复星医药芦沃美替尼新增成人NF1相关PN适应症获批

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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 Registration of an Additional
Indication for Drug 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
3 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 2026-117

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*
Announcement in Relation to the Approval for
Registration of an Additional Indication for Drug
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 ， the drug registration application for the additional indication of
Luvometinib Tablets (trade name:复迈宁, project no.: FCN-159, the “Drug”) of Shanghai
Fosun Pharmaceutical Industrial Development Company Limited* (上海復星醫藥產業
發展有限公司), 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”), has been approved by the National
Medical Products Administration. The additional indication is for the treatment of adult
patients with neurofibromatosis type 1 (NF1) who have symptomatic plexiform
neurofibromas (PN) not amenable to complete resection.

II. Registration Information of the Drug
Generic Name: Luvometinib Tablets
Dosage Form: Oral Tablet
Strength: 4mg, 1mg
Registration Category: Chemical, Class 2.4
Marketing Authorization Holder: Shanghai Fosun Pharmaceutical Industrial
Development, Co., Ltd. * (上海復星醫藥產業發展有限公司)

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Drug Approval Number: Guo Yao Zhun Zi H20250025、H20250026

III. Research and Development of the Drug and Marketing Situation of Similar
Drugs
The Drug is an innovative small molecule chemical drug self-developed by the
Group (i.e., the Company and its subsidiaries/units, the same applies below), which is a
MEK1/2 selective inhibitor.
As at the date of this announcement (i.e., 3 September 2026), the regulatory or
clinical progress of the Drug is as follows:
1. In addition to the newly indication approved, three other indications of the Drug
has already been approved for marketing in China1, including the treatment of (1) adult
patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms; (2) pediatric
patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have
symptomatic plexiform neurofibromas (PN) not amenable to complete resection; (3)
pediatric patients 2 years of age and older with relapsed or refractory Langerhans cell
histiocytosis (LCH) after systemic therapy.
2. Several indications of the Drug are still in clinical trials in China, including (1) the
Drug for the treatment of pediatric patients with low-grade glioma is at the stage of Phase
III clinical trial; (2) the Drug for the treatment of extracranial arteriovenous
malformations is at the stage of Phase II clinical trial; (3) the Drug in combination with
Anlotinib for the treatment of patients with KRAS-mutant advanced non-small cell lung
cancer (NSCLC) is at the stage of Phase II clinical trial.
As of July 2026, the Group had invested approximately RMB714 million (unaudited)
in total in the research and development of the Drug at this stage.
According to the latest data from IQVIA MIDAS™2, the sales of MEK1/2 selective
inhibitor worldwide amounted to approximately US$2,359 million in 2025.

1

excluding Hong Kong, Macau and Taiwan, the same hereinafter.
Data provided by IQVIA, a provider of professional medical and health information and strategic consultation service
in the world.
2

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IV. Impact on Listed Companies and Risk Warning
The approval of this additional indication will provide new treatment option for the
relevant rare tumor patients in China, and will further enhance the Drug's market
competitiveness.
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.*
3 September 2026

* For identification purposes only

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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。

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 新 增 適 應 症 獲 註 冊 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3 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 2026-117

上海复星医药（集团）股份有限公司
关于控股子公司药品新增适应症获注册批准的公告
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就芦沃美替尼片（商品名：复迈宁、项目代号：
FCN-159；以下简称“该药品”）新增适应症的药品注册申请获国家药品监督管理局
批准，本次获批的新适应症为用于伴有症状、无法手术的丛状神经纤维瘤（PN）的
I 型神经纤维瘤病（NF1）成人患者。

二、该药品的注册信息
药品通用名称：芦沃美替尼片
剂型：片剂
规格：4mg、1mg
注册分类：化学药品 2.4 类
上市许可持有人：上海复星医药产业发展有限公司
药品批准文号：国药准字 H20250025、H20250026

三、该药品的研发及同类药品的市场情况
该药品为本集团（即本公司及控股子公司/单位，下同）自主研发的创新型小分
子化学药物，为 MEK1/2 选择性抑制剂。

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截至本公告日期（即 2026 年 9 月 3 日），该药品的注册或临床进展如下：
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1、除本次获批的新适应症外，该药品另有三项适应症已于中国境内 获批上市，
包括用于（1）朗格汉斯细胞组织细胞增生症（LCH）和组织细胞肿瘤成人患者；
（2）
2 岁及 2 岁以上伴有症状、无法手术的丛状神经纤维瘤（PN）的Ⅰ型神经纤维瘤病
（NF1）儿童及青少年患者；
（3）2 岁及 2 岁以上经系统治疗后复发或难治的朗格汉
斯细胞组织细胞增生症（LCH）儿童及青少年患者。
2、该药品尚有多项适应症于中国境内处于临床试验阶段，包括（1）用于治疗
儿童低级别脑胶质瘤处于Ⅲ期临床试验阶段、（2）用于治疗颅外动静脉畸形处于Ⅱ
期临床试验阶段、（3）联合安罗替尼用于治疗鼠类肉瘤病毒癌基因（KRAS）突变的
晚期非小细胞肺癌（NSCLC）处于Ⅱ期临床试验阶段。
截至 2026 年 7 月，本集团现阶段针对该药品的累计研发投入约为人民币 7.14
亿元（未经审计）。
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根据 IQVIA MIDAS™最新数据 ，2025 年，MEK1/2 选择性抑制剂于全球范围的销
售额约为 23.59 亿美元。

四、对上市公司的影响及风险提示
本次新增适应症获批，可为中国境内相关罕见肿瘤患者提供新的治疗选择，并
进一步增强该药品的市场竞争力。
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
二零二六年九月三日

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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。

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