海西新药HX9428完成nAMD I期并递交DME IIa期IND申请

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

Fujian Haixi Pharmaceuticals Co., Ltd.
福建海西新藥創制股份有限公司
(A joint stock company incorporated in the People’s Republic of China with limited liability)
(Stock Code: 2637)

VOLUNTARY ANNOUNCEMENT
HX9428 SUCCESSFULLY COMPLETES PHASE I CLINICAL STUDY
IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
AND SUBMITS PHASE IIA IND APPLICATION FOR NEW
INDICATION OF DIABETIC MACULAR EDEMA
This announcement is made by Fujian Haixi Pharmaceuticals Co., Ltd. (the
“Company”, together with its subsidiaries, the “Group” or “Haixi
Pharmaceuticals”) on a voluntary basis to inform the shareholders and potential
investors of the Company about the latest business updates of the Group.
The board of directors of the Company (the “Board”) is pleased to announce that
HX9428, the candidate drug molecule of the innovative drug project HXP056
independently developed by the Company, formally submitted an Investigational
New Drug application (IND) for a Phase IIa clinical trial for a new indication,
diabetic macular edema (“DME”), to the Center for Drug Evaluation (CDE) of the
National Medical Products Administration (NMPA) of China on 31 August 2026.
DME is the second indication being advanced for HX9428, marking a new milestone
in the research and development of this oral innovative ophthalmic drug.
As of the date of this announcement, HX9428 has been granted Fast Track
Designation (“FTD”) by the U.S. Food and Drug Administration (the “FDA”), and
Phase II clinical studies for its first indication, neovascular age-related macular
degeneration (“nAMD”, also called wet age-related macular degeneration (wAMD)),
are ongoing concurrently in China and the United States. Recently, interim data of
the Phase I study with a data cut-off in February 2026 have been made public in the
abstracts of the 2026 Annual Meeting of the American Academy of Ophthalmology
(the “AAO”). As of the date of this announcement, the Phase I dose-escalation study
in nAMD has been fully completed, enrolling a total of 15 patients across 5 dose
cohorts of 5-40 mg QD, of which 13 patients (comprising 3 treatment-naïve patients
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and 10 patients previously treated with anti-VEGF therapy) completed the planned
24-week dosing, without the need for any additional intravitreal anti-VEGF
injections throughout the dosing period. The study data showed that best corrected
visual acuity (BCVA) improved by more than 5 letters from baseline on average in
the overall population, and by 12 letters from baseline on average among the 3
treatment-naïve patients. These preliminary data indicate a favourable safety profile
and potential efficacy signals of HX9428, and its safety and efficacy remain to be
validated through further clinical studies. The Company will continue to fully
advance the progress of multiple clinical studies of HX9428 in China and the United
States.
INFORMATION ON HX9428
HX9428 is a novel oral small-molecule innovative drug independently developed by
Haixi Pharmaceuticals, intended for the treatment of vascular retinal diseases such
as nAMD, DME and RVO. Currently, anti-vascular endothelial growth factor
(anti-VEGF) therapy remains the standard treatment for nAMD. However, existing
treatments require intravitreal injection in eye, and patients may face the medical
burden of long-term and repeated treatments, compliance challenges and
injection-related risks. Administered orally, HX9428 is expected to provide patients
with a more convenient dosing option as compared with traditional injection
therapies.
As of the date of this announcement, HX9428 has not received marketing approval
from any drug regulatory authority in any country or region, and its safety and
efficacy remain to be validated through further clinical studies.
INFORMATION ON HAIXI PHARMACEUTICALS
Haixi Pharmaceuticals is a biopharmaceutical company focused on the development
and commercialisation of innovative drugs, striving to develop innovative drug
products with clinical value for the treatment of oncology, ophthalmology and other
major diseases. The Company continuously advances the global clinical development
and commercialisation layout of its innovative drugs to address clinical needs that
have not been fully satisfied. The Company was listed on the Main Board of The
Stock Exchange of Hong Kong Limited in October 2025 (stock code: 2637).
RISK WARNING
The research and development of innovative drug candidates involves a high degree
of risk. Clinical trial results may be affected by various factors, including but not
limited to safety, efficacy, patient enrollment, adjustments to clinical protocols and
regulatory approval requirements. Currently, HX9428 has not received marketing
approval from any drug regulatory authority, and there is no assurance that it will
successfully complete clinical development or obtain marketing approval.
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FORWARD-LOOKING STATEMENTS
There is no assurance that any forward-looking statements regarding the business
development of the Group in this announcement or any of the matters set out herein
are attainable, will actually occur or will be realized or are complete or accurate. The
financial and other data relating to the Group as disclosed in this announcement has
also not been audited or reviewed by its auditor.
Shareholders and/or potential investors of the Company are advised to exercise
caution when dealing in the shares of the Company and not to place any
excessive reliance on the information disclosed herein. Any shareholder or
potential investor who is in doubt is advised to seek advice from professional
advisors.
By Order of the Board
Fujian Haixi Pharmaceuticals Co., Ltd.
Dr. Kang Xinshan
Executive Director, Chairman and General Manager
Hong Kong, 2 September 2026
As of the date of this announcement, the Board comprises (i) Dr. Kang Xinshan, Ms. Feng Yan, Dr.
Chen Guangming, Mr. Li Junqing and Mr. Chen Tingze as executive Directors; (ii) Mr. Xu Dong as
non-executive Director; and (iii) Ms. Wang Shan Shan, Ms. Pu Meiting and Mr. Lin Bin as independent
non-executive Directors.

