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]

Group 1: Trade and Economic Development - He Lifeng emphasized the need to continuously promote the quality and efficiency of foreign trade, improve high-standard logistics systems, and support high-quality development in manufacturing [1] - The Ministry of Commerce aims to guide localities in transitioning second-hand car exports from "scale growth" to "value growth," enhancing product diversity for global consumers [1] - The Ministry of Housing and Urban-Rural Development highlighted the importance of urban renewal to support high-quality living and new industries [1] Group 2: Market and Financial Updates - The initial public offering (IPO) price for Moer Technology is set at 114.28 yuan per share, with a total market value of approximately 53.715 billion yuan [1] - The Asian Infrastructure Investment Bank (AIIB) has approved Colombia's membership, increasing its total membership to 111, covering 81% of the world's population and 65% of global GDP [1] - The Guangzhou Futures Exchange announced adjustments to trading fees and limits for lithium carbonate futures starting November 24, 2025 [1] Group 3: Corporate Announcements - Yiwei Lithium Energy signed a procurement framework agreement with Simor International [6] - Chuangyin High-Tech received a tender offer from Zhongzhong Group to acquire 20% of its shares at 11.85 yuan per share [6] - Lek Electric plans to transfer 90% of its precision machinery shares for 235 million yuan [6]

Core Insights - The company reported a steady improvement in its overall innovation capabilities, with innovative drug revenue exceeding 6.7 billion yuan in the first three quarters of 2025, representing a year-on-year growth of 18.09% [1][2] - The company has set a target for a compound annual growth rate of 20% for innovative drug revenue from 2025 to 2027, driven by the commercialization of existing products and the approval of new products in the next 2 to 3 years [3] Financial Performance - In the first three quarters of 2025, the company achieved total revenue of 29.393 billion yuan and a net profit attributable to shareholders of 2.523 billion yuan, reflecting a year-on-year increase of 25.5% [1] R&D Investment - The company invested a total of 3.998 billion yuan in R&D in the first three quarters of 2025, marking a year-on-year increase of 2.12%, with R&D expenses in Q3 alone reaching 1.013 billion yuan, up 28.81% [3] AI Strategy - The company is integrating AI into various stages of drug development, utilizing platforms like PharmAID to enhance decision-making and efficiency in research and clinical trials [4] - The long-term goal is to create an intelligent system that spans the entire chain from R&D to operations and products, enhancing innovation capabilities and competitiveness [4] Global Operations - The company views its international strategy as a key growth engine, aiming to enhance its global R&D, production, registration, and commercialization capabilities [4][5] - In the U.S. market, the company has established a mature generic drug self-operated team and has launched 34 products as of June 30, 2025 [5] Emerging Markets - The company has built a marketing network covering over 40 countries in Africa and is progressing with local drug manufacturing projects [6] - It is also expanding its presence in emerging markets such as ASEAN and the Middle East [6] Shareholder Engagement - The company has completed its share repurchase plans for A-shares and H-shares in 2025, repurchasing a total of 14.23 million A-shares and 3.41 million H-shares, aimed at maintaining investor interests and boosting market confidence [6]

Core Insights - The company has demonstrated steady improvement in its innovation capabilities, with innovative drug revenue exceeding 6.7 billion yuan in the first three quarters of 2025, representing an 18.09% year-on-year growth [1][2] - The company aims for a compound annual growth rate of 20% in innovative drug revenue from 2025 to 2027, driven by ongoing commercialization of existing products, new product approvals, and contributions from overseas markets [3] Financial Performance - In the first three quarters of 2025, the company achieved total revenue of 29.393 billion yuan and a net profit attributable to shareholders of 2.523 billion yuan, reflecting a year-on-year increase of 25.5% [2] - The company's R&D investment reached 3.998 billion yuan in the first three quarters of 2025, marking a 2.12% increase, with Q3 R&D expenses amounting to 1.013 billion yuan, up 28.81% [4] Innovation and Product Development - The company has made significant progress with several self-developed innovative drugs, including a new indication approval for its CDK4/6 inhibitor in China for breast cancer treatment [2] - The second CAR-T product from the company has had its registration application accepted by the National Medical Products Administration for treating relapsed or refractory acute lymphoblastic leukemia [2] AI Strategy - The company is advancing its AI strategy, integrating AI into various stages of drug development to enhance efficiency and reduce early-stage R&D cycles [4][5] - The PharmAID decision-making platform has been launched to support commercial value assessment and pipeline selection, significantly improving R&D decision-making and execution efficiency [4][5] Global Operations - The company views its international strategy as a key growth driver, focusing on enhancing global R&D, production, registration, and commercialization capabilities [7] - In the U.S. market, the company has established a mature self-operated generic drug team and has launched 34 products as of June 30, 2025 [7] - The company has built a marketing network covering over 40 countries in Africa and is progressing with local drug manufacturing projects [7] Shareholder Engagement - The company has completed its A-share and H-share repurchase plans and has introduced stock option incentive plans to enhance long-term incentive mechanisms [8] - Since the beginning of 2025, the company has repurchased 14.23 million A-shares and 3.41 million H-shares, totaling approximately 348 million yuan and 47.84 million HKD, respectively [8]

Major Announcements - EVE Energy signed a procurement framework agreement with Smoore International for the continuous supply of battery cells and other products as raw materials, with actual amounts to be determined by future orders [3] - ST Huami's stock is under "double risk" warning due to an audit report expressing inability to provide an opinion for the 2024 financial report, with a recovery of 1.567 billion yuan in occupied funds [4] - Wuzhou Transportation received a regulatory warning for accounting irregularities and failure to fulfill integrity checks for executives, leading to inaccurate financial disclosures [5] - Wenfeng Co. announced that its vice president is under investigation, but this will not significantly impact the company's operations [6] - Fosun Pharma's subsidiary has had its drug included in the breakthrough therapy designation program for gastric cancer treatment, marking a significant development in its product pipeline [7][8] - Shandong Steel's subsidiary is applying for bankruptcy liquidation, which is expected to increase the parent company's net profit by 15.88 million yuan [9] - Zhouming Technology established a new subsidiary, Shenzhen Zhixian Robotics Co., with a registered capital of 50 million yuan [10] Share Buybacks and Holdings - Spring Airlines conducted its first share buyback, acquiring 35,800 shares for a total of 1.9997 million yuan [11] - Donghua Software's controlling shareholder reduced his stake by 1%, selling 10.9832 million shares [12] - Changshu Bank's executives plan to increase their holdings by at least 550,000 shares over the next six months [13] Major Contracts - Nanfeng Co. won contracts worth 45.7 million yuan and 47.17 million yuan for HVAC systems, with delivery scheduled for 2027 [14] - Huakang Clean announced a pre-bid win for a purification system project at Keqiao Future Medical Center, with a bid price of 176 million yuan [15][16] - Qinglong Pipe Industry secured a contract worth 294 million yuan for a pipe procurement project, expected to impact its performance from 2026 to 2030 [17] - China Nuclear Engineering signed new contracts totaling 123.84 billion yuan as of October, with cumulative revenue of 81.334 billion yuan [18]