季 節 性 和 常 年 性 過 敏 性 鼻 炎,常 年 性 非 過 敏 性 鼻 炎;亦 可 用
於 預 防 鼻 息 肉 切 除 後 鼻 息 肉 的 再 生,對 症 治 療 鼻 息 肉。為 過 敏 性 鼻 炎 的 一 線 用 藥,被 納
入《中國慢性鼻竇炎診斷與治療指南(2024版)》、《中國變應性鼻炎診斷和治療指南(2022
年,修訂版)》、《兒童變應性鼻炎診斷和治療指南(2022年,修訂版)》、《鼻用糖皮質激素
治療變應性鼻炎專家共識》、《鼻炎分類和診斷及鼻腔用藥方案的專家共識》等多項臨床指
南 和 專 家 共 識 中。該 產 品 為 國 內 首 仿,將 有 望 改 變 同 通 用 名 產 品 市 場 上 外 資 企 業 獨 佔 的
競爭格局。
丙酸氟替卡松鼻噴霧劑:
是一種鼻用皮質類固醇藥物,具有強效的局部抗炎與抗過敏作用,可直接作用於鼻粘膜,
緩解鼻炎症狀。適用預防和治療季節性過敏性鼻炎(包括枯草熱)和常年性過敏性鼻炎。
為過敏性鼻炎的一線用藥,被納入《中國慢性鼻竇炎診斷與治療指南(2024版)》、《中國變
應性鼻炎診斷和治療指南(2022年,修訂版)》、《兒童變應性鼻炎診斷和治療指南(2022年,
修訂版)》、《鼻用糖皮質激素治療變應性鼻炎專家共識》、《鼻炎分類和診斷及鼻腔用藥方
案的專家共識》等多項臨床指南和專家共識中。該產品為國內首仿,將有望改變同通用名
產品市場上外資企業獨佔的競爭格局。
— 22 —
創新研發管線
本集團基於未被滿足的臨床需求,針對膿毒症、ARDS等適應症佈局全球創新藥物。
重症治療的全球創新藥物STC3141:
STC3141為本集團自主開發的全新作用機制的小分子化合物,通過中和胞外遊離組蛋白和
中性粒細胞誘捕網來逆轉機體過度免疫反應造成的器官損傷,可用於多種重症適應症。
STC3141是全球首個以重新構建免疫穩態為核心的膿毒症治療方案,實現了治療維度的重
大 升 級,在 現 有 的 抗 感 染、液 體 復 蘇 和 維 持 器 官 運 轉 等 對 症 支 持 治 療 的 基 礎 上,針 對 機
體 免 疫 失 調 這 個 核 心 病 因 加 以 精 準 調 節,幫 助 身 體 恢 復 平 衡,有 望 填 補 了 當 前 膿 毒 症 針
對 病 因 治 療 的 臨 床 空 白。該 產 品 作 用 機 制 創 新,臨 床 前 相 關 研 究 結 果 於 二 零 二 零 年 二 月
和 二 零 二 三 年 十 一 月 分 別 發 表 於 頂 級 學 術 期 刊「 Nature Communications 」和「 Critical
Care」,具 有 深 遠 的 學 術 影 響 力。目 前 該 產 品 已 在 中 國、澳 大 利 亞、比 利 時、英 國、波 蘭
三大洲五個國家,在膿毒症、ARDS、重症新冠病毒感染(「COVID-19」)及COVID-19引發
的ARDS四個適應症上獲批七個臨床批件,完成了四項針對患者的臨床研究並成功達到了
臨床終點。此前在澳洲和比利時開展的用於治療膿毒症的Ib期臨床研究、在中國開展的針
對 急 性 呼 吸 窘 迫 綜 合 症(ARDS)的Ib期 臨 床 研 究 和 在 歐 洲 開 展 的 治 療 重 症 新 冠 病 毒 感 染
(COVID-19)的IIa期臨床研究,均展示了STC3141具有良好的安全性及耐受性,且在幫助
患者脫離呼吸機、脫離升壓藥和縮短ICU住院時間等有效性指標方面都體現了積極信號,
而在中國開展的針對膿毒症的II期臨床研究於二零二五年五月成功達到主要臨床終點,臨
床結果顯示,藥物治療組第7天SOFA評分較基線均有明顯下降,尤其是高劑量組,降幅明
顯大於安慰劑組,差異具有統計學顯著性和臨床意義;次要終點的趨勢與主要終點一致,
符合預期。此外,STC3141安全性、耐受性良好,且藥代動力學特徵也符合預期。該研究
結果證實了STC3141在膿毒症治療中的有效性和安全性,為重症治療領域帶來新的突破。
目前,該產品後續的臨床開發和註冊申報工作正在積極的推進中。
— 23 —
五官科板塊
本 集 團 五 官 科 板 塊 秉 持 中 西 結 合 與 藥 械 同 治 的 發 展 戰 略,持 續 完 善 中 成 藥、眼 科 創 新 藥
及OTC零 售 產 品 協 同 發 展 的 系 列 化 產 品 集 群。在 中 成 藥 方 向 上,本 集 團 立 足 中 醫 藥 在 慢
病 治 療 領 域 的 核 心 優 勢,持 續 深 耕,在 鞏 固 並 完 善 五 官 科 產 品 矩 陣 的 基 礎 上,通 過 戰 略
佈局多款具有顯著競爭優勢的中成藥,成功將業務拓展至心腦血管慢病以及神經內科等
治 療 領 域,實 現 了 中 成 藥 業 務 從 五 官 科 單 一 領 域 向 綜 合 慢 病 治 療 領 域 的 戰 略 轉 型;在
OTC零售產品方向上,本集團積極打造中國領先的眼健康消費品牌,提供專業、安全、便
捷 的 眼 健 康 解 決 方 案;在 眼 科 創 新 藥 方 向 上,本 集 團 通 過 合 作 引 進 和 自 主 研 發 相 結 合 的
策略,儲備了治療「乾眼症」、「蠕形蟎瞼緣炎」、「眼科術後抗炎鎮痛」、「翼狀胬肉」和「近
視」等多款全球創新產品,構建差異化競爭優勢,有望為患者提供更多治療選擇,改善生
活 質 量,同 時 通 過 持 續 加 強 產 品 的 臨 床 循 證 醫 學 體 系 建 設 與 專 業 學 術 推 廣 體 系 建 設,為
臨床專家提供完善的疾病診療方案和細緻化的產品服務方案。未來該板塊將持續深耕前
沿創新賽道,不斷強化行業影響力,實現業務領域新突破。
五官科產品
本集團五官科核心產品包括和血明目片、金嗓系列(金嗓開音片╱膠囊╱丸╱顆粒、金嗓
清 音 片╱膠 囊╱丸╱顆 粒、金 嗓 利 咽 片╱膠 囊╱丸╱顆 粒、金 嗓 散 結 片╱膠 囊╱丸╱顆
粒)、脈血康(脈血康膠囊及脈血康腸溶片)、瑞珠(聚乙烯醇滴眼液、玻璃酸鈉滴眼液)、
諾通(鹽酸賽洛唑啉)、丹珍頭痛膠囊、酒石酸伐尼克蘭鼻噴霧劑等。
和血明目片:
由四物湯、二至丸和生蒲黃湯三個經典名方化裁而成,具有涼血止血、滋陰化瘀、養肝明
目 的 功 效,主 要 用 於 陰 虛 肝 旺,熱 傷 絡 脈 所 引 起 的 眼 底 疾 病。和 血 明 目 片 為 中 國 全 國 獨
家品種,國家中藥保護品種,國家醫保目錄和國家基本藥物目錄收載品種,上市30餘年來,
積累了大量在眼底出血方面的臨床研究資料和應用經驗,被納入《2型糖尿病中醫防治指
南(2024版)》、《病理性近視眼底病變黃斑出血中醫診療指南(2022版)》、《和血明目片治
療濕性年齡相關性黃斑變性臨床應用專家共識》等多個權威指南與共識,為產品的臨床使
用提供有價值的文獻支援。
— 24 —
金嗓系列產品:
全 國 獨 家 產 品,覆 蓋 喉 科 全 病 種,其 中 金 嗓 散 結 膠 囊 用 於 熱 毒 蓄 結、氣 滯 血 瘀 而 形 成 的
慢 喉 喑(聲 帶 小 結、聲 帶 息 肉、聲 帶 粘 膜 增 厚)及 由 此 而 引 起 的 聲 音 嘶 啞 等 症。金 嗓 散 結
膠 囊 上 市 三 十 多 年 以 來,在 臨 床 得 到 廣 泛 應 用。金 嗓 利 咽 膠 囊 為 治 療 肝 鬱 氣 滯、痰 濕 內
阻 所 致 咽 喉 疾 病 唯 一 中 成 藥,也 是 臨 床 中 咽 異 感 症,胃 食 管 反 流 性 咽 炎、慢 性 肥 厚 性 咽
喉炎理想用藥。金嗓開音膠囊針對急性咽炎、急性喉炎引起的咽喉紅、腫、熱、痛、聲音
嘶啞起效迅速。該系列產品獲得廣泛的臨床認可,《中醫耳鼻咽喉科常見病診療指南》、《活
血化瘀類中成藥合理用藥指南》、臨床醫師診療叢書《臨床用藥指南》、權威專著《常見眼
耳鼻咽喉科中成藥手冊》、《實用耳鼻咽喉頭頸外科學》等多部臨床路徑及專家診療指南均
對其予以收載。二零二二年一月和二零二四年八月,中華中醫藥學會分別發佈了《金嗓散
結膠囊治療聲帶小結、聲帶息肉臨床應用專家共識》和《金嗓開音膠囊(丸╱片╱顆粒)臨
床應用專家共識》,也為金嗓散結和金嗓開音產品的循證之路增添了新的支持。金嗓散結
和 金 嗓 開 音 膠 囊 為 國 家 醫 保 目 錄 產 品,金 嗓 開 音、清 音 屬 於 兼 具 處 方 藥 和 非 處 方 藥 屬 性
的雙跨品種。
— 25 —
多普泰®(脈血康膠囊及脈血康腸溶片):
具有抗凝、抗血栓、抗纖維化、改善血液循環等功效,可用於治療冠心病、急性腦梗死、
缺 血 性 腦 卒 中、不 穩 定 性 心 絞 痛 等 心 腦 血 管 疾 病。為 國 家 醫 保 和 基 本 藥 物 目 錄 品 種,也
是目前國內唯一標注了抗凝血酶活性單位的中成藥(每粒╱片相當於14個抗凝血酶活性單
位),已被納入《腦卒中中西醫結合康復臨床循證實踐指南》、《腦卒中中西醫結合防治指
南》、《腦梗死中西醫結合診療指南》、《特發性膜性腎病中醫臨床實踐指南》、《脈血康膠
囊(腸溶片)治療心腦血管疾病臨床應用專家共識》等眾多權威的臨床指南中。
丹珍頭痛膠囊:
由四物湯、天麻鈎藤飲、通竅活血湯等經典名方化裁而成,具有平肝熄風,散瘀通絡,解
痙止痛的功效,適用於治療肝陽上亢、瘀血阻絡所致的頭痛、背痛頸酸、煩燥易怒等症狀。
該 產 品 臨 床 定 位 清 晰、循 證 研 究 充 分,治 療 領 域 可 涵 蓋 原 發 性 頭 痛、繼 發 性 頭 痛 以 及 預
防 頭 痛,具 有 廣 泛 的 臨 床 應 用 前 景,為 全 國 獨 家 品 種,國 家 醫 保 目 錄 和 國 家 基 本 藥 物 目
錄收載品種,並被納入《原發性頭痛中西醫結合診療中國專家共識(2026版)》、《中國偏頭
痛中西醫結合防治指南(2022版)》等臨床指南和專家共識中。
瑞珠®(聚乙烯醇滴眼液、玻璃酸鈉滴眼液):
為單支裝無防腐劑人工淚液,現為治療乾眼的一線用藥。為《中國乾眼臨床診療專家共識
(2024版)》、《中國白內障圍手術期乾眼防治專家共識(2021版)》、《中國乾眼專家共識(2020
版)》、《中國激光角膜屈光手術圍手術期用藥專家共識(2019版)》、《我國瞼板腺功能障礙
診斷與治療專家共識(2017版)》等多個專家共識中推薦用藥。瑞珠具有良好的品牌知名度,
二零一七年獲得中國馳名商標;二零一六年至二零二四年連續九年獲得西普金獎-「健康
產業品牌榜」。
— 26 —
諾通(鹽酸賽洛唑啉鼻用噴霧劑╱滴鼻液):
是一款緩解鼻塞的鼻減充血劑。適用於減輕急慢性鼻炎、鼻竇炎、過敏性鼻炎、肥厚性鼻
炎 等 鼻 腔 疾 病 引 起 的 鼻 塞 症 狀。其 不 含 有 激 素 和 麻 黃 堿,成 人 和 兒 童 均 可 適 用。諾 通 分
為 滴 鼻 劑 和 鼻 用 噴 霧 劑 兩 個 劑 型,其 中 鼻 用 噴 霧 劑 為 國 產 獨 家 劑 型,在 同 通 用 名 產 品 中
處 於 領 跑 地 位。產 品 被 納 入《兒 童 慢 性 鼻 竇 炎 的 診 斷 和 治 療 中 國 專 家 共 識(杭 州,
2024)》、《中國變應性鼻炎診斷和治療指南(2022年,修訂版)》、《兒童變應性鼻炎診斷和
治療指南(2022年,修訂版)》等臨床指南。
酒石酸伐尼克蘭鼻噴霧劑(「OC-01」):
是 一 款 高 選 擇 性 的 乙 醯 膽 鹼 能 受 體 激 動 劑,可 通 過 啟 動 三 叉 神 經 副 交 感 神 經 通 路,增 加
天然淚液的分泌,從而達到治療乾眼症的目的。根據OC-01的III期臨床研究結果顯示,與
對照組相比,OC-01在改善乾眼症患者淚液分泌方面顯示出具有統計學和臨床意義的顯著
改善,受試者的自然淚液分泌較基線明顯增加(Schirmer評分較基線增加大於或等於10毫
米的受試者比例顯著佔優),且安全性和耐受性良好。該產品於二零二一年十月在美國獲
批上市,是目前全球首款且唯一一款獲批治療輕、中、重度乾眼的無防腐劑、多劑量、無
菌 包 裝 鼻 噴 霧 劑;中 國 註 冊 方 面,該 產 品 於 二 零 二 三 年 二 月 在 中 國 澳 門 特 別 行 政 區 獲 批
上 市;於 二 零 二 三 年 四 月 作 為 進 口 臨 床 急 需 藥 品,落 地 海 南 樂 城 醫 療 先 行 區;於 二 零
二三年十二月在香港大學深圳醫院開出粵港澳大灣區的首張處方;於二零二四年十一月
獲 得 中 國 藥 監 局 批 准 上 市;且 於 同 月 在 中 國 台 灣 地 區 獲 批 上 市;於 二 零 二 五 年 七 月 在 中
國大陸實現正式獲批後的首批商業化處方落地,目前,該產品被納入《兒童青少年近視相
關乾眼診療指南(2026版)》、《中國乾眼臨床診療專家共識(2024版)》、國際淚膜與眼表協
會發佈的2025版《TFOS DEWS III:管理與治療報告》、美國眼科學會發佈的2023版《乾眼
臨床實踐指南》等國內外權威臨床指南和共識。
— 27 —
用於治療蠕形蟎瞼緣炎的全球創新眼用製劑TP-03(洛替拉納滴眼液,0.25%):
是一款對γ-氨基丁酸門控氯離子通道(「GABA-Cl」)具有選擇性的非競爭性拮抗劑,其
通過選擇性抑制蠕形蟎體內的GABA-Cl,使蟲體麻痹和死亡,進而徹底治愈蠕形蟎瞼緣炎。
該 產 品 具 有 高 度 親 脂 性,可 促 進 其 在 蟎 蟲 棲 息 的 睫 毛 毛 囊 油 脂 中 的 吸 收。目 前,該 產 品
已 在 美 國 完 成 了 兩 項 關 鍵 性 臨 床 研 究,均 達 到 了 主 要 終 點 和 所 有 次 要 終 點,具 有 統 計 學
意義,且未發生與治療相關的嚴重不良事件,並已於二零二三年七月獲得FDA批准上市,
是 目 前FDA批 准 的 首 款 也 是 唯 一 一 款 針 對 蠕 形 蟎 瞼 緣 炎 的 藥 物,於 二 零 二 五 年 五 月 獲 中
國 澳 門 藥 監 局 批 准 上 市,於 二 零 二 六 年 三 月 獲 中 國 藥 監 局 批 准 上 市。目 前,該 產 品 被 納
入國際淚膜與眼表協會發佈的2025版《TFOS DEWS III:管理與治療報告》、國際蠕形蟎治
療與眼瞼健康專家小組共識發佈的2025版《DEPTH專家共識》、美國眼科學會發佈的2023
版《乾眼臨床實踐指南》、《中國瞼板腺功能障礙專家共識:診斷和治療(2023版)》等國內
外權威臨床指南和共識。
創新研發管線
本 集 團 在 眼 科 術 後 抗 炎 鎮 痛、翼 狀 胬 肉、近 視 等 存 在 明 確 臨 床 需 求 的 方 向 佈 局 了 三 款 創
新藥物:
眼科術後抗炎鎮痛改良型新藥激素納米混懸滴眼液GPN00833:
其主要活性成分丙酸氯倍他索是一種強效的糖皮質激素,具有高效的局部抗炎活性和較
強的毛細血管收縮作用,同時其獨特的納米製劑工藝有效解決了激素產品低水溶性導致
的 生 物 利 用 度 低 及 安 全 性 風 險,該 產 品 已 於 二 零 二 四 年 三 月 獲 得 美 國FDA批 准 上 市,中
國註冊方面,該產品於二零二四年十一月完成在中國開展的III期臨床研究並成功達到了
臨床終點,與對照組相比,該產品在抗炎和鎮痛方面具有顯著的統計學差異和臨床意義,
且 該 產 品 的 安 全 性、耐 受 性 良 好,藥 代 動 力 學 特 徵 也 符 合 預 期。目 前,該 產 品 正 處 於
NDA準備階段。
— 28 —
治療翼狀胬肉改良型新藥GPN00153(「CBT-001」):
為已上市治療肺纖維化藥物尼達尼布的創新改良產品,對新生血管生成和組織纖維化均
有抑制作用。目前已在美國完成II期臨床試驗,安全性高,臨床療效顯著,可抑制翼狀胬
肉生長並控制病情惡化。CBT-001全球開發於二零二二年六月進入III期臨床階段,在中國
於二零二三年三月獲得中國藥監局批准開展III期臨床研究,於二零二五年六月完成了全
部患者入組。
用於延緩兒童近視進展的新型眼用製劑GPN00884:
為本集團與溫州醫科大學(「溫醫大」)附屬眼視光醫院共同開發的全新作用機制的創新藥,
與低濃度阿托品滴眼液相比,GPN00884滴眼液無瞳孔散大效應,不會出現畏光、調節下
降 等 不 良 反 應,給 藥 時 段 不 受 限 制,可 提 高 患 者 的 依 從 性。該 產 品 已 於 二 零 二 四 年 三 月
在中國獲批開展I期臨床研究,於二零二五年三月完成了I期臨床研究,於二零二五年十月
完成了在中國開展的IIa期臨床研究的首例患者入組。
此外,本集團中成藥方向在慢病管理領域也佈局了兩款中藥1類創新藥:
治療抑鬱症的中藥創新藥GPN01360:
是一款用於治療抑鬱症(肝鬱脾虛證)的1.1類中藥創新藥,基於古代經典方劑「逍遙散」,
通過現代藥理學與臨床研究篩選優化而成,處方由柴胡、郁金、佛手等12味中藥組成,具
有 疏 肝 健 脾、解 鬱 安 神 的 功 效。該 中 藥 主 要 用 於 治 療 肝 鬱 脾 虛 型 抑 鬱 症,其 典 型 症 狀 包
括情緒低落、思維遲緩、意志活動減退、心煩焦慮、失眠健忘、食少納呆及神疲乏力等。
前期近百人的人用經驗研究表明,GPN01360在改善抑鬱症狀、緩解焦慮失眠及調理脾胃
功能方面表現出良好療效與安全性。該產品於二零二五年十二月完成了中國的II期臨床研
究並成功達到臨床終點,根據研究結果顯示,GPN01360在抑鬱症的治療方面有較好的安
全 性 和 有 效 性,且 對 抑 鬱 伴 焦 慮、失 眠 等 症 狀 的 改 善 也 較 為 明 顯;於 二 零 二 六 年 七 月 完
成了中國III期臨床研究的首例患者入組給藥。
— 29 —
預防性治療偏頭痛的中藥創新藥GPN01020:
為1.1類中藥創新藥,擬用於偏頭痛(瘀血阻滯證)的預防性治療,由三級甲等醫療機構院
內製劑轉化而來,臨床應用已逾三十年,功能主治為活血化瘀、理氣補虛,適用於氣虛血
瘀證的血管神經性頭痛、外傷頭痛、高血壓病、腦動脈硬化等。本產品既往臨床主要應用
領域主要包括原發性頭痛(如緊張型頭痛、偏頭痛等)及繼發性頭痛(如血管性頭痛、神經
血 管 性 頭 痛 等)。前 期 數 百 人 的 人 用 經 驗 研 究 結 果 顯 示,GPN01020在 減 少 偏 頭 痛 發 作 天
數與發作頻次、改善偏頭痛相關症狀等方面表現出良好療效與安全性。二零二六年三月,
該產品獲得中國藥監局批准開展II期臨床研究。
心腦血管急救板塊
本 集 團 心 腦 血 管 急 救 板 塊 兼 顧 了 急 搶 救 與 慢 性 疾 病 管 理 兩 大 方 向,在 急 救 方 向,本 集 團
被列為「國家基本用藥生產基地」、「國家戰備儲備急救用藥生產企業」、「國家小品種藥(短
缺 藥)集 中 生 產 基 地 建 設 單 位」,擁 有 超 過30個 品 種,其 中14個 品 種 納 入 了 中 國 國 家 急 搶
救 藥 品 目 錄,16個 品 種 納 入 了 短 缺 藥 品 目 錄,產 品 管 線 數 量 位 居 行 業 前 列,產 品 覆 蓋 院
內急救、院前急救及社會急救三大急救場景,持續為國內心腦血管急搶救患者提供多場景、
多選擇、安全且有效的產品組合。在慢性疾病管理方向,核心產品能氣朗®、力美通®依普
利酮片、合心爽®╱合貝爽®等,持續領跑細分市場。目前心腦血管急救板塊通過自主創新
研發與高難度仿製技術突破相結合,繼續佈局和開發臨床急需的心腦血管急救與慢性疾
病治療領域的產品。
心腦血管急救產品
產品主要覆蓋血壓控制、血管活性藥、心肌代謝、心衰、急性過敏反應、肺動脈高壓等領
域,主要產品包括合心爽®╱合貝爽®(鹽酸地爾硫䓬片╱鹽酸地爾硫䓬緩釋膠囊、鹽酸地
爾硫䓬注射液)、能氣朗®(輔酶Q10片)、力美通®依普利酮片等。
— 30 —
合心爽®╱合貝爽®(鹽酸地爾硫䓬片╱鹽酸地爾硫䓬緩釋膠囊、鹽酸地爾硫䓬注射液):
作為經典的鈣離子通道阻滯劑,具有臨床療效明確且安全性高等特點,擁有口服常釋劑型、
緩 釋 劑 型 和 注 射 劑 型,可 以 極 大 程 度 的 滿 足 高 血 壓、冠 心 病 等 心 腦 血 管 疾 病 患 者 的 臨 床
需求,被納入《圍產期降壓藥物臨床應用管理指南(2025版)》、《中國心肌病綜合管理指南
(2025版)》、《老年 慢 性 腎 臟 病 綜 合 管 理 指 南(2025版)》、《中 國 兒 童 肥 厚 型 心 肌 病 診斷治
療與管理專家共識(2025版)》、《急性ST段抬高型心肌梗死經皮冠狀動脈介入治療術中冠
狀 動 脈 內 溶 栓 專 家 共 識(2025版)》、《英 國 腎 臟 病 協 會 臨 床 實 踐 指 南:成 人、兒 童 和 青 少
年 透 析 患 者 的 血 壓 管 理(2025版)》、《ACC/AHA/ACEP/NAEMSP/SCAI急 性 冠 狀 動 脈 綜 合
征患者管理指南(2025版)》等眾多國內外權威的臨床指南與專家共識。
能氣朗®(輔酶Q10片):
用於改善心肌代謝和能量供應,具有促進氧化磷酸化反應和保護生物膜結構完整性的功能。
對慢性心功能不全患者可以顯著改善氣促、乏力症狀,有效聯合常規治療,改善患者預後,
改善生活質量。上市至今三十餘年,先後進入《全球男性學論壇(GAF)抗氧化劑治療男性
不育臨床指南(2026版)》、《兒童暴發性心肌炎診治專家建議(2025版)》、《中國心肌病綜
合管理指南(2025版)》、《顱腦衝擊傷後創傷後應激障礙綜合防治專家共識(2025版)》、《中
國兒童肥厚型心肌病診斷治療與管理專家共識(2025版)》、《兒童周期性嘔吐綜合征治療
指南(2025版)》、《重症發熱伴血小板減少綜合征診治專家共識(2025版)》、《中國成人心
肌炎臨床診斷與治療指南2024》、《慢性酒精相關性腦損害的中國診療指南(2024版)》、《中
國遺傳性共濟失調診治專家共識(2024版)》、《中國心力衰竭診斷和治療指南(2024版)》等
眾多國內外權威的臨床指南與專家共識。
— 31 —
力美通®依普利酮片:
一款新型的MRA藥物,可通過與醛固酮受體(mineralocorticoid receptor,「MR」)結合,來
阻斷MR過度啓動所引發的心臟病變和血管損傷。《ESC指南:心血管疾病和妊娠的管理(2025
版)》、《ACC/AHA/ACEP/NAEMSP/SCAI急性冠狀動脈綜合征患者管理指南(2025版)》、《
TES臨 床 實 踐 指 南:原 發 性 醛 固 酮 增 多 症( 2025版)》、《 AHA/ACC/AANP/AAPA/ABC/
ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM成 人 高 血 壓 預 防、檢 測、評 估 和 管 理 指
南(2025版)》、《高血壓患者高容量負荷的評估和管理專家共識(2025版)》、《中國高血壓
防治指南(2024版)》、《中國心力衰竭診斷和治療指南(2024版)》、《難治性高血壓血壓管
理中國專家共識》、《鹽皮質激素受體拮抗劑臨床應用多學科中國專家共識(2022版)》等眾
多國內外知名的臨床指南和專家共識推薦臨床上使用MRA藥物來治療心力衰竭和高血壓
等心血管疾病。與第一代MRA藥物螺內酯相比,依普利酮具有更高的MR的選擇性,對於
雄 激 素 受 體 和 孕 激 素 受 體 的 親 和 力 較 低,因 此 副 作 用 較 小,是 一 款 安 全 有 效 的 新 一 代
MRA藥物。本品於二零二三年八月獲中國藥監局批准上市,彌補了中國國內二代選擇性
醛 固 酮 受 體 拮 抗 劑 藥 物 的 空 白;二 零 二 四 年 五 月,完 成 了 首 張 處 方 的 開 具,正 式 在 國 內
實現商業化;二零二四年十一月,正式納入中國的《國家基本醫療保險、工傷保險和生育
保險藥品目錄(2024版)》。
— 32 —
優敏速®腎上腺素鼻噴霧劑:
優敏速®是首個FDA批准的用於I型過敏反應(包括嚴重過敏反應)的非注射治療產品,採用
創新的鼻噴給藥方式,使用便捷,小巧易攜帶,能夠在發生過敏反應的緊急情況下,第一
時 間 由 患 者 本 人 或 他 人 完 成 給 藥。該 產 品 擁 有 長 達30個 月 的 保 質 期,能 顯 著 減 少 因 藥 品
過期造成的浪費,減輕患者的經濟與用藥負擔。關鍵性臨床研究結果顯示,接受優敏速®
或已批准的腎上腺素注射產品治療的受試者體內腎上腺素血液濃度相當,並且已證實優
敏速®對過敏反應患者具有快速起效和短時間內緩解症狀的作用。憑藉其獨特的便攜性與
操作友好性,優敏速®有望迅速滲透至家庭、學校、旅行等多種院外場景,並填補嚴重過
敏反應急救藥物在院外場景使用的空白。
潤漠德霖®曲前列尼爾注射液:
是 一 款 治 療 肺 動 脈 高 壓 的 罕 見 病 藥 物,為 一 種 內 源 性 前 列 環 素 的 人 工 合 成 類 似 物,通 過
作用於特定的前列腺素受體以及對血栓素A2的拮抗作用,促進血管平滑肌的舒張,減少
血栓形成,抑制血管壁細胞增殖,進而增加血流量,減輕心臟負擔。該產品與現有治療手
段聯用可顯著改善患者的長期生存率,《成人先天性心臟病相關肺動脈高壓診斷與治療指
南(2026版)》、《ESC指 南:心 血 管 疾 病 和 妊 娠 的 管 理(2025版)》、《動 脈 性 肺 動 脈 高 壓 靶
向藥物治療醫藥共管專家共識(2025版)》、《急性肺栓塞診斷和治療指南(2025版)》
《慢性
血栓栓塞性肺動脈高壓診斷與治療指南(2024版)》、《 ESC/ERS肺動脈高壓診斷與治療指
南(2022版)》、《中國肺動脈高壓診斷與治療指南(2021版)》等國內外權威指南均推薦使用
該 產 品。潤 漠 德 霖®為 中 國 目 前 僅 有 的 兩 款 獲 批 上 市 的 曲 前 列 尼 爾 產 品 之 一,並 於 二 零
二三年一月,正式納入中國的《國家基本醫療保險、工傷保險和生育保險藥品目錄(2022
版)》,可顯著提高患者的藥物可及性並降低了治療負擔,惠及廣大的肺動脈高壓患者。
— 33 —
原料藥板塊
本集團原料藥板塊產品管線豐富,產品集群優勢顯著,大宗原料藥與特色原料藥銷售並行,
銷售渠道遍布全球。作為原料製劑一體化供應鏈前端的重要一環,現已擁有多個裝備完整、
工藝精湛、產業化能力突出、質量控制規範的現代化原料藥生產基地,圍繞心腦血管、抗
感 染、解 熱 鎮 痛、消 化 系 統 及 抗 腫 瘤 五 大 領 域 進 行 原 料 藥 生 產 研 發 佈 局,全 面 支 持 製 藥
科 技 領 域 的 製 劑 生 產 與 研 發 工 作,源 頭 保 障 公 司 製 劑 品 質 的 高 標 準 和 一 致 性,真 正 實 現
上下游產業優勢的整合。
mRNA平台
本集團以南京奧羅 生 物 科 技 有 限 公 司(「奧 羅 生 物」)為 核 心 搭 建 了 全 球 領 先 的mRNA技術
平台。奧羅生物作為集團全球化mRNA創新技術平台,擁有自主知識產權的mRNA核酸藥
物 開 發、脂 質 納 米 顆 粒(LNP)遞 送 兩 大mRNA核 心 底 層 技 術,分 別 解 決 疫 苗 抗 原 設 計、
LNP體內靶向遞送和工藝開發等多項行業關鍵痛點,技術底座具備跨項目複用能力,可拓
展性強,可支持多元化mRNA候選藥物開發。奧羅生物的研發主要聚焦於腫瘤治療和傳染
病 防 治 等 具 有 重 大 臨 床 及 公 共 衛 生 意 義 的 方 向。目 前 平 台 重 點 推 進HPV-16宮 頸 癌、
HSV-2生殖器皰疹兩款治療性mRNA疫苗研發,並基於自研平台技術開展多項早期研發項
目概念驗證。
— 34 —
生物科技
本 集 團 踐 行 綠 色 低 碳、可 持 續 發 展 理 念,以 全 球 領 先 的 合 成 生 物 製 造 創 新 技 術 推 動 板 塊
高 質 量 發 展。生 物 科 技 領 域 以 氨 基 酸 產 品 為 核 心 業 務,定 位 於 全 球 高 品 質 氨 基 酸 優 質 服
務 商。本 集 團 在 生 物 科 技 領 域 的 發 展 注 重 技 術 創 新 和 高 質 量 體 系 構 建,通 過 打 造 技 術 與
品質壁壘,全面推進國際註冊進程,強化本集團在國際市場上的綜合競爭力。目前,本集
團生物科技領域已擁有發明專利約350項,主導及參與制定國家、行業、團體標準近70餘
項,已經發佈的標準達50項;擁有完備的國內外質量體系認證,榮獲國家級綠色工廠、國
家製造業單項冠軍示範企業、國家級專精特新「小巨人」企業、國家知識產權示範企業、
中國輕工業含硫氨基酸綠色製造工程技術研究中心、中國生物發酵行業先進企業等多項
殊榮。
氨基酸板塊
本集團在氨基酸領域已深耕20餘年,始終秉承科技創新的精神,以合成生物學為核心、中
國 首 創 全 球 領 先 的 生 物 法 新 技 術 生 產 多 種 氨 基 酸,填 補 了 行 業 空 白。本 集 團 承 擔 中 國 國
家工業強基項目和產業基礎再造項目,是國內首家獲批氨基酸「同線同標同質」三同認證
證書的企業,保障中國國內高品質氨基酸的供應鏈和產業鏈的安全性和穩定性。
本 集 團 始 終 堅 持 以「新 技 術,高 質 量,產 業 鏈,國 際 化」為 核 心 的 經 營 理 念,持 續 加 強 氨
基酸產業拓展,以藥品級氨基酸為基礎,發揮產業優勢,向多元化氨基酸方面繼續延伸。
— 35 —
新技術:
本集團緊密圍繞合成生物學領域,經過多年研發創新,目前已建成合成生物學、酶工程、
發酵工程、過程優化、質量研究、應用轉化等八大技術平台,開展細胞工廠構建、發酵工
藝精細調控、分離純化全技術鏈條的研究,通過多個技術領域的創新集成,已具備「新產
品開發、新技術工程化和產業化、應用解決方案」一體化的協同體系,為持續創新和產業
落地提供了強有力的支撐,部分技術填補國內空白。目前,本集團已與武漢大學、華中科
技 大 學、天 津 科 技 大 學、華 中 農 業 大 學 等 多 家 科 研 院 校 建 立 了 長 期 的 深 度 合 作 關 係,合
作開發了新型氨基酸發酵技術和酶表達系統,同時深化細胞培養基級別氨基酸的技術開發,
為 自 產 細 胞 培 養 基 的 研 究 提 供 了 原 料 保 障;運 用 分 子 生 物 學 和 蛋 白 組 學 等 技 術,對 生 物
酶 結 構 進 行 改 造,有 效 地 提 高 了 生 物 酶 活 性,提 升 了 產 品 的 產 量 與 質 量。其 中 以 菌 種 構
建優化為核心的發酵法工藝和以固定化酶為核心的酶轉化工藝,不僅可替代傳統化學合
成 工 藝,提 高 工 藝 安 全 性 和 生 產 便 利 性,還 可 大 幅 降 低 生 產 過 程 中 二 氧 化 碳 的 排 放,充
分彰顯了「碳達峰、碳中和」的節能減排和綠色環保的發展理念,展現出巨大的經濟和環
境 效 益;本 集 團 在 氨 基 酸 板 塊 搭 建 的 產 業 技 術 高 速 公 路 初 具 規 模,為 技 術 的 源 頭 創 新 和
產品的產業化奠定了堅實基礎。
本集團高度重視研發團隊建設和產研緊密融合。目前氨基酸板塊擁有以湖北省百人計劃
人 才 領 銜 的 核 心 技 術 團 隊,產 學 研 用 結 合 的 創 新 模 式 以 及 分 工 明 確、優 勢 互 補 的 技 術 創
新人才梯隊,已結出豐碩成果,授權發明專利數量位居同行業領先水平。
— 36 —
高質量:
本 集 團 氨 基 酸 產 品 國 內 外 質 量 認 證 體 系 完 善,眾 多 核 心 產 品 通 過 歐 美 日、東 南 亞、中 國
等多個國家及地區的藥品╱食品體系認證和註冊,包括歐盟EU GMP認證、歐盟REACH註
冊、出 口 歐 盟W C認 證、美 國F D A認 證、韓 國K F D A註 冊、I S O質 量 管 制 體 系 認 證、
FSSC22000食品體系認證、FAMI-QS飼料認證、IP非轉基因認證、HALAL清真食品認證、
KOSHER猶 太 食 品 認 證 等,既 確 保 了 核 心 產 品 海 外 經 營 的 合 規 性,又 為 後 續 拓 展 產 品 的
新 的 市 場 應 用 奠 定 了 基 礎;同 時 本 集 團 也 加 大 了 對 南 美 等 新 型 經 濟 體 的 註 冊 力 度,為 本
集 團 核 心 產 品 的 全 球 化 經 營 鋪 平 道 路。完 善 的 國 際 體 系 認 證 和 註 冊,展 現 出 本 集 團 在 海
外市場業務拓展的強大競爭力。
產業鏈:
本 集 團 擁 有 各 類 氨 基 酸 及 其 衍 生 品 近50種,擁 有26個 氨 基 酸 原 料 藥 註 冊 文 號,是 國 內 氨
基 酸 原 料 藥 註 冊 文 號 最 多 的 製 藥 企 業。同 時,本 集 團 也 新 增 了 多 款 食 品 級 和 飼 料 級 的 氨
基 酸 產 品,以 差 異 化 路 徑 打 開 增 長 空 間,彰 顯 市 場 攻 堅 與 產 品 創 新 雙 輪 驅 動 效 能。豐 富
的 氨 基 酸 產 品 集 群,能 更 好 地 滿 足 下 游 市 場 的 個 性 化 定 制 需 求,提 供 多 品 種 多 品 規 一 站
式服務,增強高端應用場景的客戶粘性。除原料產品外,本集團亦積極拓展製劑產品,自
主 研 發 的 兩 款 功 能 型 膳 食 營 養 補 充 劑 已 獲 得 美 國FDA認 證 並 已 在 美 國 實 現 了 商 業 化,國
內方面,本集團已有十餘款自主研發的功能性食品獲批上市。
國際化:
本集團氨基酸板塊銷售網絡覆蓋了包括歐美日、東南亞、中國等主流市場在內的全球140
多個國家和地區,海外業務佔比近40%,其中部分氨基酸品種市場佔有率名列前三。依託
技術突破和成本優勢,核心產品長期服務於包括世界500強企業在內的境內外優質客戶,
在產業鏈上下遊客戶建立了長效穩定的合作關係,在全球範圍內建立了較高的品牌知名
度和市場口碑,為該板塊的業績持續快速增長奠定了扎實的客戶基礎。
— 37 —
未 來,本 集 團 將 繼 續 依 托 在 高 品 質 氨 基 酸 領 域 全 球 領 先 的 生 物 法 製 造 新 技 術,扎 實 的 工
業 基 礎 和 產 業 積 累,豐 富 的 氨 基 酸 產 品 集 群,高 標 準 的 質 量 認 證 體 系,強 大 的 國 際 註 冊
及 商 業 化 能 力,重 點 佈 局 高 端 腸 外 營 養 製 劑、創 新 多 肽 類 藥 物、細 胞 培 養 基 等 藥 品 相 關
的 高 附 加 值 領 域,及 運 動 保 護 等 功 能 型 膳 食 營 養 補 充 劑、特 醫 及 嬰 配 食 品、美 妝 及 寵 物
食品等大健康消費領域,下游廣闊的市場空間和巨大的發展潛力將為本集團氨基酸板塊
提供持續強勁的發展動力。
財務回顧
收益及溢利
截至二零二六年六月三十日止六個月,本集團的業務穩健增長,收益約港幣6,388,910,000
元(去 年 同 期 重 述1:港 幣6,189,200,000元),同 比 上 漲 約3.2%。創 新 和 壁 壘 產 品2收 益 佔 總
收益的比例約50%。於本回顧期間,本公司擁有人應佔期內溢利約為港幣1,061,540,000元(去
年 同 期 重 述:港 幣1,193,170,000元)。期 內,本 集 團 對Telix投 資 的 公 允 價 值 變 動 和 處 置 合
計收益約港幣88,780,000元(去年同期收益重述:港幣151,720,000元),與去年同期相比減
少了港幣62,940,000元,如果撇除Telix投資對利潤的影響,本期的本公司擁有人應佔經調
整 的 經 營 性 純 利3約 為 港 幣972,760,000元(去 年 同 期 重 述:港 幣1,041,440,000元),主 要 系
因應對市場競爭調整銷售策略帶來的短期影響。
期 內,本 集 團 核 藥 抗 腫 瘤 診 療 及 心 腦 血 管 精 準 介 入 診 療 科 技 產 品 錄 得 收 益 約 港 幣
745,130,000元,較二零二五年同期(約港幣577,740,000元)比較上漲約29%。其中核藥抗腫
瘤 板 塊 錄 得 收 益 約 港 幣655,240,000元,較 二 零 二 五 年 同 期(約 港 幣421,780,000元)比 較 上
漲約55.4%,其上漲主要因為核心產品的臨床需求快速增長以及新產品快速放量所帶來的
收入增長,心腦血管精準介入診療板塊收益錄得收益約港幣89,890,000元。
期 內,本 集 團 製 藥 科 技 產 品 錄 得 收 益 約 港 幣3,274,080,000元,較 二 零 二 五 年 同 期(約 港 幣
3,845,190,000元)比較下降14.9%。其中,呼吸及危重症板塊錄得收益約港幣1,041,730,000
元,較二零二五年同期(約港幣1,047,350,000元)比較基本持平;五官科板塊錄得收益約港
幣1,115,510,000元,較 二 零 二 五 年 同 期(約 港 幣1,494,710,000元)比 較 下 降 約25.4%;心 腦
血 管 急 救 板 塊 錄 得 收 益 約 港 幣792,300,000元,較 二 零 二 五 年 同 期(約 港 幣904,410,000元)
比較下降了約12.4%,五官科板塊和心腦血管急救板塊收入下降,主要系因應對市場競爭
調整銷售策略帶來的短期影響。
— 38 —
期內,本集團生物科技產品錄得收益約港幣2,369,700,000元,較二零二五年同期重述結果
(約港幣1,766,260,000元)比較上漲約34.2%。其中氨基酸板塊(含牛磺酸)錄得收益約港幣
1,870,280,000元,較 二 零 二 五 年 同 期(約 港 幣1,428,490,000元)比 較 上 漲 約30.9%,其 上 漲
主要得益於核心產品銷售價格提升,同時下游市場需求擴大,帶動業務規模增長。
附註:
1
於二零二六年上半年,本公司成功收購河北九孚和保定加合100%股權。於收購時點,中國遠大為河
北九孚和保定加合的控股股東,且同時為本公司的控股股東,故此收購事項被視為涉及受共同控制
實體之業務合併,並採用合併會計法原則入賬。因此,截至二零二五年六月三十日止六個月之比較
簡明綜合損益及其他全面收益表以及於二零二五年十二月三十一日及二零二五年一月一日之簡明綜
合財務狀況表已重列,藉此納入合併實體自其首次受共同控制之日起計之資產及負債、溢利以及現
金流量。具體請參見簡明綜合財務報表附註2。
2
創新和壁壘產品指公司原研產品、獨家市場地位產品、擁有獨家商業化權益的產品以及打破外資壟
斷的首仿產品。
3
本公司擁有人應佔經調整的經營性純利界定為本公司擁有人應佔期內溢利但不包括Telix投資的公允
價值變動和處置收益的影響。
— 39 —
分銷成本及行政費用
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 集 團 分 銷 成 本 及 行 政 費 用 分 別 約 為 港 幣
1,582,340,000元 及668,100,000元,而 二 零 二 五 年 同 期 重 述 結 果 分 別 約 為 港 幣1,919,440,000
元及705,470,000元。分銷成本下降約港幣337,100,000元,主要是期間內營銷組織優化及銷
售策略調整的結果。行政費用亦較去年同期重述結果下降約港幣37,380,000元,主要是期
間內組織架構調整和精細化運營的結果。
財務費用
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 集 團 之 財 務 費 用 約 為 港 幣76,760,000元,二 零
二五年同期重述結果約為港幣82,000,000元。財務費用下降的原因為置換貸款使綜合利率
下降。
研發及項目投入
截至二零二六年六月三十日止六個月,本集團繼續投入資源用於在研項目的推進及創新
項 目 的 引 進,研 發 費 用 加 上 資 本 化 研 發 支 出、新 項 目 的 預 付 款 及 其 他 投 入,本 集 團 於 研
發工作及項目的投入約港幣7.64億元。
應收款項及應付款項
於二零二六年六月三十日,本集團之應收貿易賬款及其他應收款約為港幣5,397,240,000元,
較 二 零 二 五 年 重 述 後 結 餘 增 加 約 港 幣664,650,000元,主 要 原 因 為 本 期 的 業 務 增 加,而 且
市場上一般慣例為會於年末時加大催收貨款的力度致使應收賬款結餘會相對較小,因此
本期的應收貿易賬款及應收票據結餘較去年年末的結餘增加約港幣898,520,000元。
於二零二六年六月三十日,本集團之應付貿易賬款及其他應付款約為港幣4,002,710,000元,
較 二 零 二 五 年 重 述 結 餘 基 本 持 平,主 要 原 因 為 本 期 的 業 務 增 加,致 使 應 付 貿 易 賬 款 及 應
付 票 據 共 增 加 約 港 幣110,280,000元。另 外,因 年 內 營 銷 組 織 優 化 及 銷 售 策 略 調 整 而 減 少
預提銷售及經營費用如工資、市場推廣及宣傳、研發費用等,共約港幣159,160,000元。
— 40 —
重大投資
價值超過本集團的資產總值5%的投資為被視為重大投資。於二零二六年六月三十日,本
集團之重大投資包括(i) Grand Pharma Sphere Pte Limited(「Grand Pharma Sphere」)及(ii)
上海旭東海普藥業有限公司(「旭東海普」)。
Grand Pharma Sphere為一組公司的控股公司,主要從事研發、製造及銷售核藥及腫瘤介入
產 品。本 集 團 實 益 持 有 其 約57.98%股 本 權 益。截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本
集團應佔Grand Pharma Sphere之利潤為約港幣40,480,000元(截至二零二五年六月三十日止
六個月:應佔之利潤約港幣39,300,000元)。
旭東海普及其附屬公司為一組公司,主要從事製造及銷售不同容量的注射液類醫藥製劑。
本集團實益持有其55%股本權益。截至二零二六年六月三十日止六個月,本集團應佔旭東
海 普 之 利 潤 為 約 港 幣38,110,000元(截 至 二 零 二 五 年 六 月 三 十 日 止 六 個 月:約 港 幣
42,820,000元)。
於聯營公司的重大投資並無可取的市場公平值,原因為重大聯營公司均為私人公司及並
無可取的市場價格。聯營公司之業績和資產及負債採用權益會計法計入本集團的綜合財
務報表。
本集團於投資到這些聯營公司時會考慮不同的條件,主要包括:
1.
尋找機會進入新市場及開拓產品組合,例如投資到Grand Pharma Sphere提供了機會給
本 集 團 進 入 核 藥 抗 腫 瘤 領 域,而 投 資 其 他 聯 營 公 司 即 有 助 本 集 團 進 入 其 他 市 場,例
如取得先進的技術並進入心腦血管介入器械的國際市場;
2.
