复星医药许可引进的BCMA×CD3双抗维可妥获国家药监局附条件批准上市

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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 for Drug Registration of
Licensed-in Pharmaceutical Product ” 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 abovementioned 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
27 August 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 2026-113

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*
Announcement in Relation to the Approval for Drug
Registration of Licensed-in Pharmaceutical Product
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
On 28 May 2026, Yao Pharmaceutical Company Limited.* (重慶藥友製藥有限責任
公司) (the “Yao Pharma”), 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”), entered into a license
agreement with Chongqing Genrix Biopharmaceutical Co.,ltd. * (重慶智翔金泰生物製
藥股份有限公司) (the “Genrix Bio”), pursuant to which Yao Pharma was granted the
sole and exclusive rights to the clinical development and commercialization of the
licensed product (namely a bispecific antibody product that uses GR1803 as the sole
active ingredient and/or as agreed, simultaneously targeting BCMA and CD3) within the
licensed territory (i.e., the Chinese mainland 1, Hong Kong, Macau and Taiwan regions)
and the licensed field (i.e., for the diagnosis, prevention and treatment of human diseases),
as well as the exclusive rights to the research and production of manufacturing processes,
and Yao Pharma will act as the marketing authorization holder (MAH) of the product in
the licensed territory. For details, please refer to the relevant announcements published by
the Company on 29 May 2026 in the China Securities Journal, Shanghai Securities News,
Securities

Times

and

on

the

website

of

the

(http://www.sse.com.cn).

1

Excluding Hong Kong, Macau and Taiwan regions (the same applies below).
1

Shanghai

Stock

Exchange

Recently, the marketing registration application for GR1803 Injection (Generic name:
Velinotamig Injection, trade name in the Chinese mainland: 维可妥®; the “Drug”) has
been approved with conditions by the National Medical Products Administration, for the
indication of adult patients with relapsed or refractory multiple myeloma who have
received at least three prior lines of therapy (including a proteasome inhibitor, an
immunomodulatory agent and an anti-CD38 monoclonal antibody) .
II. Registration Information of the Drug
Generic Name: Velinotamig Injection
Dosage Form: Injection
Strength: 20 mg (2 ml)/vial
Registered Category: Therapeutic Biological Product Category 1
Manufacturer: Chongqing Genrix Biopharmaceutical Co.,ltd. * (重慶智翔金泰生物
製藥股份有限公司)
Drug Approval Number: Guo Yao Zhun Zi S20260066
III. Research and Development of the Drug and Marketing Situation of Similar
Drugs
GR1803 is a bispecific antibody that can simultaneously bind to BCMA and CD3
antigens, thereby redirecting cytotoxic T cells to cells expressing BCMA. Apart from the
approved indication for registration, as at the date of this announcement (i.e., 27 August
2026, the same hereinafter), multiple clinical studies of the Drug for the treatment of adult
relapsed or refractory multiple myeloma and systemic lupus erythematosus are orderly
advancing in Chinese mainland.
According to the latest data 2 of IQVIA MIDAS™, the global sales of BCMA×CD3
targeted antibody products in 2025 was approximately USD1,139 million. As at the date
of this announcement, two BCMA×CD3 targeted antibody products have been
conditionally approved for marketing in the PRC, namely Elranatamab Injection of Pfizer
Inc. (approved for marketing in March 2025) and Teclistamab Injection of Janssen-Cilag
International NV (approved for marketing in June 2024).

Provided by IQVIA, a provider of professional medical and health information and strategic consultation service in
the world.

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IV. Impact on the Listed Company and Risk Warning
The approval for marketing of the Drug will provide a new treatment option for adult
patients with relapsed or refractory multiple myeloma in the Chinese mainland and will
further enrich the product line of the Group (i.e., the Company and its subsidiaries/units).
Subsequently, Yao Pharma and Genrix Bio will advance the procedures for the change of
the marketing authorization holder (MAH) of the Drug in accordance with the agreement.
Due to the industry characteristics of pharmaceutical products, the specific sales
performance after the market launch of pharmaceutical products may be affected by
factors including, but not limited to, the demand for medication, market competition and
sales channels, etc., and is subject to considerable uncertainty. Investors should take note
of the investment risks.

Announcement is hereby made.

Board of Directors of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*
27 August 2026

* For identification purposes only

3

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
許 可 藥 品 獲 註 冊 批 准 的 提 示 性 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8 月27 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 2026-113

上海复星医药（集团）股份有限公司
关于许可药品获注册批准的提示性公告
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
2026 年 5 月 28 日，上海复星医药（集团）股份有限公司（以下简称“本公司”）
控股子公司重庆药友制药有限责任公司（以下简称“药友制药”）与重庆智翔金泰
生物制药股份有限公司（以下简称“智翔金泰”）签订许可协议，（其中包括）药友
制药获授予许可产品（即以 GR1803 为唯一活性成分及/或约定的同时靶向 BCMA 和
CD3 的双特异性抗体药品）于中国境内1及港澳台地区的临床开发、商业化的独占权
利以及生产工艺研究、生产的排他权利，并将由药友制药作为该（等）产品于许可
区域的上市许可持有人（MAH）。以上详情请见本公司于 2026 年 5 月 29 日在《中
国证券报》
《上海证券报》
《证券时报》和上海证券交易所网站（http://www.sse.com.cn）
刊发的相关公告。
近日，GR1803 注射液（通用名：纬利妥米单抗注射液、中国境内商品名：维可
妥®，以下简称“该药品”）获国家药品监督管理局附条件批准，获批适应症为用于
既往至少接受过三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗 CD38
单克隆抗体）的复发或难治性多发性骨髓瘤成人患者。

二、该药品的注册信息
药品通用名称：纬利妥米单抗注射液
剂型：注射剂
规格：20mg（2ml）/瓶
注册分类：治疗用生物制品 1 类

1

不包括港澳台地区，下同。

1

生产企业：重庆智翔金泰生物制药股份有限公司
药品批准文号：国药准字 S20260066

三、该药品的研发和同类药品的市场情况
GR1803 是一种双特异性抗体，可同时结合 BCMA 和 CD3 抗原，从而将细胞毒性 T
细胞重定向至表达 BCMA 的细胞。除本次获批适应症外，截至本公告日期（即 2026
年 8 月 27 日，下同），该药品用于治疗成人复发或难治性多发性骨髓瘤、系统性红
斑狼疮等多项临床研究正于中国境内有序开展。
TM

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根据 IQVIA MIDAS 最新数据 ，2025 年，BCMA×CD3 靶点抗体药品于全球范围的
销售额约为 11.39 亿美元。截至本公告日期，已有 2 款 BCMA×CD3 靶点抗体药品于
中国境内获附条件上市批准，分别是 Pfizer Inc.的埃纳妥单抗注射液（2025 年 3
月获批上市）、Janssen-Cilag International NV 的特立妥单抗注射液（2024 年 6
月获批上市）。

四、对上市公司的影响及风险提示
该药品本次获批上市，可为中国境内复发或难治性多发性骨髓瘤成人患者提供
新的治疗选择，并将进一步丰富本集团（即本公司及控股子公司/单位）产品线。后
续，药友制药与智翔金泰将依约推进该药品上市许可持有人（MAH）的变更工作。
由于医药产品的行业特点，药品上市后的具体销售情况可能受到（包括但不限
于）用药需求、市场竞争、销售渠道等因素影响，具有较大的不确定性。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
二零二六年八月二十七日

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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。

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