中国生物制药附属正大天晴与Cipla就HER2双抗ADC TQB2102订立印度等七个新兴市场独家授权协议，潜在里程碑最高1.23亿美元

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reliance upon the whole or any part of the contents of this announcement.

(Incorporated in the Cayman Islands with limited liability)
Website: www.sbpgroup.com
(Stock code: 1177)

VOLUNTARY ANNOUNCEMENT
EXCLUSIVE LICENSE AGREEMENT FOR TQB2102 WITH CIPLA
The board of directors (the “Board”) of Sino Biopharmaceutical Limited (the “Company”, together
with its subsidiaries, the “Group”) is pleased to announce that Chia Tai Tianqing Pharmaceutical Group
Co., Ltd. (“CTTQ”), a subsidiary of the Company, has entered into an exclusive license and supply
agreement (the “Agreement”) with Cipla Limited (“Cipla”) for TQB2102, also known as rolditamig
deuderuxtecan, the Group’s potential best-in-class HER2 bispecific antibody-drug conjugate (“ADC”).
This is the second regional partnership for TQB2102. Together, these partnerships have generated
approximately US$30 million in upfront and milestone payments for the Group, underscoring the
commercial potential of the asset and the Group’s disciplined regional partnering strategy.
Deal Details
Subject to the terms and conditions of the Agreement, the Group will grant Cipla an exclusive licence
to develop and commercialize TQB2102 in India, South Africa and five other emerging markets
(“Licensed Territories”). Cipla will be responsible for local clinical development, regulatory activities
and commercialization in the Licensed Territories, while CTTQ will continue to manufacture and supply
TQB2102.
The Group will receive an upfront payment, and is eligible for potential development, regulatory and
sales milestone payments of up to US$123 million and tiered double-digit royalties based on net sales of
TQB2102.

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Accelerating Global Expansion and Patient Access
The Agreement advances the Group’s strategy of bringing late stage innovative medicines to patients
globally through carefully selected partners with strong local capabilities and market access. Cipla’s
established regulatory, medical and commercial presence across India, South Africa and other emerging
markets provides a strong platform to accelerate the local development and regulatory approvals of
TQB2102 throughout the Licensed Territories.
The collaboration is expected to support future patient access to this potential best-in-class HER2 ADC,
subject to applicable regulatory approvals, while supporting the Group’s international expansion and
long-term value creation.
About Cipla
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth,
complex generics, and deepening portfolio in our home markets of India, South Africa, North America,
and key regulated and emerging markets. Our strengths in the respiratory, antiretroviral, urology,
cardiology, anti-infective and CNS segments are well-known. Our 48 manufacturing sites around the
world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater
to our 70+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Jun’26), 2nd largest in
the pharma prescription market in South Africa (IQVIA MAT May’26), and 2nd largest by prescription
in the US Gx (Repulses + MDI) products (IQVIA MAT Jun’26).
For nine decades, making a difference to patients has inspired every aspect of Cipla’s work. Our
paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in
Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and
affordability to the center of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian
approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links
wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders.
About Rolditamig Deuderuxtecan (TQB2102)
TQB2102 is a next-generation HER2 dual-epitope bispecific ADC independently developed by the
Group. It simultaneously binds to the ECD II and ECD IV domains of HER2 and incorporates a
cleavable linker and topoisomerase I inhibitor payload. These differentiated designs have overcome
the limitations of conventional HER2 monoclonal antibodies or single-target ADCs. In particular, the
dual-epitope binding mode can enhance the cross-link to receptors and endocytosis efficiency, thereby
possessing clearly differentiated advantages in the treatment of patients with HER2-low expression.

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At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the Group announced
results from a Phase Ib clinical study of TQB2102 in HER2-low advanced breast cancer, demonstrating
favorable efficacy and showing a manageable safety profile. In HER2-low patients who had received
multiple prior lines of therapy (median of 4 lines of late-stage systemic therapy and 2 lines of palliative
chemotherapy), the overall objective response rate (ORR) was 53.4% (39/73). Among patients who had
previously progressed on ADC therapy, 44.4% achieved remission following TQB2102 treatment. In
terms of safety, there was one case (0.55%) of grade 2 interstitial lung disease (ILD), with the incidence
reported to be lower than that of other HER2 ADCs.
TQB2102 has received three Breakthrough Therapy Designations from the Center for Drug Evaluation
of China’s National Medical Products Administration. It is currently being evaluated in several Phase
III clinical trials covering HER2-low, HER2-positive breast cancer, colorectal cancer and biliary tract
cancer across multiple treatment settings. The Group will present the Phase III clinical study data
of TQB2102 for the treatment of HER2-low breast cancer at the 2026 European Society for Medical
Oncology (ESMO) Annual Meeting as a Late-Breaking Abstract (LBA). The Group will present the
Phase III clinical study data of TQB2102 for the treatment of HER2-low breast cancer at the 2026
European Society for Medical Oncology (ESMO) Annual Meeting as a Late-Breaking Abstract (LBA).
By order of the Board
Sino Biopharmaceutical Limited
Tse, Theresa Y Y
Chairwoman
Hong Kong, 31 August 2026

As at the date of this announcement, the Board of the Company comprises five executive directors,
namely Ms. Tse, Theresa Y Y, Mr. Tse Ping, Ms. Cheng Cheung Ling, Mr. Tse, Eric S Y and Mr. Tse
Hsin and six independent non-executive directors, namely Mr. Lu Zhengfei, Ms. Lu Hong, Mr. Zhang
Lu Fu, Dr. Li Kwok Tung Donald, Dr. Chen Lieping and Dr. Lu Bai.

