复星医药子公司FXS5626片获批开展非节段型白癜风II/III期临床试验

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liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this
announcement.

上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*
(a joint stock company incorporated in the People ’s Republic of China with limited liability)
(Stock Code: 02196)

OVERSEAS REGULATORY ANNOUNCEMENT
This announcement is made pursuant to Rule 13.10B of the Rules Governing the Listing of Securities on
The Stock Exchange of Hong Kong Limited.
The following sets out the “Announcement in Relation to the Approval of Drug Clinical Trial of a
Subsidiary” published by Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* (the “Company”) on the
website of the Shanghai Stock Exchange, for your reference only. The following is a translation of the
above mentioned announcement solely for the purpose of providing information. Should there be any
discrepancies, the Chinese version will prevail.
By order of the Board
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*
Chen Yuqing
Chairman
Shanghai, the PRC
8 September 2026
As at the date of this announcement, the executive directors of the Company are Mr. Chen Yuqing, Ms. Guan Xiaohui, Mr.
Wen Deyong, Mr. Wang Kexin and Mr. Liu Yi; the non-executive directors of the Company are Mr. Chen Qiyu and Mr. Pan
Donghui; the independent non-executive directors of the Company are Mr. Yu Tze Shan Hailson, Mr. Wang Quandi, Mr.
Chen Penghui and Mr. Yang Yucheng; and the employee director of the Company is Ms. Yan Jia.
*

for identification purposes only

Stock Code:600196

Stock Abbreviation: Fosun Pharma

No.: Lin 2026-122

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*
Announcement in Relation to the Approval of
Drug Clinical Trial of a Subsidiary
The board of directors of the Company and all directors warrant that this
announcement does not contain any false information, misleading statement or
material omission, and accept legal liability for the truthfulness, accuracy and
completeness of the contents herein contained.

I. Overview
Recently, Shanghai Fosun Pharmaceutical Industrial Development Company
Limited* (上海復星醫藥產業發展有限公司) (the “Fosun Pharma Industrial”), a
subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* (上海復星醫藥（集團）
股份有限公司) (the “Company”) received the approval from the National Medical
Products Administration for a Phase II/III adaptive seamless design clinical trial of
FXS5626 (formerly project no.: AC-201, the “FXS5626”) for the treatment of
non-segmental vitiligo. Fosun Pharma Industrial intends to commence the relevant
clinical trial of the drug in Chinese mainland1 when the conditions are fulfilled.
II. Basic Information and Development Progress on FXS5626
FXS5626 is an oral small-molecule JAK inhibitor (TYK2/JAK1 dual-target inhibitor)
licensed in by the Group (i.e., the Company and its subsidiaries/units, the same applies
below). The Group is granted an exclusive license to research, develop, manufacture,
register and commercialize the Drug in Chinese mainland, Hong Kong and Macau.
FXS5626 is primarily indicated for autoimmune diseases. As of the date of this
announcement (i.e. 8 September 2026, the same applies below), the Phase II clinical trial
of the drug for moderate-to-severe plaque psoriasis has been completed in Chinese
mainland, and the drug for non-infectious uveitis is at the stage of Phase II clinical trial in
1

excluding Hong Kong, Macau and Taiwan for the purpose of this announcement, the same applies below.

1

Chinese mainland.
As of August 2026, the Group has invested approximately RMB108 million
(including license fees; unaudited) in total in the research and development (“R&D”) of
FXS5626 at this stage.
According to the latest data of IQVIA CHPA2, the sales of JAK inhibitors in Chinese
mainland in 2025 was approximately RMB1,980 million. As of the date of this
announcement, no TYK2/JAK1 dual-target inhibitor has been approved for launch in
Chinese mainland.
III. Impact on the Listed Company and Risk Warning
As required by the relevant laws and regulations, FXS5626 is subject to undergo a
series of clinical studies and approval by the relevant drug authority in Chinese mainland
before it can be launched. There are certain risks in the R&D of drugs based on our
experience. For example, clinical trials may be terminated due to issues such as safety
and/or efficacy.
The R&D and launch of drugs is a long-term task involving various uncertainties.
Investors should take note of the investment risks.
Announcement is hereby made.