尋找本集團現有產品及市場協同效應,例如旭東海普的主要產品可以與本集團的製
劑產品產生協同效應並豐富本集團的急救藥品、心腦血管和呼吸科產品的產品組合,
並可強化本集團在這些領域的產品質量、市場份額及品牌;
3.
尋求機會與在早期研發階段的公司合作,以取得附有強大潛力的產品之經營權。
— 41 —
有關這些聯營公司的產品研發和前景的進一步詳情,請見以上標題為「業務回顧及前景」
一節的描述。
研究與開發
本集團創新管線充足,期內創新項目34個,分布於臨床前到新藥上市申請的不同階段,管
線佈局合理,形成了良好的梯隊效應。
研發管線
領域
板塊
方向
放射性核素偶聯藥物(RDC)
核藥抗腫瘤診療
核藥抗腫瘤診療及心腦
血管精準介入診療科技
介入治療
通路管理
心腦血管精準介入
診療
結構性心臟病與
心衰
中國大陸
前列腺癌
TLX591-CDx
(68Ga-PSMA-11)
前列腺癌-診斷
TLX250
(177Lu-girentuximab)
腎透明細胞癌
TLX250-CDx
(89Zr-girentuximab)
腎透明細胞癌-診斷
TLX101
(131I-IPA)
腦膠質瘤
ITM-11
胃腸胰腺神經內分泌瘤
GPN01530-2
實體瘤-診斷
GPN02006
肝細胞癌-診斷
釔[90Y]微球注射液
原發性肝癌
溫敏栓塞劑
富血管性實質臟器腫瘤
Kona
腦動靜脈畸形
AuroLase
前列腺癌
優護
前列腺癌
優愛MRD
尿路上皮癌
aXess
血液透析
GPN01037
顱內狹窄病變
結構性心臟病
Saturn
二尖瓣返流
心衰
CoRisma
心衰
GPN00153(CBT-001)
翼狀胬肉
GPN00833
眼部炎症
GPN00884
近視防治
中成藥
mRNA平台
TLX591
(177Lu-rosapatumab)
神經介入
眼科
呼吸及危重症
適應症
血管介入
五官科
製藥科技
產品
GPN01360
抑郁症
GPN01020
神經系統疾病
抗感染
呼吸
GPN01411
危重症
STC3141
膿毒症
腫瘤
ARC01 (A002)
HPV16型陽性實體瘤
海外
— 42 —
研發進度
臨床前
IND╱型檢
I期
II期
III期
NDA╱註冊
上市
研發中心
目前,本集團在全球範圍內參與及建立了多個研發技術平台以及研發中心:
在製藥科技領域,位於中國武漢的光谷國際研發中心是本集團製藥科技領域在中國的研
發主體,為本集團高端製劑產品的研發提供技術支援;糖組學技術平台位於澳洲研發中心,
專 注 於 抗 病 毒 藥 物 的 開 發;mRNA技 術 平 台 位 於 中 國 南 京,專 注 於 抗 腫 瘤 及 抗 感 染 類
mRNA藥物的開發,未來也將進一步拓展至罕見病及蛋白替代療法等領域。
在 核藥抗腫瘤診 療 板 塊,腫 瘤 介 入 技 術 平 台 和RDC技 術 平 台 分 別 是 美 國 波 士 頓 研 發中心
以及中國成都放射性藥物研發中心。
在 心 腦 血 管 精 準 介 入 診 療 板 塊,本 集 團 的 高 端 醫 療 器 械 研 發 技 術 平 台,由 武 漢 光 谷 器 械
研發中心以及常州器械研發中心組成。
仿製藥開發
回 顧 期 內,甲 硝 唑 凝 膠、醋 酸 艾 替 班 特 注 射 液、鹽 酸 阿 莫 羅 芬 搽 劑 以 及 吸 入 用 乙 酰 半 胱
氨酸溶液獲中國藥監局頒發藥品註冊證書。
一致性評價
回顧期內,甲硝唑凝膠、醋酸艾替班特注射液、鹽酸阿莫羅芬搽劑、吸入用乙酰半胱氨酸
溶 液、地 西 泮 注 射 液 以 及 硫 酸 阿 米 卡 星 注 射 液 獲 批 通 過 或 視 同 通 過 一 致 性 評 價。新 申 報
氫溴酸替格列汀片、鹽酸納美芬注射液、富馬酸比索洛爾片、乙酰半胱氨酸泡騰片。目前
本集團共有70個產品獲批通過或視同通過一致性評價,另19個產品在審評。
— 43 —
知識產權保護
回 顧 期 內,本 集 團 新 增 申 請55項,新 增 專 利 授 權33項,其 中 發 明 專 利 授 權17項,佔 比
52%,新增海外專利授權1件。本集團累計有效專利數1028項,其中有效發明專利599項。
本集團高度重視自主創新項目的知識產權保護,創新領域專利持有量274項,圍繞抗感染、
腫 瘤、醫 療 器 械 及mRNA技 術 平 台 等 創 新 領 域 新 增 專 利 申 請23項,佔 集 團 新 增 申 請 總 量
42%,其中,抗感染領域核心專利已在中國、美國、歐洲、日本、韓國、以色列、新加坡、
澳大利亞等地獲得授權。
商業化能力
本集團業績持續提升,創新產品持續上市並產生利潤貢獻離不開商業化能力的持續提升。
於 本 公 告 日 期,本 集 團 有 銷 售 人 員 超 過5,000人,其 中 製 藥 領 域 銷 售 人 員 超 過4,000人(含
OTC),中 國 範 圍 內 覆 蓋 醫 院 及 基 層 醫 療 機 構 約50,000家,其 中 等 級 醫 院 超 過13,000家;
OTC方 向 銷 售 人 員 超 過1,000人,輻 射 藥 店 超 過50萬 家;心 腦 血 管 精 準 介 入 診 療 板 塊 銷 售
團隊約150人,覆蓋了近1800家醫院;核藥抗腫瘤診療板塊全球銷售人員超過900人,全球
銷售網絡覆蓋50多個國家和地區,並在中國積極進行易甘泰®釔[90Y]微球注射液的入院及
學術推廣工作。
國際化水平
本 集 團 全 球 化 步 伐 持 續 不 斷 加 快,在 核 藥 抗 腫 瘤 診 療、心 腦 血 管 精 準 介 入 診 療、危 重 症
等領域擁有多家獨立運營的海外公司,推進多款全球創新產品的海外臨床試驗,在美國、
澳大利亞、比利時、波蘭、英國五個國家獲得了8項臨床批件,涉及原發性肝癌、實體瘤、
膿毒症等多個適應症。目前,本集團連同聯營公司在海外員工總數超過350人。
— 44 —
重大投資、併購與合作
本集團延續「自主研發+全球拓展」的發展戰略,在全球範圍內進一步挖掘優質創新項目來
擴充本集團的產品管線和提高本集團的綜合實力,大力向創新和國際化轉型。於報告期內,
本集團進行了以下的重要合作:
•
與香港大學達成戰略合作
二零二六年四月,本集團與香港大學及其全資子公司港大科橋有限公司(「港大科橋」)
達 成 戰 略 合 作。雙 方 將 於 學 術 研 究、資 源 分 享、人 才 培 養 以 及 產 品 開 發 等 方 面 展 開
深 度 合 作,合 力 推 進 抗 感 染 領 域 的 創 新 藥 物 研 發 與 成 果 產 業 化 落 地。本 次 合 作 將 以
創 新 抗 菌 藥 物 開 發 為 起 點,相 關 項 目 由 李 學 臣 教 授 的 團 隊 承 接,旨 在 開 發 具 備 更 優
療 效 與 安 全 性 的 全 新 治 療 方 案,以 解 決 抗 菌 治 療 領 域 未 被 滿 足 的 臨 床 需 求。後 續 香
港大學將把其擁有的相關知識產授權予本集團獨家許可,由本集團全權負責後續的
開 發、註 冊 及 商 業 化,高 效 實 現 前 沿 科 研 成 果 的 產 業 轉 化。本 次 合 作 標 誌 著 本 集 團
在 聯 動 國 際 頂 尖 高 校、深 度 融 合 前 沿 學 術 研 究 與 產 業 轉 化 應 用 方 面,再 度 邁 出 關 鍵
性步伐。
投資者關係
一直以來,本集團致力提高企業管治水平,以確保本集團的長遠發展。期內,本集團通過
在本公司及香港交易及結算所有限公司網站公佈年報、年度業績公告、其他公告及通函,
並主動發放自願性公告,向股東及投資者披露本集團的最新業務發展。
同時,本集團積極通過不同渠道與投資者保持密切溝通,包括券商路演、大型電話會議、
一 對 一 會 議 等 多 元 化 對 話 方 式,向 投 資 者 介 紹 本 集 團 的 業 務 情 況、發 展 情 況 及 海 外 成 員
企業業務等,並同步通過不同媒體渠道發佈最新業務動態,旨在搭建一個公開、雙向、透
明、誠懇的溝通平台,從而讓投資者即時掌握本集團之業務進展及發展前景。期內,本集
團 通 過 業 績 發 佈 會、投 資 者 現 場 調 研 等 活 動 積 極 與 資 本 市 場 及 投 資 者 進 行 溝 通,並 參 與
— 45 —
多 場 由 大 型 投 資 銀 行 及 證 券 公 司 等 機 構 舉 辦 的 峰 會、論 壇、策 略 會 及 專 題 路 演 等 活 動,
吸 引 了 數 百 名 機 構 投 資 者 和 分 析 師 參 與。藉 由 與 投 資 者 溝 通 交 流 的 機 會,本 集 團 冀 望 聽
取更多寶貴意見,建立積極、高效的資訊溝通機制,廣泛收集投資者反饋,以期進一步提
升企業管治水平。
本集團的投資者關係管理工作有助於樹立優質的企業形象、傳遞科技創新的核心戰略,
在多維度獲得業內的高度認可,於二零二六年一月榮膺第十二屆「港股100強」年度醫藥醫
療創新先鋒榜單、第二屆聚董秘「百佳IRM公司(二十佳)」以及第二屆聚董秘「百佳ESG公
司(二十佳)」。
其他重大事項
認股權計劃
截 至 二 零 二 六 年 六 月 三 十 日 止,本 公 司 並 沒 有 採 納 任 何 認 股 權 計 劃,亦 無 尚 未 行 使 之 認
股權。
截 至 二 零 二 六 年 六 月 三 十 日 止,並 無 根 據 任 何 認 股 權 計 劃 授 出 或 行 使 認 股 權,亦 無 尚 未
行使之認股權。
股份獎勵計劃
於 二 零 二 一 年 九 月 一 日,本 公 司 採 納 了 股 份 獎 勵 計 劃(「該 計 劃」),而 本 集 團 的 僱 員、董
事及顧問將有權參與該計劃。該計劃的詳情載於本公司日期為二零二一年九月一日的公告。
本 集 團 已 向 為 該 計 劃 成 立 的 信 托 支 付 了 約 港 幣278,560,000元,連 同 之 前 購 買 的 股 票 所 得
的股息,受托人已用了約港幣268,500,000元購買47,761,500股本公司之股份(「股份」)作為
信 托 基 金 一 部 分,而 該 等 股 份 由 受 托 人 就 信 托 項 下 合 資 格 參 與 者 的 利 益 持 有,並 為 該 計
劃下可供授出的獎勵股份總額,佔本公司之已發行股份約1.35%。受託人為在收到本集團
的購買股份指示及必要的資金後,在合理切實可行的範圍內儘快以當時的市場價格在市
場上購買股份。
— 46 —
除 以 上 所 述 外,截 至 二 零 二 六 年 六 月 三 十 日 止,本 集 團 並 無 授 出 任 何 獎 勵,亦 無 促 使 向
受 託 人 支 付 信 託 基 金 以 購 買 或 認 購 股 份。待 日 後 授 出 獎 勵 予 合 資 格 人 士 時,將 根 據 當 時
適 用 之 上 市 規 則 及 其 他 監 管 守 則,規 限 每 名 人 士 可 享 有 之 獎 勵 股 份 數 目、獎 勵 價 格、獎
勵 的 歸 屬 條 件 及 歸 屬 時 間 表,並 以 獎 勵 函 件 通 知。董 事 會 不 會 授 出 任 何 獎 勵 股 份 而 會 致
使董事會根據該計劃授出的累計股份數量超過採納該計劃之日時本公司的已發行股份數
目的5%(即177,478,557股),而每名該計劃的參與者每十二個月內累計最多可享有的數目
為不超過採納該計劃之日時本公司的已發行股份數目的1%(即35,495,711股)。
該計劃之目的
該計劃的目的為認可被選定之參與者的貢獻並激勵彼等留任本集團,從而促進本集團的
持續經營、成長及發展。
該計劃之剩餘年期
受限於該計劃可能根據計劃規則而由董事會提前終止,該計劃將於計劃期間(即自生效日
期起計十年期間)有效及生效。截止二零二六年六月三十日止,該計劃之有效年期尚餘約
五年半。
買入、出售或贖回股份
截 至 二 零 二 六 年 六 月 三 十 日 止 期 間 內,本 公 司 或 其 任 何 附 屬 公 司 並 無 買 入、出 售 或 贖 回
本公司任何上市證券。
僱員及薪酬政策
於二零二六年六月三十日,本集團於香港及中國境內聘用12,326名職員及工人(二零二五
年十二月三十一日:12,614名)。本集團根據員工表現及經驗釐定員工薪酬,管理層亦會
定 期 檢 討 員 工 薪 酬 制 度。其 他 員 工 福 利 包 括 醫 療 保 險、退 休 計 劃、適 當 培 訓 計 劃 及 認 股
權計劃。
競爭利益
本公司董事或管理層股東(定義見上市規則)概無於任何會或可能會與本集團業務構成競
爭之業務擁有權益。
— 47 —
董事於交易、安排或合約之權益
董事概無於本公司、其任何控股公司或附屬公司或其他附屬公司所訂立直至本年度結束
或於本年度期間任何時間仍然存續之任何就本集團業務而言屬重大之交易、安排或合約
擁有重大權益。
證券交易之標準守則
本公司已採納上市規則附錄C3所載之上市發行人董事進行證券交易的標準守則(「標準守則」)
為 其 董 事 進 行 證 券 交 易 之 操 守 準 則。本 公 司 已 向 本 公 司 董 事 作 出 個 別 查 詢,於 截 至 二 零
二六年六月三十日止期內一直遵守標準守則所載之所有相關規定。
獨立非執行董事之獨立性
本公司已根據上市規則第3.13條收到各獨立非執行董事每年對其獨立性之確認。獨立非執
行董事已確認彼等均為獨立。
企業管治常規守則
截至二零二六年六月三十日止期間,本公司已遵守上市規則附錄C1所載之企業管治守則
之所有適用守則條文(「企業管治守則」)。
審核委員會
本公司已成立審核委員會,以監察本集團財務報表之完整性及審視財務匯報程式及內部
監 控 系 統。現 時,審 核 委 員 會 由 獨 立 非 執 行 董 事 蘇 彩 雲 女 士 擔 任 主 席,其 他 成 員 包 括 三
名獨立非執行董事胡野碧先生、裴更博士及邢麗娜博士。蘇彩雲女士具備上市規則第3.10(2)
和3.21條所規定的適當專業資格。
本集團截至二零二六年六月三十日止期內之簡明中期財務報表為未經審核,但已由審核
委員會審閱。
— 48 —
薪酬委員會
本 公 司 已 成 立 薪 酬 委 員 會,以 考 慮 本 公 司 所 有 董 事 及 高 級 管 理 層 之 薪 酬。現 時,薪 酬 委
員 會 由 獨 立 非 執 行 董 事 蘇 彩 雲 女 士 擔 任 主 席,其 他 成 員 包 括 執 行 董 事 唐 緯 坤 博 士、林 芷
伊女士及獨立非執行董事胡野碧先生。
提名委員會
本公司已成立提名委員會,以協助董事會對本公司的董事提名制度實行整體管理。現時,
提名委員會由獨立非執行董事蘇彩雲女士擔任主席,其他成員包括執行董事周超先生及
獨立非執行董事胡野碧先生。
註: 於本公告中,機構及產品之中文譯名為非官方翻譯,僅為作展示用途。
承董事會命
遠大醫藥集團有限公司
主席
唐緯坤博士
香港,二零二六年八月二十六日
於本公告日期,董事會由四名執行董事唐緯坤博士、周超先生、楊光先生及林芷伊女士,
及四名獨立非執行董事蘇彩雲女士、邢麗娜博士、裴更博士及胡野碧先生組成。
* 僅供識別
— 49 —
中期業績
遠大醫藥集團有限公司(「本公司」)董事(「董事」)會(「董事會」)欣然公佈本公司及其附屬
公司(統稱「本集團」)截至二零二六年六月三十日止六個月之未經審核綜合中期業績,連
同過往期間之比較數字一並列示。
簡明綜合損益及其他全面收益表
截至二零二六年六月三十日止六個月
截至六月三十日止六個月
二零二六年 二零二五年
附註
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
4
6,388,913
(3,021,240)
6,189,196
(2,536,157)
毛利
其他收入及虧損淨額
分銷成本
行政費用
按公平值計入損益之金融資產的公平值變動
應佔聯營公司業績
財務費用
3,367,673
44,914
(1,582,343)
(668,097)
114,376
58,314
(76,756)
3,653,039
205,405
(1,919,443)
(705,473)
174,593
57,944
(81,995)
除稅前溢利
所得稅開支
5
1,258,081
(189,475)
1,384,070
(180,769)
期內溢利
6
1,068,606
1,203,301
收益
銷售成本
— 50 —
截至六月三十日止六個月
二零二六年 二零二五年
附註
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
其他全面收益╱(虧損),除所得稅後
其後不會重新歸類至損益的項目:
按公平值計入其他全面收益之於股本之投資的
公平值變動
應佔聯營公司其他全面虧損
(31,875)
(34,353)
24,155
(29,212)
其後可能重新歸類至損益的項目:
換算海外業務產生之匯兌差額
350,507
423,642
除所得稅後期內其他全面收益
284,279
418,585
除所得稅後期內總全面收益
1,352,885
1,621,886
下列人士應佔期內溢利:
-本公司擁有人
-非控股權益
1,061,538
7,068
1,193,167
10,134
1,068,606
1,203,301
1,352,196
689
1,615,402
6,484
1,352,885
1,621,886
下列人士應佔期內總全面溢利:
-本公司擁有人
-非控股權益
股息
7
–
–
每股盈利
-基本及攤薄(港仙)
8
30.31
34.07
— 51 —
簡明綜合財務狀況表
於二零二六年六月三十日
附註
非流動資產
物業、機器及設備
使用權資產
投資性房地產
於聯營公司之權益
按公平值計入其他全面收益之股本工具
商譽
無形資產
遞延稅項資產
預付款項
流動資產
存貨
應收貿易賬款及其他應收款
應收關連公司款項
按公平值計入損益的金融資產
已抵押銀行存款
現金及現金等價物
流動負債
應付貿易賬款及其他應付款
合約負債
銀行借款及其他借款
租賃負債
應付關連公司款項
應付直接控股公司款項
應付所得稅項
9
9
10
10
— 52 —
二零二五年
二零二六年
十二月 二零二五年
六月三十日
三十一日
一月一日
港幣千元
港幣千元
港幣千元
(未經審核) (未經審核) (未經審核)
(經重列) (經重列)
4,567,707
504,875
183,832
7,916,349
178,733
1,801,648
3,323,751
110,508
1,328,248
4,407,175
500,955
176,694
7,604,716
209,656
1,731,688
3,270,771
70,639
1,028,713
3,864,305
490,340
174,356
7,791,030
247,724
1,352,345
2,089,911
33,463
1,073,670
19,915,651
19,001,007
17,117,144
1,479,251
5,397,239
48,814
602,504
43,632
623,081
1,517,638
4,732,590
52,775
924,169
22,588
1,182,397
1,434,231
3,519,769
51,534
1,799,961
–
1,351,086
8,194,521
8,432,157
8,156,581
4,002,710
200,406
1,666,244
11,708
4,671
2,331
220,710
4,003,962
337,802
2,893,036
14,841
46,496
2,331
198,018
3,046,160
242,719
3,216,102
20,422
13,151
2,331
243,978
6,108,780
7,496,486
6,784,863
附註
二零二五年
二零二六年
十二月 二零二五年
六月三十日
三十一日
一月一日
港幣千元
港幣千元
港幣千元
(未經審核) (未經審核) (未經審核)
(經重列) (經重列)
淨流動資產
2,085,741
935,671
1,371,718
總資產減流動負債
22,001,392
19,936,678
18,488,862
非流動負債
銀行借款及其他借款
租賃負債
遞延稅項負債
其他應付款
遞延收入
3,331,121
42,036
366,622
569,068
333,186
1,840,763
40,277
367,265
224,671
321,149
1,256,280
40,604
300,351
–
299,843
4,642,033
2,794,125
1,897,078
資產淨值
17,359,359
17,142,553
16,591,784
本公司擁有人應佔股本及儲備
股本
儲備
35,496
17,223,941
35,496
16,953,391
35,496
16,493,123
本公司擁有人應佔權益
非控股權益
17,259,437
99,922
16,988,887
153,666
16,528,619
63,165
權益總額
17,359,359
17,142,553
16,591,784
10
— 53 —
附註:
1.
編制基準
本簡明綜合中期財務報表是根據香港會計師公會(「香港會計師公會」)頒佈的香港會計準則第34號(「香
港會計準則第34號」)
「中期財務報告」及香港聯合交易所有限公司證券上市規則(「上市規則」)的適用
披露規定而編製。
本 簡 明 綜 合 中 期 財 務 報 表 包 括 綜 合 財 務 業 績 及 經 選 擇 的 說 明 附 註。附 註 包 括 對 了 解 本 集 團 自 二 零
二五年年度財務報表起的財務狀況及業績變動而言屬重要的事件及交易的說明。於批准簡明綜合財
務報表時,本公司董事合理預期本集團有充足資源於可見將來繼續經營。因此,彼等於編製簡明綜
合財務報表時繼續採用持續經營會計基準。
載列於本綜合中期財務業績中有關截至二零二五年十二月三十一日止財政年度的財務資料(作為過
往所呈報的資料)並不構成本公司於該財政年度的法定財務報表,惟該等資料是源自該等財務報表。
截至二零二五年十二月三十一日止年度的法定財務報表於本公司註冊辦事處可供查閱。核數師於二
零二六年三月二十六日發表對該財務報表作出無保留意見的報告。
2.
涉及受共同控製實體的業務合併之合併會計法
於二零二五年十二月三十一日,本公司作為買方與中國遠大及武漢九祥生物科技合夥企業(有限合伙)
就河北九孚和保定加合100%股權之收購事項訂立協議,代價為人民幣316,000,000元。河北九孚及其
附屬公司主要從事生產及銷售氨基酸類產品,保定加合主要從事硫醇類產品加工、製造和銷售。
於收購時點,中國遠大為河北九孚和保定加合的控股股東,其持有河北九孚81.3217%股權且同樣持
有保定加合81.3217%股權。就收購事項而言,由於中國遠大同時為本公司的控股股東,間接持有本
公司之全部已發行股本的約53.42%股權,故此收購事項被視為涉及受共同控制實體之業務合併,並
採用合併會計法原則入賬。
因此,截至二零二五年六月三十日止六個月之比較簡明綜合損益及其他全面收益表以及於二零二五
年十二月三十一日及二零二五年一月一日之簡明綜合財務狀況表已重列,藉此納入合併實體自其首
次受共同控制之日起計之資產及負債、溢利以及現金流量。
就收購事項所採用之合併會計法導致截至二零二五年六月三十日止六個月本公司擁有人應佔全面收
益總額及本公司擁有人應佔溢利分別增加港幣2,618萬元及港幣2,415萬元。
— 54 —
應用合併會計法對截至二零二五年六月三十日止六個月之簡明綜合損益及其他全面收益表中各項目
之影響如下:
截止二零二五年
截止二零二五年
六月三十日 收購事項引致的
六月三十日
止六個月 合並會計重列
止六個月
港幣千元
港幣千元
港幣千元
(未經審核)
(未經審核)
(原列)
(經重列)
收益
銷售成本
6,107,323
(2,507,159)
81,873
(28,998)
6,189,196
(2,536,157)
毛利
其他收入及虧損淨額
分銷成本
行政費用
按公平值計入損益之金融資產的公平值變動
應佔聯營公司業績
財務費用
3,600,164
203,578
(1,916,285)
(691,751)
174,593
57,944
(80,350)
52,875
1,827
(3,158)
(13,722)
–
–
(1,645)
3,653,039
205,405
(1,919,443)
(705,473)
174,593
57,944
(81,995)
除稅前溢利
所得稅開支
1,347,893
(174,023)
36,177
(6,746)
1,384,070
(180,769)
期內溢利
1,173,870
29,431
1,203,301
其他全面收益╱(虧損),除所得稅後
其後不會重新歸類至損益的項目:
按公平值計入其他全面收益之於股本之投資
的公平值變動
應佔聯營公司其他全面年收益
其後可能重新歸類至損益的項目:
換算海外業務產生之匯兌差額
24,155
(29,212)
–
–
24,155
(29,212)
421,201
2,441
423,642
除所得稅後期內其他全面收益
416,144
2,441
418,585
除所得稅後期內總全面收益
1,590,014
31,872
1,621,886
下列人士應佔期內溢利:
-本公司擁有人
-非控股權益
1,169,019
4,851
24,148
5,283
1,193,167
10,134
1,173,870
29,431
1,203,301
1,589,226
788
26,176
5,696
1,615,402
6,484
1,590,014
31,872
1,621,886
0.69
34.07
下列人士應佔期內總全面溢利:
-本公司擁有人
-非控股權益
–
股息
每股盈利
-基本及攤薄(港仙)
33.38
— 55 —
應用合併會計法對二零二五年十二月三十一日之簡明綜合財務狀況表中各項目之影響如下:
二零二五年 收購事項引致的
二零二五年
十二月三十一日 合並會計重列 十二月三十一日
港幣千元
港幣千元
港幣千元
(未經審核)
(未經審核)
(原列)
(經重列)
非流動資產
物業、機器及設備
使用權資產
投資性房地產
於聯營公司之權益
按公平值計入其他全面收益之股本工具
商譽
無形資產
遞延稅項資產
預付款項
流動資產
存貨
應收貿易賬款及其他應收款
應收關連公司款項
按公平值計入損益的金融資產
已抵押銀行存款
現金及現金等價物
流動負債
應付貿易賬款及其他應付款
合約負債
銀行借款及其他借款
租賃負債
應付關連公司款項
應付直接控股公司款項
應付所得稅項
淨流動資產
總資產減流動負債
— 56 —
4,332,283
492,214
176,694
7,604,716
209,656
1,676,875
3,269,431
70,632
1,026,776
74,892
8,741
–
–
–
54,813
1,340
7
1,937
4,407,175
500,955
176,694
7,604,716
209,656
1,731,688
3,270,771
70,639
1,028,713
18,859,277
141,730
19,001,007
1,484,191
4,679,486
54,723
924,169
22,588
1,142,370
33,447
53,104
(1,948)
–
–
40,027
1,517,638
4,732,590
52,775
924,169
22,588
1,182,397
8,307,527
124,630
8,432,157
3,936,683
323,926
2,828,720
12,646
16,778
2,331
195,627
67,279
13,876
64,316
2,195
29,718
–
2,391
4,003,962
337,802
2,893,036
14,841
46,496
2,331
198,018
7,316,711
179,775
7,496,486
990,816
(55,145)
935,671
19,850,093
86,585
19,936,678
二零二五年 收購事項引致的
二零二五年
十二月三十一日 合並會計重列 十二月三十一日
港幣千元
港幣千元
港幣千元
(未經審核)
(未經審核)
(原列)
(經重列)
非流動負債
銀行借款及其他借款
租賃負債
遞延稅項負債
其他應付款
遞延收入
1,840,763
40,277
367,265
105,798
316,305
–
–
–
118,873
4,844
1,840,763
40,277
367,265
224,671
321,149
2,670,408
123,717
2,794,125
資產淨值
17,179,685
(37,132)
17,142,553
本公司擁有人應佔股本及儲備
股本
儲備
35,496
16,981,543
–
(28,152)
35,496
16,953,391
本公司擁有人應佔權益
非控股權益
17,017,039
162,646
(28,152)
(8,980)
16,988,887
153,666
權益總額
17,179,685
(37,132)
17,142,553
— 57 —
上述有關收購事項之合併會計重列對二零二五年一月一日之簡明綜合財務狀況表中各項目之影響如下:
二零二五年 收購事項引致的
一月一日 合並會計重列
港幣千元
港幣千元
(未經審核)
(原列)
非流動資產
物業、機器及設備
使用權資產
投資性房地產
於聯營公司之權益
按公平值計入其他全面收益之股本工具
商譽
無形資產
遞延稅項資產
預付款項
二零二五年
一月一日
港幣千元
(未經審核)
(經重列)
3,784,285
481,783
174,356
7,791,030
247,724
1,299,741
2,082,728
33,456
1,070,540
80,020
8,557
–
–
–
52,604
7,183
7
3,130
3,864,305
490,340
174,356
7,791,030
247,724
1,352,345
2,089,911
33,463
1,073,670
16,965,643
151,501
17,117,144
1,370,582
3,454,589
59,411
1,799,961
1,340,979
63,649
65,180
(7,877)
–
10,107
1,434,231
3,519,769
51,534
1,799,961
1,351,086
8,025,522
131,059
8,156,581
2,928,087
242,719
3,127,347
18,315
13,151
2,331
241,273
118,073
–
88,755
2,107
–
–
2,705
3,046,160
242,719
3,216,102
20,422
13,151
2,331
243,978
6,573,223
211,640
6,784,863
淨流動資產
1,452,299
(80,581)
1,371,718
總資產減流動負債
18,417,942
70,920
18,488,862
流動資產
存貨
應收貿易賬款及其他應收款
應收關連公司款項
按公平值計入損益的金融資產
現金及現金等價物
流動負債
應付貿易賬款及其他應付款
合約負債
銀行借款及其他借款
租賃負債
應付關連公司款項
應付直接控股公司款項
應付所得稅項
— 58 —
二零二五年 收購事項引致的
一月一日 合並會計重列
港幣千元
港幣千元
(未經審核)
(原列)
非流動負債
銀行借款及其他借款
租賃負債
遞延稅項負債
遞延收入
二零二五年
一月一日
港幣千元
(未經審核)
(經重列)
1,256,280
40,604
300,351
295,369
–
–
–
4,474
1,256,280
40,604
300,351
299,843
1,892,604
4,474
1,897,078
資產淨值
16,525,338
66,446
16,591,784
本公司擁有人應佔股本及儲備
股本
儲備
35,496
16,437,714
–
55,409
35,496
16,493,123
本公司擁有人應佔權益
非控股權益
16,473,210
52,128
55,409
11,037
16,528,619
63,165
權益總額
16,525,338
66,446
16,591,784
— 59 —
3.
會計政策
本簡明綜合財務報表乃按歷史成本基準編製,惟按公允值計量(倘適用)的若干金融工具除外。
除因應用經修訂香港財務報告準則會計準則而造成其他會計政策╱會計政策變動外,截至二零二六
年六月三十日止六個月的簡明綜合財務報表採用的會計政策及計算方法與本集團截至二零二五年
十二月三十一日止年度的年度綜合財務報表所呈列者一致。
應用經修訂香港財務報告準則會計準則
於本中期期間,本集團已首次應用以下由香港會計師公會頒佈的經修訂香港財務報告準則會計準則,
且於二零二六年一月一日開始年度期間強制生效,以編製本集團之簡明綜合財務報表:
香港財務報告準則第9號及
香港財務報告準則第7號(修訂本)
香港財務報告準則第9號及
香港財務報告準則第7號(修訂本)
香港財務報告準則會計準則(修訂本)
金融工具分類及計量
涉及依賴自然能源生產電力的合約
香港財務報告準則會計準則的年度改進-第11冊
於本期間應用經修訂香港財務報告準則會計準則不會對本集團於本期間及過往期間之財務狀況及表
現及╱或於該等簡明綜合財務報表所載列之披露造成重大影響。
4.
收益及分類資料
截至二零二六年六月三十日止六個月期間,本集團的經營一貫只有一個可報告分部,即從事製造及
銷售製藥科技產品、生物技術產品以及核藥抗腫瘤診療及心腦血管精準介人診療科技產品。而董事
會作為本集團之主要經營決策者,會審閱本集團之整體經營業績以作出有關資源分配之決定。
本集團之收益指扣除折扣及銷售相關稅項之已售貨品發票值。
— 60 —
地區資料
本集團之業務主要位於中華人民共和國(「中國」)
(所處國家),亦來自美國、歐洲及亞洲產生收益。
本集團按客戶所在地劃分之來自外界客戶收益截及有關其按資產所在地劃分之非流動資產資料如下:
來自外界客戶之收益
截至六月三十日止六個月
非流動資產
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
二零二六年
港幣千元
(未經審核)
二零二五年
港幣千元
(未經審核)
(經重列)
中國
美洲
歐洲
亞洲(不包括中國)
其他
5,295,014
565,770
242,358
253,941
31,830
5,370,813
373,186
229,197
184,721
31,279
13,759,994
250,827
–
106,922
–
13,079,416
261,327
–
103,689
–
總計
6,388,913
6,189,196
14,117,743
13,444,432
附註: 非流動資產並不包括按公平值計入其他收益之股本工具、遞延稅項資產及部份於聯營公司
之權益。
有關主要客戶之資料
截至二零二六年及二零二五年六月三十日止六個月期間,本集團概無來自單一客戶之收益佔本集團
總收益之10%或以上。
— 61 —
收益
來自客戶之合約的收益
截至六月三十日止六個月
二零二六年
二零二五年
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
貨物及服務種類
生產及銷售製藥科技產品
銷售生物技術產品
銷售核藥抗腫瘤診療及心腦血管精準介入診療科技產品
3,274,083
2,369,701
745,129
3,845,193
1,766,260
577,743
於個別時間點確認之收益
6,388,913
6,189,196
於分部資訊中披露的收益
外部客戶
6,388,913
6,189,196
收益確認時間
於個別時間點
6,388,913
6,189,196
本集團的所有收益為於個別時間,按貨物送給客戶、或客戶接受後或貨物的控制權轉移給客戶後確認。
所有收益合約為期一年或更短,而根據香港財務報告準則第15號之實務規則所準許,分配至該等未
獲滿足的合同之交易價格並沒有被披露。
5.
所得稅開支
簡明綜合損益及其他全面收益表所示的所得稅為:
截至六月三十日止六個月
二零二六年
二零二五年
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
本期稅項
遞延稅項
— 62 —
245,202
(55,727)
189,434
(8,665)
189,475
180,769
根據香港利得稅的利得稅兩級制,合資格集團實體之首港幣2,000,000元溢利將按8.25%之稅率徵稅,
而超過港幣2,000,000元之溢利則按16.5%之稅率徵稅。不符合利得稅兩級制的集團實體之溢利將繼續
按16.5%之統一稅率徵稅。
根據中華人民共和國企業所得法(「企業所得稅法」)及企業所得稅法之執行規定,中國附屬公司之稅
率自二零零八年一月一日開始為25%。
根據有關中國稅務法例,企業獲相關機構評定為高新科技企業(「高新科技企業」)可享寬減企業所得
稅(「企 業 所 得 稅」)稅 率15%。若 干 附 屬 公 司 獲 確 認 為 高 新 科 技 企 業,因 此 須 按 稅 率15%繳 納 企 業 所
得稅。有關政府團體每三年進行檢討以認定高新科技企業之資格。
6.
期內溢利
截至六月三十日止六個月
二零二六年
二零二五年
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
本年度溢利已扣除下列各項:
員工成本包括:
-工資及薪金
-退休福利計劃供款
1,084,957
92,334
1,095,557
89,955
1,177,291
1,185,512
物業、機器及設備折舊
使用權資產之折舊
無形資產之攤銷
194,336
16,603
138,556
185,847
24,875
84,278
折舊及攤銷總額
349,495
295,000
3,011,784
2,487
263,179
2,536,157
3,574
280,611
確認為開支之存貨成本
土地及樓宇之經營租賃租金
研發開支
7.
中期股息
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,董 事 會 宣 派 及 支 付 了 每 股 港 幣0.169元 或 合 共 約 港 幣
591,810,000元 股 息,作 為 截 至 二 零 二 五 年 十 二 月 三 十 一 日 止 年 度 之 末 期 股 息(二 零 二 五 年:每 股 港
幣0.26元或合共約港幣910,471,000元)。
截至二零二六年六月三十日止六個月期間,本公司概無派付或宣派中期股息(截至二零二五年六月
三十日止六個月:無)。
— 63 —
8.
每股盈利
每股基本盈利由本公司擁有人應佔溢利除以期內之普通股加權平均數結餘,當中並不包括本集團購
入並持有作為庫存股之普通股。
截至六月三十日止六個月
二零二六年
二零二五年
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
盈利:
計算每股基本盈利之溢利
股份數目:
計算每股基本盈利之普通股加權平均數(附註)
1,061,538
1,193,167
千股
(未經審核)
千股
(未經審核)
(經重列)
3,501,810
3,501,810
附註:
於二零二六年六月三十日及二零二五年六月三十日,作為計算每股盈利用途,已發行股份中已扣除
庫存股。
因為並無已發行潛在普通股,故截至二零二六年及二零二五年六月三十日止六個月期間的每股基本
及攤薄盈利為一致。
9.
應收貿易賬款及其他應收款
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
應收貿易賬款,淨額
應收票據
按金及預付款
其他應收稅款
其他應收款,淨額
3,919,472
505,508
2,041,189
160,090
99,228
1,798,997
1,727,468
1,869,788
167,440
197,610
減:預付款的非流動部分
6,725,487
(1,328,248)
5,761,303
(1,028,713)
5,397,239
4,732,590
— 64 —
本集團向其貿易客戶提供30天至180天之信用期。本集團並未向其應收貿易賬款及其他應收款收取任
何擔保物。以下為應收貿易賬款於呈報日期按發票日期呈列之賬齡分析。應收票據之到期日為本報
告日期之180日內。
應收貿易賬款賬齡分析如下:
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
90天以內
91天至180天
181天至365天
10.
2,375,923
802,277
741,272
1,413,503
247,698
137,796
3,919,472
1,798,997
應付貿易賬款及其他應付款
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
應付貿易賬款
應付票據
應記費用及其他應付賬款
其他應付稅款
1,191,717
791,297
2,412,858
175,906
903,878
968,855
2,227,621
128,279
減 :其他應付款的非流動部分
4,571,778
(569,068)
4,228,633
(224,671)
4,002,710
4,003,962
200,406
337,802
合約負債(附註a)
— 65 —
附註:
(a)
與銷售產成品相關的合約負債為預期於一年內支付。
以下為應付貿易賬款於呈報期末按發票日期呈列之賬齡分析:
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
90天以內
90天以上
11.
479,298
712,419
506,493
397,385
1,191,717
903,878
或然負債
於二零二六年六月三十日,本集團概無重大或然負債(二零二五年十二月三十一:無)。
— 66 —
responsibility for the contents of this announcement, make no representation as to its accuracy or
completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in
reliance upon the whole or any part of the contents of this announcement.
GRAND PHARMACEUTICAL GROUP LIMITED
遠 大 醫 藥 集 團 有 限 公 司*
(Incorporated in Bermuda with limited liability)
(Stock Code: 00512)
2026 INTERIM RESULTS ANNOUNCEMENT
Financial Highlights
-
For the six months ended 30 June 2026, the Group’s business grew steadily, with revenue of
approximately HK$6,388.91 million (restated for the same period last year1: HK$6,189.20
million), representing an increase of approximately 3.2% as compared to the corresponding
period of last year. Revenue from innovative and barrier products2 accounted for approximately
50% of total revenue.
-
For the six months ended 30 June 2026, the profit for the period attributable to owners of the
Company amounted to approximately HK$1,061.54 million (restated for the same period last
year: HK$1,193.17 million). During the period, the Group’s fair value change gain and disposal
gain on Telix investment amounted to approximately HK$88.78 million (same period last year:
HK$151.72 million), representing a decrease of HK$62.94 million compared to the same period
last year. If the impact of Telix investment on profit is excluded, the adjusted net operating
profit attributable to owners of the Company3 was approximately HK$972.76 million (restated
for the same period last year: HK$1,041.44 million).
-
For the six months ended 30 June 2026, the Group’s nuclear medicine anti-tumor diagnosis and
treatment segment recorded revenue of approximately HK$655.24 million, representing an
increase of approximately 55.4% compared to the corresponding period in 2025 (approximately
HK$421.78 million). This increase was primarily attributable to revenue growth driven by the
rapid rise in clinical demand for core products and the rapid scaling-up of sales volumes for new
products.
—1—
–
The Group is firmly committed to implementing an innovation-driven strategy, and “Go Global”
strategies, optimizing the allocation of R&D resources, and focusing on high-barrier sectors such
as nuclear medicine for anticancer therapy and anti-infective treatments for critical illnesses,
whilst also expanding into cutting-edge fields such as innovative mRNA medicines and
innovative ophthalmic drugs. Leveraging its end-to-end R&D platform, the Group has built a
tiered innovation pipeline spanning the short, medium, and long term, resulting in continuous
improvements in R&D-to-commercialization efficiency. The Group has established a mature
global clinical trial and “simultaneous China-U.S. filing” registration system, with multiple
products having received clinical trial approvals from international regulatory authorities.
Clinical results for core products have been published in top-tier international journals and
successively incorporated into authoritative domestic and international diagnostic and treatment
guidelines, providing strong support for the commercialization process. The Group currently has
more than 30 high-value projects in development, with a concentration of R&D milestones
expected to be achieved in 2027–2028. This robust pipeline will provide growth momentum for
long-term development.
Note:
1.
In the first half of 2026, the Company successfully acquired 100% of the equity interests in Hebei Yuanda
Jiufu Biotechnology Co., Ltd. (“Hebei Jiufu”) and Baoding Jiahe Fine Chemicals Co., Ltd. (“Baoding
Jiahe”). At the time of the acquisition, China Grand Enterprises Incorporation (“China Grand”) was the
controlling shareholder of both Hebei Jiufu and Baoding Jiahe, and was also the controlling shareholder of
the Company. Therefore, the acquisition was treated as a business combination involving entities under
common control and accounted for using the merger accounting method. Consequently, the comparative
condensed consolidated statements of income and other comprehensive income for the six months ended 30
June 2025, as well as the condensed consolidated statements of financial position as of 31 December 2025,
and 1 January 2025, have been restated to incorporate the assets, liabilities, profits, and cash flows of the
combined entity from the date on which it first came under common control. For details, please refer to
Note 2 to the condensed consolidated financial statements.
2.
Innovative and barrier products refer to the Company’s original research products, products with exclusive
market positions, products with exclusive commercialization rights, and first-to-market generic products
that break foreign monopolies.
3.
Adjusted net operating profit attributable to owners of the Company is defined as the profit attributable to
owners of the Group for the period which excludes the impact of fair value changes and disposal gains on
the Telix investment.
—2—
MANAGEMENT DISCUSSION AND ANALYSIS
GROUP POSITIONING
The Group is an international pharmaceutical company of technological innovation. Its core businesses
cover three major areas, namely nuclear medicine anti-tumor diagnosis and treatment and
cerebrocardiovascular precision interventional diagnosis and treatment technology, pharmaceutical
technology and biotechnology. Based on the pharmaceutical and biological industries, the Group focuses
on the needs of patients, and takes technological innovation as the driving force. In response to the
unmet clinical needs, the Group will increase its investment in global innovative products and advanced
technologies, enrich and improve its product pipelines, consolidate and strengthen its industrial chain
layout, and fully leverage the Group’s industrial strengths and R&D capabilities to provide more
advanced and diverse treatment solutions to patients worldwide.
With unremitting efforts in recent years, the Group has laid a more solid foundation for development,
consolidated its operation scale, gradually optimized its business structure, continued to improve its
operation mode, accelerated its pace of transformation and upgrading, and made various achievements in
innovative layout. The Group’s profitability continues to improve and help facilitate R&D and
innovation; its good ability in mergers and acquisitions and integration continues to consolidate the scale
of development; the integration of raw materials and preparations improves the structure of the industrial
chain; and the diversification of business and entities has effectively enhanced the comprehensive
advantages.
“Maintain stable growth, strive in innovation and strategic planning”, the Group will stick with the
development concept of “comprehensive strengths, innovation leading and global expansion” and the
strategy of “dual-wheel driving development of independent R&D, global expansion and dual-cycle
operation”. The Group has formed a new pattern of domestic and international cycles that synergize with
each other, and is committed to becoming an international pharmaceutical company of technological
innovation, delivering on its promises for doctors and patients, and making significant contribution to
the society.
BUSINESS REVIEW AND PROSPECTS
During 2026 up to the date of this report, the Group had a total of 18 significant milestones, including 8
innovative products, 6 generic products, 3 API products and 1 major collaboration. Meanwhile, the
continued rapid scale-up of the Group’s innovative and barrier products, such as Yttrium-90 microsphere
injections, liquid embolic agent Lava™, together with the simultaneous growth in both volume and price
of core products within the biotechnology segment, has successfully contributed to the Group’s steady
growth in performance.
—3—
Innovative products
Nuclear medicine anti-tumor diagnosis and treatment:
–
–
–
The New Drug Application (NDA) for the global innovative radiopharmaceutical TLX591-CDx for
the diagnosis of prostate cancer has been accepted for review by the National Medical Products
Administration of the People’s Republic of China (“NMPA”);
A clinical trial conducted in the United States with the globally innovative radioactive product
SIR-Spheres ® Y-90 resin microsphere injection for the treatment of primary hepatocellular
carcinoma (HCC) has met its clinical endpoints;
The global innovative radionuclide-drug conjugate (“RDC”) GPN01530-2 for the diagnosis of
solid tumors, has been granted Fast Track Designation (“FTD”) by the U.S. Food and Drug
Administration (“FDA”).
Cerebrocardiovascular precision interventional diagnosis and treatment:
–
The innovative device GPG04862 for intravascular imaging has been approved for marketing by
the NMPA.
Respiratory and critical and severe disease:
–
The class 1 innovative chemical drug GPN01411 for the treatment of infections, has received
approval from the NMPA to conduct a Phase I clinical trial;
ENT:
–
–
–
TP-03, a globally innovative ophthalmic drug for the treatment of demodicosis blepharitis, has
been approved for commercialization by the NMPA;
GPN01360, a Class 1.1 innovative TCM for the treatment of depression, has completed the
enrollment and administration of the first patient in its Phase III clinical trial in China;
GPN01020, a Class 1.1 innovative TCM drug intended for the prophylactic treatment of migraine,
has received approval from the NMPA to conduct a Phase II clinical trial in China.
Generic products
There were 6 products that have been approved for marketing by the NMPA.
API products
There were 3 API products approved for commercialization by the NMPA.
—4—
Key Partnership
The Group has entered into a strategic partnership with the University of Hong Kong and its whollyowned subsidiary, University of Hong Kong Versitech Limited (“HKU Versitech”). The two parties will
engage in in-depth collaboration in areas such as academic research, resource sharing, talent
development, and product development, and will work together to advance the research and development
of innovative drugs in the field of anti-infective therapy and the commercialization of research
outcomes.
