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].

Core Insights - Fosun Pharma's subsidiary, Fosun Kairui (Shanghai) Biotechnology Co., Ltd., has had its second CAR-T product, Brexucabtagene Autoleucel (code name FKC889), accepted for drug registration by the National Medical Products Administration (NMPA) [1] - The indication for this application is for adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) [1] Company Summary - Fosun Pharma is advancing its CAR-T product pipeline with the acceptance of Brexucabtagene Autoleucel for regulatory review [1] - The focus on treating relapsed or refractory ALL highlights the company's commitment to addressing unmet medical needs in oncology [1] Industry Summary - The CAR-T therapy market continues to expand, with increasing regulatory approvals for innovative treatments targeting specific cancer types [1] - The acceptance of new CAR-T products indicates a growing trend in the biopharmaceutical industry towards personalized medicine and advanced therapies for complex diseases [1]

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]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has had its drug registration application for FKC889 accepted by the National Medical Products Administration for treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adult patients [1] Group 1: Product Development - FKC889 is a CAR-T cell therapy product targeting CD19, developed through technology transfer from Kite Pharma, a subsidiary of Gilead Sciences [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020 respectively [1] - As of September 24, 2025, FKC889 is in the bridging clinical trial phase for another indication, treating adult patients with relapsed or refractory mantle cell lymphoma after second-line treatment [1] Group 2: Financial Investment - The cumulative R&D investment for FKC889 as of August 2025 is approximately RMB 183 million (unaudited) [2]

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]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has received acceptance from the National Medical Products Administration for the drug registration application of FKC889, aimed at treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) in adult patients [1] Group 1 - The product FKC889 is a targeted CD19 CAR-T cell therapy developed and localized in China based on the Tecartus technology licensed from Kite Pharma, a subsidiary of Gilead Sciences [1] - Tecartus was approved for market launch in the United States and Europe in July and December 2020, respectively [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has received acceptance from the National Medical Products Administration for the drug registration application of FKC889, aimed at treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adult patients [1] Group 1 - The product FKC889 is a targeted CD19 CAR-T cell therapy developed and localized in China based on the technology transferred from Kite Pharma, a subsidiary of Gilead Sciences [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020 respectively [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kerry, has received acceptance from the National Medical Products Administration for the drug registration application of Brukinsa injection (project code: FKC889), aimed at treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) in adult patients [1] Group 1 - The drug is classified as a therapeutic biological product under category 3.2 [1] - The application is specifically for adult patients suffering from relapsed or refractory precursor B-cell acute lymphoblastic leukemia [1]

证券代码：600196 股票简称：复星医药 编号：临 2025-150 二、该产品的基本信息及研究情况 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）于中国境内（不包括港澳台地区，下同）处于桥接临床试验阶段。 截至 2025 年 8 月，本集团（即本公司及控股子公司/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）。 截至本公告日期，包括复星凯瑞的奕凯达（阿基仑赛注射液）在内，已有多款 CAR-T 细胞治疗产品于中国境内获批上市，由于数据库覆盖的销售渠道等原因，其 整体市场情况无法通过公开数据库准确查询。 上海复星医 ...