Group 1 - The core point of the news is that Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, received approval from the National Medical Products Administration for a new indication of the drug FCN-437c (brand name: Fuzhuoning) for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer in adults [1] - The newly approved indication allows the drug to be used in combination with aromatase inhibitors as initial endocrine therapy [1] - The drug is an innovative small molecule CDK4/6 inhibitor with independent intellectual property rights, classified as a new structure oral medication [1] Group 2 - The drug had previously received approval for another indication for HR-positive, HER2-negative recurrent or metastatic breast cancer patients who have progressed after prior endocrine therapy, which was approved for market entry in China by May 2025 [1] - As of August 2025, the cumulative R&D investment for this drug is approximately RMB 617 million (unaudited) [1] - According to IQVIA MIDAS™ data, global sales of CDK4/6 inhibitors are projected to be around $14.912 billion in 2024, indicating a strong market potential for the newly approved indication [2]

Core Viewpoint - Shanghai Fosun Pharmaceutical's subsidiary, Jinzhou Aohong Pharmaceutical, has received approval from the National Medical Products Administration for the registration of Famotidine injection, indicating a significant advancement in the company's product pipeline and potential market expansion [1] Group 1: Product Approval - The approved drug, Famotidine injection, is a self-developed chemical medication by the group [1] - The indication for the drug is for treating upper gastrointestinal bleeding caused by peptic ulcers, excluding those due to tumors and esophageal or gastric varices [1] Group 2: Research and Development Investment - As of August 2025, the group has invested approximately RMB 7.67 million (unaudited) in the research and development of this drug [1]

Core Viewpoint - Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, has received approval from the National Medical Products Administration for the registration of Famotidine Injection, which is developed in-house and targets upper gastrointestinal bleeding caused by various factors excluding tumors and esophageal or gastric variceal bleeding [1][2]. Group 1: Product Approval - The approval of Famotidine Injection enhances the company's product portfolio [1]. - The drug is specifically indicated for upper gastrointestinal bleeding due to peptic ulcers and other causes [1]. Group 2: Financial Investment and Market Potential - The company has invested approximately RMB 7.67 million in the research and development of this drug as of August 2025 [2]. - The projected sales revenue for Famotidine Injection in mainland China (excluding Hong Kong, Macau, and Taiwan) is estimated to be around RMB 1.377 billion in 2024 [2].

该药品本次获批上市，将进一步丰富本集团产品线。 复星医药（600196）(02196)发布公告，近日，该公司控股子公司锦州奥鸿药业有限责任公司就法莫替 丁注射液(以下简称"该药品")的药品注册申请获国家药品监督管理局批准。 该药品为本集团(即本公司及控股子公司/单位，下同)自主研发的化学药品,本次获批适应症为用于消化 性溃疡所致上消化道出血，除肿瘤及食道、胃底静脉曲张以外的各种原因所致的胃及十二指肠粘膜糜烂 出血者。 截至2025年8月，本集团现阶段针对该药品累计研发投入约为人民币767万元(未经审计)。 根据IQVIA CHPA最新数据，2024年，法莫替丁注射剂于中国境内(不包括港澳台地区)的销售额约为人 民币13.77亿元。 ...

Core Insights - Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, received approval from the National Medical Products Administration for a new indication of the drug FCN-437c (brand name: Fuzhuoning) for treating HR-positive, HER2-negative locally advanced or metastatic breast cancer in adults [1][2] - The drug is an innovative small molecule CDK4/6 inhibitor with independent intellectual property rights, classified as a major new drug creation project in China since 2018 [1] - The cumulative R&D investment for this drug reached approximately RMB 617 million (unaudited) as of August 2025 [1] Market Impact - The approval of the new indication is expected to enhance the market competitiveness of the drug and provide more treatment options for breast cancer patients in China [2] - Global sales of CDK4/6 inhibitors are projected to be approximately $14.912 billion in 2024 [2]

截至2025年8月，集团现阶段针对该药品的累计研发投入约为人民币6.17亿元(未经审计)。 上海复星医药(02196.HK)公告，近日，上海复星医药(集团)股份有限公司(以下简称"公司")控股子公司 锦州奥鸿药业有限责任公司就枸橼酸伏维西利胶囊(商品名：复妥宁，项目代号：FCN-437c；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。本次获批适应症为用于激素受体 (HR)阳性、人表皮生长因子受体2(HER2)阴性局部晚期或转移性乳腺癌成人患者：与芳香化酶抑制剂联 合使用作为初始内分泌治疗。 该药品为本集团(即本公司及控股子公司/单位，下同)拥有自主知识产权的创新型小分子CDK4/6抑制 剂，是一种口服、强效、高选择性、全新结构的创新小分子药物，于2018年被列入国家"重大新药创 制"科技重大专项。除本次获批的新适应症外，该药品另一适应症(联合氟维司群用于既往接受内分泌治 疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子2(HER2)阴性的复发或转移性成年乳腺癌患 者)已于2025年5月获批于中国境内(不包括港澳台地区，下同)上市。 根据IQVIAMIDAS最新数据1，2024年 ...

复星医药公告，控股子公司锦州奥鸿药业有限责任公司就枸橼酸伏维西利胶囊新增适应症的药品注册申 请获国家药品监督管理局批准。本次获批适应症为用于激素受体（HR）阳性、人表皮生长因子受体2 （HER2）阴性局部晚期或转移性乳腺癌成人患者：与芳香化酶抑制剂联合使用作为初始内分泌治疗。 ...

上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* 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 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 （股份代號：02196） 中國，上海 2025 年9 月1 5 日 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 控股子公司藥品獲註冊批准的公告》，僅供參閱。 承董事會命 上海复星医药（集团）股份有限公司 关于控股子公司药品获注册批准的公告 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。 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 ...

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 中國，上海 2025 年9 月1 5 日 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 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、潘東輝先生及吳以芳先生；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。 * ...

Group 1 - The core stock price of Fosun Pharma (600196) closed at 32.03 yuan on September 15, 2025, with a market capitalization of 85.534 billion yuan, reflecting a 1.62% increase from the previous trading day [1] - The stock opened at 31.53 yuan, reached a high of 32.45 yuan, and a low of 31.4 yuan, with a trading volume of 1.674 billion yuan and a turnover rate of 2.47% [1] - Fosun Pharma announced a guarantee for its subsidiaries, involving 11 entities including Fosun Pharma Industry, Fosun Industrial, and Fosun Health, with a total guarantee amount of 25 million USD and 1.226 billion yuan [1] Group 2 - The guarantee method primarily involves joint liability guarantees or maximum joint liability guarantees, with some guarantees having counter-guarantee arrangements [1] - As of September 12, 2025, the actual external guarantee balance of the group was approximately 23.6024 billion yuan, accounting for 49.94% of the audited net assets as of the end of 2024, with no overdue guarantees [1] - The guarantee has undergone internal decision-making procedures and does not require further approval, although some guaranteed entities have asset-liability ratios exceeding 70% [1]