BUSINESS INTRODUCTION
The Group has strong technological innovation strength, outstanding internationalization strength, solid
industrial foundation, complete industrial chain and significant comprehensive advantages in the
integration of raw materials and preparations. The Group has more than 130 products included in the
National Essential Drug List (2026 version) 「
( 國家基本藥物目錄」
(2026年版)) and more than 260
products included in the National Reimbursement Drug List for Basic Medical Insurance, Work-Related
Injury Insurance and Maternity Insurance (2025 version) 「
( 國家基本醫療保險、工傷保險和生育保險
藥品目錄(2025年版)」).
Nuclear Medicine Anti-tumor Diagnosis and Treatment as well as Cerebro-cardiovascular
Precision Interventional Diagnosis and Treatment Technology
By fully capitalizing “accurate and stable business development capabilities at home and abroad, the
introduction and digestion of international leading technologies, excellent marketing and sales
capabilities”, the Group is aiming at the frontier areas of technological innovation and focusing on the
layout of the “nuclear medicine anti-tumor diagnosis and treatment” and “cerebro-cardiovascular
precision interventional diagnosis and treatment” segments. It has become a leading enterprise in nuclear
medicine anti-tumor diagnosis and treatment in China, and a comprehensive cerebro-cardiovascular
precision interventional diagnosis and treatment technology platform with international cutting-edge
technologies.
Nuclear Medicine Anti-tumor Diagnosis and Treatment Segment
In the nuclear medicine anti-tumor diagnosis and treatment segment, the Group has achieved a
comprehensive layout in the fields of R&D, production, distribution, and sales, with over 1,200
employees worldwide. The Group has established a global nuclear medicine industry chain layout based
on its R&D centers in Boston and Chengdu, production facilities in Boston, Frankfurt, Singapore, and
Chengdu, and a sales network covering over 50 countries and regions worldwide.
—5—
As the Group’s core domestic R&D and production facility within its global nuclear pharmaceuticals
industry layout, Grand Pharmaceutical’s Radiopharmaceutical R&D and Production Base(遠大醫藥放
射性藥物研發及生產基地), located in Chengdu was completed and accepted in April 2025, obtained a
Class A Radiation Safety Licence issued by the Ministry of Ecology and Environment in May of the
same year, and officially commenced operations at the end of June. This facility is the world’s first fully
integrated closed-loop nuclear medicine supply chain platform, covering the entire value chain from
“isotope production – nuclear medicine R&D – manufacturing – clinical trials – commercialization”. It
has established end-to-end management capabilities spanning the entire lifecycle from early-stage R&D
to clinical translation to commercialization, with R&D efficiency leading globally. It addresses the
‘bottleneck’ challenges in nuclear medicine, achieving 100% domestic production to break free from
reliance on imports. Fourteen high-standard GMP production lines meet the demand for multi-product,
large-scale production. Established a fully intelligent management system, featuring nuclear-grade safety
and unmanned intelligent manufacturing, achieving “zero radiation leakage”, “zero pollution discharge”,
and “zero occupational exposure exceeding standards”, meeting the standards of the world’s top nuclear
facilities. We have established a world-class research, production, quality, and operational system,
making it one of the most comprehensive and highly automated intelligent factories in the world in
terms of isotope variety and automation levels. This R&D and production base will further solidify the
foundation of the Group’s nuclear pharmaceutical industry, accelerate the implementation of global
innovative R&D pipelines, drive the Group’s high-quality development in the nuclear pharmaceutical
sector, cultivate high-value blockbuster products, and lay a solid foundation for the domestic production
of the Group’s radioactive drugs.
The Group, together with Sirtex, cooperated with Telix Pharmaceutical Limited (“Telix”) and ITM
Isotope Technologies Munich SE (“ITM”) to establish a world-class tumor intervention technology
platform and a RDC technology platform. The Group adheres to the treatment concept of integrated
oncology diagnosis and treatment. Currently, the Group has 14 innovative products in the pipeline at the
R&D registration stage, covering five radionuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr as well as
seven cancers including liver cancer, prostate cancer and brain cancer. The early stages of R&D focused
primarily on RDC drugs, with a product pipeline now comprising more than 10 products. In terms of
product types, it covers two types of radionuclide drugs for diagnosis and therapy, providing patients
with global leading anti-tumor solutions with multi-indication treatment options, multi-means and
integrated diagnosis and treatment.
Global R&D efforts for innovative products within the segment are progressing smoothly. In China,
YiGanTai ® Yttrium-90 microsphere injection was successfully launched in January 2022 for the
treatment of liver metastases from colorectal cancer (“mCRC”), and in May 2025, it received approval
from the NMPA to conduct a Phase II registrational clinical trial for the treatment of unresectable
hepatocellular carcinoma (“HCC”); The global innovative temperature-sensitive embolization agent
GPN00289 completed the enrollment of all patients in its registrational clinical study in October 2025.
Overseas registration-wise, SIR-Spheres® Yttrium-90 microsphere injection was formally approved in
the United States for a new indication, used to treat unresectable HCC. The Group’s independently
developed and globally innovative GPN01530, is a small molecule radionuclide-drug conjugate (“RDC”)
drug that targets fibroblast activating protein (“FAP”). It has been approved in the United States to
—6—
conduct a Phase I/II clinical study for the diagnosis of solid tumors and has been granted FTD by the
FDA, which is the Group’s first self-developed RDC product that receives FDA approval for clinical
trials. The successful approval of the GPN01530 clinical trial provides an important paradigm for the
international development of the Group’s nuclear medicine product pipeline. At the same time, it fully
demonstrates the Group’s comprehensive strength in the construction of cutting-edge nuclear medicine
technology platforms, international clinical development, and registration applications, etc. To date, the
Group has six RDC drugs approved for clinical studies worldwide. Among them, TLX591-CDx for
diagnosing prostate cancer, has entered the NDA stage, while three have entered Phase III clinical trials,
including TLX591 for treating prostate cancer, TLX250-CDx for diagnosing clear cell renal cell
carcinoma, and ITM-11 for treating GEP-NETs. In the future, the Group will continue to strengthen the
R&D in and establishment of the nuclear medicine anti-tumor diagnosis and treatment segment, as well
as enrich and improve the product pipeline and industrial layout, forming a nuclear medicine anti-tumor
diagnosis and treatment product cluster with the core of YiGanTai® Yttrium-90 microsphere injections,
which continuously consolidates the Group’s global leading position in the field of nuclear medicine
anti-tumor diagnosis and treatment.
Core products
YiGanTai® Yttrium-90 microsphere injections, the global innovative product:
The Group’s global blockbuster innovative product, YiGanTai® Yttrium-90 microsphere injections,
received marketing approval from the NMPA in January 2022 for the treatment of patients with
unresectable colorectal cancer liver metastases who have failed standard therapy. In July 2025, based on
the breakthrough interim results of the DOORwaY90 clinical trial, the FDA granted accelerated approval
for the new indication of treating unresectable hepatocellular carcinoma (HCC). In April 2026, all
clinical studies were completed, and the clinical endpoints were successfully met. YiGanTai® Yttrium-90
microsphere injections is the first and currently the only FDA-approved selective internal radiation
therapy (“SIRT”) product for the dual indications of unresectable HCC and liver metastases from
colorectal cancer. It has been used by more than 150,000 people in over 50 countries and regions around
the world. It is also recommended by the treatment guidelines issued by different international
authoritative organizations such as Barcelona Clinic Liver Cancer Guidelines (BCLC), National
Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO) Clinical
Practice Guideline for diagnosis, treatment and follow-up of hepatocellular carcinoma (2025 edition),
European Association for the Study of the Liver EASL Guideline on hepatocellular carcinoma (2025
Edition) European Association for the Study of the Liver (EASL), National Institute for Health and Care
Excellence (NICE), etc. And it has been included in several authoritative clinical practice guidelines in
China, including the “Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2026 Edition)”
《
( 原發性肝癌診療指南(2026版)》), “CSCO Guidelines for Diagnosis and Treatment of Primary Liver
Cancer (2024 Edition)” (《 CSCO原 發 性 肝 癌 診 療 指 南( 2024版)》), Guidelines for Diagnosis and
Comprehensive Treatment of Colorectal Cancer Liver Metastases (2025 Edition)” 《
( 結直腸癌肝轉移診
斷 和 綜 合 治 療 指 南( 2025版)》), “Clinical Practice Guidelines for Liver Cancer and Liver
Transplantation in China (2021 Edition)” 《
( 中國肝癌肝移植臨床實踐指南(2021版)》), etc.
—7—
In May 2022, YiGanTai® Yttrium-90 microsphere injections was officially commercialized in China.
The treatment of liver malignancies in China has entered a new “Y-90 era”. Since the official
commercialization of YiGanTai®, over 110 hospitals have completed the nuclide transfer procedures, its
official surgeries have been carried out in over 70 hospitals in 22 provinces and cities in China. In order
to speed up the implementation and popularization of YiGanTai ® microsphere injections precise
interventional therapy in China, the Group, based on the surgeon supervision and training system
approved by the Chinese NMPA and the U.S. FDA, concentrated global resources to provide
comprehensive training to surgeons in China on patient screening knowledge, surgical operation skills,
and prognosis assessment methods, helping doctors to master and accumulate clinical experience to
ensure a wider, safe and effective applications of the product, and assisted domestic doctors in
conducting multiple personalized practical trainings by well-known overseas clinical experts. At present,
9 surgery, treatment and training centers have been established. The Group has trained more than 1,200
doctors in 80 hospitals on the surgery theory or skills of YiGanTai®, more than 340 doctors have
obtained the surgeon registration for YiGanTai®. Among which, 161 doctors have obtained the operation
qualification of independent surgery through strict one-to-one training by international and domestic
renowned experts, and 120 doctors have been qualified as assistants in surgical operation. Another 32
experts have obtained the qualification of training instructor, which will further accelerate the clinical
popularization of YiGanTai® radioactive interventional operation.
Since its commercialization, YiGanTai® Yttrium-90 microsphere injection has been included in over 50
inclusive insurances such as Beijing Puhui Health Insurance(北京普惠健康保), Shanghai Hu Hui Bao
(上海滬惠保), Wuhan Fuhankang(武漢福漢康), Chongqing Yukuaibao(重慶渝快保), Nanjing Ning
Hui Bao(南京寧惠保)and 1 special medical insurances, which covers more than 30 provincial-level
administrative regions and over 100 cities with a significant increase in the accessibility of such product
to patients with liver cancer.
In terms of academic research,, researchers in mainland China published a wealth of high-value realworld data on Yigantai ® Yttrium-90 Microspheres Injection: at the American Society of Clinical
Oncology Gastrointestinal Cancers (ASCO GI) Symposium, the American Society of Clinical Oncology
(ASCO) Annual Meeting, the European Society for Medical Oncology (ESMO Asia) Annual Meeting,
the Asia-Pacific Primary Liver Cancer Experts Alliance (APPLE) Conference, the Annual Meeting of
the Asia-Pacific HepatoPancreato-Biliary Association (A-PHPBA), the Annual Meeting of the Asian
Oncology Society (AOS), the Annual Meeting of the Asia-Pacific Association for the Study of the Liver
(APASL), and the Annual Meeting of the International Hepato-Pancreato Biliary Association (IHPBA)
among other leading international academic conferences in the fields of oncology and hepatology, with a
cumulative total of 100 poster presentations and 7 oral presentations. Concurrently, related research
findings have been consistently published in internationally renowned journals. Among these, a study
comparing Transcatheter Arterial Chemoembolization (TACE) in patients with high tumor burden was
published in the International Journal of Surgery; a retrospective study systematically evaluating the
dual effects of Yttrium-90 (Y-90) resin microspheres on tumor shrinkage and contralateral hepatic lobe
—8—
hyperplasia was published in EJNMMI Research. Dozens of other research papers, including case
studies and reviews, have also been published subsequently. The above cover the treatment of liver
cancer patients at all stages, for early-stage patients, it can undergo radioactive liver segment ablation;
for intermediate-stage patients, helps downstaging to liver transplantation/hepatectomy,demonstrating
potent tumor shrinkage effects even for tumors larger than 10 cm or 15 cm; for advanced patients,
combination therapy with systemic treatment/, TACE, Hepatic Artery Infusion Chemotherapy (HAIC),
etc. Compared to traditional treatments, which require longer treatment durations, this approach offers
comprehensive care for patients with complex conditions. The “Chinese Protocol” for Yttrium-90 (Y-90)
resin microsphere therapy is gaining increasing attention and recognition from the international
academic community, thanks to its consecutive appearances at top-tier international academic
conferences and in authoritative journals, as well as the presentation of its significant findings.
LavaTM, a global innovative liquid embolic agent
LavaTM is the first innovative liquid embolic agent approved for the treatment of peripheral vascular
arterial hemorrhage in the United States. Its radiopacity makes the product less prone to artifacts during
the imaging process, thus giving a better imaging effect. LavaTM can be easily prepared in 2 minutes,
while it takes about 20 minutes to prepare similar products, saving doctors’ preparation time in
emergency situations and increasing the probability of patient survival; the solid embolization upon
conversion offers two viscosities which can be used flexibly for patients with different conditions.
LavaTM can create synergies with radioisotopes brachytherapy and interventional therapies. The product
was approved for commercialization in the United States in April 2023 and its formal commercialization
commenced in October of the same year.
The early detection product for urothelial carcinoma, AcornMed • UI-SEEK®
This product employs a dual-target design combining methylation and gene mutations. According to data
from a registrational clinical study involving over 1,000 cases, UI-SEEK® demonstrates a sensitivity of
92.5% and a specificity of 95.8%. The clinical results are excellent, and the test is non-invasive,
unaffected by external factors such as haematuria or stones, thereby aiding in the early detection,
diagnosis, treatment, and benefits for patients with urothelial carcinoma. The product has been approved
for market launch by the NMPA and achieved its first commercial prescription in April 2025. It is
currently the only approved product in China with a dual mechanism of methylation and gene mutation
for early detection of urothelial carcinoma. Additionally, it is the only product recommended in
authoritative guidelines such as CSCO Urothelial Carcinoma Diagnosis and Treatment Guidelines (2025
Edition) 《(CSCO尿路上皮癌診療指南(2025版)》), the Expert Consensus on Early Detection and
Treatment of Bladder Cancer (2024 Edition) (《膀 胱 癌 早 診 早 治 專 家 共 識( 2024版)》), and the
Technical Expert Consensus of the China Cancer Screening Center 《
( 中國癌症篩查中心技術專家共
®
識》). UI-SEEK achieves precise, non-invasive early diagnosis of urothelial carcinoma patients with ‘a
single urine sample’.
—9—
Innovative R&D pipeline
The products of the nuclear medicine anti-tumor diagnosis and treatment segment are mainly divided
into two categories: interventional therapy and RDC.
Interventional therapy:
GPN00289, a global innovative temperature sensitive embolic agent:
GPN00289 is an NMPA innovative medical device approved temperature sensitive embolic material for
the treatment of vascular–rich benign and malignant tumors. At room temperature, the gel has good
flowability and is delivered to the vasculature of the diseased tissue through a microcatheter. The gel is
then solidified in situ at body temperature from the peripheral vessels to the main donor vessel to
achieve embolization of the diseased tissue. It is suitable for the embolization of various vascular-rich
solid organ tumors, especially benign and moderate malignant tumors in the liver. The product
completed the enrollment of all patients in the registration clinical study in October 2025. Currently,
clinical study and regulatory submissions for this product are is progressing smoothly.
KonaTM, a global innovative liquid embolic agent
The product, for the treatment of preoperative embolization of cerebral arteriovenous malformations, is
developed with a transient radiopacity that diminishes over time, which can present clear post-operative
organ visualization. In addition, with its drug loading potential, KonaTM can load other chemical or
radiopharmaceuticals to develop new drug-device combination products, so as to provide more
diversified treatment options for the treatment of other tumors or vascular diseases. Currently, an
application for Premarket Approval (PMA) has been submitted to the FDA for KonaTM.
AuroLase®, a global innovative solid tumor ablation therapy
AuroLase® is a global innovative therapeutic technology for prostate cancer tissue ablation that uses a
new type of optically tunable nanoparticle, delivered intravenously and enriched in the tumor, to
selectively absorb laser energy and convert light into heat, thereby precisely destroying the tumor and
the blood vessels supplying it without severely damaging the surrounding healthy tissue. AuroLase®
therapy can maximize treatment outcomes while minimizing the side effects associated with surgery,
radiation and alternative focal therapies compared to surgery, radiation or traditional alternative focal
therapies. Currently, an application for PMA has been submitted to the FDA for the product.
RDC drugs:
There are currently 8 product candidates under research, and a number of products have made important
progress during the period.
— 10 —
TLX591/TLX591CDx, global innovative products for prostate cancer diagnosis and treatment:
TLX591 is a therapeutic RDC drug targeting prostate-specific membrane antigen (PSMA), and its early
overseas clinical studies have shown positive treatment outcomes, with a median imaging progressionfree survival (rPFS) of 8.8 months and a good safety profile. The product has undergone international
multi-center Phase III clinical trials overseas, and in April 2025, an application to join the international
multi-center Phase III clinical trials was submitted to the NMPA. The application was formally approved
by the NMPA in July of the same year. TLX591-CDx is diagnostic RDC drugs targeting PSMA, which
could form an integrated radiotherapy portfolio with TLX591 for prostate cancer. TLX591-CDx was
approved for commercialization in Australia in November 2021 and in the United States in December of
the same year.In March 2023, it was approved in the United States for an expanded indication for
screening prostate cancer patients eligible for PSMA-targeted radiopharmaceutical therapy. In 2025, the
TLX591-CDx was approved for commercialization in more than 20 countries, including those in Europe
and the Americas. The phase III study in China of TLX591-CDx has successfully achieved the clinical
endpoint in December 2025. According to top-line clinical results, the overall positive predictive value
(“PPV”) was 94.8% for detection of tumors with TLX591-CDx (confidence intervals, CI: 85.9%98.2%). The PPV was 100.0% in the prostate bed and in extra-pelvic soft tissue, lymph nodes, and organ
metastases (non-bone); 94.7% in the pelvic region outside of the prostate bed, including lymph nodes;
and 87.0% in bone metastases. At the same time, patients with suspected biochemical recurrence (BCR)
were assigned to groups according to their baseline prostate specific antigen (“PSA”) level in this trial.
TLX591-CDx PET imaging demonstrated high PPV in all patient groups, including at very low PSA
levels, in the subgroup of participants with extremely low PSA levels, the PPV remained above 90%.
This suggests that PET imaging detection of TLX591-CDx has very positive clinical significance for the
early diagnosis of prostate cancer patients with suspected biochemical recurrence. In addition, more than
two-thirds (67.2%) of patients experienced a change in their treatment plan following TLX591-CDx
PET/CT or PET/MRI compared with the initial plan at baseline. This indicates that PET imaging with
TLX591-CDx had a meaningful impact on clinical decision-making, potentially leading to improved
treatment strategies for participants with BCR. At present, the marketing application for TLX591-CDx
has been officially accepted by the NMPA.
TLX250/TLX250CDx, global innovative products for the treatment of clear cell renal cell carcinoma:
TLX250 and TLX250-CDx form an integrated radiotherapy portfolio for clear cell renal cell carcinoma
(ccRCC). TLX250-CDx was granted a breakthrough therapy by the FDA in July 2020, and the overseas
phase III clinical study successfully met clinical endpoints in November 2022. According to the study
results, for the patients with renal masses suggested by computerized tomography (CT) or magnetic
resonance imaging (MRI) but unable to determine whether it is ccRCC, the sensitivity and specificity of
positron emission tomography (PET) imaging with TLX250-CDx in the diagnosis of ccRCC reached
86% and 87% respectively, which far exceeded the preset threshold required by the FDA (both
sensitivity and specificity higher than or equal to 70%). Its positive predictive value has reached 93%.
For early ccRCC in stage T1a, which is currently difficult to diagnose (the tumor is confined to the
kidney with the largest tumor diameter smaller than or equal to 4 cm), the sensitivity and specificity of
TLX250-CDx diagnosis reached 85% and 89% respectively. These breakthrough clinical results
demonstrate that TLX250-CDx is expected to rovide a highly accurate and non-invasive diagnostic
— 11 —
solution for ccRCC, and has the potential to become a new clinical diagnostic standard for ccRCC.
Moreover, clinical studies of TLX250-CDx on a number of extended indications such as CAIX-positive
solid cancer, bladder and Urothelial carcinoma are progressing worldwide. In terms of registration in
China, the product completed the first patient enrollment and dosing in Phase III clinical trials in
November 2024. TLX250 is undergoing phase II clinical study overseas.
ITM-11, a global innovative product for the treatment of gastroenteropancreatic neuroendocrine tumors
(“GEP-NETs”):
ITM-11 is an RDC product that uses radionuclide-drug conjugate technology to target and destroy GEPNETs. This product consists of carrier-free 177Lu conjugated to a somatostatin analog, which kills
tumor cells by binding to the somatostatin receptor (SSTR) highly expressed on the surface of GEPNETs. This product has received an orphan drug status from FDA and European Medicines Agency
(“EMA”), and its Phase III clinical study (COMPETE) overseas has reached its primary clinical
endpoint in January 2025, and its NDA in the United States was formally accepted by the FDA in
December 2025. For the registration in China, the product was approved by the Chinese NMPA in April
2023 for use in the treatment of unresectable, progressive, SSTR+ GEP-NETs. In March 2024, it was
approved by the NMPA to join an international multi-center Phase III clinical study (COMPOSE
International Multi-center Study) targeting high-grade invasive Grade 2 and Grade 3, SSTR+ GEPNETs, and the first patient was enrolled and dosed in March 2025; Additionally, the product received
approval from the Chinese NMPA in December 2024 to initiate a Phase III bridging clinical trial for the
treatment of well-differentiated Grade 1 or 2, SSTR+ GEP-NETs. The product is expected to achieve
comprehensive coverage of all stages of GEP-NET disease progression.
TLX101, a global innovative product for glioblastoma treatment:
TLX101 is a RDC drug for the treatment of glioblastoma multiforme. It can pass through the bloodbrain barrier entering the brain freely, and targets the overexpressed L-type amino acid transporter 1
(LAT–1) in glioblastoma to precisely irradiate cancer cells, and promote their apoptosis to achieve
therapeutic effect. The product has been granted orphan drug designation by the FDA. Preliminary
results from an earlier overseas Phase II clinical trial of TLX101 (the IPAX-Linz study) have confirmed
patient benefits. These results indicate that TLX101 was well tolerated, with no serious adverse events
observed, and that the median overall survival (OS) for patients treated with TLX101 was approximately
11.9 months (approximately 32.2 months from initial diagnosis). In contrast, the median survival for
patients with recurrent glioblastoma receiving external beam radiation therapy (EBRT) alone was only
9.9 months. In May 2026, the Phase I clinical trial of TLX101 (the IPAX-2 study), conducted in
Australia, Austria, and the Netherlands, completed patient enrollment and dosing. In addition, TLX101
is currently being evaluated in another pivotal clinical trial (IPAX BrIGHT) to compare the safety and
efficacy of TLX101 in combination with chemotherapy versus chemotherapy alone (lomustine) in
patients with recurrent glioblastoma (last-line treatment). IPAX BrIGHT is actively enrolling patients
and administering treatment in Australia and the Netherlands; the trial has also been approved in Austria
and Belgium, where patient enrollment is set to begin shortly. This marks TLX101 as the first
radiopharmaceutical therapy to enter Phase 3 development for glioblastoma. Currently, this product has
been approved for clinical trials in China.
— 12 —
GPN01530-2, a global innovative solid tumors diagnostic product
GPN01530-2 is a small molecule RDC drug that targets fibroblast activating protein (“FAP”). FAP is
one of the important markers of cancer-associated fibroblasts (“CAFs”), participating in processes such
as extracellular matrix remodeling, regulation of tumor cell proliferation, and tumor immunosuppression,
thus promoting tumor growth and invasion. It is a novel and specific target for tumor diagnosis and
treatment. Studies have shown that FAP is not expressed or is expressed at low levels in normal tissues,
but is highly expressed in 90% of epithelial tumor tissues and CAFs in various tumor
microenvironments. GPN01530-2 optimizes the structure of the FAP ligand, improving its uptake in
tumor tissues, while reducing its uptake in normal tissues. Preclinical studies have shown that this
product, compared to other FAP-targeted ligands, exhibits rapid tumor targeting, higher tumor uptake,
and superior pharmacokinetic properties. Furthermore, ongoing IIT human studies have demonstrated a
favorable safety profile for GPN01530-2, rapid background clearance, strong and sustained lesion
uptake, and superior clinical image contrast and accurate detection rate of positive lesions compared to
18F-FDG. Based on these preclinical and clinical results, this product significantly improves the
diagnostic efficacy of FAP-targeted RDC drugs, and provide a brand-new tumor diagnosis solution for a
large number of solid tumor patients. At present, the product has been approved by the FDA in
December 2025 to conduct a Phase I/II clinical study for the diagnosis of solid tumors, and was granted
FTD by the FDA in August 2026..
GPN02006, a global innovative hepatocellular carcinoma diagnostic product
GPN02006 is a globally innovative diagnostic radiopharmaceutical based on radiopharmaceuticalantibody conjugation technology, targeting phosphoinositide glycoprotein 3 (“GPC-3”). It exhibits high
specificity and affinity for the GPC-3 target, with good safety profiles, making it suitable for precise
diagnosis of hepatocellular carcinoma (HCC). Currently, drug development targeting the GPC-3 target is
still in the early stages of research and development globally, with no drugs targeting this target yet
available on the market. The investigator-initiated clinical study (IIT clinical study) of GPN02006
conducted in China achieved breakthrough progress in April 2025, and the clinical results were
presented at the Chengdu 2025 Future XDC New Drug Conference and the North American Society of
Nuclear Medicine and Molecular Imaging Annual Meeting. The clinical study data demonstrated that
GPN02006 exhibits excellent safety and imaging efficacy: No drug-related adverse reactions were
reported in any of the participants after administration, demonstrating excellent safety and tolerability;
high-quality imaging can be achieved within 30 minutes after administration, fully meeting the clinical
demand for rapid diagnosis of hepatocellular carcinoma. The drug has three significant advantages in
terms of imaging quality: 1) extremely low background signal; 2) high specificity of uptake in HCC
lesions; and 3) superior diagnostic contrast. Based on its unique molecular targeting mechanism, the
drug can achieve: 1) early precise localization of HCC lesions; 2) dynamic assessment of treatment
— 13 —
response; and 3) Early warning of recurrence and metastasis, providing robust molecular imaging
evidence for clinicians to develop personalized treatment plans; Compared to current HCC diagnostic
protocols, GPN02006 demonstrates superior diagnostic efficacy in detecting early-stage, small HCC
lesions. This product has the potential to improve the current clinical challenges of low early diagnosis
rates and difficulties in monitoring recurrence and metastasis in HCC patients. Currently, the clinical
registration development of this product is being actively advanced.
Cerebro-cardiovascular Precision Interventional Diagnosis and Treatment Segment
The Group adheres to the treatment concept of “precision treatment” and conducts comprehensive layout
in multiple directions, namely channel management, chronic disease management, structural heart
disease and heart failure, to build a high-end medical device product cluster. At present, the segment has
reserved over 30 products, of which 23 products in channel management have been approved for
commercialization in China. 1 product in the chronic disease management category has been approved
for commercialization in China, and 3 products in the field of structural heart disease has been approved
for commercialization in China. Additionally, clinical registration efforts in China are actively underway
for other innovative products currently in development. Furthermore, in July 2026, the Group formally
entered into a comprehensive commercialization strategic partnership with Siemens Healthineers System
Co., Ltd. (“Siemens Healthineers”), under which Grand Pharma is responsible for the exclusive
commercialization and promotion in China of Siemens Healthineers’ AcuNav LumosTM 4D ICE real-time
3D intracardiac echocardiography catheter, a product that has already been approved for marketing by
the NMPA; the transcatheter mitral valve clip system NeoBlazar®, developed in collaboration between
the Group and Jiangsu Zhenyi Medical Technology Co., Ltd., received marketing approval from the
NMPA in July 2026. The Group will continue to expand its innovative product pipeline to drive steady
growth in this business segment.
The Group has completed the comprehensive construction of the “active + passive” innovative device
platform in this segment. Among them, the Active Equipment R&D and Production Base in Optics
Valley, Wuhan and the Passive Equipment R&D and Production Base in Changzhou have been put into
use. At present, the Group has carried out technology cooperation with clinical centers or R&D
platforms in the Unites States, Canada, Germany, Italy and Switzerland, and gradually started a new
process of globalized R&D. The Group is committed to developing this segment into a leading “cerebrocardiovascular precision interventional therapy platform” in China and worldwide.
— 14 —
Core Products
RESTORE DEB®, a coronary drug-coating balloon:
RESTORE DEB® is the first drug-coating balloon with the dual indications of original coronary artery
disease mutation and stent restenosis in China. Its clinical research results were published in the
important journal JACC (Journal of the American College of Cardiology) Cardiovascular Interventions
in the field of cardiovascular disease. The unique SAFEPAX patented technology ensures a uniform and
stable drug coating with a low shedding rate. Since its launch, it has been recognized by a large number
of clinicians and patients and has a good market reputation, and its clinical status was also affirmed in
the guidelines and expert consensus such as the “Expert Consensus on the Clinical Application of Drugcoated Balloons Guided by Intravascular Imaging (2026 Edition)(冠狀動脈腔內影像學指導藥物塗層
球囊臨床應用專家共識(2026版))”, and the “Guidelines for Treatment of Percutaneous Coronary
Intervention (2025 Edition)”(中國經皮冠狀動脈介入治療指南(2025版)).
APERTO® OTW, a drug coated balloon for dialysis access:
APERTO® OTW is the first drug-coating balloon for the indication of arteriovenous fistula stenosis in
dialysis patients. This product has the dual characteristics of high pressure resistance and drug coating.
Compared with ordinary high pressure balloon, APERTO® OTW has a significant advantage in the
passing rate of target lesions for six months after surgery, which will greatly contribute to the extension
of the life time of fistula and the improvement of the quality of life of dialysis patients. Its clinical
research results are published in “American Journal of Kidney Diseases”, an important journal in the
field of kidney disease treatment.
Lu Ci®, the first domestically produced adjustable intracranial thrombectomy stent product:
Lu Ci ® features a circular wire braided structure design, allowing manual adjustment to the ideal
diameter outside the body to match the target vessel. During stent implantation, the entire process is
visible and radiopaque, enabling surgeons to better adjust the stent based on the location and total length
of the thrombus to better adapt to the occluded vessel, thereby achieving a higher vascular recanalization
rate. The adjustable characteristics of Lu Ci® enhance the stent’s ability to engage with the thrombus,
improving surgical efficacy, while also reducing vascular damage and enhancing surgical safety.
Additionally, Lu Ci ® is fully radiopaque, facilitating precise manipulation by physicians. The
commercialization of Lu Ci® provides a new option for thrombus removal therapy in acute ischemic
stroke.
— 15 —
Multi-polar renal artery radiofrequency ablation system Platinum Wisdom IberisTM
Utilizing advanced renal nerve ablation technology, the system delivers the ablation catheter precisely to
the renal artery via minimally invasive intervention. Radiofrequency energy is then used to ablate the
renal sympathetic nerves, effectively blocking the transmission of overly excited renal sympathetic nerve
signals, thereby achieving stable blood pressure regulation. IberisTM has demonstrated excellent clinical
efficacy in the treatment of patients with uncontrolled primary hypertension. and related research
findings have been published in full in the top-tier international cardiovascular academic journal
Circulation (Impact Factor: 35.5), receiving high recognition from the international academic
community. It is currently the only renal artery denervation ablation (RDN) product globally that has
obtained EU CE certification and features a dual-access design via the radial and femoral arteries.
AcuNav LumosTM 4D ICE Catheter: Real-Time 3D Intracardiac Echocardiography Catheter
The AcuNav LumosTM 4D ICE Catheter represents a significant leap forward in imaging capabilities,
advancing from 2D and 3D to real-time 3D imaging. It is suitable for a wide range of complex
interventional procedures for structural heart disease, including mitral valve repair, left atrial appendage
closure, and congenital heart defect closure. This product features technical enhancements in imaging
capabilities, intraoperative guidance, and procedural adaptability: equipped with an improved multiplane reconstruction and dual-plane imaging function, it outputs real-time 4D volumetric imaging with
clear and smooth dynamic visuals, providing surgeons with high-resolution visual references for
intraoperative anatomical assessment and device guidance; The catheter can penetrate deep into the
cardiac chambers, minimizing obstruction by tissue structures, and is suitable for use throughout
complex procedures such as transcatheter edge-to-edge repair (TEER). Additionally, the catheter
features 180º bending capability in four directions, offering flexible maneuverability to facilitate
exploration of different regions within the heart. During TEER procedures, the AcuNav LumosTM 4D
ICE Catheter supports the entire process, from preoperative assessment to intraoperative instrument
manipulation and postoperative outcome verification. During the valve assessment phase, it clearly
visualizes valve morphology, the degree of regurgitation, and leaflet prolapse, assisting the surgeon in
developing a tailored surgical plan; during surgery, it provides real-time tracking of the position and
orientation of instruments such as clamps, assisting the surgeon in performing critical procedures such
as valve leaflet grasping and clamp release; during the postoperative assessment phase, it rapidly detects
residual regurgitation, allowing for timely evaluation of surgical outcomes and helping physicians
optimize clinical decisions.
— 16 —
Domestic Transcatheter Mitral Valve Clip System NeoNova®
This product enables edge-to-edge mitral valve repair for patients with mitral regurgitation via an
interventional approach, improving cardiac function, reducing surgical trauma, and shortening recovery
time. The product is easy to operate and has good safety. It uses an elastic self-locking mechanism that
allows the clamp arms to automatically adapt to the valve strength and lock automatically, ensuring
stable clamping while maximizing the avoidance of the risk of valve tears during and after surgery; The
‘I-shaped’ clamp design allows flexible adaptation to complex scenarios such as chordal entanglement
and transvalvular crossing at the commissure; it offers stable bending control with a smaller radius,
reducing the surgical space required within the atrium and providing greater operational flexibility. This
product could offer a new treatment option for patients with mitral regurgitation.
NeoBlazar® Domestic Transcatheter Tricuspid Valve Clip System
It is China’s first domestically produced transcatheter tricuspid valve clip system. It performs edge-toedge tricuspid valve repair via an interventional approach for patients with tricuspid regurgitation,
improving cardiac function and enhancing patients’ quality of life. The product features several core
design advantages. Its unique “I-shaped” design is structurally minimalist and easy to operate,
effectively mitigating the risk of chordal entanglement during surgery. It supports rapid device release
and allows for multiple precise adjustments, retrieval, and repositioning during the procedure, enabling
physicians to confidently handle various complex intraoperative situations. This significantly lowers the
procedural barrier, shortens the physician’s learning curve, and markedly enhances procedural
controllability and safety; The innovative elastic self-locking mechanism delivers a stable and sustained
clamping force on the valve leaflets while effectively cushioning intraoperative and postoperative
stresses. This maximizes protection of the patient’s fragile valve leaflets and myocardial tissue, prevents
secondary damage, and ensures long-term surgical efficacy. This product offers a new treatment option
for patients with tricuspid regurgitation.
First Domestically Produced Braided Intracranial Aneurysm Co-embolization Stent Blue WhaleTM
Suitable for intracranial aneurysms patients aged 18 and older. This device consists of a delivery system,
and a nickel-titanium braided self-expanding stent. With its innovative structural and performance
design, it overcomes the limitations of existing products, better adapts to complex anatomical structures,
and meets diverse clinical needs. Utilizing a 16-strand nickel-titanium monofilament braiding process, it
balances robust radial support with excellent flexibility and conformability. The V-shaped occlusion
design at both the proximal and distal ends ensures secure anchoring within the vessel and prevents
displacement; Leveraging unique winding and radiopaque technology, four radiopaque wires are
uniformly wound around the stent. Four radiopaque markers at the proximal end, combined with
V-shaped reinforcement at the distal end, ensure clear tracking throughout the procedure, providing the
operator with precise visualization. In terms of manipulation and delivery, the stent offers excellent
controllability and can be retrieved even after 80% deployment, enabling precise implantation. Stents
— 17 —
with a diameter of 3 mm or less can be delivered and deployed via a 17-gauge microcatheter,
significantly enhancing maneuverability and delivery performance; Compared to laser-cut stents, its
metal coverage has been increased to 18%, enabling moderate blood flow diversion. The angiographic
aneurysm occlusion rate exceeds 95%, optimizing treatment outcomes. This product is expected to offer
a new treatment option for patients with intracranial aneurysms.
Innovative and R&D pipeline
aXess, a global innovative endogenous tissue repair product:
aXess is a global innovative endogenous tissue repair product for end-stage renal disease (ESRD)
patients with arteriovenous graft (AVGs) for hemodialysis treatment. The product is expected to provide
safer and more effective blood access for dialysis patients by providing a basic structural framework for
autologous tissue repair of patients, accelerating the establishment of dialysis access, and reducing the
incidence of thrombosis and related complications. aXess can further synergize with APERTO® OTW in
the field of hemodialysis. The product received Breakthrough Device designation from the FDA in
November 2024, and enrolled its first patient in a pivotal clinical trial approved for conduct in the
United States that same month, while the pivotal clinical trial conducted in Europe successfully met its
clinical endpoints in October 2025. Specific results show that, compared to standard therapy, aXess
achieved significant improvements across all key clinical metrics. Compared to other arteriovenous
grafts, aXess demonstrated superior patency rates for both primary and secondary endpoints, with fewer
interventions. Compared to autologous arteriovenous fistulas (AVFs), aXess had a lower reintervention
rate and exhibited high resistance to infection; Regarding safety, among all 120 patients, only one case
of (partial) graft removal related to puncture site infection occurred, indicating that aXess possesses
extremely high resistance to infection; aXess enables near-immediate puncture, with a bleeding
complication rate of less than 0.02% across more than 15,000 dialysis treatments. These data
demonstrate that aXess possesses excellent safety and efficacy profiles, outperforming current standard
therapies in all aspects. This product received CE certification in April 2026. Regarding registration in
China, the product is currently in the preclinical development stage.
Saturn, a global innovative mitral valve replacement system:
Saturn is a global innovative medical device for mitral valve replacement. The product is implanted in
an interventional manner via a room septum to minimize surgical trauma and shorten post-operative
recovery time, and innovatively combines annular reconstruction technology with valve replacement
technology to enhance device adaptability and suitability for all common mitral valve structures. The
product underwent a clinical study using the transcatheter approach in Europe in 2020 and completed
patient enrollment in 2022. The five-year follow-up has now been completed, and the results are in line
with expectations. In May 2024, the first patient enrollment for clinical study using the femoral vein
approach was completed in Europe. The follow-up results are in line with expectations, and the
product’s safety and efficacy have been preliminarily validated. Meanwhile, the registration of the
product in China is also under active progress.
— 18 —
CoRISMA, a global innovative ventricular assisted device:
CoRISMA is a fully implanted transcatheter ventricular assisted medical device for the treatment of
class III and end-stage heart failure. By adopting the world’s most advanced energy transmission
technology for wireless power supply, it provides a minimally invasive, safe, power-line infection-free
and complication-free treatment for patients with end-stage heart failure through minimally invasive
surgery. Currently, the Group is working with an innovative medical device company incubated by Yale
University on product development.
PHARMACEUTICAL TECHNOLOGY
With years of experience in the respiratory and critical and severe disease, ENT and cerebrocardiovascular emergency fields, the Group currently has a number of products with high entry barrier
and exclusive products with leading market shares, a strong brand name and a solid market position, and
also reserves a number of innovative products.
Through an innovation model combining global technology cooperation and independent R&D, the
Group has established the International R&D Center in Optics Valley, Wuhan, the Glycomics R&D
Center in Australia and the mRNA R&D Center in Aoluo, Nanjing in the field of pharmaceutical
technology. These R&D centers and technology platforms will continue to work in concert to empower
the Group, providing cutting-edge technological resources and sustained R&D momentum for innovation
in the field of pharmaceutical technology.
Respiratory and Critical and Severe Disease Segment
The Group’s products on sale in the respiratory and critical and severe disease segment covers a wide
range of indications such as rhinitis, bronchitis, pneumonia, asthma and chronic obstructive pulmonary
disease, etc. The core products, Qie Nuo (Eucalyptol, Limonene and Pinene Enteric Soft Capsules),
Compound Nasal Spray Ryaltris ®, Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® are exclusive
products nationwide, which are in the leading position in their respective segments.
The innovative strategic plan in this field focuses on the unmet significant clinical needs, with a number
of products under research, covering sepsis and Acute Respiratory Distress Syndrome (“ARDS”) etc. In
the future, the Group will continue to adopt the R&D concept of independent R&D and global expansion
to create a full-cycle management product cluster for chronic airway diseases and a pipeline of products
for critical and severe diseases, so as to continuously strengthen the Group’s industry position in this
field.
— 19 —
Respiratory products
The main products include Qie Nuo®, Enerzair®, Breezhaler® and Atectura®, Breezhaler®, new compound
nasal spray Ryaltris®, Budesonide Nasal Spray, Fluticasone propionate Nasal Spray etc.
Qie Nuo®:
It is a soluble and phlegm-free drug for viscosity, and is suitable for acute and chronic rhinosinusitis as
well as respiratory diseases such as acute and chronic bronchitis, pneumonia, bronchial dilation,
pulmonary abscess, chronic obstructive pulmonary disease, bacterial infection in the lungs, tuberculosis,
and silica lungs. It can also be used for bronchoscopic angiography to facilitate the discharge of contrast
medium. It is an exclusive product in China independently developed by the Group with two separate
types of drugs for adult and children’s use and was included in both the China’s National
Reimbursement Drug List and China’s National Essential Drug List, and was listed in the Top Brands of
the Health Industry in 2025(二零二五年健康產業品牌榜), Potential Brands in China’s Pharmaceutical
Retail Market 2024(2024年度中國藥品零售市場潛力品牌), top Brands of Family Medicine in China
2022-2023(2022-2023年中國家庭常備藥上榜品牌). Currently, there are dozens of guidelines and
expert consensus recommending the use of viscosity dissolving promotors for clinical use. Among them,
more than 10 guidelines and expert consensus explicitly recommend eucalyptol, limonene and pinene
enteric soft capsules or its active ingredients for clinical treatment, such as Guidelines for the diagnosis,
treatment and management of cough in China (2024 Edition)《中國咳嗽基層診療與管理指南((2024年
版)》), the Expert Consensus on the Diagnosis and Treatment of Adult Bronchiectasis in China (2021
Edition)(《中國成人支氣管擴張症診斷與治療專家共識(2021版)》), Guidelines for the Diagnosis and
Treatment of Secretory Otitis Media in Children (2021 Edition) 《
( 兒童分泌性中耳炎診斷和治療指南
(2021版)》), the Guidelines for Rational Use of Drugs for Chronic COPD in Primary Care (2020
Edition) 《
( 慢性阻塞性肺疾病基層合理用藥指南(2020版)》), Chinese Guidelines for Perioperative
Airway Management in Thoracic Surgery (2020 Edition)(《中國胸外科圍手術期氣道管理指南(2020
版)》), Expert Consensus on Classification and Diagnosis of Rhinitis and Nasal Medication Regimen
(《鼻 炎 分 類 和 診 斷 及 鼻 腔 用 藥 方 案 的 專 家 共 識》)and Expert Consensus on Childhood Recurrent
Respiratory Infections(《兒童反復呼吸道感染專家共識》), etc. Its clinical status is prominent, and the
level of recognition among doctors and patients is high, continuing to lead the market of oral cough
relieving and phlegm relieving drugs.
— 20 —
Enerzair® Breezhaler® (indacaterol acetate, glycopyrronium bromide and mometasone furoate powder for
inhalation II) and Atectura ® Breezhaler ® (indacaterol acetate and mometasone furoate powder for
inhalation II, III):
Enerzair ® Breezhaler ® is the first triple combination inhalation preparation for asthma indications
approved in China for the maintenance treatment of asthma in adults not adequately controlled with the
maintenance combination treatment of long-acting beta2 adrenergic agonist (LABA) and inhaled
corticosteroid (ICS). The product has clear efficacy, is convenient to use, and has achieved
breakthroughs in three aspects: (1) using an optimized drug combination of ICS, LABA and long-acting
muscarinic receptor antagonist (LAMA) (i.e. mometasone furoate/indacaterol acetate/glycopyrronium
bromide), the three effective ingredients can provide synergy benefit, and compared with the
conventional high dose ICS-LABA and high dose ICS-LABA combined with LAMA opened triple
combination, Enerzair® Breezhaler® can effectively improve the clinical symptoms and lung function of
patients with moderate to severe asthma, and significantly reduce the risk of acute attacks; (2) dosing
once a day, which significantly facilitates the patient and is expected to improve the compliance; (3)
using the advanced Breezhaler® inhalation device, which is easy to operate, and provides patients with
triple confirmation of dosing as audible, tasteable, and visible, enhancing patients’ confidence that the
complete dose has been taken. The ARGON phase III clinical study of the product shows that, compared
with high dose Salmeterol-Fluticasone powder for inhalation combined with Tiotropium Bromide Spray
opened triple combination, Enerzair® Breezhaler® significantly reduce the annualized rate of moderate
exacerbations (based on 24 weeks data) by 43%. Atectura® Breezhaler® is an innovative combination of
ICS mometasone furoate and LABA indacaterol acetate for the maintenance treatment of adult and
12years old above adolescent patients with asthma. Atectura® Breezhaler® also has the characteristics
including “visible and controllable, precise inhalation, once a day” etc. It can significantly improve the
lung function of patients and reduce the risk of acute attacks, and is a new choice for optimal treatment
of asthma patients. The phase III clinical study of the product shows that, compared with the
conventional high dose Salmeterol-Fluticasone powder for inhalation, Atectura ® Breezhaler ® can
significantly improve the risk of acute attack in patients, and the risk of severe, moderately severe and
all acute attack categories is reduced by approximately 26%, 22% and 19% respectively. Both products
have been included in the Chinese Expert Consensus on the Standardized Application of Inhalation
Devices for Stable Chronic Airway Diseases (2023 Edition) 《
( 穩定期慢性氣道疾病吸入裝置規範應
用中國專家共識(2023版)》), Chinese Expert Consensus on the Diagnosis and Management of Severe
Asthma (2024 Edition) (《重 度 哮 喘 診 斷 與 處 理 中 國 專 家 共 識( 2024版)》), Guidelines for the
Prevention and Treatment of Bronchial Asthma (2024 Edition) 《
( 支氣管哮喘防治指南(2024年版)》),
the Global Strategy for Asthma Management and Prevention (2025 Edition) 《
( 全球哮喘管理和預防策
略( 2025版)》) and other authoritative clinical guidelines and expert consensus documents both
domestically and internationally. Additionally, both products have been officially included in the
Category B drug management scope of China’s National Basic Medical Insurance, Work Injury
Insurance, and Maternity Insurance Drug Directory 《
( 國家基本醫療保險、工傷保險和生育保險藥品
目錄》), providing new treatment options for individuals undergoing long-term asthma therapy.
— 21 —
New Compound Nasal Spray Ryaltris®:
Ryaltris® is a novel antihistamine and corticosteroid combination nasal spray for the treatment of
moderate to severe seasonal AR in adult and pediatric patients 6 years of age and older, and moderate to
severe perennial AR in adult and pediatric patients 12 years of age and older. Authoritative clinical
guidelines and expert consensus documents both domestically and internationally, such as Chinese
Guideline for Diagnosis and Treatment of Allergic Rhinitis (2022 Edition) 《
( 中國變性鼻炎診斷與治療
指引(2022版)》), Clinical Consensus on Classification and Diagnosis of Rhinitis and Nasal Medication
Regimen (2019 Edition) 《
( 鼻炎分類及診斷及鼻腔用藥方案(2019版)》), ARIA Clinical Pathway for
Allergen Immunotherapy (2019 Edition),《(ARIA變應原免疫治療的醫療路徑(2019版)》), recommend
intranasal antihistamines and intranasal corticosteroids as the first-line treatments for allergic rhinitis.
