Core Viewpoint - Fosun Pharma's subsidiary has received acceptance for a drug registration application for the treatment of Langerhans cell histiocytosis (LCH) in children aged 2 and above, which has been included in the priority review process by the National Medical Products Administration (NMPA) [1] Group 1: Drug Development and Approval - The drug, Rumaine (generic name: Luwomeitini tablets), is already approved in China for two indications: treatment of LCH in adults and treatment of symptomatic, inoperable plexiform neurofibromas in children and adolescents with Neurofibromatosis Type 1 (NF1) [1] - The drug is currently in Phase III clinical trials for the treatment of adult NF1 and low-grade gliomas in children, and in Phase II clinical trials for the treatment of extra-cranial arteriovenous malformations [1] - The NMPA has included the drug for the treatment of inoperable or residual/recurrent NF1-related plexiform neurofibromas in adults in its breakthrough therapy program [1] Group 2: Financial Investment and Market Potential - As of October 2025, the cumulative R&D investment for the drug is approximately RMB 638 million (unaudited) [2] - According to IQVIA MIDAS™ data, the global sales for MEK1/2 selective inhibitors are projected to be approximately USD 2.068 billion in 2024 [2]

Core Insights - Fosun Pharma's subsidiary has received acceptance for a drug registration application for Luvofatin (复迈宁) to treat pediatric patients with Langerhans Cell Histiocytosis (LCH) aged 2 and above, which is now included in the priority review process by the National Medical Products Administration (NMPA) [1] - The drug is already approved in China for two indications: treating LCH in adults and symptomatic, inoperable plexiform neurofibromas in children and adolescents with Neurofibromatosis Type 1 (NF1) [1] - The drug is currently in Phase III clinical trials for treating adult NF1 and low-grade gliomas in children, and in Phase II trials for treating extra-cranial arteriovenous malformations [1] - The drug has been included in the breakthrough therapy program for adult patients with inoperable or residual/recurrent NF1-related plexiform neurofibromas by the NMPA [1] Financial Insights - As of October 2025, the cumulative R&D investment for the drug is approximately RMB 638 million (unaudited) [2] - According to IQVIA MIDAS data, the global sales for MEK1/2 selective inhibitors are projected to be around USD 2.068 billion in 2024 [2]

Core Viewpoint - Fosun Pharma's subsidiary has received acceptance for a drug registration application for Rumaine (generic name: Luwomeitini tablets) to treat children aged 2 and above with Langerhans cell histiocytosis (LCH), which is now included in the priority review process by the National Medical Products Administration (NMPA) [1] Group 1: Drug Development and Approval - The drug has already been approved in China for two indications: treatment of LCH and adult patients with tissue cell tumors, and treatment of symptomatic, inoperable plexiform neurofibromas (PN) in children and adolescents with Neurofibromatosis type 1 (NF1) [1] - The drug is currently in Phase III clinical trials for treating adult NF1 and low-grade gliomas in children, and in Phase II clinical trials for treating extra-cranial arteriovenous malformations [1] - The drug for treating inoperable or residual/recurrent NF1-related plexiform neurofibromas in adult patients has been included in the breakthrough therapy program by the NMPA [1] Group 2: Financial Investment and Market Potential - As of October 2025, the cumulative R&D investment for this drug is approximately RMB 638 million (unaudited) [2] - According to IQVIA MIDAS™ data, the global sales of MEK1/2 selective inhibitors are projected to be approximately USD 2.068 billion in 2024 [2]

Market Overview - The precision medicine sector experienced a decline of 1.61% on November 21, with Berry Genomics leading the drop [1] - The Shanghai Composite Index closed at 3834.89, down 2.45%, while the Shenzhen Component Index closed at 12538.07, down 3.41% [1] Stock Performance - Key stocks in the precision medicine sector showed varied performance, with the following notable changes: - United Imaging Healthcare (688271) increased by 2.15% to a closing price of 133.50 [1] - Berry Genomics (000710) fell by 8.67% to a closing price of 11.59, with a trading volume of 233,200 shares and a turnover of 278 million [2] - WuXi AppTec (603259) decreased by 2.00% to a closing price of 91.80, with a significant trading volume of 346,800 shares and a turnover of 3.197 billion [1] Capital Flow - The precision medicine sector saw a net outflow of 678 million from institutional investors, while retail investors contributed a net inflow of 705 million [2] - The following stocks experienced notable capital flows: - New Open Source (300109) had a net inflow of 22.76 million from institutional investors [3] - ST Xiangxue (300147) faced a significant net outflow of 17.12 million from institutional investors [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.* （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 控股子公司藥品註冊申請獲受理的公告》，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 （於中華人民共和國註冊成立的股份有限公司） 陳玉卿 中國，上海 2025 年1 1 月2 1 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、文德鏞先生及王可心先生；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；以及本公司之職工董事為嚴佳女士。 * ...