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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。

Fujian Haixi Pharmaceuticals Co., Ltd.
福建海西新藥創制股份有限公司
（於中華人民共和國註冊成立的股份有限公司）
（股份代號：2637）

自願公告
HX9428 順 利 完 成 新 生 血 管 性 年 齡 相 關 性 黃 斑 變 性 (nAMD) 之
I 期 臨 床 研 究 並 遞 交 新 適 應 症 糖 尿 病 性 黃 斑 水 腫 (DME) 之
IIa 期 新 藥 臨 床 試 驗 申 請 (IND)
本公告由福建海西新藥創制股份有限公司（「本公司」，連同其附屬公司統稱「本集
團」或「海西新藥」）自願作出，以告知本公司股東及潛在投資者有關本集團的最新業
務更新。
本公司董事會（「董事會」）欣然宣佈，本公司自主研發的創新藥項目 HXP056 之候選
藥物分子 HX9428，已於 2026 年 8 月 31 日正式向中國國家藥品監督管理局 (NMPA)
藥品審評中心 (CDE) 遞交新適應症糖尿病性黃斑水腫（diabetic macular edema，簡稱
「DME」）的 IIa 期新藥臨床試驗申請 (IND)。DME 是 HX9428 推進的第二個適應症，
標誌著這款口服眼底創新藥研發的又一個里程碑。
截 至 本 公 告 日 期，HX9428 已 獲 美 國 食 品 藥 品 監 督 管 理 局（U.S. Food and Drug
Administration， 簡 稱「FDA」）授 予 快 速 通 道 資 格（Fast Track Designation， 簡 稱
「FTD」），並正同步在中美兩地開展第一個適應症新生血管性年齡相關性黃斑變性
（neovascular age-related macular degeneration，簡稱「nAMD」，亦稱濕性年齡相關
性黃斑變性，wAMD）的 II 期臨床研究。近日，I 期研究截至 2026 年 2 月的階段性數
據已在美國眼科學會（American Academy of Ophthalmology，簡稱「AAO」）2026 年

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會的摘要公開。截至目前，I 期 nAMD 的劑量爬坡研究已全部完成，入組 5-40 mg/
QD 共 5 個劑量的 15 例患者，其中 13 例患者（包含 3 例初治患者和 10 例既往接受過抗
VEGF 治療的患者）完成了計劃 24 週給藥，全程無需接受額外玻璃體注射抗 VEGF
藥物；研究數據顯示：整體人群最佳矯正視力 (BCVA) 平均提升大於 5 個字母，其
中 3 例初治患者的 BCVA 平均提升 12 個字母。上述初步數據顯示 HX9428 具有良好
的安全性特徵及潛在療效信號，其安全性及有效性尚需透過進一步臨床研究予以驗
證。本公司將繼續全力推進 HX9428 在中美兩地多項臨床研究的進展。

關於 HX9428
HX9428 是 海 西 新 藥 自 主 研 發 的 全 新 口 服 小 分 子 創 新 藥 物， 擬 用 於 治 療 nAMD、
DME 及 RVO 等血管性視網膜相關疾病。目前，抗血管內皮生長因子 (anti-VEGF)
治療仍是 nAMD 的標準治療方式。然而，現有治療需要透過眼球的玻璃體腔注射給
藥，患者可能面臨長期、反覆治療所帶來的醫療負擔、依從性挑戰以及注射相關風
險。HX9428 採用口服給藥方式，有望為患者提供較傳統注射療法更為便捷的給藥
選擇。
截至本公告日期，HX9428 尚未獲得任何國家或地區藥品監督管理機構批准上市，
其安全性及有效性尚需透過進一步臨床研究予以驗證。

關於海西新藥
海西新藥是一家專注於創新藥研發及商業化的生物醫藥企業，致力於開發具有臨床
價值的創新藥產品，覆蓋腫瘤、眼科及其他重大疾病治療領域。本公司持續推進創
新藥全球臨床開發及商業化佈局，以滿足尚未被充分滿足的臨床需求。本公司於
2025 年 10 月在香港聯合交易所有限公司主板上市（股份代號：2637）。

風險提示
創新藥候選藥物的研發具有高風險，臨床試驗結果可能受到安全性、有效性、患者
入組、臨床方案調整及監管審批要求等多種因素影響。目前，HX9428 尚未獲得任
何藥品監管機構批准上市，亦不能保證其最終能夠成功完成臨床開發或獲得上市批
准。

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前瞻性陳述
概不保證本公告所載關於本集團業務發展之任何前瞻性聲明，或任何事宜將可達
成、將真實發生或將實現或屬完整或準確。本公告所披露有關本集團財務及其他方
面的數據亦未經其核數師審核或審閱。
本公司股東及╱或潛在投資者於買賣本公司股份時務請審慎行事，不應過分依賴本
公告所披露的資料。如有疑問，股東或潛在投資者應諮詢專業顧問的意見。
承董事會命
福建海西新藥創制股份有限公司

執行董事、董事長兼總經理
康心汕博士
香港，2026 年 9 月 2 日
截至本公告日期，董事會由 (i) 執行董事康心汕博士、Feng Yan 女士、Chen Guangming 博士、李俊
青先生及陳廷澤先生；(ii) 非執行董事許冬先生；及 (iii) 獨立非執行董事王珊珊女士、蒲美婷女士及
林斌先生組成。

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