As a combination formulation, Ryaltris offers patients a more convenient and effective treatment option,
improves patient adherence, and provides a new therapeutic option for AR patients in China. The
product received FDA approval in January 2022 and was approved by the NMPA in November 2025.
Budesonide Nasal Spray:
It is a nasal corticosteroid medication with potent local anti-inflammatory and anti-allergic effects,
which can directly act on the nasal mucosa to relieve rhinitis symptoms. It is used for the treatment of
seasonal and perennial allergic rhinitis, perennial non-allergic rhinitis; it can also be used to prevent the
recurrence of nasal polyps after nasal polyp removal and for symptomatic treatment of nasal polyps. As
a first-line medication for allergic rhinitis, it has been included in multiple clinical guidelines and expert
consensus documents such as the product has been included in clinical guidelines such as Guidelines for
the Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2024 Edition) 《
( 中國慢性
鼻竇炎診斷與治療指南(2024版)》), Chinese Guidelines for the Diagnosis and Treatment of Allergic
Rhinitis (2022 Revised Edition) 《
( 中國變應性鼻炎診斷和治療指南(2022年,修訂版)》), Chinese
Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition)
《
( 兒童變應性鼻炎診斷和治療指南(2022年,修訂版)》), the Expert Consensus on the Treatment of
Allergic Rhinitis with Nasal Corticosteroids 《
( 鼻用糖皮質激素治療變應性鼻炎專家共識》), and the
Expert Consensus on the Classification, Diagnosis, and Nasal Medication Regimens for Rhinitis 《
( 鼻炎
分類和診斷及鼻腔用藥方案的專家共識》). This product is the first generic in China and is expected
to alter the competitive landscape in the market for products with the same generic name, which has
been dominated by foreign companies.
Fluticasone propionate Nasal Spray:
It is a nasal corticosteroid medication with potent local anti-inflammatory and anti-allergic effects, it
directly acts on the nasal mucosa to alleviate nasal inflammation symptoms. It is indicated for the
prevention and treatment of seasonal allergic rhinitis (including hay fever) and perennial allergic
rhinitis. It is a first-line treatment for allergic rhinitis and is included in the Chinese Guidelines for the
Diagnosis and Treatment of Chronic Sinusitis (2024 Edition) 《
( 中國慢性鼻竇炎診斷與治療指南(2024
版)), Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)
《
( 中國變應性鼻炎診斷和治療指南(2022年,修訂版)》), Chinese Guidelines for the Diagnosis and
— 22 —
Treatment of Allergic Rhinitis in Children (2022 Revised Edition) 《
( 兒童變應性鼻炎診斷和治療指南(
2022年,修 訂 版)), the Expert Consensus on the Treatment of Allergic Rhinitis with Nasal
Corticosteroids (《鼻用糖皮質激素治療變應性鼻炎專家共識》), and the Expert Consensus on the
Classification, Diagnosis, and Nasal Medication Regimens for Rhinitis 《
( 鼻炎分類和診斷及鼻腔用藥
方案的專家共識》). This product is the first generic in China and is expected to alter the competitive
landscape in the market for products with the same generic name, which has been dominated by foreign
companies.
Innovative R&D pipeline
Based on unmet clinical needs, the Group has reserved a number of global innovative drugs for the
indications of sepsis, ARDS, etc.
STC3141, a global innovative drug for the treatment of severe diseases:
STC3141 is a small molecule compound with a novel mechanism of action independently developed by
the Group, which can be used to reverse organ damage caused by excessive immune responses by
neutralizing extracellular free histones and neutrophil traps and is applicable to multiple severe disease
indications. STC3141 is the world’s first sepsis treatment solution centered on rebuilding immune
homeostasis, representing a major upgrade in treatment dimensions. Building on existing symptomatic
supportive treatments such as anti-infection, fluid resuscitation and organ function maintenance, it
precisely regulates the core cause of the disease, which is immune dysregulation, to help the body
restore balance. This is expected to fill the current clinical gap in sepsis treatment targeting the
underlying cause. The product has a novel mechanism, and the results of related preclinical research
have been published in “Nature Communications” and “Critical Care”, both top academic journals with
far-reaching academic influence, in February 2020 and November 2023, respectively. At present, the
product has been granted 7 clinical approvals in four indications of sepsis, ARDS, severe COVID-19
infection (“COVID-19”), and ARDS caused by COVID-19 in five countries around three continents
including China, Australia, Belgium, United Kingdom and Poland. Four patient-specific clinical studies
were completed and have successfully met the clinical endpoints. Previous Phase Ib clinical studies
conducted in Australia and Belgium for the treatment of sepsis, a Phase Ib clinical study conducted in
China targeting acute respiratory distress syndrome (ARDS), and a Phase IIa clinical study conducted in
Europe for the treatment of severe COVID-19 infection have all demonstrated that STC3141 exhibits
good safety and tolerability. Additionally, it has shown positive signals in helping patients wean off
ventilators, discontinuing vasopressors, and shortening ICU hospitalization duration. The Phase II
clinical study targeting sepsis conducted in China successfully achieved its primary clinical endpoint in
May 2025. Clinical results showed that the SOFA scores of the drug treatment group on day 7 were
significantly lower than baseline, particularly in the high-dose group, with a reduction significantly
greater than that of the placebo group, and the difference was statistically significant and clinically
meaningful; the trends for secondary endpoints were consistent with the primary endpoint and met
expectations. Additionally, STC3141 demonstrated good safety and tolerability, with pharmacokinetic
characteristics also in line with expectations. These study results confirm the efficacy and safety of
STC3141 in the treatment of sepsis, marking a new breakthrough in critical care medicine. Currently,
the product’s subsequent clinical development and regulatory filing are actively underway.
— 23 —
ENT segment
The ENT segment adheres to a development strategy combining traditional Chinese and Western
medicine with integrated pharmaceutical and medical device therapies, continue to refine our portfolio
of product clusters that promote the coordinated development of traditional Chinese patent medicines,
innovative ophthalmic drugs, and OTC retail products. In the traditional Chinese patent medicine sector,
the Group leverages the core strengths of traditional Chinese medicine in the treatment of chronic
diseases and continues to deepen its expertise. Building upon the consolidation and enhancement of our
otolaryngology product portfolio, we have successfully expanded our business into therapeutic areas
such as cardiovascular and cerebrovascular chronic diseases and neurology through strategic initiatives
involving several TCM products with significant competitive advantages, we have successfully expanded
our business into therapeutic areas such as cardiovascular and cerebrovascular chronic diseases and
neurology. This has enabled a strategic transformation of our TCM business from a single focus on ENT
to a comprehensive approach to chronic disease treatment; In the OTC retail sector, the Group is
actively building China’s leading eye health consumer brand, providing professional, safe, and
convenient eye health solutions; In the field of innovative ophthalmic drugs,through a combination of
collaborative introductions and independent R&D, the Group has developed a portfolio of globally
innovative products for the treatment of “dry eye syndrome”, “demodicosis blepharitis”, “post-surgical
anti-inflammatory” and “analgesic therapy” in ophthalmology, “pterygium”, and “myopia”, establishing
a differentiated competitive advantage. These products are expected to provide patients with more
treatment options and improve their quality of life. At the same time, by continuously strengthening the
development of our clinical evidence-based medicine framework and professional academic promotion
system, we provide clinical experts with comprehensive disease management protocols and detailed
product service solutions. Moving forward, this division will continue to focus on cutting-edge
innovation areas, further enhance its industry influence, and achieve new breakthroughs in its business
domains.
ENT products
The ENT core products of the Group include He Xue Ming Mu tablets, Jinsang Series (Jinsang Kaiyin
Tablet/Capsule/Pill/Granules, Jinsang Qingyin Tablet/Capsule/Pill/Granules, Jinsang Liyan Tablet/
Capsule/Pill/Granules, Jinsang Sanjie Tablet/Capsule/Pill/Granules), Maixuekang (Maixuekang capsules
and Maixuekang enteric-coated tablets), Rui Zhu (polyvinyl alcohol eye drop, sodium hyaluronate eye
drop) and Nuo Tong (Xylometazoline Hydrochloride), Dan Zhen Headache Capsules, Valinic acid
tartrate nasal spray etc.
He Xue Ming Mu tablets:
Which is produced by three classical formulae, namely the Siwutang(四物湯), Erzhiwan(二至丸)and
Shengpuhuangtang(生蒲黃湯), has the functions of cooling blood hemostasis, moisturising dryness and
removing blood stasis, and nourishing liver and eye-brightening, and is mainly used for the treatment of
retinal disease caused by the cloudy liver and the heat-burn winding. Since He Xue Ming Mu tablets
have been the exclusive product in China, the State Protected Chinese Medicine, the National
— 24 —
Reimbursement Drug List and the National Essential Drug List for the last 30 years since its
commercialization, the Group has accumulated a large number of clinical research data and application
experience in the field of retinal hemorrhage, which has been included in a number of guidelines/
consensus such as Guidelines for the Prevention and Treatment of Type 2 Diabetes in Traditional
Chinese Medicine (2024 Edition)《(2型糖尿病中醫防治指南(2024版)), Guidelines for the Diagnosis
and Treatment of Pathological Myopia with Macular Hemorrhage in Traditional Chinese Medicine (2022
Edition) (《病理性近視眼底病變黃斑出血中醫診療指南(2022版)), and the Expert Consensus on
Clinical Application of He Xue Ming Mu Tablets for the Treatment of Wet Age-related Macular
Degeneration (《和 血 明 目 片 治 療 濕 性 年 齡 相 關 性 黃 斑 變 性 臨 床 應 用 專 家 共 識》) and provides
valuable literature support for clinical use of the products.
Jinsang Series Products:
They are exclusive products nationwide, covering all the diseases of the throat, among which, Jinsang
Sanjie Capsule is used for the treatment of chronic hoarseness disease caused by heat and poisoning
storage and airtight blood stasis (vocal nodules, polyp of vocal cords, thickening of mucosa of vocal
cords) and the resulting hoarseness. Jinsang Sanjie Capsule has been widely used in clinical application
for more than 30 years since its commercialization. Jinsang Liyan Capsule is the only Chinese patent
medicine for the treatment of throat diseases caused by intraocular obstruction of liver depression and
phlegm and humidification. It is also an ideal medicine for the treatment of pharyngeal symptoms in
clinical operation, gastroesophageal reflux pharyngitis, and chronic and thick pharyngitis. Jinsang
Kaiyin Capsule is designed for the rapid effect of acute pharyngitis as well as throat redness, swelling,
heat, pain and hoarning caused by acute pharyngitis. This series of product has received widespread
clinical recognition. Guidelines for the Diagnosis and Treatment of Common Diseases in
Otorhinolaryngology of Traditional Chinese Medicine (《中 醫 耳 鼻 咽 喉 科 常 見 病 診 療 指 南》),
Guidelines for the Rational Use of Traditional Chinese Medicines for Promoting Blood Circulation and
Removing Blood Stasis 《
( 活血化瘀類中成藥合理用藥指南》), the Clinical Drug Guidelines 《
( 臨床用
藥指南》) for the diagnosis and treatment of clinicians, he authoritative monographs of the Manual for
Common Traditional Chinese Medicine of Otorhinolaryngology 《
( 常見眼耳鼻咽喉科中成藥手冊》)
and the Practical Otorhinolaryngology Head and Neck Surgery 《
( 實用耳鼻咽喉頭頸外科學》), etc.,
has been included in numerous clinical pathways and expert treatment guidelines. In January 2022 and
August 2024, the Expert Consensus on the Clinical Application of Jinsang Sanjie Capsules for the
Treatment of Vocal Nodules and Polyp of Vocal Cords 《
( 金嗓散結膠囊治療聲帶小結、聲帶息肉臨
床應用專家共識》) and the Expert Consensus on the Clinical Application of Jinshao Kaiyin Capsules
(Pills/Tablets/Granules)(《金 嗓 開 音 膠 囊(丸/片/顆 粒)臨 床 應 用 專 家 共 識》) were issued by the
Chinese Association of Traditional Chinese Medicine, which has also provided new support for the
evidence-based development of Jinsang Sanjie and Jinsang Kaiyin products. Jinsang Sanjie and Jinsang
Kaiyin Capsules are products on the National Reimbursement Drug List. Jinsang Kaiyin and Qingyin are
dual cross-over products with both prescription and over-the-counter drugs.
— 25 —
Duoputai®, Maixuekang capsules and Maixuekang enteric-coated tablets:
It has the effects of anticoagulation, antithrombosis, antifibrosis, and improvement of blood circulation,
and can be used in the treatment of cerebro-cardiovascular diseases such as coronary heart disease, acute
cerebral infarction, ischemic stroke, and unstable angina. It is included in the National Reimbursement
Drug List and the Essential Drug List, and is currently the only Chinese patent medicine that is labeled
with antithrombin activity units in China (each capsule/tablet is equivalent to 14 units of antithrombin
activity). It has been included in many authoritative clinical guidelines, such as the Clinical EvidenceBased Practice Guidelines for Integrated Traditional Chinese and Western Medicine Rehabilitation for
Stroke, Guidelines for Integrated Traditional Chinese and Western Medicine Prevention and Treatment
of Stroke, Guideline for the Diagnosis and Treatment of Cerebral Infarction with the Integrated
Traditional Chinese and Western Medicine, the Clinical Practice Guideline for Chinese Medicine in the
Treatment of Idiopathic Membranous Nephropathy, and the Expert Consensus on the Use of Maixuekang
Capsule (Enteric-coated Tablet) for Patients with Cardiovascular and Cerebrovascular diseases in
Clinical Practice.
Dan Zhen Headache Capsules:
Formulated from classic prescriptions such as Si Wu Tang, Tian Ma Gou Teng Yin, and Tong Qiao Huo
Xue Tang, these capsules have the effects of calming the liver and subduing wind, dispersing blood
stasis and unblocking meridians, and relieving spasms and pain. They are indicated for the treatment of
headaches, back pain, neck stiffness, irritability, and anger caused by liver yang hyperactivity and blood
stasis obstructing the meridians. This product has a clear clinical indication and is supported by robust
evidence-based research. Its therapeutic scope encompasses primary headaches, secondary headaches,
and headache prevention, offering broad clinical application prospects. It is a nationally exclusive
product listed in the National Medical Insurance Directory and the National Essential Medicines List,
and has been included in clinical guidelines and expert consensus such as the Chinese Guidelines for the
Chinese Expert Consensus on the Integrated Traditional Chinese and Western Medicine Diagnosis and
Treatment of Primary Headaches (2026 Edition)(《原發性頭痛中西醫結合診療中國專家共識(2026
版)》) and the Integrated Traditional and Western Medicine Prevention and Treatment of Migraine (2022
Edition) 《
( 中國偏頭痛中西醫結合防治指南(2022年版)》).
Rui Zhu® (polyvinyl alcohol eye drop, sodium hyaluronate eye drop):
It is a single-piece preservative-free artificial tear and currently the first-line drug for the treatment of
dry eye. It is recommended by experts such as the Chinese Expert Consensus on the Clinical Diagnosis
and Treatment of Dry Eye (2024 Edition)(《中 國 乾 眼 臨 床 診 療 專 家 共 識( 2024版)》), the Expert
Consensus on Prevention and Control of Cataract Surgery in China (2021 Edition) 《
( 中國白內障圍手
術 期 乾 眼 防 治 專 家 共 識( 2021年 版)》), the Expert Consensus on Sterily Surgery in China (2020
Edition) 《
( 中國乾眼專家共識(2020年版)》), the Expert Consensus on Refractive Surgery in Laser
Corneal Surgery in China (2019 Edition) 《
( 中國激光角膜屈光手術圍手術期用藥專家共識(2019年
版)》), and the Expert Consensus on Diagnosis and Treatment of Functional Disorder of Bleacne in
China (2017 Edition) 《
( 我國瞼板腺功能障礙診斷與治療專家共識(2017年版)》). Rui Zhu has good
brand recognition and was awarded the China Well-known Trademark in 2017; and was awarded the
CPEO Gold Award for nine consecutive years from 2016 to 2024, namely the “Healthy Industry Brand
List”.
— 26 —
Nuo Tong (xylometazoline hydrochloride nasal spray/nasal drops):
It is a nasal decongestant to relieve nasal congestion, and is suitable for relieving nasal congestion
caused by acute and chronic rhinitis, sinusitis, allergic rhinitis, hypertrophic rhinitis and other nasal
disorders. It does not contain hormones or ephedrine and is suitable for both adults and children. Nuo
Tong is divided into two dosage forms: nasal drops and nasal spray, of which the nasal spray is the
exclusive domestic dosage form and is the leading product among its generic counterparts. The product
has been included in clinical guidelines such as Chinese Expert Consensus on the Diagnosis and
Treatment of Chronic Sinusitis in Children (Hangzhou, 2024) 《
( 兒童慢性鼻竇炎的診斷和治療中國專
家共識(杭州,2024)》), Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China
(Revised Edition 2022) 《
( 中國變應性鼻炎診斷和治療指南(2022年,修訂版)》), Guidelines for the
Diagnosis and Treatment of Allergic Rhinitis in Children (Revised Edition 2022) 《
( 兒童變應性鼻炎診
斷和治療指南(2022年,修訂版)》).
Valinic acid tartrate nasal spray (“OC-01”):
It is a highly selective acetylcholine receptor agonist that activates the trigeminal nerve parasympathetic
pathway to increase natural tear secretion, thereby achieving the therapeutic effect for dry eye syndrome.
According to the results of the Phase III clinical study of OC-01, compared with the control group, OC01 demonstrated statistically and clinically significant improvements in tear secretion in patients with
dry eye syndrome. with a significant increase in natural tear secretion compared to baseline (a higher
proportion of participants showed an increase of 10 millimetres or more in Schirmer scores compared to
baseline), and demonstrated good safety and tolerability. The product was approved for marketing in the
United States in October 2021 and is currently the first and only preservative-free, multi-dose, sterilepackaged nasal spray approved for the treatment of mild, moderate, and severe dry eye syndrome
globally; In terms of registration in China, the product was approved for marketing in the Macau Special
Administrative Region of China in February 2023; In April 2023, it was introduced as an imported
clinically urgent medication in the Hainan Lecheng Medical Pilot Zone; in December 2023, the first
prescription was issued in the Guangdong-Hong Kong-Macao Greater Bay Area at the University of
Hong Kong-Shenzhen Hospital; in November 2024, it was approved for commercialization by the
Chinese NMPA; and in the same month, it was approved for market launch in Taiwan, China; In July
2025, the first commercial prescriptions were issued in mainland China following formal approval.
Currently, the product is included in authoritative clinical guidelines and consensus documents such as
the Guidelines for the Diagnosis and Treatment of Dry Eye Associated with Myopia in Children and
Adolescents (2026 Edition) 《
( 兒童青少年近視相關干眼診療指南(2026版)》), the Chinese Expert
Consensus on the Clinical Diagnosis and Treatment of Dry Eye (2024 Edition) 《
( 中國乾眼臨床診療專
家共識(2024版)》), the 2025 Edition of TFOS DEWS III: Management and Therapy (2025版《TFOS
DEWS III:管理與治療報告》) published by the Tear Film & Ocular Surface Society and the 2023
Edition of the Clinical Practice Guidelines for Dry Eye (2023版《乾眼臨床實踐指南》) published by the
American Academy of Ophthalmology.
— 27 —
TP-03, a globally innovative ophthalmic formulation for the treatment of demodex blepharitis TP-03
(lotilaner ophthalmic solution 0.25%):
Is a non-competitive antagonist selective for gamma-aminobutyric acid-gated chloride channels
(“GABA-Cl”). By selectively inhibiting GABA-Cl in Demodex mites, TP-03 paralyzes and kills the
mites, which are the root cause of Demodex blepharitis. The product is highly lipophilic, which
promotes its absorption into the oils of eyelash follicles where mites reside. Currently the product has
completed two pivotal clinical studies in the United States, both trials met the primary endpoint and all
secondary endpoints, with statistical significance and no serious treatment-related adverse events. and
was approved for commercialization by the United States Food and Drug Administration (“FDA”) in
July 2023. It is the first and only drug approved by the FDA for Demodex blepharitis. It was approved
for marketing by the Macau Medicines and Healthcare Products Regulatory Authority in May 2025 and
approved for marketing by NMPA in March 2026. Currently, this product is included in the 2025
Edition of TFOS DEWS III: Management and Therapy (2025版《TFOS DEWS III:管理與治療報告》)
published by the Tear Film & Ocular Surface Society, the 2025 Edition of the DEPTH Expert Consensus
issued by the Demodex Expert Panel on Treatment and Eyelid Health 《
( DEPTH專家共識》), the 2023
Edition of the Clinical Practice Guidelines for Dry Eye (2023版《乾眼臨床實踐指南》) published by the
American Academy of Ophthalmology, the Chinese Expert Consensus on the Diagnosis and Treatment
of Meibomian Gland Dysfunction (2023 Edition)(《中國瞼板腺功能障礙專家共識:診斷和治療(2023
版)》), among other authoritative domestic and international clinical guidelines and consensus
documents.
Innovative R&D pipeline
The Group reserved three innovative drugs in the direction of clear clinical needs for anti-inflammatory
and pain relief after ophthalmology surgery, pterygium and myopia etc.:
GPN00833, an improved new drug hormone nano-suspension eye drops for anti-inflammatory and pain
relief after ophthalmology surgery:
Its main active ingredient, clobetasol propionate, is a potent glucocorticoid, and has efficient local antiinflammatory and strong capillary contraction effect. Its unique nano-preparation technique effectively
eliminates the low bioavailability and safety risks caused by low water solubility of hormones products.
This product received marketing approval from the US FDA in March 2024. Regarding its registration in
China, the product completed its Phase III clinical study in November 2024 and successfully achieved
clinical endpoints. Compared to the control group, the product demonstrated statistically significant and
clinically meaningful differences in anti-inflammatory and analgesic effects. The product also
demonstrated good safety and tolerability, and its pharmacokinetic profile met expectations. Currently,
the product is in the New Drug Application (NDA) preparation stage.
— 28 —
GPN00153, an improved new drug for the treatment of pterygium (CBT-001):
It is an innovative and improved product, Nintedanib, which is used for the treatment of pulmonary
fibrosis. It inhibits neovascularization and tissue fibrosis. Currently, the phase II clinical trial has been
completed in the United States with high safety and significant clinical efficacy, which can inhibit the
growth of pterygium and control the aggravation of the disease. The global phase III clinical trial for
CBT-001 has conducted in June 2022 and it has been approved to conduct phase III clinical trial in
China by the NMPA in March 2023, and all patients were enrolled in June 2025.
Novel ophthalmic preparation GPN00884 for delaying the progression of myopia in children:
It is an innovative drug with a new mechanism jointly developed by the Group and the Eye Hospital of
Wenzhou Medical University (“WMU”). Compared with low-concentration atropine eye drops,
GPN00884 eye drops have no mydriasis effect, no adverse reactions such as photophobia and decreased
accommodation, and the dosing period is not limited, which can improve patient compliance. The
product has been approved to conduct phase I clinical study in China in March 2024, which was
accepted by the NMPA, completed the Phase I clinical study in March 2025, and completed the
enrollment of the first patient in Phase IIa clinical trial conducted in China in October 2025.
In addition, the Group’s traditional Chinese medicine division has also developed two Class 1 innovative
TCM drugs for use in chronic disease management:
An Innovative Traditional Chinese Medicine for the Treatment of Depression GPN01360:
This is a Class 1.1 innovative TCM for the treatment of depression (liver stagnation and spleen
deficiency syndrome). Based on the ancient classic formula “Xiaoyaosan(逍遙散)”, it was developed
and optimized through modern pharmacological and clinical research. The prescription consists of 12
TCM herbs, including Bupleurum, Turmeric Root Tuber, and Finger Citron, with the effects of soothing
the liver and strengthening the spleen, relieving depression, and calming the mind. This TCM is mainly
used to treat depression of the liver stagnation and spleen deficiency type, of which the typical
symptoms include low mood, slow thinking, decreased willpower, irritability, anxiety, insomnia,
forgetfulness, poor appetite, and fatigue. Preliminary human clinical studies involving nearly 100 people
have shown that GPN01360 demonstrates favorable efficacy and safety in improving depressive
symptoms, relieving anxiety and insomnia, and regulating spleen and stomach function. In December
2025, this TCM reached its clinical endpoint in Phase II clinical trials conducted in China. Research
findings indicate that GPN01360 demonstrates good safety and efficacy in the treatment of depression,
and shows significant improvement in symptoms such as anxiety and insomnia associated with
depression. Currently, the registration process for further studies of this product is proceeding smoothly.
In July 2026, the first patient was enrolled and dosed in the Phase III clinical trial in China.
— 29 —
An Innovative Traditional Chinese Medicine for the Preventive Treatment of Migraines GPN01020:
This is a Class 1.1 innovative TCM drug intended for the prophylactic treatment of migraine
(characterized by blood stasis obstruction). Derived from an in-house formulation developed at a Grade
A Level 3 medical institution, it has been in clinical use for over 30 years. Its primary functions and
indications include promoting blood circulation and removing blood stasis, as well as regulating qi and
tonifying deficiency. It is suitable for vascular-neurogenic headaches, traumatic headaches,
hypertension, and cerebral arteriosclerosis associated with qi deficiency and blood stasis. The product’s
primary historical clinical applications have included primary headaches (such as tension-type headaches
and migraines) and secondary headaches (such as vascular headaches and neurovascular headaches).
Results from preliminary human experience studies involving hundreds of participants indicate that
GPN01020 demonstrates good efficacy and safety in reducing the number of migraine attack days and
attack frequency, as well as in improving migraine-related symptoms. In March 2026, the product was
approved by the NMPA to proceed with Phase II clinical trials.
Cerebro-cardiovascular emergency segment
The Group’s cerebro-cardiovascular emergency segment specializes in both emergency care and chronic
disease management. In terms of emergency care, the Group is listed as a “national essential drug
production base”, an “emergency medicines manufacturer for national ready reserve” and a “national
centralized production base and construction unit for minority-variety medicines (drugs in short
supply)”, etc. with over 30 varieties, 14 of which are included in the national emergency drugs catalogue
of China, while 16 of which are included in the shortage drugs catalogue, which has ranked the top in
the industry in terms of product pipeline. Our products cover three major emergency scenarios, namely
in-hospital emergency care, pre-hospital emergency care and civilian emergency care. Through this, we
continue to provide cerebro-cardiovascular emergency patients in China with a portfolio of safe and
effective products with application in multiple scenarios and various choices. In terms of chronic disease
management, core products such as Nengqilang, Limetone® eplerenone tablets, Herbesser(合貝爽®及合
心爽®)continue to lead the segmented market. Currently, the Group will continue to invest in and
develop products in the fields of cerebro-cardiovascular emergency and chronic disease treatment that
are in urgent clinical need through a combination of independent innovation and research and
development and making breakthroughs in difficult generic technologies.
Cerebro-cardiovascular emergency products
The products mainly cover the fields of blood pressure control, vascular active drugs, myocardial
metabolism, heart failure and anticoagulation. The main products include Li Shu An (norepinephrine
bitartrate injection, epinephrine hydrochloride injection), Herbesser (Diltiazem Hydrochloride Tablets/
Diltiazem Hydrochloride Sustained-Release Capsules, Diltiazem Hydrochloride Injection), Nengqilang
(coenzyme Q10 tablets), Limetone® eplerenone tablets, etc.
— 30 —
Herbesser(合 貝 爽®及 合 心 爽® ), diltiazem hydrochloride tablets/diltiazem hydrochloride extendedrelease capsule, diltiazem hydrochloride injection):
As a classic calcium channel blocker with proven clinical efficacy and high safety, it is available in oral,
sustained-release, and injectable formulations, effectively meeting the clinical needs of patients with
cardiovascular and cerebrovascular diseases such as hypertension and coronary artery disease. It has
been included in numerous authoritative clinical guidelines and domestic and international expert
consensus, including Clinical Management Guidelines for Antihypertensive Drugs in the Perinatal
Period (2025 Edition) (《圍 產 期 降 血 壓 藥 物 臨 床 應 用 管 理 指 引( 2025版)》), Comprehensive
Management Guidelines for Cardiomyopathy in China (2025 Edition) 《
( 中國心肌病變綜合管理指引
(2025版)》), Comprehensive Management Guidelines for Chronic Kidney Disease in the Elderly (2025
Edition) 《
( 老年慢性腎臟病綜合管理指引(2025版)》), Chinese Expert Consensus on the Diagnosis,
Treatment, and Management of Hypertrophic Cardiomyopathy in Children (2025 Edition) 《
( 中國兒童
肥 厚 型 心 肌 病 變 診 斷 治 療 與 管 理 專 家 共 識( 2025版)》), Expert Consensus on Intra-procedural
Coronary Artery Thrombolysis During Percutaneous Coronary Intervention for Acute ST-Elevation
Myocardial Infarction (2025 Edition) 《
( 急性ST段上升型心肌梗塞經皮冠狀動脈介入治療術中冠狀
動 脈 內 溶 栓 專 家 共 識( 2025版)》), British Renal Association Clinical Practice Guidelines: Blood
Pressure Management in Adult, Paediatric, and Adolescent Dialysis Patients (2025 Edition) 《
( 英國腎臟
病 協 會 臨 床 實 務 指 引:成 人、兒 童 及 青 少 年 透 析 病 患 的 血 壓 管 理(2025版)》), ACC/AHA/ACEP/
NAEMSP/SCAI Guidelines for the Management of Patients with Acute Coronary Syndrome (2025
Edition)《(ACC/AHA/ACEP/NAEMSP/SCAI急性冠狀動脈症候群病患管理指引(2025版)》).
Nengqilang® (Coenzyme Q10 Tablets):
It is used to improve myocardial metabolism and energy supply, promoting oxidative phosphorylation
and protecting the structural integrity of biological membranes. For patients with chronic heart failure,
this drug can significantly improve symptoms of shortness of breath and fatigue, effectively combining
with conventional treatment to improve patient prognosis and quality of life. Over the past 30 years
since its launch, it has been included in numerous authoritative guidelines and domestic and
international expert consensus documents, including the Global Andrology Forum Clinical Guidelines on
Antioxidant Use in the Treatment of Male Infertility (2026 Edition) 《
( 全球男性學論壇(GAF)抗氧化
劑治療男性不育臨床指南(2026版)》), the Expert Recommendations for the Diagnosis and Treatment
of Fulminant Myocarditis in Children (2025 Edition) 《
( 兒童暴發性心肌炎診治專家建議(2025版)》),),
Comprehensive Management Guidelines for Cardiomyopathy in China (2025 Edition) 《
( 中國心肌病變
綜合管理指引(2025版)》), Expert Consensus on the Comprehensive Prevention and Treatment of PostTraumatic Stress Disorder Following Traumatic Brain Injury (2025 Edition) 《
( 顱腦衝擊傷後創傷後應
激障礙綜合防治專家共識(2025版)》), Chinese Expert Consensus on the Diagnosis, Treatment, and
— 31 —
Management of Hypertrophic Cardiomyopathy in Children (2025 Edition) 《
( 中國兒童肥厚型心肌病變
診斷治療與管理專家共識(2025版)》), Guidelines for the Management of Cyclic Vomiting Syndrome
in Children (2025 Edition) 《
( 兒童週期性嘔吐症候群治療指引(2025版)》), Expert Consensus on the
Diagnosis and Treatment of Severe Fever with Thrombocytopenia Syndrome (2025 Edition) 《
( 重症發燒
伴血小板減少症候群診治專家共識(2025版)》), Chinese Guidelines for the Clinical Diagnosis and
Treatment of Myocarditis in Adults (2024) 《
( 中國成人心肌炎臨床診斷與治療指引2024》), Chinese
Guidelines for the Diagnosis and Treatment of Chronic Alcohol-Related Brain Damage (2024 Edition)
《
( 慢性酒精相關性腦損傷的中國診療指引(2024版)》), Chinese Expert Consensus on the Diagnosis
and Treatment of Hereditary Ataxia (2024 Edition) 《
( 中國遺傳性共濟失調診治專家共識(2024版)》),
Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2024 Edition) 《
( 中國心力衰竭診
斷和治療指南(2024版)》), etc.
Limetone® eplerenone tablets(力美通®依普利酮片):
It is a new MRA drug. It can block heart disease and vascular damage caused by excessive activation of
mineralocorticoid receptor (“MR”) by binding to the MR. ESC Guidelines: Management of
Cardiovascular Disease and Pregnancy (2025 Edition)《(ESC指南:心血管疾病和妊娠的管理(2025
版)》), ACC/AHA/ACEP/NAEMSP/SCAI Guidelines for the Management of Patients with Acute
Coronary Syndrome (2025 Edition) 《(ACC/AHA/ACEP/NAEMSP/SCAI急性冠狀動脈綜合症患者管
理指引(2025版)》), TES Clinical Practice Guidelines: Primary Aldosteronism (2025 Edition)《(TES臨
床實務指引:原發性醛固酮增多症(2025版)》), AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/
AMA/ASPC/NMA/PCNA/SGIM Guidelines for the Prevention, Detection, Evaluation, and Management
of Hypertension in Adults (2025 Edition),《(AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/
ASPC/NMA/PCNA/SGIM成人高血壓預防、檢測、評估與管理指引(2025版)》), Expert Consensus
on the Evaluation and Management of High-Volume Loads in Patients with Hypertension (2025 Edition)
(《高 血 壓 患 者 高 容 量 負 荷 的 評 估 與 管 理 專 家 共 識( 2025版)》), Guidelines for Prevention and
Treatment of Hypertension in China (2024 Edition) 《
( 中國高血壓防治指南(2024版)》), the Guidelines
for Diagnosis and Treatment of Heart Failure in China (2024 Edition) 《
( 中國心力衰竭診斷和治療指
南)
(2024版)》, Chinese Expert Consensus on Blood Pressure Management of Refractory Hypertension
(《難 治 性 高 血 壓 血 壓 管 理 中 國 專 家 共 識》), the Multidisciplinary Expert Consensus for Clinical
Application of Mineralocorticoid Receptor Antagonists in China (2022 Edition) 《
( 鹽皮質激素受體拮
抗劑臨床應用多學科中國專家共識(2022版)》) and many other well-known clinical guidelines and
expert consensus at home and abroad recommend the clinical use of MRA drugs in the treatment of
cardiovascular diseases such as heart failure and hypertension. Compared with the first-generation MRA
drug Spironolactone, Eplerenone has higher MR selectivity and lower affinity for androgen receptor and
progesterone receptor, so it has fewer side effects and is a safe and effective new generation of MRA
drug. This product was approved for commercialization by the NMPA in August 2023, bridging the gap
of second-generation selective mineralocorticoid receptor antagonist drugs in China. In May 2024, the
first prescription was completed, and the commercialization was officially realized in China. In
November 2024, it was officially included in China’s National Basic Medical Insurance, Work-related
Injury Insurance and Maternity Insurance Drug List (2024 Edition) 《
( 國家基本醫療保險、工傷保險和
生育保險藥品目錄(2024版)》).
— 32 —
Neffy® Adrenaline Nasal Spray:
Neffy® is the first non-injectable treatment product approved by FDA for the treatment of type I allergic
reactions (including severe allergic reactions). It uses an innovative nasal spray delivery method, which
is convenient to use, compact and easy to carry, and can be administered by the patient or others in the
event of an allergic reaction The product has a shelf life of up to 30 months, which can significantly
reduce waste caused by expired medicines, and alleviate the economic and medication burden on
patients. Its pivotal clinical study results show that subjects treated with Neffy® or approved adrenaline
injection products had comparable blood concentrations of adrenaline, and Neffy® has been shown to
have a rapid onset of action and provide short-term symptom relief in patients with allergic reactions.
With its unique portability and user-friendly operation, Neffy® is expected to quickly penetrate various
out-of-hospital scenarios, including homes, schools, and travel, and fill the gap in the availability of
emergency medications for severe allergic reactions in out-of-hospital settings.
Runmodelin® Treprostinil Injection:
This is a rare disease drug for the treatment of pulmonary arterial hypertension. It is a synthetic
analogue of endogenous prostacyclin. By acting on specific prostaglandin receptors and antagonizing
thromboxane A2, it promotes vascular smooth muscle relaxation, reduces thrombosis, inhibits vascular
wall cell proliferation, and thereby increases blood flow and reduces cardiac stress. This product, when
used in combination with existing treatments, can significantly improve patients’ long-term survival. Its
use is recommended by authoritative domestic and international guidelines, including the Guidelines for
the Diagnosis and Treatment of Pulmonary Arterial Hypertension Associated with Congenital Heart
Disease in Adults (2026 Edition) 《
( 成人先天性心臟病相關肺動脉高壓診斷與治療指南(2026版)》),
the ESC Guidelines: Management of Cardiovascular Disease and Pregnancy (2025 Edition)《(ESC指南:
心血管疾病和妊娠的管理(2025版)》), the Expert Consensus on Joint Management of Targeted Drug
Therapy for Pulmonary Arterial Hypertension (2025 Edition) 《
( 動脈性肺動脈高壓標靶藥物治療醫學
共 管 專 家 共 識( 2025版)》), the Guidelines for the Diagnosis and Treatment of Acute Pulmonary
Embolism (2025 Edition) 《
( 急性肺栓塞診斷與治療指南(2025版)》), the Guidelines for the Diagnosis
and Treatment of Chronic Thromboembolic Pulmonary Hypertension (2024 Edition) 《
( 慢性血栓栓塞性
肺動脈高壓診斷與治療指南(2024版)》), the ESC/ERS Guidelines for the Diagnosis and Treatment of
Pulmonary Hypertension (2022 Edition) 《 (ESC/ERS肺 動 脈 高 壓 診 斷 與 治 療 指 南( 2022版)》), the
Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension (2021 Edition) in China 《
( 中國
®
肺 動 脈 高 壓 診 斷 與 治 療 指 南( 2021版)》). Runmodelin is one of only two treprostinil products
currently approved for marketing in China. In January 2023, it was officially included in China’s
“National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List
(2022 Edition)”, significantly improving patient accessibility and reducing the treatment burden,
benefiting a large number of patients with pulmonary arterial hypertension.
— 33 —
Pharmaceutical Raw Materials Segment
The Group’s pharmaceutical raw materials segment has a rich product pipeline and significant
advantages in terms of product concentration. Our bulk APIs and specialty APIs are sold in parallel,
with sales channels spread all over the world. As an important link in the front-end of the integrated
supply chain of raw materials and preparations, the Group now owns several modernized production
bases of pharmaceutical raw materials with complete equipment, superb technique, outstanding
industrialization capability and standardized quality control. The Group focuses on the R&D of API
production in five major areas, namely cerebro-cardiovascular, anti-infection, antipyretic analgesic, the
digestive system and anti-tumor, and fully supports the production of preparations and R&D work in the
field of pharmaceutical technology, so as to ensure high quality standard and consistency of the
Company’s preparations at the source, and truly realize the integration of upstream and downstream
industrial advantages.
mRNA platform
The Group has established a world-leading mRNA technology platform centered on Nanjing AuroRNA
Biotech Co., Ltd. (“AuroRNA Biotech”). As the Group’s global mRNA innovation technology platform,
AuroRNA Biotech possesses two core underlying mRNA technologies–the development of mRNA
nucleic acid therapeutics and lipid nanoparticle (LNP) delivery–both of which are protected by its own
intellectual property rights. These technologies address a number of key industry challenges, including
vaccine antigen design, in vivo targeted delivery via LNPs, and process development. The technological
foundation is capable of cross-project reuse and is highly scalable, enabling the development of a
diverse range of mRNA drug candidates. AuroRNA Biotech’s research and development is primarily
focused on areas of significant clinical and public health importance, such as cancer treatment and the
prevention and control of infectious diseases. The platform is currently prioritizing the development of
two therapeutic mRNA vaccines–one for HPV-16-related cervical cancer and the other for HSV-2related genital herpes–whilst also conducting proof-of-concept studies for several early-stage research
projects based on its proprietary platform technology.
— 34 —
Biotechnology
The Group pursues the concept of green, low-carbon and sustainable development and promotes highquality development of the segment with the world’s leading innovative technology in synthetic
biotechnology. The amino acid products are the core business in the field of biotechnology, and it is
positioned as a global premium service provider of high-quality amino acids. The Group’s development
in the biological field focuses on technological innovation and the construction of high-quality systems.
We are comprehensively advancing the international registration process by establishing technical and
quality barriers, thereby strengthening the Group’s overall competitiveness in the international market.
Currently, the Group holds approximately 350 invention patents and has led and participated in the
formulation of more than 70 national, industrial and group standards, with approximately 50 standards
published. We have a complete domestic and international quality system certification, and have won
many honors such as National Green Factory(國家級綠色工廠), the National Manufacturing Individual
Champion Demonstration Enterprise(國家製造業單項冠軍示範企業), National-level “Little Giant”
Enterprises(國 家 級 專 精 特 新「小 巨 人」企 業), the National Intellectual Property Demonstration
Enterprise(國 家 知 識 產 權 示 範 企 業), the China Light Industry Green Manufacturing Engineering
Technology Research Centers for Sulfur-containing Amino Acids(中國輕工業含硫氨基酸綠色製造工
程技術研究中心), and the Advanced Enterprise in China’s Bio-fermentation Industry(中國生物發酵
行業先進企業).
Amino acids segment
The Group has been cultivating in the field of amino acids for more than 20 years and has always
adhered to the spirit of technological innovation, taking synthetic biology as the core, it pioneered a
world’s leading innovative technology in China based on biotechnology method to produce various
amino acids by biological method, which filled the gap in the industry. The Group has undertaken the
project for national industrial strong foundation engineering and the industrial foundation transformation
project of the PRC, and is the first company in China to be approved for the “Same production line,
same standard, same quality” three-in-one certification for amino acids, to ensure the safety and stability
of the supply chain and industrial chain of high-quality amino acids in China.
The Group has always adhered to the core business philosophy of “new technology, high quality,
industrial chain, and internationalization” and has continued to strengthen the expansion of the amino
acid industry. Based on pharmaceutical-grade amino acids and by leveraging our industrial advantages,
the Group continues to expand into diversified amino acids.
— 35 —
New technology:
Focusing closely on the field of synthetic biology and after years of scientific research, at present, we
have built eight technology platforms, including synthetic biology, enzyme engineering, fermentation
engineering, process optimization, quality research and application transformation, while taking
initiatives in construction of cell factory, fine control of fermentation processes, and research of the full
technology chain of separation and purification. Through the innovation and integration of several
technology areas, we have had an integrated synergistic system with new product development, new
technology engineering, industrialization and application solutions, which provides strong support for
continuous innovation and industrial implementation, and some of the technologies have filled the
domestic gaps in China. Currently, the Group has established long-term deep cooperation relationship
with a number of scientific research institutions such as Wuhan University, Huazhong University of
Science and Technology, Tianjin University of Science and Technology and Huazhong Agricultural
University, under which, a new amino acid fermentation technology and an enzyme expression system
were developed. Meanwhile, the technological development of cell culture media-level amino acid has
been further deepened, providing raw material guarantee for the research of self-produced cell culture
medium. We have applied the technologies of molecular biology and proteomics to modify the structure
of biological enzymes, thus effectively improving the activity of biological enzymes and the yield and
quality of the products. Among them, the fermentation process with strain construction optimization as
the core and the enzyme conversion process with immobilized enzymes as the core can not only replaces
the traditional chemical synthesis process, improving process safety and production convenience, but
also significantly reduces carbon dioxide emissions during the production process, which fully
demonstrates the development concept of energy saving, emission reduction and green environment
protection of emission peak and carbon neutrality, generating great economic and environmental
benefits. The industrial technology highway built by the Group in the amino acid segment is beginning
to take shape, which has laid a solid foundation for Original technological innovation and product
industrialization.
The Group attaches great importance to the construction of R&D team and the close integration of
production and research. At present, the amino acid segment has a core technical team led by talents
from the 100 Talents Plan of Hubei Province(湖北省百人計劃). The innovative model of combining
production, academia, research and application in this segment, as well as the echelon of technical
innovation talents with clear division of labor and complementary strengths, has yielded fruitful results
with the number of granted invention patents ranking at the leading level in the same industry.
— 36 —
High quality:
The Group’s amino acid products have a complete quality certification system at home and abroad.
Many core products have passed the drug/food system certification and registration in Europe, the
United States, Japan, Southeast Asia, China and other countries and regions, including European Union
GMP certification, EU REACH registration, Export to European Union WC certification, the US FDA
certification, KFDA Registration in Korea, the ISO quality management system certification, the
FSSC22000 food system certification, FAMI-QS feed certification, IP non-GMO certification, the
HALAL certification, the KOSHER certification, etc, not only ensuring the compliance of overseas
operations of core products, but also laying the foundation for the subsequent expansion of new market
applications of products. Meanwhile, the Group has also made efforts to increase registration in new
economies such as South America, paving the way for the globalization of the Group’s core products.
Our comprehensive system certification and registration have demonstrated the Group’s strong
competitiveness for business expansion in overseas markets.
Industry chain:
The Group has nearly 50 types of various amino acids and their derivatives. It has 26 registered amino
acid APIs and is the pharmaceutical company with the largest number of registered amino acid APIs in
China. At the same time, the Group has also added a number of food-grade and feed-grade amino acid
products, opening up growth space through differentiated paths and demonstrating the dual-wheel drive
effectiveness of market breakthroughs and product innovation. The rich amino acid product cluster can
better meet the customized needs of the downstream market, provide one-stop services of multiple
varieties and specifications, and enhance customer adhesion in high-end application scenarios. In
addition to raw material products, the Group is also actively expanding its pharmaceutical products. Two
of the self-developed functional dietary supplements, have obtained the U.S. FDA approval and have
been commercialized in the United States. The Group already has over 10 independently developed
functional foods approved for commercialization in China.
Internationalization:
The sales network of the Group’s amino acid segment covers more than 140 countries and regions
worldwide, including mainstream markets in Europe, the United States, Japan, Southeast Asia and
China, with overseas business accounting for about 40% of the total. Among which, some of our amino
acid varieties ranking among the top three in terms of market share. Relying on technological
breakthroughs and cost advantages, the core products have long served domestic and international highquality customers including Fortune 500 companies, and established long-term and stable cooperative
relationships with customers in the upstream and downstream of the industrial chain as well as a high
brand awareness and market reputation worldwide, which has laid a solid customer base for the
continuous and rapid growth of the segment’s performance.
— 37 —
In the future, the Group will continue to rely on its world-leading new bio-method manufacturing
technology in the field of high-quality amino acids, solid industrial base and industrial accumulation,
rich amino acid product clusters, high-standard quality certification systems, strong international
registration and commercialization capabilities, with a focus on high-end parenteral nutrition
preparations, innovative peptide drugs, cell culture base and other pharmaceutical-related high valueadded fields, as well as functional dietary supplements such as sports protection, special medical and
infant food, beauty and pet food and other large health consumer areas. The extensive market space and
huge development potential of the downstream segment will provide the Group’s amino acid segment
with strong and sustainable development momentum.