Board of Directors of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*
8 September 2026

*For identification purpose only

2 Provided by IQVIA, a provider of professional medical and health information and strategic consultation service in
the world; IQVIA CHPA data cover the drug sales market of hospitals with more than 100 beds in China, the actual
sales of different drugs may vary from the IQVIA CHPA data to varying degrees due to their different sales channels.

2

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。

上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. *
（於中華人民共和國註冊成立的股份有限公司）
（股份代號：02196）

海外監管公告
本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出。
茲 載 列 上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司（「 本 公 司 」）在 上 海 證 券 交 易 所 網 站 刊 登 的《 關 於
控 股 子 公 司 藥 品 獲 臨 床 試 驗 批 准 的 公 告 》， 僅 供 參 閱 。
承董事會命
上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司
董事長
陳玉卿
中國，上海
2026 年9 月8 日
於本公告日期，本公司之執行董事為陳玉卿先生、關曉暉女士、文德鏞先生、王可心先生及劉毅先生；本公
司之非執行董事為陳啟宇先生及潘東輝先生；本公司之獨立非執行董事為余梓山先生、王全弟先生、Chen
Penghui先生及楊玉成先生；以及本公司職工董事為嚴佳女士。
*

僅供識別

证券代码：600196

股票简称：复星医药

编号：临 2026-122

上海复星医药（集团）股份有限公司
关于控股子公司药品获临床试验批准的公告
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述
或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。

一、 概况
近日，上海复星医药（集团）股份有限公司（以下简称“本公司”）控股子公
司上海复星医药产业发展有限公司（以下简称“复星医药产业”）收到国家药品监
督管理局关于同意 FXS5626 片（原项目代号：AC-201, 以下简称“FXS5626”）用于
治疗非节段型白癜风开展 II/III 期适应性无缝设计临床试验的批准。复星医药产业
1

拟于条件具备后于中国境内 开展该药品的相关临床研究。

二、FXS5626 的基本信息及研究情况
FXS5626 系本集团（即本公司及控股子公司/单位，下同）许可引进的口服小分
子 JAK 抑制剂（TYK2/JAK1 双靶点抑制剂），本集团享有该药品于中国境内及港澳
地区研究、开发、生产、注册及商业化的独占权利。FXS5626 拟主要用于自身免疫
性疾病领域，截至本公告日期（即 2026 年 9 月 8 日，下同），该药品用于中重度斑
块型银屑病已于中国境内完成 II 期临床试验、用于非感染性葡萄膜炎于中国境内处
于 II 期临床试验阶段。
截至 2026 年 8 月，本集团现阶段针对 FXS5626 的累计研发投入约为人民币 1.08
亿元（包含许可费用；未经审计）。
2

根据 IQVIA CHPA 最新数据 ，2025 年，JAK 抑制剂于中国境内的销售额约为人
民币 19.80 亿元。截至本公告日期，中国境内尚无 TYK2/JAK1 双靶点抑制剂获批上
市。

1

不包括港澳台地区，下同。
由 IQVIA 提供，IQVIA 是全球医药健康产业专业信息和战略咨询服务提供商；IQVIA CHPA 数据代表中国境内
100 张床位以上的医院药品销售市场，不同的药品因其各自销售渠道布局的不同，实际销售情况可能与 IQVIA
CHPA 数据存在不同程度的差异。
2

1

三、风险提示
根据相关法规要求，FXS5626 尚需在中国境内开展一系列临床研究并经国家药
品审评部门审批通过后，方可上市。根据研发经验，药品研发存在一定风险，例如
临床试验可能会因为安全性和/或有效性等问题而终止。
药品研发及至上市是一项长期工作，存在诸多不确定因素，敬请广大投资者注
意投资风险。

特此公告。

上海复星医药（集团）股份有限公司
董事会
二零二六年九月八日

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