Core Viewpoint - Fosun Pharma's subsidiary has received acceptance for a drug registration application for Rumaine (generic name: Lenvatinib) to treat children aged 2 and above with Langerhans Cell Histiocytosis (LCH), which has been included in the priority review process by the National Medical Products Administration [1] Group 1: Drug Information - Rumaine is a selective MEK1/2 inhibitor [1] - The drug has already been approved for two indications in China: treatment of LCH in adult patients and treatment of symptomatic, inoperable plexiform neurofibromas (PN) in children and adolescents aged 2 and above with Neurofibromatosis Type 1 (NF1) [1]

2、该药品用于治疗成人Ⅰ型神经纤维瘤病、儿童低级别脑胶质瘤于中国境内均处于Ⅲ期临床试验阶 段，该药品用于治疗颅外动静脉畸形于中国境内处于Ⅱ期临床试验阶段。其中，该药品用于治疗无法手 术或术后残留/复发的NF1相关的丛状神经纤维瘤成人患者已被国家药监局药品审评中心纳入突破性治 疗药物程序。 该药品为集团自主研发的创新型小分子化学药物，为MEK1/2选择性抑制剂。截至本公告日期(即2025年 11月21日)，该药品的其他注册或临床情况如下： 智通财经APP讯，复星医药(600196.SH)发布公告，近日，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")就复迈宁®(通用名：芦沃美替尼片;以下简称"该药品")用于治疗2岁及2 岁以上朗格汉斯细胞组织细胞增生症(LCH)儿童患者(以下简称"新增适应症")的药品注册申请获国家药 品监督管理局(以下简称"国家药监局")受理并已被纳入优先审评程序。 1、该药品已于中国境内1上市并获批两项适应症，包括用于治疗(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 ...

2、该药品用于治疗成人Ⅰ型神经纤维瘤病、儿童低级别脑胶质瘤于中国境内均处于Ⅲ期临床试验阶 段，该药品用于治疗颅外动静脉畸形于中国境内处于Ⅱ期临床试验阶段。其中，该药品用于治疗无法手 术或术后残留/复发的NF1相关的丛状神经纤维瘤成人患者已被国家药监局药品审评中心纳入突破性治 疗药物程序。 该药品为集团自主研发的创新型小分子化学药物，为MEK1/2选择性抑制剂。截至本公告日期(即2025年 11月21日)，该药品的其他注册或临床情况如下： 1、该药品已于中国境内1上市并获批两项适应症，包括用于治疗(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。 复星医药（600196）(600196.SH)发布公告，近日，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")就复迈宁(通用名：芦沃美替尼片;以下简称"该药品")用于治疗2岁及2岁以上朗 格汉斯细胞组织细胞增生症(LCH)儿童患者(以下简称"新增适应症")的药品注册申请获国家药品监督管 理局(以下简称"国家药监局")受 ...

证券代码：600196 股票简称：复星医药 编号：临 2025-179 上海复星医药（集团）股份有限公司 关于控股子公司药品注册申请获受理的公告 1 不包括港澳台地区，下同。 1 截至 2025 年 10 月，本集团现阶段针对该药品的累计研发投入约为人民币 6.38 亿元（未经审计）。 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"）就复迈宁®（通用 名：芦沃美替尼片；以下简称"该药品"）用于治疗 2 岁及 2 岁以上朗格汉斯细胞 组织细胞增生症（LCH）儿童患者（以下简称"新增适应症"）的药品注册申请获国 家药品监督管理局（以下简称"国家药监局"）受理并已被纳入优先审评程序。 二、该药品的基本信息及研究情况 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。 截至本公告日期（即 2025 年 11 月 21 日），该药品的其 ...

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received breakthrough therapy designation for its independently developed Sru Li Anti-Inflammatory Injection for use in combination chemotherapy for gastric cancer [1] Company Summary - The drug is an innovative anti-PD-1 monoclonal antibody developed by Fosun Pharma [1] - As of November 20, 2025, the drug has been approved for marketing in multiple countries, including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [1] - In China, the approved indications include first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [1] - Multiple combination therapies involving this drug are currently undergoing clinical trials in various countries, targeting indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [1]