FINANCIAL REVIEW
Revenue and profit
For the six months ended 30 June 2026, the business of the Group grew steadily and recorded a revenue
of approximately HK$6,388.91 million (same period last year (restated) 1: HK$6,189.20 million),
representing a year-on-year increase of approximately 3.2%. Revenue from innovative and barrier
products2 accounted for approximately 50% of total revenue. During the current period under review, the
profit for the period attributable to the owners of the Company was approximately HK$1,061.54 million
(same period last year (restated): HK$1,193.17 million). During the period, the Group’s fair value
changes and disposal gains from its investment in Telix totaled approximately HK$88.78 million (same
period last year (restated): HK$151.72 million), a decrease of HK$62.94 million compared to the same
period last year. If the impact of the Telix investment on profits is excluded, the adjusted operating net
profit for the period attributable to the owners of the Company3 was approximately HK$972.76 million
(same period last year (restated): HK$1,041.44 million), which was mainly due to the short-term impact
of adjusting sales strategies in response to market competition.
During the current period, the Group recorded a revenue of HK$745.13 million from the nuclear
medicine anti-tumor diagnosis and treatment and cerebro-cardiovascular precision interventional
diagnosis and treatment technology products, representing an increase of approximately 29%, as
compared with the same period of 2025 (approximately HK$577.74 million). In particular, we recorded
a revenue of HK$655.24 million from the nuclear medicine anti-tumor sector, representing an increase
of approximately 55.4%, as compared with the same period of 2025 (approximately HK$421.78 million),
due to revenue growth as a result of the rapid growth in clinical demand for core products and the rapid
release of new products; and a revenue of HK$89.89 million from the cerebro-cardiovascular precision
interventional diagnosis and treatment sector.
During the current period, the Group recorded a revenue of approximately HK$3,274.08 million from
pharmaceutical technology products, representing a decrease of 14.9% as compared with the
corresponding period in 2025 (approximately HK$3,845.19 million). In particular, we recorded a
revenue of approximately HK$1,041.73 million from the respiratory and critical and severe disease
segment, remaining almost the same as compared with the corresponding period in 2025 (approximately
HK$1,047.35 million); a revenue of approximately HK$1,115.51 million from the ENT segment,
— 38 —
representing a decrease of approximately 25.4% as compared with the corresponding period in 2025
(approximately HK$1,494.71 million); and a revenue of approximately HK$792.30 million from the
cerebro-cardiovascular emergency segment, representing a decrease of approximately 12.4% as
compared with the corresponding period in 2025 (approximately HK$904.41 million). The revenue in
the ENT segment and cardiovascular emergency care segment declined, was primarily due to the shortterm impact of sales strategy adjustments made in response to market competition.
During the current period, the Group recorded a revenue of approximately HK$2,369.70 million from
biotechnology products, representing an increase of approximately 34.2% as compared with the restated
result of corresponding period in 2025 (approximately HK$1,766.26 million). In particular, we recorded
a revenue of approximately HK$1,870.28 million from the amino acid segment (including taurine),
representing an increase of approximately 30.9% as compared with the restated result of corresponding
period in 2025 (approximately HK$1,428.49 million), which was mainly driven by higher sales prices
for core products and expanding demand in downstream markets, driving business growth in scale.
Notes:
1
In the first half of 2026, the Company successfully acquired 100% of the equity interests in Hebei Jiufu and
Baoding Jiahe. At the time of the acquisition, China Grand was the controlling shareholder of both Hebei
Jiufu and Baoding Jiahe, and was also the controlling shareholder of the Company. Therefore, the
acquisition was treated as a business combination involving entities under common control and accounted
for using the merger accounting method. Consequently, the comparative condensed consolidated statements
of income and other comprehensive income for the six months ended 30 June 2025, as well as the
condensed consolidated statements of financial position as of 31 December 2025, and 1 January 2025, have
been restated to incorporate the assets, liabilities, profits, and cash flows of the combined entity from the
date on which it first came under common control. For details, please refer to Note 2 to the condensed
consolidated financial statements.
2
Innovative and barrier products refer to the Company’s original research products, products with exclusive
market position, products with exclusive commercialization rights, and first-to-market generic products that
break foreign monopolies.
3
The Group’s adjusted operating profit attributable to owners of the Company is defined as the profit for the
period attributable to owners of the Company, excluding the impact of fair value changes and disposal gains
on the Telix investment.
— 39 —
Distribution costs and administrative expenses
For the six months ended 30 June 2026, the Group’s distribution costs and administrative expenses were
approximately HK$1,582.34 million and HK$668.10 million respectively as compared to the restated
amounts of approximately HK$1,919.44 million and HK$705.47 respectively for the corresponding
period in 2025. The distribution costs during the current period decreased by approximately HK$337.10
million, which was mainly due to the optimisation of the marketing organisation and the adjustment of
sales strategies during the current period. The administrative expenses also decreased by approximately
HK$37.38 million as compared to the restated result of corresponding period of last year mainly due to
the organisational restructuring and refined operational management during the current period.
Finance costs
For the six months ended 30 June 2026, the Group’s finance costs were approximately HK$76.76 million
as compared to the restated amount of approximately HK$82.00 million for the corresponding period in
2025. The decrease in finance costs was due to a decrease in the overall interest rate as a result of loan
replacement.
R&D and project investment
For the six months ended 30 June 2026, the Group continuously invested resources in the stages of
research project and introduction of innovative projects. If including the R&D expenses and also the
capitalized R&D expenses, prepayments for new projects and other investments, the Group’s investment
in R&D and various projects is approximately HK$764 million.
Receivables and payables
As of 30 June 2026, trade and other receivables of the Group amounted to approximately HK$5,397.24
million, representing an increase of approximately HK$664.65 million as compared to the restated
balance in 2025, mainly due to the increase in trade and bills receivables of approximately HK$898.52
million as compared to the closing balance of last year. This is mainly a result of the increase in
business during the current period, and also as general market practise it will put more force to collect
receivables at the year end and thus the trade receivable year-end balances always recorded
comparatively lower.
As of 30 June 2026, the Group’s trade and other payables amounted to approximately HK$4,002.71
million, substantially remaining the same as compared to the restated balance in 2025, mainly due to the
increase in trade and bills payables of approximately HK$110.28 million as a result of the increase in
business during the period. Furthermore, due to the optimisation of the marketing organisation and the
adjustment of sales strategies during the year, we accrued reduced selling and operating expenses such
as salaries, marketing and promotion expenses and R&D expenses amounted to approximately
HK$159.16 million.
— 40 —
Significant investments
The Group’s investments with value over 5% of value of its total assets are considered as significant
investments. As at 30 June 2026, our significant investments include (i) Grand Pharma Sphere Pte
Limited (“Grand Pharma Sphere”) and (ii) Shanghai Xudong Haipu Pharmaceutical Company Limited
(“Xudong Haipu”).
Grand Pharma Sphere is the holding company of a group of companies principally engaged in the
research and development, manufacturing and sales of nuclear medicine and tumor intervention
products. The Group effectively owned approximately 57.98% equity interests of it. For the six months
ended 30 June 2026, the Group’s share of profit in Grand Pharma Sphere was approximately HK$40.48
million (for the six months ended 30 June 2025: profit attributable to the Company approximately
HK$39.3 million).
Xudong Haipu and its subsidiaries is a group of companies principally engaged in the manufacturing and
sales of pharmaceutical injections of various volumes. The Group effectively owned 55% equity
interests of it. For the six months ended 30 June 2026, the Group’s share of profit in Xudong Haipu was
approximately HK$38.11 million (for the six months ended 30 June 2025: approximately: HK$42.82
million).
The quote fair value of significant investments in associates is not available, since the significant
associates are private entities and do not have quoted market price. The results and assets and liabilities
of associates are incorporated in the consolidated financial statements of the Group using the equity
method of accounting.
The Group may consider to make investments in these associates due to different criteria, mainly
including:
1.
Looking for opportunities to enter into new markets and expand product pools. For instance, the
investment in Grand Pharma Sphere offered an opportunity for the Group to venture into the field
of nuclear drug anti-tumor, and investment in other associates may help the Group get into other
markets like grasp advanced technology and step into the global market of cardiovascular
interventional medical devices;
2.
Looking for synergy effect to the Group’s existing products and markets. For example, Xudong
Haipu’s core product line may create synergy with the Group’s preparation products, and enrich
the Group’s core product pool in the areas of emergency medications and cerebro-cardiovascular
and respiratory products. It can also strengthen the Group’s product quality, market share and
brand in those areas; and
3.
Seeking opportunities to cooperate with companies in early R&D stage and obtain the commercial
rights for products with strong potentials.
— 41 —
For further details of the product research and development and business prospects of these associates,
please refer to the section with heading “Business Review and Prospects” above.
Research and development
The Group has sufficient innovation pipeline. During the period, there were 34 innovation projects,
which were in different stages from preclinical to new drug commercialization application. The pipeline
layout was reasonable, forming a good echelon effect.
R&D Pipeline
Field
Sector
Direction
Radionuclide-drug conjugate (RDC)
Technologies on nuclear medicine
and anti-tumor diagnosis and
treatment
as well as cerebrocardiovascular
precision interventional diagnosis
and treatment
Nuclear medicine and
anti-tumor diagnosis and
treatment
Product
Indication
TLX591
(177Lu-rosapatumab)
Prostate cancer
TLX591-CDx
(68Ga-PSMA-11)
Prostate cancer – diagnosis
TLX250
(177Lu-girentuximab)
Clear cell renal cell carcinoma
TLX250-CDx
(89Zr-girentuximab)
Clear cell renal cell carcinoma
– diagnosis
TLX101
(131I-IPA)
Glioblastoma
ITM-11
Gastroenteropancreatic
neuroendocrine tumor
GPN01530-2
Solid tumor - diagnosis
GPN02006
Hepatocellular carcinoma diagnosis
Y-90 microsphere injection
Primary liver cancer
Thermosensitive embolic agent
Vascular-rich solid organ tumors
product
Interventional treatment
Cerebrocardiovascular
precision
interventional
diagnosis
and treatment
Cerebral arteriovenous
malformations
AuroLase
Prostate cancer
UPro-SEEK
Prostate cancer
UI-MRD
Urothelial carcinoma
Vascular intervention
aXess
Hemodialysis
Neurointervention
GPN01037
Intracranial stenosisss
Structural heart disease
and heart failure
Structural heart
disease
Saturn
Mitral regurgitation
Heart failure
Heart failure
CoRisma
HPV-16-positive solid tumors
Access management
Ophthalmology
ENT
Pharmaceutical Technology
Kona
Traditional Chinese Medicine
GPN00153(CBT-001)
Pterygium
GPN00833
Anti-inflammatory and analgesic
GPN00884
Myopia prevention and control
GPN01360
Depression
GPN01020
Neurological Disorders
Anti-infection
Respiratory and
severe disease
Respiratory
GPN01411
Severe disease
STC3141
Sepsis
mRNA platform
Tumor
ARC01 (A002)
HPV-16 positive solid tumors
Mainland China
Overseas
— 42 —
R&D progress
Preclinical
IND/Model
Inspection
Phase I
Phase II
Phase III
NDA/
Registration
Launch
R&D center
Currently, the Group is involved in and has established a number of R&D technology platforms and
R&D centers around the world:
In the field of pharmaceutical technology, the International R&D Center in Optics Valley (光谷國際研
發中心) in Wuhan, China is the main R&D body of the Group in the pharmaceutical technology field in
China, providing technical support for the R&D of the Group’s high-end preparation products; the
Glycomics technology platform is located at the R&D center in Australia, focusing on the development
of antiviral drugs; the mRNA technology platform is located in Nanjing, China, focusing on the
development of anti-tumor and anti-infective mRNA drugs, and will further expand into the fields of
rare disease and protein replacement therapy in the future.
In the segment of nuclear medicine anti-tumor diagnosis and treatment, the tumor intervention
technology platform and the RDC technology platform involve the Boston R&D Center in the United
States and the Chengdu Radiopharmaceutical Research and Development Center in China, respectively.
In the cerebro-cardiovascular precision interventional diagnosis and treatment sector, the Group’s highend medical device R&D technology platform comprises the International R&D Center in Optics Valley
in Wuhan and the Changzhou Device R&D Center.
Development of generic drugs
During the period under review, the Company obtained drug registration certificates from the NMPA for
its products of metronidazole gel, icatibant acetate injection, amorolfine hydrochloride liniment and
acetylcysteine solution for inhalation.
Consistency Evaluation
During the period under review, metronidazole gel, icatibant acetate injection, amorolfine hydrochloride
liniment, acetylcysteine solution for inhalation, diazepam injection and amikacin sulfate injection were
approved or deemed to have passed the consistency evaluation. New applications were submitted for
teneligliptin hydrobromide tablets, nalmefene hydrochloride injection, bisoprolol fumarate tablets, and
acetylcysteine effervescent tablets. Currently, the Group has a total of 70 products approved or deemed
to have passed the consistency evaluation, with another 19 products under review.
— 43 —
Intellectual Property Protection
During the period under review, the Group had an addition of 55 applications. There were 33 new
patents being granted, of which 17 were invention patents, accounting for 52%, and 1 new foreign patent
being granted. The Group has accumulated 1,028 valid patents, of which 599 are valid invention patents.
The Group attaches great importance to the protection of intellectual property rights in independent
innovation projects, with 274 patents in the field of innovation. It has filed 23 new patent applications in
innovative fields such as anti-infection, oncology, medical devices, and mRNA technology platforms,
accounting for 42% of the group’s total new applications. Among them, core patents in the anti-infection
field have been authorized in China, the United States, Europe, Japan, South Korea, Israel, Singapore,
Australia, and other regions.
Commercialization Capability
The Group’s performance continued to improve, and the continuous commercialization of innovative
products and profit contribution cannot be separated from the continuous improvement of
commercialization capabilities. As at the date of this announcement, the Group had approximately 5,000
sales personnel, of which more than 4,000 were in the pharmaceutical area (including OTC), covering
more than 50,000 hospitals and primary medical and healthcare institutions in China, of which more
than 13,000 were ranked hospitals. In the OTC area, we had over 1,000 sales personnel with a reach of
more than 500,000 pharmacies in China. The cerebro-cardiovascular precision interventional diagnosis
and treatment segment had a sales team comprising approximately 150 staff covering nearly 1,800
hospitals. The nuclear medicine anti-tumor diagnosis and treatment segment has over 900 sales
personnel worldwide, with its global sales network covering more than 50 countries and regions. It has
also actively carried out the hospital admission and academic promotion of YiGanTai® Yttrium-90
microsphere injections in China.
International Standard
The Group continues to accelerate the pace of globalization and has a number of independently
operating overseas companies in the fields of nuclear medicine anti-tumor diagnosis and treatment,
cerebro-cardiovascular precision interventional diagnosis and treatment, and critical and severe diseases,
etc. The Group has advanced overseas clinical trials of a number of global innovative products and
obtained 8 clinical approvals in five countries, including the United States, Australia, Belgium, Poland
and the United Kingdom, involving a number of indications such as primary liver cancer, solid tumor
and sepsis. Currently, the Group and its associates have over 350 employees overseas.
— 44 —
Material Investment, M&A and Cooperation
The Group continued to implement the development strategy of “self-development + global expansion”,
further exploring high– quality innovative projects around the world to expand the Group’s product
pipeline and enhance the Group’s comprehensive strengths and putting vigorous efforts in transformation
towards innovation and internationalization. During the reporting period, the Group has carried out the
following material investment, M&A and cooperation:
•
Strategic Collaboration with The University of Hong Kong
In April 2026, the Group entered into a strategic collaboration with The University of Hong Kong
and its wholly-owned subsidiary, Versitech Limited (“HKU Versitech”). The parties will engage
in in-depth collaboration in areas including academic research, resource sharing, talent
development and product development, jointly advancing innovative drug R&D and
industrialisation of research outcomes in the anti-infection field. This collaboration will commence
with the development of innovative antibacterial agents. The relevant projects will be undertaken
by the research team of professor Li Xuechen(李學臣), aiming to develop novel therapeutic
solutions with improved efficacy and safety profiles to address the unmet clinical needs in the
antibacterial treatment landscape. Subsequently, The University of Hong Kong will grant the
Group an exclusive license to the relevant intellectual property rights it owns, and the Group will
be fully responsible for the subsequent development, registration and commercialisation, thereby
efficiently translating cutting-edge scientific research outcomes into industrial applications. This
collaboration marks another pivotal step for the Group in engaging with world-class universities
and deeply integrating frontier academic research with industrial translation and application.
INVESTOR RELATIONS
The Group has been committing to improving its corporate governance to ensure the long-term
development. During the period, the Group published annual reports, annual results announcements, and
other announcements and circulars on the websites of the Company and the Hong Kong Exchanges and
Clearing Limited, and issued voluntary announcements, so as to disclose the latest business
developments of the Group to shareholders and investors.
At the same time, the Group actively maintains close communication with investors through various
channels, including securities company roadshows, large-scale telephone conferences, one-on-one
meetings and other diversified communication methods, to introduce the Group’s business situation,
development progress and overseas member companies’ businesses to investors, and simultaneously
releases the latest business updates through different media channels, aiming to build an open, two-way,
transparent and sincere communication platform, so that investors can keep abreast of the Group’s
business progress and development prospects. During the period, the Group actively communicated with
— 45 —
the capital market and investors through promotional activities such as results announcements and
investor site visit, and participated in a number of summits, forums, strategy conferences and special
roadshows held by large investment banks and securities companies, attracting hundreds of institutional
investors and analysts. Through communication with investors, the Group hopes to listen to more
valuable opinions and extensively collect feedback from investors by establishing an active and efficient
information and communication mechanism, so as to further enhance its corporate governance.
The Group’s investor relations management efforts have helped establish a high-quality corporate image
and communicate its core strategy of technological innovation, earning widespread recognition within
the industry across multiple dimensions. In January 2026, the Company was honored on the 12th “Top
100 Hong Kong Stocks” Annual Pharmaceutical and Healthcare Innovation Pioneer List, as well as the
2nd JuDongmi “Top 100 IRM Companies (Top 20)” and the 2nd JuDongmi “Top 100 ESG Companies
(Top 20)”.
Other Significant Matters
SHARE OPTION SCHEME
As at 30 June 2026, the Company did not adopt any share option scheme and no outstanding share
options.
No share options were granted or exercised under any share option scheme, and there were no
outstanding share options as at 30 June 2026.
Share Award Scheme
On 1 September 2021, the Company has adopted the Share Award Scheme (“Scheme”) in which the
Group’s employees, directors or consultants will be entitled to participate. Details of the Scheme are set
out in the Company’s announcement dated 1 September 2021.
The Group has paid to the trust established for the Scheme approximately HK$278.56 million, and
including the dividend belongs to the shares acquired previously, the trustee used approximately
HK$268.5 million to purchase 47,761,500 shares of the Company (“Shares”) as part of the trust fund,
and such Shares are held by the trustee for the benefit of the eligible participants under the trust and are
the total number of award shares available for grant under the Scheme, representing approximately
1.35% of the issued Shares of the Company. Where the trustee has received instructions from the Group
to acquire Shares and necessary funds, the trustee shall acquire such number of Shares on-market at the
prevailing market price as soon as reasonably practicable.
— 46 —
Save for the aforesaid, as at 30 June 2026, the Group did not grand any awards nor caused to pay the
trustee the trust fund for purchase nor subscription of Shares. When any awards were granted later, the
number of Shares to be awarded, award price, vesting criteria and vesting schedule of awards of each
participant will be subject to the applicable Listing Rules and other applicable regulations by that time,
and will inform the participants in the form of an award letter. The Board shall not make any award of
Shares which will result in the aggregate number of the Shares awarded by the Board under the Scheme
exceeding 5% of the number of issued Shares of the Company as at the adoption date of the Scheme (i.e.
177,478,557 Shares), and the maximum entitlement of each participant under the Scheme in every
12-months in aggregate shall not exceed 1% of the issued Shares as at the adoption date of the Scheme
(i.e. 35,495,711 Shares).
Purpose of the Scheme
The purpose of the Scheme is to recognise the contributions of the Selected Participants and provide
them with incentives in order to retain them for the continual operation, growth and development of the
Group.
Remaining Term of the Scheme
Subject to any early termination as may be determined by the Board pursuant to the Scheme Rules, the
Scheme shall be valid and effective for the Scheme Period, i.e. a term of 10 years commencing on the
Effective Date. As of 30 June 2026, the Scheme has approximately 5.5 years remaining in force.
Purchase, Sale or Redemption of Shares
During the period ended 30 June 2026, neither the Company nor any of its subsidiaries has purchased,
sold or redeemed any of the Company’s listed securities.
Employees and Remuneration Policy
As at 30 June 2026, the Group employed about 12,326 staff and workers in Hong Kong and the PRC (31
December 2025: about 12,614). The Group remunerates its employees based on their performance and
experience and their remuneration package will be reviewed periodically by the management. Other
employee benefits include medical insurance, retirement scheme, appropriate training program and share
option scheme.
Competing Interest
No Directors or the management shareholders of the Company (as defined in the Listing Rules) had an
interest in a business which competes or may compete with the business of the Group.
— 47 —
Directors’ Interests in Transaction, Arrangements or Contracts
No transaction, arrangement or contract of significance to which the Company, or any of its holding
company, subsidiaries or fellow subsidiaries was a party, and in which a director of the company had a
material interest, subsisted at the end of the year or at any time during the year.
Model Code for Securities Transactions
The Company has adopted the Model Code for Securities Transactions by Directors of Listed Issuers
(the “Model Code”) as set out in Appendix C3 of the Listing Rules as its own code of conduct for
securities transactions by directors. Having made specific enquiry of the Company’s directors, all
directors have confirmed their compliance with all the relevant requirements as set out in the Model
Code during the period ended 30 June 2026.
Independence of Independent Non-executive Directors
The Company has received from each independent non-executive director an annual confirmation for
independence pursuant to Rule 3.13 of the Listing Rules. The independent non-executive directors have
confirmed that they are independent.
Code of Corporate Governance Practices
The Company has complied with all of the code provisions of the Corporate Governance Code and
Corporate Governance Report (the “CG Code”) as set out in Appendix C1 of the Listing Rules during
the six months ended 30 June 2026.
Audit Committee
The Company has established the audit committee for the purpose of monitoring the integrity of the
financial statements and overseeing the financial reporting process and the internal control system of the
Group. Currently, the audit committee is chaired by independent non-executive director Ms. So Tosi
Wan, Winnie and other members include the three independent non-executive directors Mr. Hu Yebi,
Dr. Pei Geng and Dr. Xing Li Na. Ms. So Tosi Wan, Winnie, has appropriate professional qualifications
as required by Rules 3.10(2) and 3.21 of the Listing Rules.
The Group’s condensed interim financial statements for the period ended 30 June 2026 are unaudited but
have been reviewed by the audit committee.
— 48 —
Remuneration Committee
The Company has established the remuneration committee to consider the remuneration of all directors
and senior management of the Company. Currently, the remuneration committee is chaired by
independent non-executive Director Ms. So Tosi Wan, Winnie and other members including the
executive Director Dr. Tang Weikun, Ms. Lam Chit Yee Jessica and independent non-executive Director
Mr. Hu Yebi.
Nomination Committee
The Company has established the nomination committee to assist the Board in the overall management
of the director nomination systems of the Company. Currently, the nomination committee is chaired by
independent non-executive Director Ms. So Tosi Wan, Winnie and other members including the
executive Director Mr. Zhou Chao and independent non-executive Director Mr. Hu Yebi.
By order of the Board
Grand Pharmaceutical Group Limited
Chairman
Dr. Tang Weikun
Hong Kong, 26 August 2026
As at the date of this announcement, the Board comprises four executive directors, namely, Dr. Tang
Weikun, Mr. Zhou Chao, Mr. Yang Guang and Ms. Lam Chit Yee Jessica, and four independent nonexecutive directors, namely, Ms. So Tosi Wan, Winnie, Dr. Xing Li Na, Dr. Pei Geng and Mr. Hu Yebi.
*
For identification purpose only
— 49 —
INTERIM RESULTS
The board (the “Board”) of directors (the “Directors”) of Grand Pharmaceutical Group Limited (the
“Company”) is pleased to announce the unaudited consolidated interim results for the six months ended
30 June 2026 of the Company and its subsidiaries (collectively the “Group”), together with comparative
figures for the previous period.
CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME
For the Six Months Ended 30 June 2026
Note
4
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
6,388,913
(3,021,240)
6,189,196
(2,536,157)
Gross profit
Other gains and losses, net
Distribution costs
Administrative expenses
Changes in fair value of financial assets at fair value through
profit or loss
Share of results of associates
Finance costs
3,367,673
44,914
(1,582,343)
(668,097)
3,653,039
205,405
(1,919,443)
(705,473)
114,376
58,314
(76,756)
174,593
57,944
(81,995)
Profit before tax
Income tax expense
5
1,258,081
(189,475)
1,384,070
(180,769)
Profit for the period
6
1,068,606
1,203,301
Revenue
Cost of sales
— 50 —
Note
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Other comprehensive income/(loss), net of income tax
Items that will not be reclassified subsequently to profit or loss:
Changes in fair value of equity investments recognised in
other comprehensive income at fair value
Share of other comprehensive loss of associates
(31,875)
(34,353)
24,155
(29,212)
Items that may be reclassified subsequently to profit or loss:
Exchange difference on translation of foreign operations
350,507
423,642
Other comprehensive income for the period,
net of income tax
284,279
418,585
Total comprehensive income for the period,
net of income tax
1,352,885
1,621,886
Profit for the period attributable to:
– Owners of the Company
– Non-controlling interests
1,061,538
7,068
1,193,167
10,134
1,068,606
1,203,301
1,352,196
689
1,615,402
6,484
1,352,885
1,621,886
Total comprehensive profit for the period attributable to:
– Owners of the Company
– Non-controlling interests
Dividend
7
–
–
Earnings per share
– Basic and diluted (HK cents)
8
30.31
34.07
— 51 —
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
As at 30 June 2026
Note
Non-current assets
Property, plant and equipment
Right-of-use assets
Investment properties
Interests in associates
Equity instruments at fair value through other
comprehensive income
Goodwill
Intangible assets
Deferred tax assets
Prepayments
Current assets
Inventories
Trade and other receivables
Amounts due from related companies
Financial assets at fair value through profit
or loss
Pledged bank deposits
Cash and cash equivalents
Current liabilities
Trade and other payables
Contract liabilities
Bank and other borrowings
Lease liabilities
Amounts due to related companies
Amounts due to immediate holding company
Income tax payable
9
9
10
10
— 52 —
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
1 January
2025
HK$’000
(Unaudited)
(Restated)
4,567,707
504,875
183,832
7,916,349
4,407,175
500,955
176,694
7,604,716
3,864,305
490,340
174,356
7,791,030
178,733
1,801,648
3,323,751
110,508
1,328,248
209,656
1,731,688
3,270,771
70,639
1,028,713
247,724
1,352,345
2,089,911
33,463
1,073,670
19,915,651
19,001,007
17,117,144
1,479,251
5,397,239
48,814
1,517,638
4,732,590
52,775
1,434,231
3,519,769
51,534
602,504
43,632
623,081
924,169
22,588
1,182,397
1,799,961
–
1,351,086
8,194,521
8,432,157
8,156,581
4,002,710
200,406
1,666,244
11,708
4,671
2,331
220,710
4,003,962
337,802
2,893,036
14,841
46,496
2,331
198,018
3,046,160
242,719
3,216,102
20,422
13,151
2,331
243,978
6,108,780
7,496,486
6,784,863
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
1 January
2025
HK$’000
(Unaudited)
(Restated)
Net current assets
2,085,741
935,671
1,371,718
Total assets less current liabilities
22,001,392
19,936,678
18,488,862
Non-current liabilities
Bank and other borrowings
Lease liabilities
Deferred tax liabilities
Other payables
Deferred income
3,331,121
42,036
366,622
569,068
333,186
1,840,763
40,277
367,265
224,671
321,149
1,256,280
40,604
300,351
–
299,843
4,642,033
2,794,125
1,897,078
Net assets
17,359,359
17,142,553
16,591,784
Share capital and reserves attributable to
owners of the Company
Share capital
Reserves
35,496
17,223,941
35,496
16,953,391
35,496
16,493,123
Equity attributable to owners of the
Company
Non-controlling interests
17,259,437
99,922
16,988,887
153,666
16,528,619
63,165
Total equity
17,359,359
17,142,553
16,591,784
Note
10
— 53 —
Notes:
1.
BASIS OF PREPARATION
This condensed consolidated interim financial report has been prepared in accordance with Hong Kong
Accounting Standard 34 (“HKAS 34”) “Interim Financial Reporting” issued by the Hong Kong Institute
of Certified Public Accountants (the “HKICPA”) and the applicable disclosure requirements of the Rules
Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the “Listing Rules”).
This condensed consolidated interim financial report contains consolidated financial results and selected
explanatory notes. The notes include an explanation of events and transactions that are significant to an
understanding of the changes in financial position and performance of the Group since the 2025 annual
financial statements. Upon approval of the condensed consolidated financial statements, the directors of the
Company have a reasonable expectation that the Group has adequate resources to continue in operational
existence for the foreseeable future. Accordingly, they continue to adopt the going concern basis of
accounting in preparing the condensed consolidated financial statements.
The financial information relating to the financial year ended 31 December 2025 included in this
consolidated interim financial report as being previously reported information does not constitute the
Company’s statutory financial statements for that financial year but is derived from those financial
statements. Statutory financial statements for the year ended 31 December 2025 are available from the
Company’s registered office. The auditor has expressed an unqualified opinion on those financial statements
in their report dated 26 March 2026.
2.
MERGER ACCOUNTING FOR BUSINESS COMBINATION INVOLVING ENTITIES UNDER
COMMON CONTROL
On 31 December 2025, the Company, as the purchaser, entered into an agreement with China Grand and
Wuhan Jiuxiang Biotechnology Partnership (Limited Partnership) in relation to the acquisition of the entire
100% equity interests in Hebei Jiufu and Baoding Jiahe, for a total consideration of RMB316 million. Hebei
Jiufu and its subsidiaries are principally engaged in the production and sales of amino acid products, while
Baoding Jiahe is principally engaged in the processing, manufacturing and sales of mercaptan products.
At the time of the acquisition, China Grand was the controlling shareholder of Hebei Jiufu and Baoding
Jiahe, holding 81.3217% equity interest in Hebei Jiufu and 81.3217% equity interest in Baoding Jiahe. In
respect of the acquisition, since China Grand is also the controlling shareholder of the Company, indirectly
holding approximately 53.42% of the total issued share capital of the Company, the acquisition is regarded
as a business combination involving entities under common control and is accounted for using the principles
of merger accounting.
Accordingly, the comparative condensed consolidated statement of profit or loss and other comprehensive
income for the six months ended 30 June 2025, and the condensed consolidated statement of financial
position as at 31 December 2025 and 1 January 2025 have been restated to include the assets and liabilities,
profits and cash flows of the combined entities from the date when they first came under common control.
The application of merger accounting for the Acquisition resulted in an increase in total comprehensive
income attributable to owners of the Company and profit attributable to owners of the Company for the six
months ended 30 June 2025 by HKD26.18 million and HKD24.15 million, respectively.
— 54 —
The effects of the merger accounting restatement on each item in the condensed consolidated statement of
profit or loss and other comprehensive income for the six months ended 30 June 2025 are as follows:
For the six
months ended
30 June
2025
HK$’000
(Unaudited)
(As originally
presented)
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
For the six
months ended
30 June
2025
HK$’000
(Unaudited)
(Restated)
Revenue
Cost of sales
6,107,323
(2,507,159)
81,873
(28,998)
6,189,196
(2,536,157)
Gross profit
Other income and losses, net
Distribution costs
Administrative expenses
Fair value change on financial assets at fair value
through profit or loss
Share of results of associates
Finance costs
3,600,164
203,578
(1,916,285)
(691,751)
52,875
1,827
(3,158)
(13,722)
3,653,039
205,405
(1,919,443)
(705,473)
174,593
57,944
(80,350)
–
–
(1,645)
174,593
57,944
(81,995)
Profit before tax
Income tax expense
1,347,893
(174,023)
36,177
(6,746)
1,384,070
(180,769)
Profit for the period
1,173,870
29,431
1,203,301
Other comprehensive income/(loss), net of income
tax
Items that will not be reclassified to profit or loss:
Changes in fair value of equity investments recognised
in other comprehensive income at fair value
Share of other comprehensive income associates
Item that may be reclassified subsequently to profit or
loss:
Exchange difference on translating foreign operations
24,155
(29,212)
–
–
24,155
(29,212)
421,201
2,441
423,642
Other comprehensive income for the period, net of
income tax
416,144
2,441
418,585
Total comprehensive income for the period, net of
income tax
1,590,014
31,872
1,621,886
Profit for the period attributable to:
-Owners of the Company
-Non-controlling interests
1,169,019
4,851
24,148
5,283
1,193,167
10,134
1,173,870
29,431
1,203,301
1,589,226
788
26,176
5,696
1,615,402
6,484
1,590,014
31,872
1,621,886
0.69
34.07
Total comprehensive profit for the period
attributable to:
-Owners of the Company
-Non-controlling interests
Dividends
–
Earnings per share
-Basic and diluted (HK cents)
33.38
— 55 —
The effects of the merger accounting restatement in respect of the above acquisition on each item in the
condensed consolidated statement of financial position as at 31 December 2025 are as follows:
As at
31 December
2025
HK$’000
(Unaudited)
(As originally
presented)
Non-current assets
Property, plant and equipment
Right-of-use assets
Investment properties
Interests in associates
Equity instruments at fair value through other
comprehensive income
Goodwill
Intangible assets
Deferred tax assets
Prepayments
Current assets
Inventories
Trade and other receivables
Amounts due from related companies
Financial assets at fair value through profit or loss
Pledged bank deposits
Cash and cash equivalents
Current liabilities
Trade and other payables
Contract liabilities
Bank and other borrowings
Lease liabilities
Amounts due to related companies
Amount due to the immediate holding company
Income tax payable
Net current assets
Total assets less current liabilities
— 56 —
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
As at
31 December
2025
HK$’000
(Unaudited)
(Restated)
4,332,283
492,214
176,694
7,604,716
74,892
8,741
–
–
4,407,175
500,955
176,694
7,604,716
209,656
1,676,875
3,269,431
70,632
1,026,776
–
54,813
1,340
7
1,937
209,656
1,731,688
3,270,771
70,639
1,028,713
18,859,277
141,730
19,001,007
1,484,191
4,679,486
54,723
924,169
22,588
1,142,370
33,447
53,104
(1,948)
–
–
40,027
1,517,638
4,732,590
52,775
924,169
22,588
1,182,397
8,307,527
124,630
8,432,157
3,936,683
323,926
2,828,720
12,646
16,778
2,331
195,627
67,279
13,876
64,316
2,195
29,718
–
2,391
4,003,962
337,802
2,893,036
14,841
46,496
2,331
198,018
7,316,711
179,775
7,496,486
990,816
(55,145)
935,671
19,850,093
86,585
19,936,678
As at
31 December
2025
HK$’000
(Unaudited)
(As originally
presented)
Non-current liabilities
Bank and other borrowings
Lease liabilities
Deferred tax liabilities
Other payables
Deferred income
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
As at
31 December
2025
HK$’000
(Unaudited)
(Restated)
1,840,763
40,277
367,265
105,798
316,305
–
–
–
118,873
4,844
1,840,763
40,277
367,265
224,671
321,149
2,670,408
123,717
2,794,125
Net assets
17,179,685
(37,132)
17,142,553
Capital and reserves attributable to owners of
the Company
Share capital
Reserves
35,496
16,981,543
–
(28,152)
35,496
16,953,391
Equity attributable to owners of the Company
Non-controlling interests
17,017,039
162,646
(28,152)
(8,980)
16,988,887
153,666
Total equity
17,179,685
(37,132)
17,142,553
— 57 —
The effects of the merger accounting restatement in respect of the above acquisition on each item in the
condensed consolidated statement of financial position as at 1 January 2025 are as follows:
As at
1 January
2025
HK$’000
(Unaudited)
(As originally
presented)
Non-current assets
Property, plant and equipment
Right-of-use assets
Investment properties
Interests in associates
Equity instruments at fair value through other
comprehensive income
Goodwill
Intangible assets
Deferred tax assets
Prepayments
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
As at
1 January
2025
HK$’000
(Unaudited)
(Restated)
3,784,285
481,783
174,356
7,791,030
80,020
8,557
–
–
3,864,305
490,340
174,356
7,791,030
247,724
1,299,741
2,082,728
33,456
1,070,540
–
52,604
7,183
7
3,130
247,724
1,352,345
2,089,911
33,463
1,073,670
16,965,643
151,501
17,117,144
1,370,582
3,454,589
59,411
1,799,961
1,340,979
63,649
65,180
(7,877)
–
10,107
1,434,231
3,519,769
51,534
1,799,961
1,351,086
8,025,522
131,059
8,156,581
2,928,087
242,719
3,127,347
18,315
13,151
2,331
241,273
118,073
–
88,755
2,107
–
–
2,705
3,046,160
242,719
3,216,102
20,422
13,151
2,331
243,978
6,573,223
211,640
6,784,863
Net current assets
1,452,299
(80,581)
1,371,718
Total assets less current liabilities
18,417,942
70,920
18,488,862
Current assets
Inventories
Trade and other receivables
Amounts due from related companies
Financial assets at fair value through profit or loss
Cash and cash equivalents
Current liabilities
Trade and other payables
Contract liabilities
Bank and other borrowings
Lease liabilities
Amounts due to related companies
Amount due to the immediate holding company
Income tax payable
— 58 —
As at
1 January
2025
HK$’000
(Unaudited)
(As originally
presented)
Non-current liabilities
Bank and other borrowings
Lease liabilities
Deferred tax liabilities
Deferred income
Merger
accounting
restatement as
a result of
the acquisition
HK$’000
As at
1 January
2025
HK$’000
(Unaudited)
(Restated)
1,256,280
40,604
300,351
295,369
–
–
–
4,474
1,256,280
40,604
300,351
299,843
1,892,604
4,474
1,897,078
Net assets
16,525,338
66,446
16,591,784
Capital and reserves attributable to owners of
the Company
Share capital
Reserves
35,496
16,437,714
–
55,409
35,496
16,493,123
Equity attributable to owners of the Company
Non-controlling interests
16,473,210
52,128
55,409
11,037
16,528,619
63,165
Total equity
16,525,338
66,446
16,591,784
— 59 —
3.
CHANGES IN ACCOUNTING POLICIES
This condensed consolidated financial report has been prepared on the historical cost basis, except for
certain financial instruments that are measured at fair value, where applicable.
Except for other accounting policies/changes in accounting policies resulting from the application of
amendments to HKFRS Accounting Standards, the accounting policies and methods of computation used in
the condensed consolidated financial statements for the six months ended 30 June 2026 are consistent with
those presented in the Group’s annual consolidated financial statements for the year ended 31 December
2025.
Application of amendments to HKFRS Accounting Standards
In the current interim period, the Group has applied the following amendments to HKFRS Accounting
Standards issued by the HKICPA for the first time, which are mandatorily effective for the annual periods
beginning on or after 1 January 2026 for the preparation of the Group’s condensed consolidated financial
statements:
Amendments to HKFRS 9 and HKFRS 7
Amendments to HKFRS 9 and HKFRS 7
Amendments to HKFRS Accounting
Standards
Classification and Measurement of Financial Instruments
Contracts Referencing Nature-dependent Electricity
Annual Improvements to HKFRS Accounting Standards –
Volume 11
The application of the amendments to HKFRS Accounting Standards in the current period has had no
material impact on the Group’s financial positions and performance for the current and prior periods and/or
on the disclosures set out in these condensed consolidated financial statements.
4.
REVENUE AND SEGMENT INFORMATION
For the six months ended 30 June 2026, the Group’s operations consistently constitute only one single
reportable segment, namely the manufacture and sales of pharmaceutical technology products,
biotechnology products and nuclear medicine anti-tumor diagnosis and treatment and cerebro-cardiovascular
precision interventional diagnosis and treatment technology products. The Board, being the chief operating
decision maker of the Group, reviews the operating results of the Group as a whole to make decisions about
resource allocation. The operation of the Group constitutes one single reportable segment under HKFRS 8
and accordingly, no separate segment information is prepared.
The Group’s revenue represents the invoiced value of goods sold, net of discounts and sales related taxes.
— 60 —
Geographical information
The Group’s operations are mainly located in the People’s Republic of China (the “PRC”) (country of
domicile) and it also derives revenue from America, Europe and Asia.
Information about the Group’s revenue from external customers is presented based on geographical location
of the customers and information about the Group’s non-current assets is presented based on geographical
location of the assets are detailed below:
Revenue from external customers
Six months ended 30 June
Non-current assets
30 June
31 December
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
2026
HK$’000
(Unaudited)
2025
HK$’000
(Unaudited)
(Restated)
The PRC
Americas
Europe
Asia, other than the PRC
Others
5,295,014
565,770
242,358
253,941
31,830
5,370,813
373,186
229,197
184,721
31,279
13,759,994
250,827
–
106,922
–
13,079,416
261,327
–
103,689
–
Total
6,388,913
6,189,196
14,117,743
13,444,432
Note:
Non-current assets excluded equity instruments at fair value through other income, deferred tax
assets and a part of interests in associates.
Information about major customers
For the six months ended 30 June 2026 and 2025, none of the Group’s revenue from a single customer
amounted to 10% or more of the Group’s total revenue.
— 61 —
Revenue
Revenue from contracts with customers
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Type of goods and services
Manufacture and sales of pharmaceutical technology products
Sales of biotechnology products
Sales of nuclear medicine anti-tumor diagnosis and treatment and
cerebro-cardiovascular precision interventional diagnosis and
treatment technology products
3,274,083
2,369,701
3,845,193
1,766,260
745,129
577,743
Revenue recognised at point in time
6,388,913
6,189,196
Revenue disclosed in segment information
External customers
6,388,913
6,189,196
Timing of revenue recognition
At a point in time
6,388,913
6,189,196
All of the Group’s revenue are recognised at point in time upon arrival of carrier designated by the
customers, or after the customer’s acceptance or upon transfer of control of the goods to customer. All
revenue contracts are for period of one year or less, as permitted by practical expedient under HKFRS 15,
the transaction price allocated to these unsatisfied contacts is not disclosed.
5.
INCOME TAX EXPENSES
Taxation in the condensed consolidated statement of profit or loss and other comprehensive income
represents:
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Current tax
Deferred tax
— 62 —
245,202
(55,727)
189,434
(8,665)
189,475
180,769
Under the two-tiered profits tax rates regime, the first HK$2,000,000 of assessable profits of the qualifying
group entity will be taxed at 8.25% and assessable profits above HK$2,000,000 wIll be taxed at 16.5%. The
assessable profits of group entity not qualifying for the two-tiered profits tax rates regime will continue to
be taxed at a flat rate of 16.5%.
Under the Law of the People’s Republic of China on Enterprise Income Tax (the “EIT Law”) and
Implementation Regulation of the EIT Law, the tax rate of the PRC subsidiaries is 25% from 1 January
2008 onwards.
According to the relevant PRC tax regulations, High-New Technology Enterprise (the “HNTE”) being
assessed by relevant government authorities are entitled to a reduced Enterprise Income Tax (the “EIT”)
rate of 15%. Certain subsidiaries are recognised as HNTE and accordingly, are subject to EIT at 15%. The
recognition as a HNTE is subject to review on every three years by the relevant government bodies.
6.
PROFIT FOR THE PERIOD
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Profit for the year is stated after charging:
Staff costs comprises:
– Wages and salaries
– Retirement benefits schemes contributions
1,084,957
92,334
1,095,557
89,955
1,177,291
1,185,512
Depreciation of property, plant and equipment
Depreciation of right-of-use assets
Amortisation of intangible assets
194,336
16,603
138,556
185,847
24,875
84,278
Total depreciation and amortisation
349,495
295,000
3,011,784
2,487
263,179
2,536,157
3,574
280,611
Cost of inventories recognised as an expense
Operating leases rentals in respect of land and buildings
Research and development costs
7.
INTERIM DIVIDEND
During the six months ended 30 June 2026, the Board declared and paid HK$0.169 per share or
approximately HK$591.81 million in aggregate as final dividend for the year ended 31 December 2025
(2025: HK$0.26 per share or approximately HK$910.471 million in aggregate).
No interim dividend has been paid or declared by the Company for the six months ended 30 June 2026 (six
months ended 30 June 2025: Nil).
— 63 —
8.
EARNINGS PER SHARE
Basic earnings per share is calculated by dividing the profit attributable to equity owners of the Company
by the weighted average number of ordinary shares outstanding during the period, excluding ordinary shares
purchased by the Group and held as treasury shares.
Six months ended 30 June
2026
2025
HK$’000
HK$’000
(Unaudited)
(Unaudited)
(Restated)
Earnings:
Earnings for the purpose of basic earnings per share calculation
Number of shares:
Weighted average number of ordinary shares for the purpose of basic
earnings per share calculation (Note)
1,061,538
1,193,167
’000
(Unaudited)
’000
(Unaudited)
(Restated)
3,501,810
3,501,810
Note:
As at 30 June 2026 and 30 June 2025, treasury shares are deducted from total shares in issue for the
purpose of calculating earnings per share.
Diluted earnings per share is the same as the basic earnings per share for the six months ended 30 June
2026 and 2025 as there were no potential dilutive ordinary shares in issue.
9.
TRADE AND OTHER RECEIVABLES
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
Trade receivables, net
Bills receivables
Deposits and prepayments
Other tax receivables
Other receivables, net
3,919,472
505,508
2,041,189
160,090
99,228
1,798,997
1,727,468
1,869,788
167,440
197,610
Less: non-current portion of prepayments
6,725,487
(1,328,248)
5,761,303
(1,028,713)
5,397,239
4,732,590
— 64 —
The Group generally allows a credit period of 30 – 180 days to its trade customers. The Group does not
hold any collaterals over the trade and other receivables. The following is an aged analysis of trade
receivables presented based on the invoice date at the reporting date. The bills receivables were all with
maturity within 180 days from the reporting date.
The ageing analysis of the trade receivables is as follows:
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
2,375,923
802,277
741,272
1,413,503
247,698
137,796
3,919,472
1,798,997
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
Trade payables
Bills payables
Accruals and other payables
Other tax payables
1,191,717
791,297
2,412,858
175,906
903,878
968,855
2,227,621
128,279
Less: non-current portion of other payables
4,571,778
(569,068)
4,228,633
(224,671)
4,002,710
4,003,962
200,406
337,802
Within 90 days
91-180 days
181-365 days
10.
TRADE AND OTHER PAYABLES
Contract liabilities (note (a))
— 65 —
Notes:
(a)
Contract liabilities in relation to sales of finished goods are expected to be settled within one year.
The following is an aged analysis of trade payables presented based on the invoice date at the end of the
reporting period:
Within 90 days
Over 90 days
11.
30 June
2026
HK$’000
(Unaudited)
31 December
2025
HK$’000
(Unaudited)
(Restated)
479,298
712,419
506,493
397,385
1,191,717
903,878
CONTINGENT LIABILITIES
The Group has no significant contingent liabilities as at 30 June 2026 (31 December 2025: Nil).
