Core Viewpoint - Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, has received approval from the National Medical Products Administration for its innovative small molecule CDK4/6 inhibitor, Fovisei (Citrus Acid Vovisil Capsules), for a new indication in the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer in premenopausal, postmenopausal, and perimenopausal women [1][3]. Group 1 - The approval allows Fovisei to be used in combination with aromatase inhibitors as initial endocrine therapy for specific breast cancer patients [1][3]. - Breast cancer is a significant health threat to women, with approximately 357,200 new cases reported in China in 2022, making it the second most common malignant tumor among women [3]. - CDK4/6 inhibitors are crucial treatment options for HR+/HER2- populations with endocrine resistance [3]. Group 2 - Fovisei is classified as a first-class new drug, characterized as an oral, potent, highly selective, and structurally novel small molecule medication [3]. - The drug can penetrate the blood-brain barrier, providing new treatment opportunities for patients with brain metastases [3]. - Taimei Medical Technology, as a partner, played a key role in the independent imaging assessment for the drug's approval, leveraging its extensive experience and quality management systems [3].

Group 1 - The pharmaceutical sector in both A-shares and Hong Kong stocks experienced a collective decline on September 26 [1] - In A-shares, Sunflower dropped by 10%, while Guangsheng Tang and Aosaikang fell over 8%. Other companies like Jimin Health, Hanyu Pharmaceutical, Wanbangde, Hengrui Medicine, and Huiyu Pharmaceutical also saw declines [1] - In Hong Kong stocks, WuXi AppTec decreased by over 5%, BeiGene fell by more than 4%, and Fosun Pharma dropped nearly 2% [1]

Company Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. was established on May 31, 1995, and listed on August 7, 1998. The company is primarily engaged in drug manufacturing and research, covering medical devices, medical diagnostics, medical services, and pharmaceutical distribution and retail [1]. Financial Performance - For the first half of 2025, Fosun Pharma reported operating revenue of 19.514 billion yuan, a year-on-year decrease of 4.63%. However, the net profit attributable to shareholders increased by 38.96% to 1.702 billion yuan [2]. - The company has cumulatively distributed 12.593 billion yuan in dividends since its A-share listing, with 2.691 billion yuan distributed over the past three years [3]. Stock Performance - As of September 26, Fosun Pharma's stock price was 29.69 yuan per share, with a market capitalization of 79.285 billion yuan. The stock has increased by 21.02% year-to-date but has seen a decline of 4.01% over the past five trading days [1]. - The stock's trading volume on September 26 was 182 million yuan, with a turnover rate of 0.29% [1]. Shareholder Structure - As of June 30, 2025, Fosun Pharma had 230,000 shareholders, a decrease of 4.37% from the previous period. The average circulating shares per shareholder remained at 0 [2]. - The top circulating shareholder is Hong Kong Central Clearing Limited, holding 75.881 million shares, an increase of 11.194 million shares from the previous period [3].

两融数据显示，该股最新融资余额为25.00亿元，近5日减少9419.10万元，降幅为3.63%。 据天眼查APP显示，上海复星医药(集团)股份有限公司成立于1995年05月31日。注册资本267042.9325万 人民币。（数据宝） 复星医药9月25日大宗交易平台出现一笔成交，成交量60.00万股，成交金额1818.00万元，大宗交易成交 价为30.30元。该笔交易的买方营业部为国泰海通证券股份有限公司总部，卖方营业部为国泰海通证券 股份有限公司郑州黄河路证券营业部。 进一步统计，近3个月内该股累计发生2笔大宗交易，合计成交金额为2698.33万元。 证券时报·数据宝统计显示，复星医药今日收盘价为30.30元，下跌0.13%，日换手率为1.40%，成交额为 9.01亿元，全天主力资金净流出4803.88万元，近5日该股累计下跌4.14%，近5日资金合计净流出2.82亿 元。 | 成交量 （万 | 成交金额 | 成交价 | 相对当日收盘折 | 买方营业部 | 卖方营业部 | | --- | --- | --- | --- | --- | --- | | | （万元） | 格 | 溢价（%） | | | | 股） ...

Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received acceptance from the National Medical Products Administration for the drug registration application of FKC889, a targeted CAR-T cell therapy product for treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) in adult patients [2][3]. Product Information and Research Status - FKC889 is a CAR-T cell therapy product targeting CD19, developed by Fosun Kerry based on technology transferred from Kite Pharma, Inc., a subsidiary of Gilead Sciences, Inc. Tecartus, the original product, was approved for marketing in the US and Europe in July and December 2020, respectively [3]. - As of September 24, 2025, FKC889 is in the bridging clinical trial phase for another indication, which is for adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have previously received second-line or higher treatment [3]. - The cumulative R&D investment for FKC889 by the group is approximately RMB 183 million (unaudited) as of August 2025 [3]. - Multiple CAR-T cell therapy products, including Fosun Kerry's Yikaida (Acilin injection), have been approved for marketing in mainland China, but the overall market situation is difficult to ascertain due to limitations in public database coverage [3].

据复星医药消息，9月24日，复星凯瑞（上海）生物科技有限公司的第二款CAR-T产品布瑞基奥仑赛注 射液（项目代号FKC889）的药品注册申请获国家药品监督管理局受理，本次申报适应症为复发或难治 性前体B细胞急性淋巴细胞白血病（ALL）成人患者。 ...

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has received acceptance for the drug registration application of FKC889, a CAR-T cell therapy for adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) [1] Company Summary - Fosun Kairui is developing FKC889, a targeted CD19 CAR-T cell therapy, based on technology transferred from Kite Pharma, a subsidiary of Gilead Sciences [1] - The product has been authorized for development and local production in China, including Hong Kong and Macau [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020, respectively [1] Industry Summary - The application for FKC889 is classified as a therapeutic biological product (Category 3.2) [1] - Before commercial production, the product must pass GMP compliance checks and obtain drug registration approval [1] - The acceptance of the drug registration application is not expected to have a significant impact on the group's current performance [1]

截至 2025 年 8 月，该集团(即公司及控股子公司/单位，下同)现阶段针对该产品的累计研发投入约为人 民币 1.83 亿元(未经审计)。 智通财经APP讯，复星医药(02196)公布，近日，公司控股子公司复星凯瑞(上海)生物科技有限公司(以下 简称"复星凯瑞")就布瑞基奥仑赛注射液(项目代号：FKC889，申请注册分类：治疗用生物制品 3.2 类; 以下简称"该产品")的药品注册申请获国家药品监督管理局受理，本次申报适应症为用于治疗复发或难 治性前体 B 细胞急性淋巴细胞白血病(ALL)成人患者。 该产品系复星凯瑞基于自 Kite Pharma,Inc.(系 Gilead Sciences, Inc.的控股子公司)引进的 Tecartus 经技术 转移并获授权于中国(包括香港、澳门)进行开发及本地化生产的靶向 CD19 的 CAR-T 细胞治疗产品。 Tecartus 已于 2020 年 7 月及 12 月先后于美国、欧洲获批上市。 截至本公告日期(即 2025 年 9 月 24 日，下同)，该产品的另一适应症(即用于治疗既往接受过二线及以上 治疗后复发或难治性套细胞淋巴瘤(r/r MCL)成人患者)于中 ...

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 （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 陳玉卿 中國，上海 2025 年9 月2 4 日 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* 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。 ...

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kerry (Shanghai) Biotechnology Co., Ltd., has had its drug registration application for Brexucabtagene Autoleucel injection accepted by the National Medical Products Administration, targeting adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) [1] Group 1 - The drug application is specifically for treating adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) [1] - Another indication for the product, aimed at adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have previously undergone second-line or higher treatment, is currently in the bridging clinical trial phase within mainland China (excluding Hong Kong, Macau, and Taiwan) [1]