石药集团SYH9087罗替高汀长效注射液获中国临床试验批准

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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.

CSPC PHARMACEUTICAL GROUP LIMITED
石藥集團有限公司
(Incorporated in Hong Kong with limited liability)

(Stock Code: 1093)

VOLUNTARY ANNOUNCEMENT
ROTIGOTINE LONG-ACTING INJECTION (SYH9087 INJECTION)
OBTAINS CLINICAL TRIAL APPROVAL IN CHINA
The Board of Directors (the ‘‘Board’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company’’,
together with its subsidiaries, the ‘‘Group’’) is pleased to announce that the dopamine receptor agonist
rotigotine long-acting injection (SYH9087 injection) (the ‘‘Product’’) developed by the Group has
obtained approval from the National Medical Products Administration of the People’s Republic of
China to conduct clinical trials in China.
The Product is the first long-acting subcutaneous rotigotine product approved for clinical trials in
China. Leveraging the Group’s long-acting delivery technology platform and based on excipients with
excellent biocompatibility, it forms an in situ depot following subcutaneous injection, thereby achieving
sustained drug delivery. The Product is administered once weekly. Compared with the marketed
rotigotine microsphere product, the Product is administered by subcutaneous rather than intramuscular
injection, and it does not require reconstitution prior to clinical use. Furthermore, the Product utilises a
finer injection needle and a smaller administration volume, which is expected to effectively alleviate
patient pain at the injection site, enhancing convenience of clinical application and patient compliance.
Preclinical study results demonstrated that, compared with the commercially available microsphere
injection, the Product exhibited superior efficacy in the treatment of Parkinson’s disease along with a
favourable safety profile.

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The indication for this clinical trial approval is Parkinson’s disease. This clinical trial approval will
further enrich the Group’s product pipeline in the psychiatric and neurological therapeutic area, and it
also represents another important research and development (R&D) achievement for the Group in the
field of long-acting formulations. The Group remains committed to developing more drugs with high
clinical value and to providing better treatment options for patients.
By Order of the Board
CSPC Pharmaceutical Group Limited
CAI Dong Chen
Chairman
Hong Kong, 9 September 2026
As at the date of this announcement, the Board comprises Mr. CAI Dong Chen, Dr. CAI Lei, Mr. WEI
Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Dr. LI Chunlei, Dr. YAO Bing, Mr. CAI Xin, Mr.
CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiwei as Executive Directors; and Mr. WANG Bo,
Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Stephen
and Ms. LI Quan 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之任何損失承擔任何責任。

CSPC PHARMACEUTICAL GROUP LIMITED
石藥集團有限公司
（於香港註冊成立之有限公司）

（ 股份 代號 ： 1093）

自願公告
羅 替 高 汀 長 效 注 射 液（ SYH 9087 注 射 液 ）
在中國獲臨床試驗批准
石 藥 集 團 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 開 發 的 多 巴 胺 受 體 激 動 劑 羅 替 高 汀 長 效 注 射 液（ SYH 9087 注 射 液 （
）「 該 產 品 」）已
獲中華人民共和國國家藥品監督管理局批准，可在中國開展臨床試驗。
該產品為國內首個獲批開展臨床試驗的皮下注射羅替高汀長效產品，利用本集團的長效遞
送技術平台，以具有良好生物相容性的輔料為基礎，經皮下注射後形成原位藥物貯庫，從
而可實現藥物長效遞送。該產品每週給藥一次，與已獲批上市的羅替高汀微球產品相比，
其給藥途徑由肌肉注射改為皮下注射，且臨床使用前無需複雜的配製。此外，該產品注射
針頭更細且給藥體積更小，預期可有效減輕患者注射部位的疼痛，提升臨床使用便捷性和
患者的用藥依從性。臨床前研究結果顯示，相對於市售微球注射劑，該產品表現出更為顯
著的抗帕金森病藥效優勢和良好的安全性。

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本次獲批的適應症為帕金森病。此次臨床試驗獲批將進一步豐富本集團在精神神經領域的
產品線，同時亦是本集團在長效制劑領域取得的又一重要研發成果。本集團將繼續致力於
開發更多具有高臨床價值的藥物，為廣大患者提供更優的治療選擇。
承董事會命
石藥集團有限公司
主席
蔡東晨
香 港 ， 2026 年 9 月 9 日

於本公告日期，董事會包括執行董事蔡東晨先生、蔡磊博士、魏青杰先生、張翠龍先生、
王振國先生、李春雷博士、姚兵博士、蔡鑫先生、陳衛平先生、屈志勇先生及張翊維先
生 ； 及 獨 立 非 執 行 董 事 王 波 先 生 、 CHEN Chuan 先 生 、 王 宏 廣 教 授 、 歐 振 國 先 生 、 羅 卓 堅 先
生及李泉女士。

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