— 66 —
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其
準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而
產生或因倚賴該等內容而引致的任何損失承擔任何責任。
GRAND PHARMACEUTICAL GROUP LIMITED
遠 大 醫 藥 集 團 有 限 公 司*
(於百慕達註冊成立之有限公司)
(股份代號: 00512)
二零二六年中期業績公佈
財務摘要
-
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 集 團 的 業 務 穩 健 增 長,收 益 約 港 幣
6,388,910,000元(去 年 同 期 重 述1:港幣6,189,200,000元),同 比 上 漲 約3.2%。創新和
壁壘產品2收益佔總收益的比例約50%。
-
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 公 司 擁 有 人 應 佔 期 內 溢 利 約 為 港 幣
1,061,540,000元(去 年 同 期 重 述:港 幣1,193,170,000元)。期 內,本 集 團 對Telix投 資
的 公 允 價 值 變 動 和 處 置 合 計 收 益 約 港 幣88,780,000元(去 年 同 期 收 益:港 幣
151,720,000元),與去年同期相比減少了港幣62,940,000元,如果撇除Telix投資對利
潤的影響,本期的本公司擁有人應佔經調整的經營性純利3約為港幣972,760,000元(去
年同期重述:港幣1,041,440,000元)。
-
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 集 團 核 藥 抗 腫 瘤 板 塊 錄 得 收 益 約 港 幣
655,240,000元,較 二 零 二 五 年 同 期(約 港 幣421,780,000元)比 較 上 漲 約55.4%,其 上
漲主要因為核心產品的臨床需求快速增長以及新產品快速放量所帶來的收入增長。
—1—
-
本集團堅定落實創新驅動和Go Global戰略,優化研發資源配置,聚焦核藥抗腫瘤、
重症抗感染等高壁壘賽道,同時佈局mRNA創新葯、眼科創新葯等前沿領域,依托
全鏈條研發平台打造短中長期階梯式創新管線,研發轉化效率持續改善。本集團全
球 化 臨 床 及「中 美 雙 報」註 冊 體 系 成 熟,多 款 產 品 獲 國 際 藥 監 機 構 臨 床 許 可;核 心
產品臨床成果登上國際頂級期刊,相繼納入國內外權威診療指南,有力支撐商業化
進 程。本 集 團 現 擁 有30餘 項 高 價 值 在 研 創 新 項 目,2027-2028年 迎 來 研 發 里 程 碑 集
中兌現,充足的管線儲備將為長期發展帶來增長動能。
附註:
1.
於二零二六年上半年,本公司成功收購河北遠大九孚生物科技有限公司(「河北九孚」)和保定加合精
細化工有限公司(「保定加合」)100%股權。於收購時點,中國遠大集團有限責任公司(「中國遠大」)為
河北九孚和保定加合的控股股東,且同時為本公司的控股股東,故此收購事項被視為涉及受共同控
制實體之業務合併,並採用合併會計法原則入賬。因此,截至二零二五年六月三十日止六個月之比
較簡明綜合損益及其他全面收益表以及於二零二五年十二月三十一日及二零二五年一月一日之簡明
綜合財務狀況表已重列,藉此納入合併實體自其首次受共同控制之日起計之資產及負債、溢利以及
現金流量。具體請參見簡明綜合財務報表附註2。
2.
創新和壁壘產品指公司原研產品、獨家市場地位產品、擁有獨家商業化權益的產品以及打破外資壟
斷的首仿產品。
3.
本公司擁有人應佔經調整的經營性純利界定為本公司擁有人應佔期內溢利但不包括Telix投資的公允
價值變動和處置收益的影響。
—2—
管理層討論及分析
企業定位
本集團是一家科技創新型國際化醫藥企業,核心業務橫跨核藥抗腫瘤診療及心腦血管精
準介入診療科技、製藥科技、生物科技三大領域。本集團以醫藥及生物工業為基礎,以患
者 需 求 為 核 心,以 科 技 創 新 為 源 動 力,針 對 尚 未 滿 足 的 臨 床 需 求,加 大 對 全 球 創 新 產 品
和 先 進 技 術 的 投 入,豐 富 和 完 善 產 品 管 線,鞏 固 和 強 化 產 業 鏈 佈 局,充 分 發 揮 本 集 團 的
產業優勢和研發實力,為全球患者提供更先進更多樣的治療方案。
經過近年的不懈努力,本集團發展基礎更加穩健,經營規模更加鞏固,業務結構逐步優化,
經營方式持續提升,轉型升級步伐加快,創新佈局多點開花。本集團盈利能力持續增強,
助力研發創新;良好的併購與整合能力,繼續鞏固發展規模;原料製劑一體化,完善產業
鏈結構;業務與實體多元化,有效加強綜合優勢。
「穩 增 長、強 創 新、謀 佈 局」,本 集 團 將 繼 續 秉 承「綜 合 優 勢、創 新 引 領 和 全 球 拓 展」的 發
展理念,採用「自主研發和全球拓展雙輪驅動,全球化運營佈局和雙循環經營發展」策略,
形成國內國外雙循環聯動發展並相互促進的新格局,致力於成為一家受醫生和患者尊重
並還原於社會的科技創新型國際化醫藥企業。
業務回顧及前景
於二零二六年至本公告日期止,本集團共有18項重要里程碑進展,其中創新產品8項,仿
製產品6項;原料藥產品3項;重要合作1項。同時,本集團易甘泰®釔[90Y]微球注射液、液
體栓塞劑LavaTM等創新和壁壘產品的持續快速放量以及生物科技板塊核心產品的量價齊升,
成功助力本集團業績的穩健增長。
—3—
創新產品
核藥抗腫瘤診療:
-
-
-
用 於 診 斷 前 列 腺 癌 的 全 球 創 新RDC產 品TLX591-CDx的 新 藥 上 市 申 請(NDA)獲 得 中
華人民共和國國家藥品監督管理局(「中國藥監局」)受理;
全 球 創 新 放 射 性 產 品SIR-Spheres ®釔[90Y]微 球 注 射 液 在 美 國 開 展 的 治 療 原 發 性 肝 細
胞癌(HCC)臨床研究達到了臨床終點;
用於診斷實體瘤的全球創新放射性核素偶聯藥物(「RDC」)GPN01530-2獲得美國食品
藥品監督管理局(「FDA」)授予的快速通道資格(Fast Track Designation,「FTD」)。
心腦血管精準介入診療:
-
用於腔內影像診斷的創新器械GPG04862獲中國藥監局批准上市。
呼吸及危重症:
-
用於抗感染的化藥1類創新藥物GPN01411獲得中國藥監局批准開展I期臨床研究;
五官科:
-
-
-
用於治療蠕形蟎瞼緣炎的全球創新眼科藥物TP-03獲得中國藥監局批准上市;
治療抑鬱症的中藥1.1類創新藥GPN01360在中國開展的III期臨床研究完成首例患者入
組給藥;
用於預防性治療偏頭痛的中藥1.1類創新藥GPN01020獲中國藥監局批准在中國開展II
期臨床研究。
仿製產品
有6款產品獲得中國藥監局批准上市。
原料產品
有3款原料藥產品獲得中國藥監局批准上市。
—4—
重要合作
本集團與香港大學及其全資子公司港大科橋有限公司(「港大科橋」)達成戰略合作。雙方
將 於 學 術 研 究、資 源 分 享、人 才 培 養 以 及 產 品 開 發 等 方 面 展 開 深 度 合 作,合 力 推 進 抗 感
染領域的創新藥物研發與成果產業化落地。
業務介紹
本集團科技創新實力強勁、國際化實力突出、工業基礎雄厚,產業鏈完整,原料製劑一體
化綜合優勢顯著。本集團有超過130款產品列入「國家基本藥物目錄」
(2026年版),有超過
260款產品入選「國家基本醫療保險、工傷保險和生育保險藥品目錄(2025年版)」。
核藥抗腫瘤診療及心腦血管精準介入診療科技
本集團充分發揮「精準和穩健的海內外業務拓展能力,國際領先技術的引進消化落地能力
和優秀的市場推廣銷售能力」,瞄準科技創新前沿領域,重點佈局「核藥抗腫瘤診療」以及
「心腦血管精準介入診療」板塊,已成為中國核藥抗腫瘤診療的龍頭企業和具備國際前沿
技術的全方位心腦血管精準介入診療科技平台。
核藥抗腫瘤診療板塊
本集團在核藥抗腫瘤診療板塊已實現了研發、生產、配送、銷售等多個環節的全方位佈局,
板塊全球員工超過1200人,以波士頓、成都為核心的研發基地,波士頓、法蘭克福、新加
坡、成 都 所 在 的 生 產 基 地 以 及 覆 蓋 全 球50多 個 國 家 和 地 區 的 銷 售 網 絡 為 基 礎,本 集 團 已
實現了全球化的核藥產業鏈佈局。
—5—
作為本集團核藥全球化產業佈局的國內核心研發及生產載體,位於成都的遠大醫藥放射
性藥物研發及生產基地於二零二五年四月竣工驗收,同年五月獲得國家生態環境部頒發
的甲級《輻射安全許可證》,並於六月底正式投入運營。該基地為全球首個核藥全產業鏈
閉環平台,覆蓋「同位素製備-核藥研發-生產-臨床-商業化」全鏈條,形成從早期研發
到臨床轉化到上市銷售的全生命周期管理能力,研發效率國際領先;解決了核藥「卡脖子」
難 題,100%自主 生 產 破 解 進 口 依 賴 困 局,14條 高 標 準GMP生 產 線 實 現 多 品 種、規模化製
備 需 求;建 立 全 流 程 智 能 管 理 體 系,核 電 級 安 全 與 無 人 化 智 造,可 實 現 輻 射「零 泄 漏」,
污染「零外排」,職業照射「零超標」,達到全球頂尖核設施標準;建立世界一流研發生產
質 量 與 運 營 體 系,是 目 前 國 際 範 圍 內 核 素 種 類 最 全、自 動 化 程 度 最 高 的 智 能 工 廠 之 一。
該研發及生產基地將進一步夯實本集團核藥產業的基礎,加速全球創新研發管線的落地,
推 動 本 集 團 實 現 核 藥 產 業 的 高 質 量 發 展,培 育 高 價 值 重 磅 品 種,為 本 集 團 放 射 性 藥 物 的
國產化落地奠定堅實的基礎。
本集團聯合Sirtex並與Telix Pharmaceutical Limited(「Telix」)和ITM Isotope Technologies
Munich SE(「ITM」)合作,搭建了具有國際化一流水平的腫瘤介入技術平台和RDC技術平
台。圍 繞 腫 瘤 診 療 一 體 化 的 治 療 理 念,目 前 在 研 發 註 冊 階 段 已 儲 備14款 創 新 產 品,涵 蓋
68
Ga、177Lu、131I、90Y、89Zr在 內 的5種 放 射 性 核 素,覆 蓋 了 肝 癌、前 列 腺 癌、腦 癌 等 在 內
的7個 癌 種;早 期 研 發 階 段 以RDC藥 物 為 主,產 品 儲 備10餘 款。在 產 品 種 類 方 面,涵 蓋 診
斷 和 治 療 兩 類 核 素 藥 物,為 患 者 提 供 多 適 應 症 治 療 選 擇、多 手 段 且 診 療 一 體 化 的 全 球 領
先的抗腫瘤方案。
板 塊 內 創 新 產 品 全 球 研 發 工 作 順 利 推 進。中 國 方 面,易 甘 泰®釔[90Y]微 球 注 射 液 於 二 零
二二年一月順利上市,用於治療結直腸癌肝轉移(「mCRC」),並於二零二五年五月獲得
中國藥監局批准開展治療不可切除肝細胞癌(「HCC」)的II期註冊性臨床試驗;全球創新
溫度敏感性栓塞劑GPN00289於二零二五年十月完成了註冊性臨床研究的全部患者入組。
海外註冊方面,SIR-Spheres ®釔[90Y]微球注射液在美國提前正式獲批新適應證,用於治療
不可切除HCC;本集團自主研發的全球創新靶向FAP的小分子放射性核素偶聯藥物(「RDC」)
GPN01530-2在美國獲批開展用於診斷實體瘤的I/II期臨床研究並獲得FDA授予的快速通道
資格,該產品是本集團首款獲得FDA批准開展臨床研究的自研RDC產品,其臨床研究的成
功獲批為本集團核藥產品管線的國際化開發提供了重要範式,同時也充分體現了本集團
在 前 沿 核 藥 技 術 平 台 建 設、國 際 化 臨 床 開 發 與 註 冊 申 報 等 方 面 的 綜 合 實 力。截 止 到 目 前
為 止,本 集 團 在 全 球 範 圍 內 共 有 六 款 創 新RDC藥 物 獲 批 開 展 註 冊 性 臨 床 研 究,其 中 診 斷
前列腺癌的產品TLX591-CDx已進入NDA階段,三款進入III期臨床階段,包括治療前列腺
癌 的 產 品TLX591、診 斷 透 明 細 胞 腎 細 胞 癌 產 品TLX250-CDx以 及 治 療GEP-NETs的 產 品
ITM-11。未 來,本 集 團 將 持 續 加 強 核 藥 抗 腫 瘤 診 療 板 塊 的 研 發 和 建 設,豐 富 和 完 善 產 品
管線及產業佈局,形成以易甘泰 ®釔[90Y]微球注射液為核心的核藥抗腫瘤診療產品集群,
持續夯實本集團在全球核藥抗腫瘤診療領域領軍企業地位。
—6—
核心產品
全球創新產品易甘泰®釔[90Y]微球注射液:
本 集 團 重 磅 全 球 創 新 產 品 易 甘 泰®釔[90Y]微 球 注 射 液 於 二 零 二 二 年 一 月 獲 得 中 國 藥 監 局
的上市許可,批准用於經標準治療失敗的不可手術切除的mCRC患者的治療,於二零二五
年七月,基於DOORwaY90臨床試驗的突破性中期結果,FDA提前正式批准用於治療不可
切 除HCC的 新 增 適 應 症,於 二 零 二 六 年 四 月 完 成 全 部 臨 床 研 究 並 成 功 達 到 臨 床 終 點。易
甘 泰 ®釔[90Y]微 球 注 射 液 是 全 球 首 個 且 目 前 唯 一 獲FDA批 准 用 於 治 療 不 可 切 除HCC和
mCRC雙重適應症 的 選 擇 性 內 放 射 治 療「SIRT」產 品,在 全 球 共 有50多 個 國 家 和 地區超過
了15萬人次使用,並被巴賽羅那臨床肝癌指南(BCLC)、美國國立綜合癌症網絡(NCCN)、
歐洲腫瘤內科學會(ESMO)肝 細 胞 癌 診 斷、治 療 和 隨 訪 臨 床 實 踐 指 南(2025版)、歐 洲 肝
臟研究學會(European Association for the Study of the Liver,EASL)肝細胞癌指南(2025
版)、英國國家健康照護專業組織(National Institute for Health and Care Excellence,NICE)
等多個國際權威機構的治療指南推薦,並進入了《原發性肝癌診療指南(2026版)》、《CSCO
原發性肝癌診療指南(2024版)》、《結直腸癌肝轉移診斷和綜合治療指南(2025版)》、《中
國肝癌肝移植臨床實踐指南(2021版)》等多項中國權威的臨床實踐指南當中。
—7—
二零二二年五月,易甘泰®釔[90Y]微球注射液在中國正式投入應用,中國肝部惡性腫瘤治
療 邁 入 了 全 新 的「釔 時 代」。自 易 甘 泰®正 式 上 市 後,中 國 已 有 超 過110家 醫 院 完 成 了 核 素
轉 讓 手 續,正 式 手 術 已 在22個 省、直 轄 市 的70餘 家 醫 院 展 開。為 加 快 易 甘 泰®微 球 注 射 液
精 準 介 入 治 療 手 段 在 中 國 的 落 地 與 普 及,本 集 團 依 據 中 國 藥 監 局 及 美 國FDA批 准 的 術 者
督 導 培 訓 體 系,集 中 全 球 資 源 對 中 國 國 內 術 者 提 供 患 者 篩 選 知 識、手 術 操 作 技 巧、預 後
評估方法等全方位培訓,幫助醫生掌握和積累臨床經驗以保證產品更加廣泛安全有效的
應 用,通 過 海 外 知 名 臨 床 專 家 協 助 國 內 醫 師 進 行 了 多 次 特 性 化 的 實 操 培 訓。目 前,已 建
立9個 手 術、治 療 及 培 訓 中 心,並 對80家 醫 院 超 過1,200名 醫 生 進 行 了 易 甘 泰®手 術 理 論 或
技能培訓,已有超過340名醫師獲得易甘泰®手術醫師登記。其中161名醫師通過了國際和
國內著名專家一對一的嚴格培訓,獲取了獨立手術的操作資格,120名醫師具備助理手術
操作資質。另外有32位專家已經獲得培訓導師的資格,將進一步加快易甘泰 ®放射性介入
操作的臨床普及。
自上市以來,易甘泰®釔[90Y]微球注射液已進入北京普惠健康保、上海滬惠保、武漢福漢
康、重 慶 渝 快 保、南 京 甯 惠 保 等50多 個 惠 民 保 和1個 特 藥 險,覆 蓋 超 過30個 省 級 行 政 區,
100餘個城市,大大增加肝癌患者對該產品的可及性。
學術研究方面,中國大陸研究者發表了大量易甘泰®釔[90Y]微球注射液的高價值真實世界
數據:在美國臨床腫瘤學會胃腸道腫瘤(ASCO GI)研討會、美國臨床腫瘤學會(ASCO)年
會、歐洲腫瘤內科學會亞洲(ESMO Asia)年會、亞太原發性肝癌專家聯盟(APPLE)會議、
亞太肝膽胰協會(A-PHPBA)年會、亞洲腫瘤學會(AOS)年會、亞太肝病研究協會(APASL)
年會、國際肝膽胰協會(IHPBA)年會等國際頂級腫瘤及肝病領域學術會議上,累計發佈
海報展示100篇、口頭報告7篇。同時,相關研究成果持續登上國際權威期刊,其中高腫瘤
負荷患者對比肝動脈化療栓塞治療(Transcatheter Arterial Chemoembolization,TACE)的研
究發表於International Journal of Surgery;系統評估釔[90Y]樹脂微球在縮瘤及對側肝葉增
生方面雙重作用的回顧性研究發表於EJNMMI research,另有典型病例、綜述等數十篇成
果相繼見刊。上述研究覆蓋了肝癌全分期治療,針對早期患者,可開展放射性肝段消融術;
針 對 中 期 患 者,可 助 力 降 期 轉 化 至 肝 移 植 術╱肝 切 除 術,對 於10cm乃 至15cm的 巨 塊 肝 癌
展現出強效縮瘤效果;針對晚期患者,可聯合系統治療、TACE、肝動脈灌注化療(Hepatic
Artery Infusion Chemotherapy,HAIC)等治療方案,相較傳統治療為患者帶來更長生存獲
益,也 為 綜 合 治 療 經 治 的 患 者 提 供 了 通 向 治 愈 的 可 能。釔[90Y]樹 脂 微 球 治 療 的「中 國 方
案」,憑藉在國際頂級學術盛會與權威期刊的接連亮相和重磅成果展示,正日益獲得國際
學術界的廣泛關注與認可。
—8—
全球創新的液體栓塞劑LavaTM
Lava TM為 美 國 首 款 獲 批 用 於 治 療 外 周 血 管 動 脈 出 血 的 創 新 液 體 栓 塞 劑,該 產 品 具 有 不 透
射線屬性,成像過程中不易出現僞影,體現出更優的成像效果。Lava TM使用便捷,製備過
程只需2分鐘(同類產品製備過程約需要20分鐘),在緊急狀況下為醫生節省準備時間提高
患者生存概率;轉化後的固體栓塞提供兩種粘度選擇,針對不同情況的患者可靈活使用。
Lava TM可 以 與 放 射 性 同 位 素 的 近 距 離 放 射 療 法 和 介 入 療 法 產 生 協 同 作 用。該 產 品 已 於 二
零二三年四月在美國獲批上市並於同年十月正式實現商業化。
尿路上皮癌早檢產品橡鑫 • 優愛®
採用甲基化+基因突變雙靶點設計,根據超過1,000例的註冊性臨床研究的資料顯示,優愛
®
的 敏 感 性 達 到92.5%,特 異 性 達 到95.8%,臨 床 結 果 優 異,而 且 無 創,不 受 血 尿、結 石 等
外界因素干擾,有助於實現對尿路上皮癌患者的早發現、早診斷、早治療與早獲益。目前
該產品已經獲得了中國藥監局批准上市,並於二零二五年四月實現了首張商業化處方落地,
是 中 國 目 前 唯 一 獲 批 上 市 的 甲 基 化+基 因 突 變 雙 機 制 的 尿 路 上 皮 癌 早 檢 產 品,同 時 作 為
《CSCO尿路上皮癌診療指南(2025版)》、《膀胱癌早診早治專家共識(2024版)》、《中國癌
症篩查中心技術專家共識》等權威指南共識唯一推薦的產品,優愛®以「一管尿」,精準無
創的實現尿路上皮癌患者的早期診斷。
—9—
創新研發管線
核藥抗腫瘤診療板塊產品主要分為介入治療和RDC兩大類別。
介入治療:
全球創新溫度敏感性栓塞劑GPN00289:
GPN00289是一款獲得中國藥監局創新型醫療器械資質認定的溫度敏感性栓塞材料,用於
治 療 富 血 管 的 良 性 及 惡 性 腫 瘤。於 常 溫 下,凝 膠 具 有 良 好 的 流 動 性,通 過 微 導 管 輸 送 到
病 變 組 織 的 血 管 後,在 人 體 溫 度 下 凝 膠 形 成 從 末 梢 血 管 到 主 供 血 管 的 原 位 固 化,實 現 病
變 組 織 血 管 的 栓 塞,適 用 於 各 種 富 血 管 性 實 質 臟 器 腫 瘤,特 別 是 肝 臟 富 血 管 的 良 性 及 中
惡性腫瘤的栓塞治療。該產品已於二零二五年十月完成了註冊性臨床研究的全部患者入組,
目前,該產品的臨床研究與註冊申報工作正在順利推進中。
全球創新的液體栓塞劑KonaTM
適 用 於 腦 動 靜 脈 畸 形 的 術 前 栓 塞,該 產 品 具 有 短 暫 不 透 射 線 屬 性,射 線 不 透 性 將 隨 時 間
而遞減,可達成清晰的術後器官可視化效果。此外,Kona TM具有載藥特性潛力,有望裝載
其 他 化 藥 或 放 射 性 藥 物,開 發 全 新 的 藥 械 組 合 產 品,可 為 其 他 腫 瘤 或 血 管 疾 病 治 療 領 域
提供更為豐富的治療方案。目前Kona TM已向FDA遞交了上市前審批(Premarket Approval,
PMA)申請。
全球創新的實體瘤消融治療技術AuroLase®
AuroLase ®是一款用於前列腺癌組織消融的全球創新治療技術,利用一種具有光學可調性
的新型納米顆粒,通過靜脈遞送並富集在腫瘤中,選擇性地吸收鐳射能量,將光轉換成熱,
從 而 精 準 地 破 壞 腫 瘤 以 及 為 腫 瘤 供 血 的 血 管,而 不 會 嚴 重 破 壞 周 圍 的 健 康 組 織。與 外 科
手術、放射療法或傳統的替代性局灶療法相比,AuroLase ®療法可以最大程度地提高治療
效 果,同 時 最 大 程 度 地 減 少 與 手 術、放 射 線 和 替 代 性 局 灶 療 法 相 關 的 副 作 用。目 前 該 產
品已向FDA遞交了PMA申請。
RDC藥物:
目前有8款在研產品,多款產品於期內取得了重要進展。
— 10 —
全球創新型前列腺癌診療產品TLX591/TLX591-CDx:
TLX591是一款靶向前列腺特異性膜抗原(PSMA)的治療性RDC藥物,其海外早期臨床研究
顯示出了積極治療結果,影像學無進展生存期(rPFS)中位數為8.8個月,且安全性良好,該
產品已在海外開展了國際多中心III期臨床研究,並於二零二五年四月向中國藥監局遞交
了 加 入 國 際 多 中 心III期 臨 床 研 究 申 請,於 同 年 七 月 獲 得 中 國 藥 監 局 正 式 批 准。TLX591–
CDx是 靶 向PSMA的 診 斷RDC藥 物,可 與TLX591形 成 前 列 腺 癌 的 放 射 診 療 一 體 化 組 合。
TLX591-CDx於二零二一年十一月在澳大利亞獲批上市,同年十二月在美國獲批上市;於
二零二三年三月在美國批准擴展適應症,用於篩選可接受PSMA靶向放射性核素治療的前
列 腺 癌 患 者;二 零 二 五 年,TLX591-CDx在 歐 洲、美 洲 等 二 十 余 個 國 家 獲 批 商 業 化。
TLX591-CDx在中國開展的III期臨床研究已於二零二五年十二月成功達到臨床終點,根據
臨床頂線結果顯示,TLX591-CDx檢測腫瘤的總體陽性預測值(「PPV」)達94.8%(置信區間,
CI: 85.9%-98.2%)。對於復發在前列腺床區和轉移到盆腔外的軟組織、淋巴結和器官(非
骨轉移)的腫瘤,PPV為100.0%;對於復發在前列腺床區以外的盆腔區域(含淋巴結)的腫
瘤,PPV為94.7%;對 於 骨 轉 移,PPV為87.0%。同 時,該 試 驗 根 據 受 試 者 不 同 的 前列腺特
異 性 抗 原(「PSA」)基 線 水 平 進 行 分 組,TLX591-CDx在 所 有 的 分 組 中 均 顯 示 出 了 較 高 的
PPV,即 使 在 極 低 的PSA水 平 的 受 試 者 亞 組 中,PPV依 然 超 過 了90%,這 提 示 了TLX591CDx的PET成像檢測對於疑似生化復發的前列腺癌患者的早期診斷有著非常積極的臨床意
義。此外,超過三分之二(67.2%)的患者在TLX591-CDx的PET成像檢測後,其治療方案較
基線時的初始方案發生了調整。這表明TLX591-CDx的PET成像檢測對臨床決策具有重要
影響,可優化疑似生化復發的前列腺癌患者的臨床治療策略。目前,TLX591-CDx的上市
申請已獲中國藥監局受理。
全球創新型透明細胞腎細胞癌診療產品TLX250/TLX250-CDx:
TLX250與TLX250-CDx形 成 了 透 明 細 胞 腎 細 胞 癌(「 ccRCC 」)的 放 射 診 療 一 體 化 組 合。
TLX250-CDx在 二 零 二 零 年 七 月 獲FDA授 予 的 突 破 性 療 法,其 海 外III期 臨 床 研 究 在 二 零
二 二 年 十 一 月 成 功 達 到 臨 床 終 點。根 據 試 驗 結 果 顯 示,對 於 通 過 目 前 臨 床 常 用 診 斷 方 法
電 子 掃 瞄(CT)或 磁 力 共 振(MRI)提 示 存 在 腎 臟 腫 塊 但 無 法 判 斷 是 否 為ccRCC的 患 者,
TLX250-CDx正電子發射斷層成像(PET)在診斷ccRCC的敏感性和特異性上分別達到86%和
87%,遠超過FDA要求的預設閾值(敏感性和特異性均大於或等於70%),陽性預測值可達
93%,針對目前難以診斷的處於T1a期的早期ccRCC(即腫瘤局限於腎內,腫瘤最大徑少於
— 11 —
或等於4cm),TLX250-CDx診斷的敏感性和特異性分別達到85%和89%。這些突破性的臨
床結果表明,TLX250-CDx將有望為臨床提供一種準確性高且無創的ccRCC診斷方案,並
有潛力成為全新的ccRCC臨床診斷標準;此外,TLX250-CDx用於CAIX陽性實體瘤、膀胱
及尿路上皮癌的多項拓展適應症臨床研究也在全球範圍內同步推進中;中國註冊方面,
該產品已於二零二四年十一月完成了III期臨床研究的首例入患者入組給藥;TLX250正在
海外開展II期臨床研究。
全球創新型胃腸胰腺神經內分泌瘤(「GEP-NETs」)治療產品ITM-11:
ITM-11是一款基於放射性核素偶聯技術靶向殺傷治療GEP-NETs 的 RDC 產品,該產品是
將 無 載 體177Lu與 生 長 抑 素 類 似 物 偶 聯,通 過 與GEP-NETs表 面 高 水 平 表 達 的 生 長 抑 素 受
體(SSTR)結合殺傷腫瘤細胞。該產品獲得FDA和歐洲藥品管理局(「EMA」)的孤兒藥資格,
海外開展的III期臨床研究(COMPETE)已於二零二五年一月達到主要臨床終點,其在美國
的 新 藥 上 市 申 請 於 二 零 二 五 年 十 二 月 獲 得FDA正 式 受 理。中 國 註 冊 方 面,該 產 品 於 二 零
二三年四月獲得中國藥監局批准開展用於治療不可手術、進展性、SSTR+的GEP-NETs的I
期 臨 床 研 究,於 二 零 二 四 年 三 月 獲 得 中 國 藥 監 局 批 准 加 入 針 對 高 分 化 侵 襲 性2級 和3級、
SSTR+的GEP– NETs的國際多中心III期臨床研究(COMPOSE研究),並於二零二五年三月
完 成 了 首 例 患 者 入 組 給 藥;此 外,該 產 品 於 二 零 二 四 年 十 二 月 獲 得 中 國 藥 監 局 批 准 開 展
用 於 治 療 高 分 化1級 或2級、SSTR+的GEP-NETs的III期 橋 接 臨 床 研 究。該 產 品 有 望 實 現 對
GEP-NETs各階段病程的全方位覆蓋。
全球創新型膠質母細胞瘤治療產品TLX101:
TLX101是一款用於治療多形性膠質母細胞瘤的RDC藥物,可自由通過血腦屏障進入大腦,
並靶向膠質母細胞瘤過度表達的L型氨基酸轉運蛋白1(LAT-1)精準輻射癌細胞,促使其
雕亡以達到治療效果。該產品已獲FDA孤兒藥認定。早前TLX101的一項海外II期臨床試驗
(IPAX-Linz研究)的初步結果已證實了患者的獲益,該臨床結果表明,TLX101治療耐受性
良好,未發現嚴重不良事件,接受TLX101治療的患者中位總生存期(OS)約為11.9個月(自
初次診斷起約32.2個月)。相比之下,僅接受體外放射治療(EBRT)的復發性膠質母細胞瘤
患者的中位生存期僅為9.9個月,二零二六年五月,TLX101在澳大利亞、奧地利和荷蘭開
展的I期臨床研究(IPAX-2研究),完成了全部患者入組給藥,此外,TLX101目前還在另一
項關鍵性臨床試驗(IPAX BrIGHT)中進行評估,以對比單用化療(洛莫司汀)與TLX101聯
合化療在復發性膠質母細胞瘤(末線)患者中的安全性和有效性。IPAX BrIGHT正在澳大
利 亞 和 荷 蘭 積 極 入 組 患 者 並 給 藥,該 實 驗 同 時 已 在 奧 地 利 和 比 利 時 獲 批,即 將 開 始 患 者
入組。這標誌著TLX101將成為首個進入膠質母細胞瘤3期研發的放射性藥物療法。目前,
該產品已獲批在中國開展臨床研究。
— 12 —
全球創新型實體瘤診斷產品GPN01530-2
GPN01530-2是 一 款 靶 向 成 纖 維 細 胞 活 化 蛋 白(「FAP」)的 小 分 子RDC藥 物。FAP是 腫 瘤 相
關成纖維細胞(cancer associated fibroblasts,「CAFs」)的重要標誌物之一,參與細胞外基質
重 塑、腫 瘤 細 胞 增 殖 調 節 和 腫 瘤 免 疫 抑 制 等 過 程 促 進 腫 瘤 的 生 長 和 侵 襲,是 腫 瘤 診 療 的
新型特異性靶點。研究表明,FAP在正常組織中不表達或低表達,但在90%的上皮性腫瘤
組 織 和 多 種 腫 瘤 微 環 境 的CAFs中 高 表 達。GPN01530-2優 化 了FAP配 體 的 結 構,提 高 了 其
在 腫 瘤 組 織 中 的 攝 取,同 時 降 低 其 在 正 常 組 織 中 的 攝 取。臨 床 前 研 究 結 果 表 明,本 產 品
與其它FAP配體相比,表現出快速的腫瘤靶向、更高的腫瘤攝取和更優的藥代動力學特性。
此外,在已開展的IIT人體研究中顯示,GPN01530-2安全性良好,具備快速的背景清除、
強而持久的病灶攝取,與18F-FDG相比表現出更優的臨床圖像對比度和陽性病灶的準確檢
出率。基於已有臨床前及臨床研究結果,本產品顯著提升了FAP靶點類的RDC藥物的診斷
效 能,並 有 望 為 廣 大 的 實 體 瘤 患 者 提 供 一 款 全 新 的 腫 瘤 診 斷 方 案。目 前,該 產 品 於 二 零
二五年十二月獲得FDA批准開展用於診斷實體瘤的I/II期臨床研究,並於二零二六年八月
獲得FDA授予的快速通道資格。
全球創新型肝細胞癌診斷產品GPN02006
GPN02006是一款全球創新、基於放射性核素-抗體偶聯技術的靶向磷脂醯肌醇蛋白聚糖3
(「GPC-3」)的診斷型放射性藥物,其對GPC-3靶點具有高特異性和高親和力,且安全性好,
適用對HCC的精準診斷。目前,全球範圍內針對GPC-3靶點的藥物開發尚處於早期研發階
段,尚未有該靶點的藥物上市,GPN02006在中國開展的IIT臨床研究於二零二五年四月取
得 了 突 破 性 進 展,並 於 成 都2025未 來XDC新 藥 大 會 和 北 美 核 醫 學 與 分 子 影 像 學 會 年 會 中
公佈了臨床結果,臨床研究數據表明,GPN02006展現出卓越的安全性和顯像效能:所有
受 試 者 給 藥 後 均 未 報 告 任 何 藥 物 相 關 不 良 反 應,安 全 耐 受 性 表 現 優 異;給 藥 後30分 鐘 即
可 實 現 高 質 量 顯 像,充 分 滿 足 肝 細 胞 癌 臨 床 快 速 診 斷 需 求。該 藥 物 在 顯 像 質 量 方 面 具 有
三大顯著優勢:1)極低的背景信號;2)HCC病灶特異性高攝取;3)優異的診斷對比度。
基於其獨特的分子靶向機制,該藥物能夠實現:1)HCC病灶的早期精準定位;2)治療反
應的動態評估;3)復發轉移的早期預警,為臨床醫生制定個體化診療方案提供強有力的
分子影像學依據;相較於現行的HCC診斷方案,GPN02006在早期微小HCC病灶檢測中展
示出更優異的診 斷 效 能,該 產 品 有 望 改 善 當 前HCC患 者 早 期 診 斷 率 不 足 及 復 發 轉 移監測
困難的臨床現狀。目前,該產品的註冊性臨床研發工作正在積極推進中。
— 13 —
心腦血管精準介入診療板塊
本 集 團 秉 承「精 準 治 療」的 治 療 理 念,圍 繞 通 路 管 理、慢 病 管 理、結 構 性 心 臟 病 及 心 衰 多
個方向進行全方位佈局,搭建高端醫療器械產品集群,目前該板塊已佈局超過30款產品,
其中通路管理方向已有23款產品在中國獲批上市,慢病管理方向已有1款產品在中國獲批
上市,結構性心臟病方向已有3款產品在中國獲批上市,其他在研創新產品也在積極推進
中國臨床註冊工作。此外,二零二六年七月,本集團與西門子醫療系統有限公司(下稱「西
門子醫療」)正式達成全面商業化戰略合作,由遠大醫藥負責西門子醫療實時三維心腔內
超聲導管AcuNav Lumos™ 4D ICE導管在中國的獨家商業化推廣工作,該產品已獲得中國
藥 監 局 批 准 上 市;本 集 團 與 江 蘇 臻 億 醫 療 科 技 有 限 公 司 合 作 的 經 導 管 三 尖 瓣 夾 系 統
NeoBlazar ®於二零二六年七月獲中國藥監局批准上市。本集團將持續豐富創新產品管線,
帶動該板塊業務穩定增長。
本集團在該板塊已實現「無源+有源」創新器械平台的全面建設,其中,武漢光谷有源器械
研發生產基地和常州無源器械研發生產基地已投入使用。目前已經和美國、加拿大、德國、
義 大 利、瑞 士 等 多 國 臨 床 中 心 或 者 研 發 平 台 進 行 技 術 合 作,逐 步 開 啓 邁 向 全 球 化 研 發 新
進程,致力於將該板塊打造成為中國乃至全球領先的「心腦血管精準介入診療平台」。
— 14 —
核心產品
冠脈藥塗球囊RESTORE DEB®:
RESTORE DEB®是中國首款具有原發冠脈血管病變和支架內再狹窄雙重適應症的藥塗球囊,
其臨床研究結果發佈於心血管疾病領域重要期刊「JACC(Journal of the American College of
Cardiology)Cardiovascular Interventions」,獨有的SAFEPAX專利技術,藥物塗層均一穩定,
且 脫 落 率 小,上 市 以 來 獲 得 了 廣 大 臨 床 醫 生 和 患 者 的 認 可 和 良 好 的 市 場 口 碑。其 臨 床 地
位也在「冠狀動脈腔內影像學指導藥物涂層球囊臨床應用專家共識(2026版)」、「中國經皮
冠狀動脈介入治療指南(2025版)」等指南和專家共識中得以肯定。
透析通路藥塗球囊APERTO® OTW:
APERTO® OTW為首款針對透析患者動靜脈內瘻狹窄適應症的藥塗球囊,這款產品具有耐
高壓和藥物塗層雙重特性,與普通高壓球囊相比,APERTO® OTW在術後六個月靶病變通
暢 率 具 有 顯 著 優 勢,對 於 延 長 內 瘺 的 使 用 時 間、改 善 透 析 患 者 的 生 活 質 量 都 會 起 到 重 大
貢 獻,其 臨 床 研 究 成 果 發 佈 於 腎 病 治 療 領 域 重 要 期 刊「 American Journal of Kidney
Diseases」。
首款國產可調節顱內取栓支架產品鸕鷀®:
鸕鷀®採用圓絲編織結構設計,可在體外進行手動調控至理想直徑以匹配目標血管,同時
支 架 植 入 過 程 中 全 程 可 視、全 程 顯 影,能 夠 更 好 的 輔 助 術 者 根 據 血 栓 部 位 與 總 長 度,來
調節支架以更好的適應閉塞血管,實現更高的血管再通率。鸕鷀®的可調節特性,一方面
提 高 了 支 架 與 血 栓 嵌 合 能 力,提 高 了 手 術 的 有 效 性,另 一 方 面 減 少 了 對 血 管 的 損 傷,提
高了手術的安全性。此外,鸕鷀®為全支架顯影,更便於醫生精準操作,鸕鷀®的上市可為
急性缺血性卒中取栓治療提供了新的選擇。
— 15 —
多極腎動脈射頻消融系統鉑睿時IberisTM
依 托 先 進 的 腎 神 經 消 融 技 術,通 過 微 創 介 入 操 作,將 消 融 導 管 精 準 送 達 腎 動 脈 血 管,利
用 射 頻 能 量 對 腎 交 感 神 經 進 行 消 融,有 效 阻 斷 過 度 興 奮 的 腎 交 感 神 經 信 號 傳 導,從 而 實
現血壓的穩定調控。IberisTM在控制不佳的原發性高血壓患者的治療中展現出優秀臨床療效,
相關研究成果已在國際心血管頂級學術期刊Circulation(影響因數:35.5)上全文發表,獲
得了國際學術界的高度認可,是目前全球範圍內唯一獲得歐盟CE認證且具備橈動脈與股
動脈雙入路設計的腎動脈去交感神經消融術(RDN)產品。
實時三維心腔內超聲導管AcuNav Lumos™ 4D ICE導管
AcuNav Lumos™ 4D ICE導管實現了從二維、三維到實時三維成像的跨越式升級可適配二
尖 瓣 修 復、左 心 耳 封 堵、先 天 性 心 臟 病 封 堵 等 多 種 復 雜 結 構 性 心 臟 病 介 入 場 景。該 產 品
在 成 像 能 力、術 中 引 導 及 操 作 適 配 層 面 進 行 了 技 術 迭 代 優 化:配 備 改 進 型 多 平 面 重 建 雙
平 面 成 像 功 能,可 輸 出 實 時4D容 積 成 像,動 態 畫 面 清 晰 流 暢,為 術 者 術 中 解 剖 評 估 與 器
械 引 導 提 供 清 晰 影 像 參 考;該 導 管 可 深 入 心 腔 內 部,減 少 組 織 結 構 遮 擋,適 配 經 導 管 瓣
膜緣對緣修復術(TEER)等復雜手術全程使用。此外,該導管可實現四向180º的打彎角度,
活動靈活,便於探查心臟內部不同區域結構。在TEER手術中,AcuNav Lumos™ 4D ICE導
管 可 覆 蓋 術 前 評 估、術 中 器 械 操 作 及 術 後 結 果 核 查 全 流 程。在 瓣 膜 評 估 階 段,能 清 晰 可
視 化 瓣 膜 形 態、反 流 程 度 及 瓣 葉 脫 垂 情 況,輔 助 術 者 制 定 適 配 手 術 方 案;術 中 可 實 時 追
蹤 夾 合 器 等 器 械 的 位 置 與 姿 態,輔 助 術 者 完 成 瓣 葉 抓 取、夾 合 器 釋 放 等 關 鍵 操 作;在 術
後評估階段,能快速檢測術後殘余反流情況,及時判斷手術效果,助力醫生優化診療決策。
— 16 —
國產經導管二尖瓣夾系統NeoNova®
通 過 介 入 方 式 對 二 尖 瓣 反 流 患 者 進 行 緣 對 緣 二 尖 瓣 修 復,提 高 心 臟 功 能,減 小 患 者 手 術
創 傷,縮 短 恢 復 時 間。該 產 品 操 作 便 捷 且 安 全 性 好,採 用 彈 性 自 鎖 機 制 可 以 讓 夾 臂 自 動
適 應 瓣 膜 強 度 並 自 動 鎖 定,在 保 證 夾 合 穩 定 的 同 時,最 大 限 度 規 避 了 術 中 和 術 後 遠 期 瓣
膜被撕裂風險;使用「一字型」夾合器,可靈活應對腱索纏繞和交界區域跨瓣等複雜情況;
控彎穩定,半徑更小,節省了手術在心房內所需的操作空間,手術操作餘地更大。該產品
可為二尖瓣反流患者提供全新的治療選擇。
國產經導管三尖瓣夾系統NeoBlazar®
是中國首款國產的經導管三尖瓣夾系統,通過介入方式對三尖瓣反流患者進行緣對緣三
尖瓣修復,改善患者心臟功能,提升患者生活質量。該產品搭載多項核心優勢設計,採用
獨 特「一 字 型」設 計,結 構 極 簡、操 作 便 捷,可 有 效 規 避 術 中 腱 索 纏 繞 風 險,支 持 器 械 快
速解脫,允許術中多次精準調整、回收重定位,助力醫生從容應對各類復雜術中情況,大
幅 降 低 手 術 操 作 門 檻、縮 短 醫 師 學 習 曲 線,顯 著 提 升 手 術 的 可 控 性 與 安 全 性;創 新 的 彈
性 自 鎖 機 制,可 在 輸 出 穩 固 持 久 的 瓣 葉 夾 持 力 的 同 時,有 效 緩 衝 術 中 及 術 後 應 力,最 大
程 度 保 護 患 者 脆 弱 的 瓣 葉 與 心 肌 組 織,規 避 二 次 損 傷,保 障 手 術 遠 期 療 效。該 產 品 可 為
三尖瓣反流患者提供全新的治療選擇。
首款國產編織型顱內動脈瘤輔助栓塞支架藍鯨™
適 用 於18歲 以 上 顱 內 動 脈 瘤 患 者,由 輸 送 系 統 及 鎳 鈦 絲 編 織 自 膨 式 支 架 構 成,憑 藉 結 構
與性能的創新設計,突破現有產品局限,可更好適配複雜解剖結構,滿足多樣化臨床需求。
採用鎳鈦單絲16頭編織工藝,兼顧強勁徑向支撐力與優異柔順貼壁性,遠近端V形封閉設
計可穩固錨定血管,防止移位;依托獨特纏繞顯影技術,4根顯影絲均勻纏繞,近端4個顯
影點搭配遠端V形加強顯影,全程清晰示蹤,為術者提供精準視野;操控與輸送方面,其
可控性出色,釋放至80%仍可回收,實現精準植入,直徑3mm以內支架可經17微導管輸送
釋放,操控及輸送性能顯著提升;相較於激光切割型支架,其金屬覆蓋率提升至18%,可
實現適度血流分流,血管造影動脈瘤閉塞率超95%,優化治療預後。該產品有望為顱內動
脈瘤患者提供全新的治療選擇。
— 17 —
創新研發管線
全球創新型內源性組織修復產品aXess:
aXess是一款用於對終末期腎臟病(ESRD)患者建立移植物血管內瘻(AVG)開展血液透析
治療的全球創新內源性組織修復產品,該產品可以為患者自體組織修復提供基礎結構框架,
加 快 透 析 通 路 的 建 立,降 低 血 栓 以 及 相 關 並 發 症 的 發 生,有 望 為 透 析 患 者 提 供 一 種 更 為
安全且有效的血液通路。aXess可進一步與APERTO ®OTW在血液透析領域形成協同。該產
品 於 二 零 二 四 年 十 一 月 獲 得FDA突 破 性 醫 療 器 械 認 定,並 於 同 月 完 成 在 美 國 獲 批 開 展 的
關鍵性臨床研究的首例患者入組,在歐洲開展的關鍵性臨床研究於二零二五年十月成功
達到臨床終點,具體結果顯示,與標準療法相比,aXess在所有關鍵臨床指標上均實現重
大提升,與其他動靜脈移植物相比,aXess在主要和次要終點均展現出優異的通暢率,且
干預次數更少,與自體動靜脈內瘻(AVF)相比,aXess的再干預率更低且具有高抗感染性;
安全性方面,在全部120名患者中,僅出現一例因穿刺感染相關的(部分)人工血管取出事
件,表明aXess具有極高抗感染性;aXess可實現近乎即時的穿刺操作,在超過1.5萬次透析
治療中出血並發症發生率低於0.02%,這些數據證明aXess擁有優秀的安全性和有效性特徵,
在各方面均優於現行標準療法。該產品於二零二六年四月獲得CE認證。中國註冊方面,
該產品尚處於臨床前開發階段。
全球創新型二尖瓣置換系統Saturn:
Saturn是一款用於二尖瓣置換的全球創新醫療器械,該產品用經房間隔的介入方式植入,
最 大 程 度 避 免 手 術 創 傷,縮 短 術 後 恢 復 時 間,創 新 性 地 將 瓣 環 重 建 技 術 與 瓣 膜 置 換 技 術
相 結 合,提 升 器 械 適 配 性,適 合 各 種 常 見 的 二 尖 瓣 結 構。該 產 品 於 二 零 二 零 年 在 歐 洲 開
展了經心間入路的臨床研究,並於二零二二年完成全部患者入組,目前五年隨訪工作完成,
隨訪結果符合預期;於二零二四年五月在歐洲完成了經股靜脈入路的臨床研究的首例患
者 入 組,隨 訪 結 果 符 合 預 期,產 品 安 全 有 效 性 得 到 初 步 驗 證。該 產 品 在 中 國 的 註 冊 工 作
也在積極地推進中。
— 18 —
全球創新型心室輔助器械CoRISMA:
CoRISMA是一款治療三級和終末期心衰的經導管完全植入的心室輔助醫療器械,採用世
界先進的能量傳輸技術無線供電,通過微創手術為心衰終末期患者提供了具有創傷小、
安全性高、無電源線感染、並發症少的治療方法。目前,本集團正在與耶魯大學孵化的創
新性醫療器械公司進行產品的合作開發工作。
製藥科技
本 集 團 在 呼 吸 及 危 重 症、五 官 科、心 腦 血 管 急 救 等 領 域 深 耕 多 年,現 有 多 款 市 場 份 額 領
先 的 高 壁 壘 產 品 和 獨 家 品 種,具 備 良 好 的 品 牌 優 勢 和 穩 固 的 市 場 地 位,亦 儲 備 多 款 創 新
產品。
通過全球技術合作與自主研發相結合的創新模式,本集團在製藥科技領域建立了武漢光
谷國際研發中心、澳洲糖組學研發中心以及南京奧羅mRNA研發中心。各研發中心及技術
平台將持續協同賦能,為本集團在製藥科技領域的研發創新輸送前沿技術儲備與長效研
發動能。
呼吸及危重症板塊
本集團呼吸及危重症板塊在售產品覆蓋鼻炎、支氣管炎、肺炎、哮喘、慢性阻塞性肺部疾
患等多個適應症。核心產品切諾®(桉檸蒎腸溶膠囊)、新型複方鼻噴劑萊特靈®、恩卓潤®
比斯海樂®和恩明潤®比斯海樂®均為全國獨家品種,處於細分領域的領先地位。
該 板 塊 針 對 未 被 滿 足 的 重 大 臨 床 需 求 進 行 創 新 佈 局,在 研 產 品 覆 蓋 膿 毒 症、呼 吸 窘 迫 綜
合征(「ARDS」)等適應症。未來,本集團將繼續採用自主研發與全球拓展的研發理念,打
造氣道慢病全周期管理產品集群和危重症產品管線,不斷鞏固本集團在該領域的行業地位。
— 19 —
呼吸科產品
主要產品包括切諾®、恩卓潤®比斯海樂®和恩明潤®比斯海樂®、新型複方鼻噴劑萊特靈®、
布地奈德鼻噴霧劑、丙酸氟替卡松鼻噴霧劑等。
切諾®(桉檸蒎腸溶膠囊):
為一款粘液溶解性祛痰藥。適用於急、慢性鼻竇炎;急慢性支氣管炎、肺炎、支氣管擴張、
肺膿腫、慢性阻塞性肺部疾患、肺部真菌感染、肺結核和硅肺等呼吸道疾病;亦可用於支
氣 管 造 影 術 後,促 進 造 影 劑 的 排 出。為 本 集 團 自 主 研 發 的 中 國 獨 家 品 種,有 成 人 裝 和 兒
童裝分別適用於成年人和兒童使用,為中國國家醫保目錄和中國國家基藥目錄收錄品種,
並榮登「二零二五年健康產業品牌榜」、「2024年度中國藥品零售市場潛力品牌」、「2022-2023