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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的內容概不負責，對其準確性或完
整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份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。

（於開曼群島註冊成立之有限公司）
網站：www.sbpgroup.com
（股份編號：1177）

自願公告
與Cipla就TQB2102訂立獨家授權協議
中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）欣然宣佈，本
集團附屬公司正大天晴藥業集團股份有限公司（「正大天晴」）已與Cipla Limited（「Cipla」）就本集團自
主研發的HER2雙抗ADC（rolditamig deuderuxtecan，研發代號：TQB2102）訂立獨家授權與供應協議
（「協議」）。
這是TQB2102達成的第二項區域授權合作。截至目前，這兩項合作已累計為本集團帶來約3,000萬美
元的首付款和里程碑付款，充分體現了該資產的商業價值，也展現了本集團穩健的區域合作佈局。
協議條款
根據協議條款及條件，本集團將授予Cipla在印度、南非及其他五個新興市場（「授權區域」）開發及商
業化TQB2102的獨家許可。Cipla將負責授權區域內的本地臨床開發、註冊申報及商業化，正大天晴
將繼續負責TQB2102的生產及供應。
本集團有權獲得首付款、潛在開發、監管及銷售里程碑付款，最高可達1.23億美元，同時還將獲得基
於TQB2102年度淨銷售額的雙位數的特許權使用費。

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加速國際化佈局，惠及更多患者
本次合作進一步推進了本集團的國際化戰略佈局。依托合作夥伴在授權區域內卓越的本地化能力與
市場准入優勢，本集團致力於把後期創新療法加速帶給全球患者。Cipla在印度、南非及其他新興市
場深耕多年，擁有成熟的註冊、醫學及商業化體系，為加速TQB2102在授權區域內的開發和商業化
奠定了堅實基礎。
此次合作有望在獲得相關監管批准後，進一步提升這款潛在同類最佳HER2 ADC藥物的全球可及
性，同時有力助推本集團的國際化進程與長期價值增長。
關於Cipla
成立於1935年，Cipla是一家全球性製藥企業，致力於實現靈活可持續的增長，專注於複雜仿製藥業
務，並持續深化其在印度、南非、北美等本土市場以及重點成熟市場和新興市場的產品組合。公司
在呼吸、抗逆轉錄病毒、泌尿、心血管、抗感染及中樞神經系統等治療領域實力突出，行業聲譽卓
著。Cipla在全球設有48處生產基地，依托前沿技術平台，生產50餘種劑型、1500餘款產品，業務覆
蓋全球70餘個市場。Cipla是印度第三大製藥公司（IQVIA MAT 2026年6月），南非處方藥市場第二大
藥企（IQVIA MAT 2026年5月），並按處方量在美國通用吸入劑及定量吸入器市場排名第二（IQVIA
MAT 2026年6月）。
九十年來，Cipla始終以改變患者生命為使命。2001年，Cipla在非洲率先推出針對HIV╱艾滋病的三
聯抗逆轉錄病毒療法，將日治療費用降至不足1美元，這一開創性舉措被公認為極大地推動了全球艾
滋病防治的包容性、可及性和可負擔性。作為負責任的企業公民，Cipla秉持「關愛生命」的宗旨，以
人道主義精神踐行醫療健康事業，在其業務所在地區積極融入社區、回饋社會，贏得了全球衛生機
構、業界同行及各方利益相關者的廣泛信賴。
關於TQB2102(rolditamig deuderuxtecan)
TQB2102是本集團自主研發的新一代HER2雙表位雙特異性抗體藥物偶聯物(ADC)。該藥物能夠同時
靶向HER2的ECD II與ECD IV結構域，並採用可裂解連接子及拓撲異構酶I抑制劑載荷。上述差異化
設計突破了傳統HER2單克隆抗體或單靶點ADC的局限，TQB2102的雙表位結合模式可增強受體交聯
及內吞效率，在治療HER2低表達患者方面具有明確的差異化優勢。

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在2025年美國臨床腫瘤學會(ASCO)年會上，本集團公布了TQB2102用於HER2低表達晚期乳腺癌的
Ib期臨床研究結果，顯示出良好的療效與安全性特徵。在既往接受過多線治療的HER2低表達患者
中（中位晚期全身治療線數4線，中位姑息化療線數2線），總體客觀緩解率(ORR)為53.4%(39/73)。值
得注意的是，即使在既往接受過ADC治療並發生疾病進展的患者中，經TQB2102治療後仍有44.4%
達到緩解。安全性方面，間質性肺病(ILD)僅發生1例（2級），發生率為0.55%，遠低於其他HER2
ADC。
TQB2102已獲中國國家藥品監督管理局藥品審評中心(CDE)的三項突破性療法認定。目前，該藥物
正在推進多項Ⅲ期臨床研究，涵蓋HER2低表達乳腺癌、HER2陽性乳腺癌、結直腸癌及膽道癌等
多個癌種。本集團將於2026年歐洲腫瘤內科學會(ESMO)年會，以最新突破性摘要(LBA)形式公布
TQB2102治療HER2低表達乳腺癌的III期臨床研究數據。
承董事會命
中國生物製藥有限公司
主席
謝其潤
香港，二零二六年八月三十一日

於本公告日期，本公司董事會包括五位執行董事，即謝其潤女士、謝炳先生、鄭翔玲女士、謝承潤
先生及謝炘先生，以及六位獨立非執行董事，即陸正飛先生、魯紅女士、張魯夫先生、李國棟醫
生、陳列平博士及魯白博士。

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