年中國家庭常備藥上榜品牌」。目前已有數十項指南和專家共識推薦使用粘液溶解促排劑
用於臨床,其中十餘項指南和專家共識均明確推薦桉檸蒎腸溶膠囊或其活性成分用於臨
床治療,如《中國咳嗽基層診療與管理指南(2024版)》、《中國成人支氣管擴張症診斷與治
療專家共識(2021版)》、《兒童分泌性中耳炎診斷和治療指南(2021版)》、《慢性阻塞性肺
疾病基層合理用藥指南(2020版)》、《中國胸外科圍手術期氣道管理指南(2020版)》、《鼻
炎分類和診斷及鼻腔用藥方案的專家共識》、《兒童反復呼吸道感染專家共識》等,臨床地
位突出,醫生及患者認可程度高,持續領跑口服止咳祛痰藥物市場。
— 20 —
恩卓潤®比斯海樂®(茚達格莫吸入粉霧劑II)和恩明潤®比斯海樂®(茚達特羅莫米松吸入粉
霧劑II、III):
恩 卓 潤®比 斯 海 樂®是 中 國 國 內 首 款 獲 批 哮 喘 適 應 症 的 三 聯 複 方 吸 入 製 劑,適 用 於 使 用 長
效β2受體激動劑(LABA)和吸入性糖皮質激素(ICS)聯合維持治療未能充分控制的成年
哮 喘 患 者 的 維 持 治 療。產 品 療 效 明 確,使 用 便 捷,並 實 現 了 三 方 面 的 突 破:(1)採 用 了 優
化的ICS、LABA和 長 效 乙 醯 膽 鹼 受 體 拮 抗 劑(LAMA)藥 物 組 合,即 糠 酸 莫 米 松╱醋酸茚
達 特 羅╱格 隆 溴 銨,三 種 有 效 成 分 協 同 增 益,對 比 常 規 高 劑 量ICS-LABA和 高 劑 量ICS–
LABA聯合LAMA開放三聯,恩卓潤®比斯海樂®可有效改善中重度哮喘患者臨床症狀和肺
功能,並顯著降低急性發作風險;(2)每日一次給藥,極大程度便利患者並有望改善依從性;
(3)採用先進的比斯海樂®吸入裝置,裝置操作簡易,為患者提供可聽、可嘗、可視的三重
給藥確認,增強患者完整劑量用藥的信心。該產品III期臨床研究ARGON顯示,相較於高
劑 量 沙 美 特 羅 替 卡 松 吸 入 粉 霧 劑 聯 合 噻 托 溴 銨 吸 入 噴 霧 劑 開 放 三 聯,恩 卓 潤®比 斯 海 樂®
可顯著降低急性發作風險,特別是24周中度急性發作風險的年化發生率降低了43%。恩明
潤®比 斯 海 樂®為 創 新 型ICS糠 酸 莫 米 松 和LABA醋 酸 印 達 特 羅 的 二 聯 複 方 製 劑,適 用 於 成
人及12歲以上青少年哮喘患者的維持治療。恩明潤®比斯海樂®同樣具備「可視可控、精準
吸入、一天一次」等特點,可顯著改善患者肺功能並減少急性發作風險,是哮喘患者優化
治療的新選擇。該產品III期臨床研究顯示,對比常規高劑量沙美特羅替卡松吸入粉霧劑,
恩明潤®比斯海樂®可顯著改善患者急性發作風險,重度、中重度和所有急性發作類別風險
分 別 降 低 約26%、22%和19%。這 兩 款 產 品 已 被 納 入《穩 定 期 慢 性 氣 道 疾 病 吸 入 裝 置 規 範
應用中國專家共識(2023版)》、《重度哮喘診斷與處理中國專家共識(2024版)》、《支氣管
哮喘防治指南(2024版)》、《全球哮喘管理和預防策略(2025版)》等國內外權威臨床指南和
專家共識中,此外,這兩款產品均已正式納入中國的《國家基本醫療保險、工傷保險和生
育保險藥品目錄》乙類藥品管理範圍,為長期接受哮喘治療的人群提供新的治療方案。
— 21 —
新型複方鼻噴劑萊特靈®:
萊 特 靈®是 一 種 新 型 的 抗 組 胺 藥 和 皮 質 類 固 醇 的 複 方 鼻 噴 劑,用 於 成 人 和6歲 及 以 上 兒 童
的中度至重度季 節 性 過 敏 性 鼻 炎 的 對症 治 療,及 成 人 和12歲 及 以 上 兒 童 的 中 度 至重度常
年性過敏性鼻炎的對症治療。《中國變應性鼻炎診斷和治療指南(2022版)》、《鼻炎分類和
診斷及鼻腔用藥 方 案 臨 床 共 識(2019版)》、《ARIA變 應 原 免 疫 治 療 的 醫 療 路 徑(2019版)》
等國內外權威臨床指南和專家共識均推薦鼻用抗組胺藥和鼻用皮質類固醇藥作為過敏性
鼻炎的首選用藥,萊特靈®作為複方製劑,能給患者帶來更便捷和有效的治療方式,提高
患者的依從性,為中國的AR患者帶來新的治療手段。該產品於二零二二年一月獲FDA批
准上市,於二零二五年十一月獲得中國藥監局批准上市。
布地奈德鼻噴霧劑:
是一種鼻用皮質類固醇藥物,具有強效的局部抗炎與抗過敏作用,可直接作用於鼻粘膜,
緩 解 鼻 炎 症 狀。適 用 於 治 療 季 節 性 和 常 年 性 過 敏 性 鼻 炎,常 年 性 非 過 敏 性 鼻 炎;亦 可 用
於 預 防 鼻 息 肉 切 除 後 鼻 息 肉 的 再 生,對 症 治 療 鼻 息 肉。為 過 敏 性 鼻 炎 的 一 線 用 藥,被 納
入《中國慢性鼻竇炎診斷與治療指南(2024版)》、《中國變應性鼻炎診斷和治療指南(2022
年,修訂版)》、《兒童變應性鼻炎診斷和治療指南(2022年,修訂版)》、《鼻用糖皮質激素
治療變應性鼻炎專家共識》、《鼻炎分類和診斷及鼻腔用藥方案的專家共識》等多項臨床指
南 和 專 家 共 識 中。該 產 品 為 國 內 首 仿,將 有 望 改 變 同 通 用 名 產 品 市 場 上 外 資 企 業 獨 佔 的
競爭格局。
丙酸氟替卡松鼻噴霧劑:
是一種鼻用皮質類固醇藥物,具有強效的局部抗炎與抗過敏作用,可直接作用於鼻粘膜,
緩解鼻炎症狀。適用預防和治療季節性過敏性鼻炎(包括枯草熱)和常年性過敏性鼻炎。
為過敏性鼻炎的一線用藥,被納入《中國慢性鼻竇炎診斷與治療指南(2024版)》、《中國變
應性鼻炎診斷和治療指南(2022年,修訂版)》、《兒童變應性鼻炎診斷和治療指南(2022年,
修訂版)》、《鼻用糖皮質激素治療變應性鼻炎專家共識》、《鼻炎分類和診斷及鼻腔用藥方
案的專家共識》等多項臨床指南和專家共識中。該產品為國內首仿,將有望改變同通用名
產品市場上外資企業獨佔的競爭格局。
— 22 —
創新研發管線
本集團基於未被滿足的臨床需求,針對膿毒症、ARDS等適應症佈局全球創新藥物。
重症治療的全球創新藥物STC3141:
STC3141為本集團自主開發的全新作用機制的小分子化合物,通過中和胞外遊離組蛋白和
中性粒細胞誘捕網來逆轉機體過度免疫反應造成的器官損傷,可用於多種重症適應症。
STC3141是全球首個以重新構建免疫穩態為核心的膿毒症治療方案,實現了治療維度的重
大 升 級,在 現 有 的 抗 感 染、液 體 復 蘇 和 維 持 器 官 運 轉 等 對 症 支 持 治 療 的 基 礎 上,針 對 機
體 免 疫 失 調 這 個 核 心 病 因 加 以 精 準 調 節,幫 助 身 體 恢 復 平 衡,有 望 填 補 了 當 前 膿 毒 症 針
對 病 因 治 療 的 臨 床 空 白。該 產 品 作 用 機 制 創 新,臨 床 前 相 關 研 究 結 果 於 二 零 二 零 年 二 月
和 二 零 二 三 年 十 一 月 分 別 發 表 於 頂 級 學 術 期 刊「 Nature Communications 」和「 Critical
Care」,具 有 深 遠 的 學 術 影 響 力。目 前 該 產 品 已 在 中 國、澳 大 利 亞、比 利 時、英 國、波 蘭
三大洲五個國家,在膿毒症、ARDS、重症新冠病毒感染(「COVID-19」)及COVID-19引發
的ARDS四個適應症上獲批七個臨床批件,完成了四項針對患者的臨床研究並成功達到了
臨床終點。此前在澳洲和比利時開展的用於治療膿毒症的Ib期臨床研究、在中國開展的針
對 急 性 呼 吸 窘 迫 綜 合 症(ARDS)的Ib期 臨 床 研 究 和 在 歐 洲 開 展 的 治 療 重 症 新 冠 病 毒 感 染
(COVID-19)的IIa期臨床研究,均展示了STC3141具有良好的安全性及耐受性,且在幫助
患者脫離呼吸機、脫離升壓藥和縮短ICU住院時間等有效性指標方面都體現了積極信號,
而在中國開展的針對膿毒症的II期臨床研究於二零二五年五月成功達到主要臨床終點,臨
床結果顯示,藥物治療組第7天SOFA評分較基線均有明顯下降,尤其是高劑量組,降幅明
顯大於安慰劑組,差異具有統計學顯著性和臨床意義;次要終點的趨勢與主要終點一致,
符合預期。此外,STC3141安全性、耐受性良好,且藥代動力學特徵也符合預期。該研究
結果證實了STC3141在膿毒症治療中的有效性和安全性,為重症治療領域帶來新的突破。
目前,該產品後續的臨床開發和註冊申報工作正在積極的推進中。
— 23 —
五官科板塊
本 集 團 五 官 科 板 塊 秉 持 中 西 結 合 與 藥 械 同 治 的 發 展 戰 略,持 續 完 善 中 成 藥、眼 科 創 新 藥
及OTC零 售 產 品 協 同 發 展 的 系 列 化 產 品 集 群。在 中 成 藥 方 向 上,本 集 團 立 足 中 醫 藥 在 慢
病 治 療 領 域 的 核 心 優 勢,持 續 深 耕,在 鞏 固 並 完 善 五 官 科 產 品 矩 陣 的 基 礎 上,通 過 戰 略
佈局多款具有顯著競爭優勢的中成藥,成功將業務拓展至心腦血管慢病以及神經內科等
治 療 領 域,實 現 了 中 成 藥 業 務 從 五 官 科 單 一 領 域 向 綜 合 慢 病 治 療 領 域 的 戰 略 轉 型;在
OTC零售產品方向上,本集團積極打造中國領先的眼健康消費品牌,提供專業、安全、便
捷 的 眼 健 康 解 決 方 案;在 眼 科 創 新 藥 方 向 上,本 集 團 通 過 合 作 引 進 和 自 主 研 發 相 結 合 的
策略,儲備了治療「乾眼症」、「蠕形蟎瞼緣炎」、「眼科術後抗炎鎮痛」、「翼狀胬肉」和「近
視」等多款全球創新產品,構建差異化競爭優勢,有望為患者提供更多治療選擇,改善生
活 質 量,同 時 通 過 持 續 加 強 產 品 的 臨 床 循 證 醫 學 體 系 建 設 與 專 業 學 術 推 廣 體 系 建 設,為
臨床專家提供完善的疾病診療方案和細緻化的產品服務方案。未來該板塊將持續深耕前
沿創新賽道,不斷強化行業影響力,實現業務領域新突破。
五官科產品
本集團五官科核心產品包括和血明目片、金嗓系列(金嗓開音片╱膠囊╱丸╱顆粒、金嗓
清 音 片╱膠 囊╱丸╱顆 粒、金 嗓 利 咽 片╱膠 囊╱丸╱顆 粒、金 嗓 散 結 片╱膠 囊╱丸╱顆
粒)、脈血康(脈血康膠囊及脈血康腸溶片)、瑞珠(聚乙烯醇滴眼液、玻璃酸鈉滴眼液)、
諾通(鹽酸賽洛唑啉)、丹珍頭痛膠囊、酒石酸伐尼克蘭鼻噴霧劑等。
和血明目片:
由四物湯、二至丸和生蒲黃湯三個經典名方化裁而成,具有涼血止血、滋陰化瘀、養肝明
目 的 功 效,主 要 用 於 陰 虛 肝 旺,熱 傷 絡 脈 所 引 起 的 眼 底 疾 病。和 血 明 目 片 為 中 國 全 國 獨
家品種,國家中藥保護品種,國家醫保目錄和國家基本藥物目錄收載品種,上市30餘年來,
積累了大量在眼底出血方面的臨床研究資料和應用經驗,被納入《2型糖尿病中醫防治指
南(2024版)》、《病理性近視眼底病變黃斑出血中醫診療指南(2022版)》、《和血明目片治
療濕性年齡相關性黃斑變性臨床應用專家共識》等多個權威指南與共識,為產品的臨床使
用提供有價值的文獻支援。
— 24 —
金嗓系列產品:
全 國 獨 家 產 品,覆 蓋 喉 科 全 病 種,其 中 金 嗓 散 結 膠 囊 用 於 熱 毒 蓄 結、氣 滯 血 瘀 而 形 成 的
慢 喉 喑(聲 帶 小 結、聲 帶 息 肉、聲 帶 粘 膜 增 厚)及 由 此 而 引 起 的 聲 音 嘶 啞 等 症。金 嗓 散 結
膠 囊 上 市 三 十 多 年 以 來,在 臨 床 得 到 廣 泛 應 用。金 嗓 利 咽 膠 囊 為 治 療 肝 鬱 氣 滯、痰 濕 內
阻 所 致 咽 喉 疾 病 唯 一 中 成 藥,也 是 臨 床 中 咽 異 感 症,胃 食 管 反 流 性 咽 炎、慢 性 肥 厚 性 咽
喉炎理想用藥。金嗓開音膠囊針對急性咽炎、急性喉炎引起的咽喉紅、腫、熱、痛、聲音
嘶啞起效迅速。該系列產品獲得廣泛的臨床認可,《中醫耳鼻咽喉科常見病診療指南》、《活
血化瘀類中成藥合理用藥指南》、臨床醫師診療叢書《臨床用藥指南》、權威專著《常見眼
耳鼻咽喉科中成藥手冊》、《實用耳鼻咽喉頭頸外科學》等多部臨床路徑及專家診療指南均
對其予以收載。二零二二年一月和二零二四年八月,中華中醫藥學會分別發佈了《金嗓散
結膠囊治療聲帶小結、聲帶息肉臨床應用專家共識》和《金嗓開音膠囊(丸╱片╱顆粒)臨
床應用專家共識》,也為金嗓散結和金嗓開音產品的循證之路增添了新的支持。金嗓散結
和 金 嗓 開 音 膠 囊 為 國 家 醫 保 目 錄 產 品,金 嗓 開 音、清 音 屬 於 兼 具 處 方 藥 和 非 處 方 藥 屬 性
的雙跨品種。
— 25 —
多普泰®(脈血康膠囊及脈血康腸溶片):
具有抗凝、抗血栓、抗纖維化、改善血液循環等功效,可用於治療冠心病、急性腦梗死、
缺 血 性 腦 卒 中、不 穩 定 性 心 絞 痛 等 心 腦 血 管 疾 病。為 國 家 醫 保 和 基 本 藥 物 目 錄 品 種,也
是目前國內唯一標注了抗凝血酶活性單位的中成藥(每粒╱片相當於14個抗凝血酶活性單
位),已被納入《腦卒中中西醫結合康復臨床循證實踐指南》、《腦卒中中西醫結合防治指
南》、《腦梗死中西醫結合診療指南》、《特發性膜性腎病中醫臨床實踐指南》、《脈血康膠
囊(腸溶片)治療心腦血管疾病臨床應用專家共識》等眾多權威的臨床指南中。
丹珍頭痛膠囊:
由四物湯、天麻鈎藤飲、通竅活血湯等經典名方化裁而成,具有平肝熄風,散瘀通絡,解
痙止痛的功效,適用於治療肝陽上亢、瘀血阻絡所致的頭痛、背痛頸酸、煩燥易怒等症狀。
該 產 品 臨 床 定 位 清 晰、循 證 研 究 充 分,治 療 領 域 可 涵 蓋 原 發 性 頭 痛、繼 發 性 頭 痛 以 及 預
防 頭 痛,具 有 廣 泛 的 臨 床 應 用 前 景,為 全 國 獨 家 品 種,國 家 醫 保 目 錄 和 國 家 基 本 藥 物 目
錄收載品種,並被納入《原發性頭痛中西醫結合診療中國專家共識(2026版)》、《中國偏頭
痛中西醫結合防治指南(2022版)》等臨床指南和專家共識中。
瑞珠®(聚乙烯醇滴眼液、玻璃酸鈉滴眼液):
為單支裝無防腐劑人工淚液,現為治療乾眼的一線用藥。為《中國乾眼臨床診療專家共識
(2024版)》、《中國白內障圍手術期乾眼防治專家共識(2021版)》、《中國乾眼專家共識(2020
版)》、《中國激光角膜屈光手術圍手術期用藥專家共識(2019版)》、《我國瞼板腺功能障礙
診斷與治療專家共識(2017版)》等多個專家共識中推薦用藥。瑞珠具有良好的品牌知名度,
二零一七年獲得中國馳名商標;二零一六年至二零二四年連續九年獲得西普金獎-「健康
產業品牌榜」。
— 26 —
諾通(鹽酸賽洛唑啉鼻用噴霧劑╱滴鼻液):
是一款緩解鼻塞的鼻減充血劑。適用於減輕急慢性鼻炎、鼻竇炎、過敏性鼻炎、肥厚性鼻
炎 等 鼻 腔 疾 病 引 起 的 鼻 塞 症 狀。其 不 含 有 激 素 和 麻 黃 堿,成 人 和 兒 童 均 可 適 用。諾 通 分
為 滴 鼻 劑 和 鼻 用 噴 霧 劑 兩 個 劑 型,其 中 鼻 用 噴 霧 劑 為 國 產 獨 家 劑 型,在 同 通 用 名 產 品 中
處 於 領 跑 地 位。產 品 被 納 入《兒 童 慢 性 鼻 竇 炎 的 診 斷 和 治 療 中 國 專 家 共 識(杭 州,
2024)》、《中國變應性鼻炎診斷和治療指南(2022年,修訂版)》、《兒童變應性鼻炎診斷和
治療指南(2022年,修訂版)》等臨床指南。
酒石酸伐尼克蘭鼻噴霧劑(「OC-01」):
是 一 款 高 選 擇 性 的 乙 醯 膽 鹼 能 受 體 激 動 劑,可 通 過 啟 動 三 叉 神 經 副 交 感 神 經 通 路,增 加
天然淚液的分泌,從而達到治療乾眼症的目的。根據OC-01的III期臨床研究結果顯示,與
對照組相比,OC-01在改善乾眼症患者淚液分泌方面顯示出具有統計學和臨床意義的顯著
改善,受試者的自然淚液分泌較基線明顯增加(Schirmer評分較基線增加大於或等於10毫
米的受試者比例顯著佔優),且安全性和耐受性良好。該產品於二零二一年十月在美國獲
批上市,是目前全球首款且唯一一款獲批治療輕、中、重度乾眼的無防腐劑、多劑量、無
菌 包 裝 鼻 噴 霧 劑;中 國 註 冊 方 面,該 產 品 於 二 零 二 三 年 二 月 在 中 國 澳 門 特 別 行 政 區 獲 批
上 市;於 二 零 二 三 年 四 月 作 為 進 口 臨 床 急 需 藥 品,落 地 海 南 樂 城 醫 療 先 行 區;於 二 零
二三年十二月在香港大學深圳醫院開出粵港澳大灣區的首張處方;於二零二四年十一月
獲 得 中 國 藥 監 局 批 准 上 市;且 於 同 月 在 中 國 台 灣 地 區 獲 批 上 市;於 二 零 二 五 年 七 月 在 中
國大陸實現正式獲批後的首批商業化處方落地,目前,該產品被納入《兒童青少年近視相
關乾眼診療指南(2026版)》、《中國乾眼臨床診療專家共識(2024版)》、國際淚膜與眼表協
會發佈的2025版《TFOS DEWS III:管理與治療報告》、美國眼科學會發佈的2023版《乾眼
臨床實踐指南》等國內外權威臨床指南和共識。
— 27 —
用於治療蠕形蟎瞼緣炎的全球創新眼用製劑TP-03(洛替拉納滴眼液,0.25%):
是一款對γ-氨基丁酸門控氯離子通道(「GABA-Cl」)具有選擇性的非競爭性拮抗劑,其
通過選擇性抑制蠕形蟎體內的GABA-Cl,使蟲體麻痹和死亡,進而徹底治愈蠕形蟎瞼緣炎。
該 產 品 具 有 高 度 親 脂 性,可 促 進 其 在 蟎 蟲 棲 息 的 睫 毛 毛 囊 油 脂 中 的 吸 收。目 前,該 產 品
已 在 美 國 完 成 了 兩 項 關 鍵 性 臨 床 研 究,均 達 到 了 主 要 終 點 和 所 有 次 要 終 點,具 有 統 計 學
意義,且未發生與治療相關的嚴重不良事件,並已於二零二三年七月獲得FDA批准上市,
是 目 前FDA批 准 的 首 款 也 是 唯 一 一 款 針 對 蠕 形 蟎 瞼 緣 炎 的 藥 物,於 二 零 二 五 年 五 月 獲 中
國 澳 門 藥 監 局 批 准 上 市,於 二 零 二 六 年 三 月 獲 中 國 藥 監 局 批 准 上 市。目 前,該 產 品 被 納
入國際淚膜與眼表協會發佈的2025版《TFOS DEWS III:管理與治療報告》、國際蠕形蟎治
療與眼瞼健康專家小組共識發佈的2025版《DEPTH專家共識》、美國眼科學會發佈的2023
版《乾眼臨床實踐指南》、《中國瞼板腺功能障礙專家共識:診斷和治療(2023版)》等國內
外權威臨床指南和共識。
創新研發管線
本 集 團 在 眼 科 術 後 抗 炎 鎮 痛、翼 狀 胬 肉、近 視 等 存 在 明 確 臨 床 需 求 的 方 向 佈 局 了 三 款 創
新藥物:
眼科術後抗炎鎮痛改良型新藥激素納米混懸滴眼液GPN00833:
其主要活性成分丙酸氯倍他索是一種強效的糖皮質激素,具有高效的局部抗炎活性和較
強的毛細血管收縮作用,同時其獨特的納米製劑工藝有效解決了激素產品低水溶性導致
的 生 物 利 用 度 低 及 安 全 性 風 險,該 產 品 已 於 二 零 二 四 年 三 月 獲 得 美 國FDA批 准 上 市,中
國註冊方面,該產品於二零二四年十一月完成在中國開展的III期臨床研究並成功達到了
臨床終點,與對照組相比,該產品在抗炎和鎮痛方面具有顯著的統計學差異和臨床意義,
且 該 產 品 的 安 全 性、耐 受 性 良 好,藥 代 動 力 學 特 徵 也 符 合 預 期。目 前,該 產 品 正 處 於
NDA準備階段。
— 28 —
治療翼狀胬肉改良型新藥GPN00153(「CBT-001」):
為已上市治療肺纖維化藥物尼達尼布的創新改良產品,對新生血管生成和組織纖維化均
有抑制作用。目前已在美國完成II期臨床試驗,安全性高,臨床療效顯著,可抑制翼狀胬
肉生長並控制病情惡化。CBT-001全球開發於二零二二年六月進入III期臨床階段,在中國
於二零二三年三月獲得中國藥監局批准開展III期臨床研究,於二零二五年六月完成了全
部患者入組。
用於延緩兒童近視進展的新型眼用製劑GPN00884:
為本集團與溫州醫科大學(「溫醫大」)附屬眼視光醫院共同開發的全新作用機制的創新藥,
與低濃度阿托品滴眼液相比,GPN00884滴眼液無瞳孔散大效應,不會出現畏光、調節下
降 等 不 良 反 應,給 藥 時 段 不 受 限 制,可 提 高 患 者 的 依 從 性。該 產 品 已 於 二 零 二 四 年 三 月
在中國獲批開展I期臨床研究,於二零二五年三月完成了I期臨床研究,於二零二五年十月
完成了在中國開展的IIa期臨床研究的首例患者入組。
此外,本集團中成藥方向在慢病管理領域也佈局了兩款中藥1類創新藥:
治療抑鬱症的中藥創新藥GPN01360:
是一款用於治療抑鬱症(肝鬱脾虛證)的1.1類中藥創新藥,基於古代經典方劑「逍遙散」,
通過現代藥理學與臨床研究篩選優化而成,處方由柴胡、郁金、佛手等12味中藥組成,具
有 疏 肝 健 脾、解 鬱 安 神 的 功 效。該 中 藥 主 要 用 於 治 療 肝 鬱 脾 虛 型 抑 鬱 症,其 典 型 症 狀 包
括情緒低落、思維遲緩、意志活動減退、心煩焦慮、失眠健忘、食少納呆及神疲乏力等。
前期近百人的人用經驗研究表明,GPN01360在改善抑鬱症狀、緩解焦慮失眠及調理脾胃
功能方面表現出良好療效與安全性。該產品於二零二五年十二月完成了中國的II期臨床研
究並成功達到臨床終點,根據研究結果顯示,GPN01360在抑鬱症的治療方面有較好的安
全 性 和 有 效 性,且 對 抑 鬱 伴 焦 慮、失 眠 等 症 狀 的 改 善 也 較 為 明 顯;於 二 零 二 六 年 七 月 完
成了中國III期臨床研究的首例患者入組給藥。
— 29 —
預防性治療偏頭痛的中藥創新藥GPN01020:
為1.1類中藥創新藥,擬用於偏頭痛(瘀血阻滯證)的預防性治療,由三級甲等醫療機構院
內製劑轉化而來,臨床應用已逾三十年,功能主治為活血化瘀、理氣補虛,適用於氣虛血
瘀證的血管神經性頭痛、外傷頭痛、高血壓病、腦動脈硬化等。本產品既往臨床主要應用
領域主要包括原發性頭痛(如緊張型頭痛、偏頭痛等)及繼發性頭痛(如血管性頭痛、神經
血 管 性 頭 痛 等)。前 期 數 百 人 的 人 用 經 驗 研 究 結 果 顯 示,GPN01020在 減 少 偏 頭 痛 發 作 天
數與發作頻次、改善偏頭痛相關症狀等方面表現出良好療效與安全性。二零二六年三月,
該產品獲得中國藥監局批准開展II期臨床研究。
心腦血管急救板塊
本 集 團 心 腦 血 管 急 救 板 塊 兼 顧 了 急 搶 救 與 慢 性 疾 病 管 理 兩 大 方 向,在 急 救 方 向,本 集 團
被列為「國家基本用藥生產基地」、「國家戰備儲備急救用藥生產企業」、「國家小品種藥(短
缺 藥)集 中 生 產 基 地 建 設 單 位」,擁 有 超 過30個 品 種,其 中14個 品 種 納 入 了 中 國 國 家 急 搶
救 藥 品 目 錄,16個 品 種 納 入 了 短 缺 藥 品 目 錄,產 品 管 線 數 量 位 居 行 業 前 列,產 品 覆 蓋 院
內急救、院前急救及社會急救三大急救場景,持續為國內心腦血管急搶救患者提供多場景、
多選擇、安全且有效的產品組合。在慢性疾病管理方向,核心產品能氣朗®、力美通®依普
利酮片、合心爽®╱合貝爽®等,持續領跑細分市場。目前心腦血管急救板塊通過自主創新
研發與高難度仿製技術突破相結合,繼續佈局和開發臨床急需的心腦血管急救與慢性疾
病治療領域的產品。
心腦血管急救產品
產品主要覆蓋血壓控制、血管活性藥、心肌代謝、心衰、急性過敏反應、肺動脈高壓等領
域,主要產品包括合心爽®╱合貝爽®(鹽酸地爾硫䓬片╱鹽酸地爾硫䓬緩釋膠囊、鹽酸地
爾硫䓬注射液)、能氣朗®(輔酶Q10片)、力美通®依普利酮片等。
— 30 —
合心爽®╱合貝爽®(鹽酸地爾硫䓬片╱鹽酸地爾硫䓬緩釋膠囊、鹽酸地爾硫䓬注射液):
作為經典的鈣離子通道阻滯劑,具有臨床療效明確且安全性高等特點,擁有口服常釋劑型、
緩 釋 劑 型 和 注 射 劑 型,可 以 極 大 程 度 的 滿 足 高 血 壓、冠 心 病 等 心 腦 血 管 疾 病 患 者 的 臨 床
需求,被納入《圍產期降壓藥物臨床應用管理指南(2025版)》、《中國心肌病綜合管理指南
(2025版)》、《老年 慢 性 腎 臟 病 綜 合 管 理 指 南(2025版)》、《中 國 兒 童 肥 厚 型 心 肌 病 診斷治
療與管理專家共識(2025版)》、《急性ST段抬高型心肌梗死經皮冠狀動脈介入治療術中冠
狀 動 脈 內 溶 栓 專 家 共 識(2025版)》、《英 國 腎 臟 病 協 會 臨 床 實 踐 指 南:成 人、兒 童 和 青 少
年 透 析 患 者 的 血 壓 管 理(2025版)》、《ACC/AHA/ACEP/NAEMSP/SCAI急 性 冠 狀 動 脈 綜 合
征患者管理指南(2025版)》等眾多國內外權威的臨床指南與專家共識。
能氣朗®(輔酶Q10片):
用於改善心肌代謝和能量供應,具有促進氧化磷酸化反應和保護生物膜結構完整性的功能。
對慢性心功能不全患者可以顯著改善氣促、乏力症狀,有效聯合常規治療,改善患者預後,
改善生活質量。上市至今三十餘年,先後進入《全球男性學論壇(GAF)抗氧化劑治療男性
不育臨床指南(2026版)》、《兒童暴發性心肌炎診治專家建議(2025版)》、《中國心肌病綜
合管理指南(2025版)》、《顱腦衝擊傷後創傷後應激障礙綜合防治專家共識(2025版)》、《中
國兒童肥厚型心肌病診斷治療與管理專家共識(2025版)》、《兒童周期性嘔吐綜合征治療
指南(2025版)》、《重症發熱伴血小板減少綜合征診治專家共識(2025版)》、《中國成人心
肌炎臨床診斷與治療指南2024》、《慢性酒精相關性腦損害的中國診療指南(2024版)》、《中
國遺傳性共濟失調診治專家共識(2024版)》、《中國心力衰竭診斷和治療指南(2024版)》等
眾多國內外權威的臨床指南與專家共識。
— 31 —
力美通®依普利酮片:
一款新型的MRA藥物,可通過與醛固酮受體(mineralocorticoid receptor,「MR」)結合,來
阻斷MR過度啓動所引發的心臟病變和血管損傷。《ESC指南:心血管疾病和妊娠的管理(2025
版)》、《ACC/AHA/ACEP/NAEMSP/SCAI急性冠狀動脈綜合征患者管理指南(2025版)》、《
TES臨 床 實 踐 指 南:原 發 性 醛 固 酮 增 多 症( 2025版)》、《 AHA/ACC/AANP/AAPA/ABC/
ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM成 人 高 血 壓 預 防、檢 測、評 估 和 管 理 指
南(2025版)》、《高血壓患者高容量負荷的評估和管理專家共識(2025版)》、《中國高血壓
防治指南(2024版)》、《中國心力衰竭診斷和治療指南(2024版)》、《難治性高血壓血壓管
理中國專家共識》、《鹽皮質激素受體拮抗劑臨床應用多學科中國專家共識(2022版)》等眾
多國內外知名的臨床指南和專家共識推薦臨床上使用MRA藥物來治療心力衰竭和高血壓
等心血管疾病。與第一代MRA藥物螺內酯相比,依普利酮具有更高的MR的選擇性,對於
雄 激 素 受 體 和 孕 激 素 受 體 的 親 和 力 較 低,因 此 副 作 用 較 小,是 一 款 安 全 有 效 的 新 一 代
MRA藥物。本品於二零二三年八月獲中國藥監局批准上市,彌補了中國國內二代選擇性
醛 固 酮 受 體 拮 抗 劑 藥 物 的 空 白;二 零 二 四 年 五 月,完 成 了 首 張 處 方 的 開 具,正 式 在 國 內
實現商業化;二零二四年十一月,正式納入中國的《國家基本醫療保險、工傷保險和生育
保險藥品目錄(2024版)》。
— 32 —
優敏速®腎上腺素鼻噴霧劑:
優敏速®是首個FDA批准的用於I型過敏反應(包括嚴重過敏反應)的非注射治療產品,採用
創新的鼻噴給藥方式,使用便捷,小巧易攜帶,能夠在發生過敏反應的緊急情況下,第一
時 間 由 患 者 本 人 或 他 人 完 成 給 藥。該 產 品 擁 有 長 達30個 月 的 保 質 期,能 顯 著 減 少 因 藥 品
過期造成的浪費,減輕患者的經濟與用藥負擔。關鍵性臨床研究結果顯示,接受優敏速®
或已批准的腎上腺素注射產品治療的受試者體內腎上腺素血液濃度相當,並且已證實優
敏速®對過敏反應患者具有快速起效和短時間內緩解症狀的作用。憑藉其獨特的便攜性與
操作友好性,優敏速®有望迅速滲透至家庭、學校、旅行等多種院外場景,並填補嚴重過
敏反應急救藥物在院外場景使用的空白。
潤漠德霖®曲前列尼爾注射液:
是 一 款 治 療 肺 動 脈 高 壓 的 罕 見 病 藥 物,為 一 種 內 源 性 前 列 環 素 的 人 工 合 成 類 似 物,通 過
作用於特定的前列腺素受體以及對血栓素A2的拮抗作用,促進血管平滑肌的舒張,減少
血栓形成,抑制血管壁細胞增殖,進而增加血流量,減輕心臟負擔。該產品與現有治療手
段聯用可顯著改善患者的長期生存率,《成人先天性心臟病相關肺動脈高壓診斷與治療指
南(2026版)》、《ESC指 南:心 血 管 疾 病 和 妊 娠 的 管 理(2025版)》、《動 脈 性 肺 動 脈 高 壓 靶
向藥物治療醫藥共管專家共識(2025版)》、《急性肺栓塞診斷和治療指南(2025版)》
《慢性
血栓栓塞性肺動脈高壓診斷與治療指南(2024版)》、《 ESC/ERS肺動脈高壓診斷與治療指
南(2022版)》、《中國肺動脈高壓診斷與治療指南(2021版)》等國內外權威指南均推薦使用
該 產 品。潤 漠 德 霖®為 中 國 目 前 僅 有 的 兩 款 獲 批 上 市 的 曲 前 列 尼 爾 產 品 之 一,並 於 二 零
二三年一月,正式納入中國的《國家基本醫療保險、工傷保險和生育保險藥品目錄(2022
版)》,可顯著提高患者的藥物可及性並降低了治療負擔,惠及廣大的肺動脈高壓患者。
— 33 —
原料藥板塊
本集團原料藥板塊產品管線豐富,產品集群優勢顯著,大宗原料藥與特色原料藥銷售並行,
銷售渠道遍布全球。作為原料製劑一體化供應鏈前端的重要一環,現已擁有多個裝備完整、
工藝精湛、產業化能力突出、質量控制規範的現代化原料藥生產基地,圍繞心腦血管、抗
感 染、解 熱 鎮 痛、消 化 系 統 及 抗 腫 瘤 五 大 領 域 進 行 原 料 藥 生 產 研 發 佈 局,全 面 支 持 製 藥
科 技 領 域 的 製 劑 生 產 與 研 發 工 作,源 頭 保 障 公 司 製 劑 品 質 的 高 標 準 和 一 致 性,真 正 實 現
上下游產業優勢的整合。
mRNA平台
本集團以南京奧羅 生 物 科 技 有 限 公 司(「奧 羅 生 物」)為 核 心 搭 建 了 全 球 領 先 的mRNA技術
平台。奧羅生物作為集團全球化mRNA創新技術平台,擁有自主知識產權的mRNA核酸藥
物 開 發、脂 質 納 米 顆 粒(LNP)遞 送 兩 大mRNA核 心 底 層 技 術,分 別 解 決 疫 苗 抗 原 設 計、
LNP體內靶向遞送和工藝開發等多項行業關鍵痛點,技術底座具備跨項目複用能力,可拓
展性強,可支持多元化mRNA候選藥物開發。奧羅生物的研發主要聚焦於腫瘤治療和傳染
病 防 治 等 具 有 重 大 臨 床 及 公 共 衛 生 意 義 的 方 向。目 前 平 台 重 點 推 進HPV-16宮 頸 癌、
HSV-2生殖器皰疹兩款治療性mRNA疫苗研發,並基於自研平台技術開展多項早期研發項
目概念驗證。
— 34 —
生物科技
本 集 團 踐 行 綠 色 低 碳、可 持 續 發 展 理 念,以 全 球 領 先 的 合 成 生 物 製 造 創 新 技 術 推 動 板 塊
高 質 量 發 展。生 物 科 技 領 域 以 氨 基 酸 產 品 為 核 心 業 務,定 位 於 全 球 高 品 質 氨 基 酸 優 質 服
務 商。本 集 團 在 生 物 科 技 領 域 的 發 展 注 重 技 術 創 新 和 高 質 量 體 系 構 建,通 過 打 造 技 術 與
品質壁壘,全面推進國際註冊進程,強化本集團在國際市場上的綜合競爭力。目前,本集
團生物科技領域已擁有發明專利約350項,主導及參與制定國家、行業、團體標準近70餘
項,已經發佈的標準達50項;擁有完備的國內外質量體系認證,榮獲國家級綠色工廠、國
家製造業單項冠軍示範企業、國家級專精特新「小巨人」企業、國家知識產權示範企業、
中國輕工業含硫氨基酸綠色製造工程技術研究中心、中國生物發酵行業先進企業等多項
殊榮。
氨基酸板塊
本集團在氨基酸領域已深耕20餘年,始終秉承科技創新的精神,以合成生物學為核心、中
國 首 創 全 球 領 先 的 生 物 法 新 技 術 生 產 多 種 氨 基 酸,填 補 了 行 業 空 白。本 集 團 承 擔 中 國 國
家工業強基項目和產業基礎再造項目,是國內首家獲批氨基酸「同線同標同質」三同認證
證書的企業,保障中國國內高品質氨基酸的供應鏈和產業鏈的安全性和穩定性。
本 集 團 始 終 堅 持 以「新 技 術,高 質 量,產 業 鏈,國 際 化」為 核 心 的 經 營 理 念,持 續 加 強 氨
基酸產業拓展,以藥品級氨基酸為基礎,發揮產業優勢,向多元化氨基酸方面繼續延伸。
— 35 —
新技術:
本集團緊密圍繞合成生物學領域,經過多年研發創新,目前已建成合成生物學、酶工程、
發酵工程、過程優化、質量研究、應用轉化等八大技術平台,開展細胞工廠構建、發酵工
藝精細調控、分離純化全技術鏈條的研究,通過多個技術領域的創新集成,已具備「新產
品開發、新技術工程化和產業化、應用解決方案」一體化的協同體系,為持續創新和產業
落地提供了強有力的支撐,部分技術填補國內空白。目前,本集團已與武漢大學、華中科
技 大 學、天 津 科 技 大 學、華 中 農 業 大 學 等 多 家 科 研 院 校 建 立 了 長 期 的 深 度 合 作 關 係,合
作開發了新型氨基酸發酵技術和酶表達系統,同時深化細胞培養基級別氨基酸的技術開發,
為 自 產 細 胞 培 養 基 的 研 究 提 供 了 原 料 保 障;運 用 分 子 生 物 學 和 蛋 白 組 學 等 技 術,對 生 物
酶 結 構 進 行 改 造,有 效 地 提 高 了 生 物 酶 活 性,提 升 了 產 品 的 產 量 與 質 量。其 中 以 菌 種 構
建優化為核心的發酵法工藝和以固定化酶為核心的酶轉化工藝,不僅可替代傳統化學合
成 工 藝,提 高 工 藝 安 全 性 和 生 產 便 利 性,還 可 大 幅 降 低 生 產 過 程 中 二 氧 化 碳 的 排 放,充
分彰顯了「碳達峰、碳中和」的節能減排和綠色環保的發展理念,展現出巨大的經濟和環
境 效 益;本 集 團 在 氨 基 酸 板 塊 搭 建 的 產 業 技 術 高 速 公 路 初 具 規 模,為 技 術 的 源 頭 創 新 和
產品的產業化奠定了堅實基礎。
本集團高度重視研發團隊建設和產研緊密融合。目前氨基酸板塊擁有以湖北省百人計劃
人 才 領 銜 的 核 心 技 術 團 隊,產 學 研 用 結 合 的 創 新 模 式 以 及 分 工 明 確、優 勢 互 補 的 技 術 創
新人才梯隊,已結出豐碩成果,授權發明專利數量位居同行業領先水平。
— 36 —
高質量:
本 集 團 氨 基 酸 產 品 國 內 外 質 量 認 證 體 系 完 善,眾 多 核 心 產 品 通 過 歐 美 日、東 南 亞、中 國
等多個國家及地區的藥品╱食品體系認證和註冊,包括歐盟EU GMP認證、歐盟REACH註
冊、出 口 歐 盟W C認 證、美 國F D A認 證、韓 國K F D A註 冊、I S O質 量 管 制 體 系 認 證、
FSSC22000食品體系認證、FAMI-QS飼料認證、IP非轉基因認證、HALAL清真食品認證、
KOSHER猶 太 食 品 認 證 等,既 確 保 了 核 心 產 品 海 外 經 營 的 合 規 性,又 為 後 續 拓 展 產 品 的
新 的 市 場 應 用 奠 定 了 基 礎;同 時 本 集 團 也 加 大 了 對 南 美 等 新 型 經 濟 體 的 註 冊 力 度,為 本
集 團 核 心 產 品 的 全 球 化 經 營 鋪 平 道 路。完 善 的 國 際 體 系 認 證 和 註 冊,展 現 出 本 集 團 在 海
外市場業務拓展的強大競爭力。
產業鏈:
本 集 團 擁 有 各 類 氨 基 酸 及 其 衍 生 品 近50種,擁 有26個 氨 基 酸 原 料 藥 註 冊 文 號,是 國 內 氨
基 酸 原 料 藥 註 冊 文 號 最 多 的 製 藥 企 業。同 時,本 集 團 也 新 增 了 多 款 食 品 級 和 飼 料 級 的 氨
基 酸 產 品,以 差 異 化 路 徑 打 開 增 長 空 間,彰 顯 市 場 攻 堅 與 產 品 創 新 雙 輪 驅 動 效 能。豐 富
的 氨 基 酸 產 品 集 群,能 更 好 地 滿 足 下 游 市 場 的 個 性 化 定 制 需 求,提 供 多 品 種 多 品 規 一 站
式服務,增強高端應用場景的客戶粘性。除原料產品外,本集團亦積極拓展製劑產品,自
主 研 發 的 兩 款 功 能 型 膳 食 營 養 補 充 劑 已 獲 得 美 國FDA認 證 並 已 在 美 國 實 現 了 商 業 化,國
內方面,本集團已有十餘款自主研發的功能性食品獲批上市。
國際化:
本集團氨基酸板塊銷售網絡覆蓋了包括歐美日、東南亞、中國等主流市場在內的全球140
多個國家和地區,海外業務佔比近40%,其中部分氨基酸品種市場佔有率名列前三。依託
技術突破和成本優勢,核心產品長期服務於包括世界500強企業在內的境內外優質客戶,
在產業鏈上下遊客戶建立了長效穩定的合作關係,在全球範圍內建立了較高的品牌知名
度和市場口碑,為該板塊的業績持續快速增長奠定了扎實的客戶基礎。
— 37 —
未 來,本 集 團 將 繼 續 依 托 在 高 品 質 氨 基 酸 領 域 全 球 領 先 的 生 物 法 製 造 新 技 術,扎 實 的 工
業 基 礎 和 產 業 積 累,豐 富 的 氨 基 酸 產 品 集 群,高 標 準 的 質 量 認 證 體 系,強 大 的 國 際 註 冊
及 商 業 化 能 力,重 點 佈 局 高 端 腸 外 營 養 製 劑、創 新 多 肽 類 藥 物、細 胞 培 養 基 等 藥 品 相 關
的 高 附 加 值 領 域,及 運 動 保 護 等 功 能 型 膳 食 營 養 補 充 劑、特 醫 及 嬰 配 食 品、美 妝 及 寵 物
食品等大健康消費領域,下游廣闊的市場空間和巨大的發展潛力將為本集團氨基酸板塊
提供持續強勁的發展動力。
財務回顧
收益及溢利
截至二零二六年六月三十日止六個月,本集團的業務穩健增長,收益約港幣6,388,910,000
元(去 年 同 期 重 述1:港 幣6,189,200,000元),同 比 上 漲 約3.2%。創 新 和 壁 壘 產 品2收 益 佔 總
收益的比例約50%。於本回顧期間,本公司擁有人應佔期內溢利約為港幣1,061,540,000元(去
年 同 期 重 述:港 幣1,193,170,000元)。期 內,本 集 團 對Telix投 資 的 公 允 價 值 變 動 和 處 置 合
計收益約港幣88,780,000元(去年同期收益重述:港幣151,720,000元),與去年同期相比減
少了港幣62,940,000元,如果撇除Telix投資對利潤的影響,本期的本公司擁有人應佔經調
整 的 經 營 性 純 利3約 為 港 幣972,760,000元(去 年 同 期 重 述:港 幣1,041,440,000元),主 要 系
因應對市場競爭調整銷售策略帶來的短期影響。
期 內,本 集 團 核 藥 抗 腫 瘤 診 療 及 心 腦 血 管 精 準 介 入 診 療 科 技 產 品 錄 得 收 益 約 港 幣
745,130,000元,較二零二五年同期(約港幣577,740,000元)比較上漲約29%。其中核藥抗腫
瘤 板 塊 錄 得 收 益 約 港 幣655,240,000元,較 二 零 二 五 年 同 期(約 港 幣421,780,000元)比 較 上
漲約55.4%,其上漲主要因為核心產品的臨床需求快速增長以及新產品快速放量所帶來的
收入增長,心腦血管精準介入診療板塊收益錄得收益約港幣89,890,000元。
期 內,本 集 團 製 藥 科 技 產 品 錄 得 收 益 約 港 幣3,274,080,000元,較 二 零 二 五 年 同 期(約 港 幣
3,845,190,000元)比較下降14.9%。其中,呼吸及危重症板塊錄得收益約港幣1,041,730,000
元,較二零二五年同期(約港幣1,047,350,000元)比較基本持平;五官科板塊錄得收益約港
幣1,115,510,000元,較 二 零 二 五 年 同 期(約 港 幣1,494,710,000元)比 較 下 降 約25.4%;心 腦
血 管 急 救 板 塊 錄 得 收 益 約 港 幣792,300,000元,較 二 零 二 五 年 同 期(約 港 幣904,410,000元)
比較下降了約12.4%,五官科板塊和心腦血管急救板塊收入下降,主要系因應對市場競爭
調整銷售策略帶來的短期影響。
— 38 —
期內,本集團生物科技產品錄得收益約港幣2,369,700,000元,較二零二五年同期重述結果
(約港幣1,766,260,000元)比較上漲約34.2%。其中氨基酸板塊(含牛磺酸)錄得收益約港幣
1,870,280,000元,較 二 零 二 五 年 同 期(約 港 幣1,428,490,000元)比 較 上 漲 約30.9%,其 上 漲
主要得益於核心產品銷售價格提升,同時下游市場需求擴大,帶動業務規模增長。
附註:
1
於二零二六年上半年,本公司成功收購河北九孚和保定加合100%股權。於收購時點,中國遠大為河
北九孚和保定加合的控股股東,且同時為本公司的控股股東,故此收購事項被視為涉及受共同控制
實體之業務合併,並採用合併會計法原則入賬。因此,截至二零二五年六月三十日止六個月之比較
簡明綜合損益及其他全面收益表以及於二零二五年十二月三十一日及二零二五年一月一日之簡明綜
合財務狀況表已重列,藉此納入合併實體自其首次受共同控制之日起計之資產及負債、溢利以及現
金流量。具體請參見簡明綜合財務報表附註2。
2
創新和壁壘產品指公司原研產品、獨家市場地位產品、擁有獨家商業化權益的產品以及打破外資壟
斷的首仿產品。
3
本公司擁有人應佔經調整的經營性純利界定為本公司擁有人應佔期內溢利但不包括Telix投資的公允
價值變動和處置收益的影響。
— 39 —
分銷成本及行政費用
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 集 團 分 銷 成 本 及 行 政 費 用 分 別 約 為 港 幣
1,582,340,000元 及668,100,000元,而 二 零 二 五 年 同 期 重 述 結 果 分 別 約 為 港 幣1,919,440,000
元及705,470,000元。分銷成本下降約港幣337,100,000元,主要是期間內營銷組織優化及銷
售策略調整的結果。行政費用亦較去年同期重述結果下降約港幣37,380,000元,主要是期
間內組織架構調整和精細化運營的結果。
財務費用
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本 集 團 之 財 務 費 用 約 為 港 幣76,760,000元,二 零
二五年同期重述結果約為港幣82,000,000元。財務費用下降的原因為置換貸款使綜合利率
下降。
研發及項目投入
截至二零二六年六月三十日止六個月,本集團繼續投入資源用於在研項目的推進及創新
項 目 的 引 進,研 發 費 用 加 上 資 本 化 研 發 支 出、新 項 目 的 預 付 款 及 其 他 投 入,本 集 團 於 研
發工作及項目的投入約港幣7.64億元。
應收款項及應付款項
於二零二六年六月三十日,本集團之應收貿易賬款及其他應收款約為港幣5,397,240,000元,
較 二 零 二 五 年 重 述 後 結 餘 增 加 約 港 幣664,650,000元,主 要 原 因 為 本 期 的 業 務 增 加,而 且
市場上一般慣例為會於年末時加大催收貨款的力度致使應收賬款結餘會相對較小,因此
本期的應收貿易賬款及應收票據結餘較去年年末的結餘增加約港幣898,520,000元。
於二零二六年六月三十日,本集團之應付貿易賬款及其他應付款約為港幣4,002,710,000元,
較 二 零 二 五 年 重 述 結 餘 基 本 持 平,主 要 原 因 為 本 期 的 業 務 增 加,致 使 應 付 貿 易 賬 款 及 應
付 票 據 共 增 加 約 港 幣110,280,000元。另 外,因 年 內 營 銷 組 織 優 化 及 銷 售 策 略 調 整 而 減 少
預提銷售及經營費用如工資、市場推廣及宣傳、研發費用等,共約港幣159,160,000元。
— 40 —
重大投資
價值超過本集團的資產總值5%的投資為被視為重大投資。於二零二六年六月三十日,本
集團之重大投資包括(i) Grand Pharma Sphere Pte Limited(「Grand Pharma Sphere」)及(ii)
上海旭東海普藥業有限公司(「旭東海普」)。
Grand Pharma Sphere為一組公司的控股公司,主要從事研發、製造及銷售核藥及腫瘤介入
產 品。本 集 團 實 益 持 有 其 約57.98%股 本 權 益。截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,本
集團應佔Grand Pharma Sphere之利潤為約港幣40,480,000元(截至二零二五年六月三十日止
六個月:應佔之利潤約港幣39,300,000元)。
旭東海普及其附屬公司為一組公司,主要從事製造及銷售不同容量的注射液類醫藥製劑。
本集團實益持有其55%股本權益。截至二零二六年六月三十日止六個月,本集團應佔旭東
海 普 之 利 潤 為 約 港 幣38,110,000元(截 至 二 零 二 五 年 六 月 三 十 日 止 六 個 月:約 港 幣
42,820,000元)。
於聯營公司的重大投資並無可取的市場公平值,原因為重大聯營公司均為私人公司及並
無可取的市場價格。聯營公司之業績和資產及負債採用權益會計法計入本集團的綜合財
務報表。
本集團於投資到這些聯營公司時會考慮不同的條件,主要包括:
1.
尋找機會進入新市場及開拓產品組合,例如投資到Grand Pharma Sphere提供了機會給
本 集 團 進 入 核 藥 抗 腫 瘤 領 域,而 投 資 其 他 聯 營 公 司 即 有 助 本 集 團 進 入 其 他 市 場,例
如取得先進的技術並進入心腦血管介入器械的國際市場;
2.
尋找本集團現有產品及市場協同效應,例如旭東海普的主要產品可以與本集團的製
劑產品產生協同效應並豐富本集團的急救藥品、心腦血管和呼吸科產品的產品組合,
並可強化本集團在這些領域的產品質量、市場份額及品牌;
3.
尋求機會與在早期研發階段的公司合作,以取得附有強大潛力的產品之經營權。
— 41 —
有關這些聯營公司的產品研發和前景的進一步詳情,請見以上標題為「業務回顧及前景」
一節的描述。
研究與開發
本集團創新管線充足,期內創新項目34個,分布於臨床前到新藥上市申請的不同階段,管
線佈局合理,形成了良好的梯隊效應。
研發管線
領域
板塊
方向
放射性核素偶聯藥物(RDC)
核藥抗腫瘤診療
核藥抗腫瘤診療及心腦
血管精準介入診療科技
介入治療
通路管理
心腦血管精準介入
診療
結構性心臟病與
心衰
中國大陸
前列腺癌
TLX591-CDx
(68Ga-PSMA-11)
前列腺癌-診斷
TLX250
(177Lu-girentuximab)
腎透明細胞癌
TLX250-CDx
(89Zr-girentuximab)
腎透明細胞癌-診斷
TLX101
(131I-IPA)
腦膠質瘤
ITM-11
胃腸胰腺神經內分泌瘤
GPN01530-2
實體瘤-診斷
GPN02006
肝細胞癌-診斷
釔[90Y]微球注射液
原發性肝癌
溫敏栓塞劑
富血管性實質臟器腫瘤
Kona
腦動靜脈畸形
AuroLase
前列腺癌
優護
前列腺癌
優愛MRD
尿路上皮癌
aXess
血液透析
GPN01037
顱內狹窄病變
結構性心臟病
Saturn
二尖瓣返流
心衰
CoRisma
心衰
GPN00153(CBT-001)
翼狀胬肉
GPN00833
眼部炎症
GPN00884
近視防治
中成藥
mRNA平台
TLX591
(177Lu-rosapatumab)
神經介入
眼科
呼吸及危重症
適應症
血管介入
五官科
製藥科技
產品
GPN01360
抑郁症
GPN01020
神經系統疾病
抗感染
呼吸
GPN01411
危重症
STC3141
膿毒症
腫瘤
ARC01 (A002)
HPV16型陽性實體瘤
海外
— 42 —
研發進度
臨床前
IND╱型檢
I期
II期
III期
NDA╱註冊
上市
研發中心
目前,本集團在全球範圍內參與及建立了多個研發技術平台以及研發中心:
在製藥科技領域,位於中國武漢的光谷國際研發中心是本集團製藥科技領域在中國的研
發主體,為本集團高端製劑產品的研發提供技術支援;糖組學技術平台位於澳洲研發中心,
專 注 於 抗 病 毒 藥 物 的 開 發;mRNA技 術 平 台 位 於 中 國 南 京,專 注 於 抗 腫 瘤 及 抗 感 染 類
mRNA藥物的開發,未來也將進一步拓展至罕見病及蛋白替代療法等領域。
在 核藥抗腫瘤診 療 板 塊,腫 瘤 介 入 技 術 平 台 和RDC技 術 平 台 分 別 是 美 國 波 士 頓 研 發中心
以及中國成都放射性藥物研發中心。
在 心 腦 血 管 精 準 介 入 診 療 板 塊,本 集 團 的 高 端 醫 療 器 械 研 發 技 術 平 台,由 武 漢 光 谷 器 械
研發中心以及常州器械研發中心組成。
仿製藥開發
回 顧 期 內,甲 硝 唑 凝 膠、醋 酸 艾 替 班 特 注 射 液、鹽 酸 阿 莫 羅 芬 搽 劑 以 及 吸 入 用 乙 酰 半 胱
氨酸溶液獲中國藥監局頒發藥品註冊證書。
一致性評價
回顧期內,甲硝唑凝膠、醋酸艾替班特注射液、鹽酸阿莫羅芬搽劑、吸入用乙酰半胱氨酸
溶 液、地 西 泮 注 射 液 以 及 硫 酸 阿 米 卡 星 注 射 液 獲 批 通 過 或 視 同 通 過 一 致 性 評 價。新 申 報
氫溴酸替格列汀片、鹽酸納美芬注射液、富馬酸比索洛爾片、乙酰半胱氨酸泡騰片。目前
本集團共有70個產品獲批通過或視同通過一致性評價,另19個產品在審評。
— 43 —
知識產權保護
回 顧 期 內,本 集 團 新 增 申 請55項,新 增 專 利 授 權33項,其 中 發 明 專 利 授 權17項,佔 比
52%,新增海外專利授權1件。本集團累計有效專利數1028項,其中有效發明專利599項。
本集團高度重視自主創新項目的知識產權保護,創新領域專利持有量274項,圍繞抗感染、
腫 瘤、醫 療 器 械 及mRNA技 術 平 台 等 創 新 領 域 新 增 專 利 申 請23項,佔 集 團 新 增 申 請 總 量
42%,其中,抗感染領域核心專利已在中國、美國、歐洲、日本、韓國、以色列、新加坡、
澳大利亞等地獲得授權。
商業化能力
本集團業績持續提升,創新產品持續上市並產生利潤貢獻離不開商業化能力的持續提升。
於 本 公 告 日 期,本 集 團 有 銷 售 人 員 超 過5,000人,其 中 製 藥 領 域 銷 售 人 員 超 過4,000人(含
OTC),中 國 範 圍 內 覆 蓋 醫 院 及 基 層 醫 療 機 構 約50,000家,其 中 等 級 醫 院 超 過13,000家;
OTC方 向 銷 售 人 員 超 過1,000人,輻 射 藥 店 超 過50萬 家;心 腦 血 管 精 準 介 入 診 療 板 塊 銷 售
團隊約150人,覆蓋了近1800家醫院;核藥抗腫瘤診療板塊全球銷售人員超過900人,全球
銷售網絡覆蓋50多個國家和地區,並在中國積極進行易甘泰®釔[90Y]微球注射液的入院及
學術推廣工作。
國際化水平
本 集 團 全 球 化 步 伐 持 續 不 斷 加 快,在 核 藥 抗 腫 瘤 診 療、心 腦 血 管 精 準 介 入 診 療、危 重 症
等領域擁有多家獨立運營的海外公司,推進多款全球創新產品的海外臨床試驗,在美國、
澳大利亞、比利時、波蘭、英國五個國家獲得了8項臨床批件,涉及原發性肝癌、實體瘤、
膿毒症等多個適應症。目前,本集團連同聯營公司在海外員工總數超過350人。
— 44 —
重大投資、併購與合作
本集團延續「自主研發+全球拓展」的發展戰略,在全球範圍內進一步挖掘優質創新項目來
擴充本集團的產品管線和提高本集團的綜合實力,大力向創新和國際化轉型。於報告期內,
本集團進行了以下的重要合作:
•
與香港大學達成戰略合作
二零二六年四月,本集團與香港大學及其全資子公司港大科橋有限公司(「港大科橋」)
達 成 戰 略 合 作。雙 方 將 於 學 術 研 究、資 源 分 享、人 才 培 養 以 及 產 品 開 發 等 方 面 展 開
深 度 合 作,合 力 推 進 抗 感 染 領 域 的 創 新 藥 物 研 發 與 成 果 產 業 化 落 地。本 次 合 作 將 以
創 新 抗 菌 藥 物 開 發 為 起 點,相 關 項 目 由 李 學 臣 教 授 的 團 隊 承 接,旨 在 開 發 具 備 更 優
療 效 與 安 全 性 的 全 新 治 療 方 案,以 解 決 抗 菌 治 療 領 域 未 被 滿 足 的 臨 床 需 求。後 續 香
港大學將把其擁有的相關知識產授權予本集團獨家許可,由本集團全權負責後續的
開 發、註 冊 及 商 業 化,高 效 實 現 前 沿 科 研 成 果 的 產 業 轉 化。本 次 合 作 標 誌 著 本 集 團
在 聯 動 國 際 頂 尖 高 校、深 度 融 合 前 沿 學 術 研 究 與 產 業 轉 化 應 用 方 面,再 度 邁 出 關 鍵
性步伐。
投資者關係
一直以來,本集團致力提高企業管治水平,以確保本集團的長遠發展。期內,本集團通過
在本公司及香港交易及結算所有限公司網站公佈年報、年度業績公告、其他公告及通函,
並主動發放自願性公告,向股東及投資者披露本集團的最新業務發展。
同時,本集團積極通過不同渠道與投資者保持密切溝通,包括券商路演、大型電話會議、
一 對 一 會 議 等 多 元 化 對 話 方 式,向 投 資 者 介 紹 本 集 團 的 業 務 情 況、發 展 情 況 及 海 外 成 員
企業業務等,並同步通過不同媒體渠道發佈最新業務動態,旨在搭建一個公開、雙向、透
明、誠懇的溝通平台,從而讓投資者即時掌握本集團之業務進展及發展前景。期內,本集
團 通 過 業 績 發 佈 會、投 資 者 現 場 調 研 等 活 動 積 極 與 資 本 市 場 及 投 資 者 進 行 溝 通,並 參 與
— 45 —
多 場 由 大 型 投 資 銀 行 及 證 券 公 司 等 機 構 舉 辦 的 峰 會、論 壇、策 略 會 及 專 題 路 演 等 活 動,
吸 引 了 數 百 名 機 構 投 資 者 和 分 析 師 參 與。藉 由 與 投 資 者 溝 通 交 流 的 機 會,本 集 團 冀 望 聽
取更多寶貴意見,建立積極、高效的資訊溝通機制,廣泛收集投資者反饋,以期進一步提
升企業管治水平。
本集團的投資者關係管理工作有助於樹立優質的企業形象、傳遞科技創新的核心戰略,
在多維度獲得業內的高度認可,於二零二六年一月榮膺第十二屆「港股100強」年度醫藥醫
療創新先鋒榜單、第二屆聚董秘「百佳IRM公司(二十佳)」以及第二屆聚董秘「百佳ESG公
司(二十佳)」。
其他重大事項
認股權計劃
截 至 二 零 二 六 年 六 月 三 十 日 止,本 公 司 並 沒 有 採 納 任 何 認 股 權 計 劃,亦 無 尚 未 行 使 之 認
股權。
截 至 二 零 二 六 年 六 月 三 十 日 止,並 無 根 據 任 何 認 股 權 計 劃 授 出 或 行 使 認 股 權,亦 無 尚 未
行使之認股權。
股份獎勵計劃
於 二 零 二 一 年 九 月 一 日,本 公 司 採 納 了 股 份 獎 勵 計 劃(「該 計 劃」),而 本 集 團 的 僱 員、董
事及顧問將有權參與該計劃。該計劃的詳情載於本公司日期為二零二一年九月一日的公告。
本 集 團 已 向 為 該 計 劃 成 立 的 信 托 支 付 了 約 港 幣278,560,000元,連 同 之 前 購 買 的 股 票 所 得
的股息,受托人已用了約港幣268,500,000元購買47,761,500股本公司之股份(「股份」)作為
信 托 基 金 一 部 分,而 該 等 股 份 由 受 托 人 就 信 托 項 下 合 資 格 參 與 者 的 利 益 持 有,並 為 該 計
劃下可供授出的獎勵股份總額,佔本公司之已發行股份約1.35%。受託人為在收到本集團
的購買股份指示及必要的資金後,在合理切實可行的範圍內儘快以當時的市場價格在市
場上購買股份。
— 46 —
除 以 上 所 述 外,截 至 二 零 二 六 年 六 月 三 十 日 止,本 集 團 並 無 授 出 任 何 獎 勵,亦 無 促 使 向
受 託 人 支 付 信 託 基 金 以 購 買 或 認 購 股 份。待 日 後 授 出 獎 勵 予 合 資 格 人 士 時,將 根 據 當 時
適 用 之 上 市 規 則 及 其 他 監 管 守 則,規 限 每 名 人 士 可 享 有 之 獎 勵 股 份 數 目、獎 勵 價 格、獎
勵 的 歸 屬 條 件 及 歸 屬 時 間 表,並 以 獎 勵 函 件 通 知。董 事 會 不 會 授 出 任 何 獎 勵 股 份 而 會 致
使董事會根據該計劃授出的累計股份數量超過採納該計劃之日時本公司的已發行股份數
目的5%(即177,478,557股),而每名該計劃的參與者每十二個月內累計最多可享有的數目
為不超過採納該計劃之日時本公司的已發行股份數目的1%(即35,495,711股)。
該計劃之目的
該計劃的目的為認可被選定之參與者的貢獻並激勵彼等留任本集團,從而促進本集團的
持續經營、成長及發展。
該計劃之剩餘年期
受限於該計劃可能根據計劃規則而由董事會提前終止,該計劃將於計劃期間(即自生效日
期起計十年期間)有效及生效。截止二零二六年六月三十日止,該計劃之有效年期尚餘約
五年半。
買入、出售或贖回股份
截 至 二 零 二 六 年 六 月 三 十 日 止 期 間 內,本 公 司 或 其 任 何 附 屬 公 司 並 無 買 入、出 售 或 贖 回
本公司任何上市證券。
僱員及薪酬政策
於二零二六年六月三十日,本集團於香港及中國境內聘用12,326名職員及工人(二零二五
年十二月三十一日:12,614名)。本集團根據員工表現及經驗釐定員工薪酬,管理層亦會
定 期 檢 討 員 工 薪 酬 制 度。其 他 員 工 福 利 包 括 醫 療 保 險、退 休 計 劃、適 當 培 訓 計 劃 及 認 股
權計劃。
競爭利益
本公司董事或管理層股東(定義見上市規則)概無於任何會或可能會與本集團業務構成競
爭之業務擁有權益。
— 47 —
董事於交易、安排或合約之權益
董事概無於本公司、其任何控股公司或附屬公司或其他附屬公司所訂立直至本年度結束
或於本年度期間任何時間仍然存續之任何就本集團業務而言屬重大之交易、安排或合約
擁有重大權益。
證券交易之標準守則
本公司已採納上市規則附錄C3所載之上市發行人董事進行證券交易的標準守則(「標準守則」)
為 其 董 事 進 行 證 券 交 易 之 操 守 準 則。本 公 司 已 向 本 公 司 董 事 作 出 個 別 查 詢,於 截 至 二 零
二六年六月三十日止期內一直遵守標準守則所載之所有相關規定。
獨立非執行董事之獨立性
本公司已根據上市規則第3.13條收到各獨立非執行董事每年對其獨立性之確認。獨立非執
行董事已確認彼等均為獨立。
企業管治常規守則
截至二零二六年六月三十日止期間,本公司已遵守上市規則附錄C1所載之企業管治守則
之所有適用守則條文(「企業管治守則」)。
審核委員會
本公司已成立審核委員會,以監察本集團財務報表之完整性及審視財務匯報程式及內部
監 控 系 統。現 時,審 核 委 員 會 由 獨 立 非 執 行 董 事 蘇 彩 雲 女 士 擔 任 主 席,其 他 成 員 包 括 三
名獨立非執行董事胡野碧先生、裴更博士及邢麗娜博士。蘇彩雲女士具備上市規則第3.10(2)
和3.21條所規定的適當專業資格。
本集團截至二零二六年六月三十日止期內之簡明中期財務報表為未經審核,但已由審核
委員會審閱。
— 48 —
薪酬委員會
本 公 司 已 成 立 薪 酬 委 員 會,以 考 慮 本 公 司 所 有 董 事 及 高 級 管 理 層 之 薪 酬。現 時,薪 酬 委
員 會 由 獨 立 非 執 行 董 事 蘇 彩 雲 女 士 擔 任 主 席,其 他 成 員 包 括 執 行 董 事 唐 緯 坤 博 士、林 芷
伊女士及獨立非執行董事胡野碧先生。
提名委員會
本公司已成立提名委員會,以協助董事會對本公司的董事提名制度實行整體管理。現時,
提名委員會由獨立非執行董事蘇彩雲女士擔任主席,其他成員包括執行董事周超先生及
獨立非執行董事胡野碧先生。
註: 於本公告中,機構及產品之中文譯名為非官方翻譯,僅為作展示用途。
承董事會命
遠大醫藥集團有限公司
主席
唐緯坤博士
香港,二零二六年八月二十六日
於本公告日期,董事會由四名執行董事唐緯坤博士、周超先生、楊光先生及林芷伊女士,
及四名獨立非執行董事蘇彩雲女士、邢麗娜博士、裴更博士及胡野碧先生組成。
* 僅供識別
— 49 —
中期業績
遠大醫藥集團有限公司(「本公司」)董事(「董事」)會(「董事會」)欣然公佈本公司及其附屬
公司(統稱「本集團」)截至二零二六年六月三十日止六個月之未經審核綜合中期業績,連
同過往期間之比較數字一並列示。
簡明綜合損益及其他全面收益表
截至二零二六年六月三十日止六個月
截至六月三十日止六個月
二零二六年 二零二五年
附註
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
4
6,388,913
(3,021,240)
6,189,196
(2,536,157)
毛利
其他收入及虧損淨額
分銷成本
行政費用
按公平值計入損益之金融資產的公平值變動
應佔聯營公司業績
財務費用
3,367,673
44,914
(1,582,343)
(668,097)
114,376
58,314
(76,756)
3,653,039
205,405
(1,919,443)
(705,473)
174,593
57,944
(81,995)
除稅前溢利
所得稅開支
5
1,258,081
(189,475)
1,384,070
(180,769)
期內溢利
6
1,068,606
1,203,301
收益
銷售成本
— 50 —
截至六月三十日止六個月
二零二六年 二零二五年
附註
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
其他全面收益╱(虧損),除所得稅後
其後不會重新歸類至損益的項目:
按公平值計入其他全面收益之於股本之投資的
公平值變動
應佔聯營公司其他全面虧損
(31,875)
(34,353)
24,155
(29,212)
其後可能重新歸類至損益的項目:
換算海外業務產生之匯兌差額
350,507
423,642
除所得稅後期內其他全面收益
284,279
418,585
除所得稅後期內總全面收益
1,352,885
1,621,886
下列人士應佔期內溢利:
-本公司擁有人
-非控股權益
1,061,538
7,068
1,193,167
10,134
1,068,606
1,203,301
1,352,196
689
1,615,402
6,484
1,352,885
1,621,886
下列人士應佔期內總全面溢利:
-本公司擁有人
-非控股權益
股息
7
–
–
每股盈利
-基本及攤薄(港仙)
8
30.31
34.07
— 51 —
簡明綜合財務狀況表
於二零二六年六月三十日
附註
非流動資產
物業、機器及設備
使用權資產
投資性房地產
於聯營公司之權益
按公平值計入其他全面收益之股本工具
商譽
無形資產
遞延稅項資產
預付款項
流動資產
存貨
應收貿易賬款及其他應收款
應收關連公司款項
按公平值計入損益的金融資產
已抵押銀行存款
現金及現金等價物
流動負債
應付貿易賬款及其他應付款
合約負債
銀行借款及其他借款
租賃負債
應付關連公司款項
應付直接控股公司款項
應付所得稅項
9
9
10
10
— 52 —
二零二五年
二零二六年
十二月 二零二五年
六月三十日
三十一日
一月一日
港幣千元
港幣千元
港幣千元
(未經審核) (未經審核) (未經審核)
(經重列) (經重列)
4,567,707
504,875
183,832
7,916,349
178,733
1,801,648
3,323,751
110,508
1,328,248
4,407,175
500,955
176,694
7,604,716
209,656
1,731,688
3,270,771
70,639
1,028,713
3,864,305
490,340
174,356
7,791,030
247,724
1,352,345
2,089,911
33,463
1,073,670
19,915,651
19,001,007
17,117,144
1,479,251
5,397,239
48,814
602,504
43,632
623,081
1,517,638
4,732,590
52,775
924,169
22,588
1,182,397
1,434,231
3,519,769
51,534
1,799,961
–
1,351,086
8,194,521
8,432,157
8,156,581
4,002,710
200,406
1,666,244
11,708
4,671
2,331
220,710
4,003,962
337,802
2,893,036
14,841
46,496
2,331
198,018
3,046,160
242,719
3,216,102
20,422
13,151
2,331
243,978
6,108,780
7,496,486
6,784,863
附註
二零二五年
二零二六年
十二月 二零二五年
六月三十日
三十一日
一月一日
港幣千元
港幣千元
港幣千元
(未經審核) (未經審核) (未經審核)
(經重列) (經重列)
淨流動資產
2,085,741
935,671
1,371,718
總資產減流動負債
22,001,392
19,936,678
18,488,862
非流動負債
銀行借款及其他借款
租賃負債
遞延稅項負債
其他應付款
遞延收入
3,331,121
42,036
366,622
569,068
333,186
1,840,763
40,277
367,265
224,671
321,149
1,256,280
40,604
300,351
–
299,843
4,642,033
2,794,125
1,897,078
資產淨值
17,359,359
17,142,553
16,591,784
本公司擁有人應佔股本及儲備
股本
儲備
35,496
17,223,941
35,496
16,953,391
35,496
16,493,123
本公司擁有人應佔權益
非控股權益
17,259,437
99,922
16,988,887
153,666
16,528,619
63,165
權益總額
17,359,359
17,142,553
16,591,784
10
— 53 —
附註:
1.
編制基準
本簡明綜合中期財務報表是根據香港會計師公會(「香港會計師公會」)頒佈的香港會計準則第34號(「香
港會計準則第34號」)
「中期財務報告」及香港聯合交易所有限公司證券上市規則(「上市規則」)的適用
披露規定而編製。
本 簡 明 綜 合 中 期 財 務 報 表 包 括 綜 合 財 務 業 績 及 經 選 擇 的 說 明 附 註。附 註 包 括 對 了 解 本 集 團 自 二 零
二五年年度財務報表起的財務狀況及業績變動而言屬重要的事件及交易的說明。於批准簡明綜合財
務報表時,本公司董事合理預期本集團有充足資源於可見將來繼續經營。因此,彼等於編製簡明綜
合財務報表時繼續採用持續經營會計基準。
載列於本綜合中期財務業績中有關截至二零二五年十二月三十一日止財政年度的財務資料(作為過
往所呈報的資料)並不構成本公司於該財政年度的法定財務報表,惟該等資料是源自該等財務報表。
截至二零二五年十二月三十一日止年度的法定財務報表於本公司註冊辦事處可供查閱。核數師於二
零二六年三月二十六日發表對該財務報表作出無保留意見的報告。
2.
涉及受共同控製實體的業務合併之合併會計法
於二零二五年十二月三十一日,本公司作為買方與中國遠大及武漢九祥生物科技合夥企業(有限合伙)
就河北九孚和保定加合100%股權之收購事項訂立協議,代價為人民幣316,000,000元。河北九孚及其
附屬公司主要從事生產及銷售氨基酸類產品,保定加合主要從事硫醇類產品加工、製造和銷售。
於收購時點,中國遠大為河北九孚和保定加合的控股股東,其持有河北九孚81.3217%股權且同樣持
有保定加合81.3217%股權。就收購事項而言,由於中國遠大同時為本公司的控股股東,間接持有本
公司之全部已發行股本的約53.42%股權,故此收購事項被視為涉及受共同控制實體之業務合併,並
採用合併會計法原則入賬。
因此,截至二零二五年六月三十日止六個月之比較簡明綜合損益及其他全面收益表以及於二零二五
年十二月三十一日及二零二五年一月一日之簡明綜合財務狀況表已重列,藉此納入合併實體自其首
次受共同控制之日起計之資產及負債、溢利以及現金流量。
就收購事項所採用之合併會計法導致截至二零二五年六月三十日止六個月本公司擁有人應佔全面收
益總額及本公司擁有人應佔溢利分別增加港幣2,618萬元及港幣2,415萬元。
— 54 —
應用合併會計法對截至二零二五年六月三十日止六個月之簡明綜合損益及其他全面收益表中各項目
之影響如下:
截止二零二五年
截止二零二五年
六月三十日 收購事項引致的
六月三十日
止六個月 合並會計重列
止六個月
港幣千元
港幣千元
港幣千元
(未經審核)
(未經審核)
(原列)
(經重列)
收益
銷售成本
6,107,323
(2,507,159)
81,873
(28,998)
6,189,196
(2,536,157)
毛利
其他收入及虧損淨額
分銷成本
行政費用
按公平值計入損益之金融資產的公平值變動
應佔聯營公司業績
財務費用
3,600,164
203,578
(1,916,285)
(691,751)
174,593
57,944
(80,350)
52,875
1,827
(3,158)
(13,722)
–
–
(1,645)
3,653,039
205,405
(1,919,443)
(705,473)
174,593
57,944
(81,995)
除稅前溢利
所得稅開支
1,347,893
(174,023)
36,177
(6,746)
1,384,070
(180,769)
期內溢利
1,173,870
29,431
1,203,301
其他全面收益╱(虧損),除所得稅後
其後不會重新歸類至損益的項目:
按公平值計入其他全面收益之於股本之投資
的公平值變動
應佔聯營公司其他全面年收益
其後可能重新歸類至損益的項目:
換算海外業務產生之匯兌差額
24,155
(29,212)
–
–
24,155
(29,212)
421,201
2,441
423,642
除所得稅後期內其他全面收益
416,144
2,441
418,585
除所得稅後期內總全面收益
1,590,014
31,872
1,621,886
下列人士應佔期內溢利:
-本公司擁有人
-非控股權益
1,169,019
4,851
24,148
5,283
1,193,167
10,134
1,173,870
29,431
1,203,301
1,589,226
788
26,176
5,696
1,615,402
6,484
1,590,014
31,872
1,621,886
0.69
34.07
下列人士應佔期內總全面溢利:
-本公司擁有人
-非控股權益
–
股息
每股盈利
-基本及攤薄(港仙)
33.38
— 55 —
應用合併會計法對二零二五年十二月三十一日之簡明綜合財務狀況表中各項目之影響如下:
二零二五年 收購事項引致的
二零二五年
十二月三十一日 合並會計重列 十二月三十一日
港幣千元
港幣千元
港幣千元
(未經審核)
(未經審核)
(原列)
(經重列)
非流動資產
物業、機器及設備
使用權資產
投資性房地產
於聯營公司之權益
按公平值計入其他全面收益之股本工具
商譽
無形資產
遞延稅項資產
預付款項
流動資產
存貨
應收貿易賬款及其他應收款
應收關連公司款項
按公平值計入損益的金融資產
已抵押銀行存款
現金及現金等價物
流動負債
應付貿易賬款及其他應付款
合約負債
銀行借款及其他借款
租賃負債
應付關連公司款項
應付直接控股公司款項
應付所得稅項
淨流動資產
總資產減流動負債
— 56 —
4,332,283
492,214
176,694
7,604,716
209,656
1,676,875
3,269,431
70,632
1,026,776
74,892
8,741
–
–
–
54,813
1,340
7
1,937
4,407,175
500,955
176,694
7,604,716
209,656
1,731,688
3,270,771
70,639
1,028,713
18,859,277
141,730
19,001,007
1,484,191
4,679,486
54,723
924,169
22,588
1,142,370
33,447
53,104
(1,948)
–
–
40,027
1,517,638
4,732,590
52,775
924,169
22,588
1,182,397
8,307,527
124,630
8,432,157
3,936,683
323,926
2,828,720
12,646
16,778
2,331
195,627
67,279
13,876
64,316
2,195
29,718
–
2,391
4,003,962
337,802
2,893,036
14,841
46,496
2,331
198,018
7,316,711
179,775
7,496,486
990,816
(55,145)
935,671
19,850,093
86,585
19,936,678
二零二五年 收購事項引致的
二零二五年
十二月三十一日 合並會計重列 十二月三十一日
港幣千元
港幣千元
港幣千元
(未經審核)
(未經審核)
(原列)
(經重列)
非流動負債
銀行借款及其他借款
租賃負債
遞延稅項負債
其他應付款
遞延收入
1,840,763
40,277
367,265
105,798
316,305
–
–
–
118,873
4,844
1,840,763
40,277
367,265
224,671
321,149
2,670,408
123,717
2,794,125
資產淨值
17,179,685
(37,132)
17,142,553
本公司擁有人應佔股本及儲備
股本
儲備
35,496
16,981,543
–
(28,152)
35,496
16,953,391
本公司擁有人應佔權益
非控股權益
17,017,039
162,646
(28,152)
(8,980)
16,988,887
153,666
權益總額
17,179,685
(37,132)
17,142,553
— 57 —
上述有關收購事項之合併會計重列對二零二五年一月一日之簡明綜合財務狀況表中各項目之影響如下:
二零二五年 收購事項引致的
一月一日 合並會計重列
港幣千元
港幣千元
(未經審核)
(原列)
非流動資產
物業、機器及設備
使用權資產
投資性房地產
於聯營公司之權益
按公平值計入其他全面收益之股本工具
商譽
無形資產
遞延稅項資產
預付款項
二零二五年
一月一日
港幣千元
(未經審核)
(經重列)
3,784,285
481,783
174,356
7,791,030
247,724
1,299,741
2,082,728
33,456
1,070,540
80,020
8,557
–
–
–
52,604
7,183
7
3,130
3,864,305
490,340
174,356
7,791,030
247,724
1,352,345
2,089,911
33,463
1,073,670
16,965,643
151,501
17,117,144
1,370,582
3,454,589
59,411
1,799,961
1,340,979
63,649
65,180
(7,877)
–
10,107
1,434,231
3,519,769
51,534
1,799,961
1,351,086
8,025,522
131,059
8,156,581
2,928,087
242,719
3,127,347
18,315
13,151
2,331
241,273
118,073
–
88,755
2,107
–
–
2,705
3,046,160
242,719
3,216,102
20,422
13,151
2,331
243,978
6,573,223
211,640
6,784,863
淨流動資產
1,452,299
(80,581)
1,371,718
總資產減流動負債
18,417,942
70,920
18,488,862
流動資產
存貨
應收貿易賬款及其他應收款
應收關連公司款項
按公平值計入損益的金融資產
現金及現金等價物
流動負債
應付貿易賬款及其他應付款
合約負債
銀行借款及其他借款
租賃負債
應付關連公司款項
應付直接控股公司款項
應付所得稅項
— 58 —
二零二五年 收購事項引致的
一月一日 合並會計重列
港幣千元
港幣千元
(未經審核)
(原列)
非流動負債
銀行借款及其他借款
租賃負債
遞延稅項負債
遞延收入
二零二五年
一月一日
港幣千元
(未經審核)
(經重列)
1,256,280
40,604
300,351
295,369
–
–
–
4,474
1,256,280
40,604
300,351
299,843
1,892,604
4,474
1,897,078
資產淨值
16,525,338
66,446
16,591,784
本公司擁有人應佔股本及儲備
股本
儲備
35,496
16,437,714
–
55,409
35,496
16,493,123
本公司擁有人應佔權益
非控股權益
16,473,210
52,128
55,409
11,037
16,528,619
63,165
權益總額
16,525,338
66,446
16,591,784
— 59 —
3.
會計政策
本簡明綜合財務報表乃按歷史成本基準編製,惟按公允值計量(倘適用)的若干金融工具除外。
除因應用經修訂香港財務報告準則會計準則而造成其他會計政策╱會計政策變動外,截至二零二六
年六月三十日止六個月的簡明綜合財務報表採用的會計政策及計算方法與本集團截至二零二五年
十二月三十一日止年度的年度綜合財務報表所呈列者一致。
應用經修訂香港財務報告準則會計準則
於本中期期間,本集團已首次應用以下由香港會計師公會頒佈的經修訂香港財務報告準則會計準則,
且於二零二六年一月一日開始年度期間強制生效,以編製本集團之簡明綜合財務報表:
香港財務報告準則第9號及
香港財務報告準則第7號(修訂本)
香港財務報告準則第9號及
香港財務報告準則第7號(修訂本)
香港財務報告準則會計準則(修訂本)
金融工具分類及計量
涉及依賴自然能源生產電力的合約
香港財務報告準則會計準則的年度改進-第11冊
於本期間應用經修訂香港財務報告準則會計準則不會對本集團於本期間及過往期間之財務狀況及表
現及╱或於該等簡明綜合財務報表所載列之披露造成重大影響。
4.
收益及分類資料
截至二零二六年六月三十日止六個月期間,本集團的經營一貫只有一個可報告分部,即從事製造及
銷售製藥科技產品、生物技術產品以及核藥抗腫瘤診療及心腦血管精準介人診療科技產品。而董事
會作為本集團之主要經營決策者,會審閱本集團之整體經營業績以作出有關資源分配之決定。
本集團之收益指扣除折扣及銷售相關稅項之已售貨品發票值。
— 60 —
地區資料
本集團之業務主要位於中華人民共和國(「中國」)
(所處國家),亦來自美國、歐洲及亞洲產生收益。
本集團按客戶所在地劃分之來自外界客戶收益截及有關其按資產所在地劃分之非流動資產資料如下:
來自外界客戶之收益
截至六月三十日止六個月
非流動資產
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
二零二六年
港幣千元
(未經審核)
二零二五年
港幣千元
(未經審核)
(經重列)
中國
美洲
歐洲
亞洲(不包括中國)
其他
5,295,014
565,770
242,358
253,941
31,830
5,370,813
373,186
229,197
184,721
31,279
13,759,994
250,827
–
106,922
–
13,079,416
261,327
–
103,689
–
總計
6,388,913
6,189,196
14,117,743
13,444,432
附註: 非流動資產並不包括按公平值計入其他收益之股本工具、遞延稅項資產及部份於聯營公司
之權益。
有關主要客戶之資料
截至二零二六年及二零二五年六月三十日止六個月期間,本集團概無來自單一客戶之收益佔本集團
總收益之10%或以上。
— 61 —
收益
來自客戶之合約的收益
截至六月三十日止六個月
二零二六年
二零二五年
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
貨物及服務種類
生產及銷售製藥科技產品
銷售生物技術產品
銷售核藥抗腫瘤診療及心腦血管精準介入診療科技產品
3,274,083
2,369,701
745,129
3,845,193
1,766,260
577,743
於個別時間點確認之收益
6,388,913
6,189,196
於分部資訊中披露的收益
外部客戶
6,388,913
6,189,196
收益確認時間
於個別時間點
6,388,913
6,189,196
本集團的所有收益為於個別時間,按貨物送給客戶、或客戶接受後或貨物的控制權轉移給客戶後確認。
所有收益合約為期一年或更短,而根據香港財務報告準則第15號之實務規則所準許,分配至該等未
獲滿足的合同之交易價格並沒有被披露。
5.
所得稅開支
簡明綜合損益及其他全面收益表所示的所得稅為:
截至六月三十日止六個月
二零二六年
二零二五年
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
本期稅項
遞延稅項
— 62 —
245,202
(55,727)
189,434
(8,665)
189,475
180,769
根據香港利得稅的利得稅兩級制,合資格集團實體之首港幣2,000,000元溢利將按8.25%之稅率徵稅,
而超過港幣2,000,000元之溢利則按16.5%之稅率徵稅。不符合利得稅兩級制的集團實體之溢利將繼續
按16.5%之統一稅率徵稅。
根據中華人民共和國企業所得法(「企業所得稅法」)及企業所得稅法之執行規定,中國附屬公司之稅
率自二零零八年一月一日開始為25%。
根據有關中國稅務法例,企業獲相關機構評定為高新科技企業(「高新科技企業」)可享寬減企業所得
稅(「企 業 所 得 稅」)稅 率15%。若 干 附 屬 公 司 獲 確 認 為 高 新 科 技 企 業,因 此 須 按 稅 率15%繳 納 企 業 所
得稅。有關政府團體每三年進行檢討以認定高新科技企業之資格。
6.
期內溢利
截至六月三十日止六個月
二零二六年
二零二五年
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
本年度溢利已扣除下列各項:
員工成本包括:
-工資及薪金
-退休福利計劃供款
1,084,957
92,334
1,095,557
89,955
1,177,291
1,185,512
物業、機器及設備折舊
使用權資產之折舊
無形資產之攤銷
194,336
16,603
138,556
185,847
24,875
84,278
折舊及攤銷總額
349,495
295,000
3,011,784
2,487
263,179
2,536,157
3,574
280,611
確認為開支之存貨成本
土地及樓宇之經營租賃租金
研發開支
7.
中期股息
截 至 二 零 二 六 年 六 月 三 十 日 止 六 個 月,董 事 會 宣 派 及 支 付 了 每 股 港 幣0.169元 或 合 共 約 港 幣
591,810,000元 股 息,作 為 截 至 二 零 二 五 年 十 二 月 三 十 一 日 止 年 度 之 末 期 股 息(二 零 二 五 年:每 股 港
幣0.26元或合共約港幣910,471,000元)。
截至二零二六年六月三十日止六個月期間,本公司概無派付或宣派中期股息(截至二零二五年六月
三十日止六個月:無)。
— 63 —
8.
每股盈利
每股基本盈利由本公司擁有人應佔溢利除以期內之普通股加權平均數結餘,當中並不包括本集團購
入並持有作為庫存股之普通股。
截至六月三十日止六個月
二零二六年
二零二五年
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
盈利:
計算每股基本盈利之溢利
股份數目:
計算每股基本盈利之普通股加權平均數(附註)
1,061,538
1,193,167
千股
(未經審核)
千股
(未經審核)
(經重列)
3,501,810
3,501,810
附註:
於二零二六年六月三十日及二零二五年六月三十日,作為計算每股盈利用途,已發行股份中已扣除
庫存股。
因為並無已發行潛在普通股,故截至二零二六年及二零二五年六月三十日止六個月期間的每股基本
及攤薄盈利為一致。
9.
應收貿易賬款及其他應收款
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
應收貿易賬款,淨額
應收票據
按金及預付款
其他應收稅款
其他應收款,淨額
3,919,472
505,508
2,041,189
160,090
99,228
1,798,997
1,727,468
1,869,788
167,440
197,610
減:預付款的非流動部分
6,725,487
(1,328,248)
5,761,303
(1,028,713)
5,397,239
4,732,590
— 64 —
本集團向其貿易客戶提供30天至180天之信用期。本集團並未向其應收貿易賬款及其他應收款收取任
何擔保物。以下為應收貿易賬款於呈報日期按發票日期呈列之賬齡分析。應收票據之到期日為本報
告日期之180日內。
應收貿易賬款賬齡分析如下:
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
90天以內
91天至180天
181天至365天
10.
2,375,923
802,277
741,272
1,413,503
247,698
137,796
3,919,472
1,798,997
應付貿易賬款及其他應付款
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
應付貿易賬款
應付票據
應記費用及其他應付賬款
其他應付稅款
1,191,717
791,297
2,412,858
175,906
903,878
968,855
2,227,621
128,279
減 :其他應付款的非流動部分
4,571,778
(569,068)
4,228,633
(224,671)
4,002,710
4,003,962
200,406
337,802
合約負債(附註a)
— 65 —
附註:
(a)
與銷售產成品相關的合約負債為預期於一年內支付。
以下為應付貿易賬款於呈報期末按發票日期呈列之賬齡分析:
二零二六年
二零二五年
六月三十日 十二月三十一日
港幣千元
港幣千元
(未經審核) (未經審核)
(經重列)
90天以內
90天以上
11.
479,298
712,419
506,493
397,385
1,191,717
903,878
或然負債
於二零二六年六月三十日,本集團概無重大或然負債(二零二五年十二月三十一:無)。
— 66 —
决策记录链 · 只追加
每次领取产生一条记录,重新决策追加一条并以 supersedes 指向被替代的记录(ADR 0014)。
这条决策早于决策账本(2026-10-08 起逐条追加),没有追加记录。