Policy Developments - The National Healthcare Security Administration (NHSA) has announced a public solicitation for information on innovative medical consumables, including brain-machine interface technologies and surgical robots, to streamline the coding process for these products [2] Drug and Device Approvals - Fosun Pharma's subsidiary, Fosun Kary, has had its drug registration application for Brexucabtagene Autoleucel accepted by the National Medical Products Administration, aimed at treating relapsed or refractory B-cell acute lymphoblastic leukemia in adults [4] - Novogene's subsidiary has received medical device registration certificates for several neurodiagnostic reagents, which can assist in diagnosing Alzheimer's and Parkinson's diseases [5] Capital Market Activities - Hengrui Medicine has signed a licensing agreement for its innovative drug SHR-A1811, receiving an upfront payment of $18 million and potential milestone payments up to $1.093 billion, which will enhance its overseas market presence [7] - Yong'an Pharmaceutical plans to acquire a 49.20% stake in its subsidiary Ling'an Technology for 27 million yuan, aiming to strengthen control and reduce management costs [8] Industry Events - The NHSA hosted discussions with domestic and international investment institutions, emphasizing support for the high-quality development of innovative drugs and the implementation of policies to facilitate this growth [10] - Illumina has announced partnerships with several global pharmaceutical companies to develop companion diagnostics based on its TruSight Oncology genomic testing platform, focusing on KRAS gene mutations [11] Regulatory and Governance Updates - The former deputy director of the Henan Provincial Medical Security Bureau is under investigation for serious violations of discipline and law [13] - Shareholder Wang Xiaopeng of Huyou Pharmaceutical plans to reduce his stake by up to 3% due to personal financial needs [14] - Independent director Huang Zhengming of Qidi Pharmaceutical has resigned due to work reasons, which may affect the board's composition [15]

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].

格隆汇9月24日丨复星医药(02196.HK)公告，近日，上海复星医药(集团)股份有限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。 该产品在进行商业化生产前，尚需(其中主要包括)通过GMP符合性检查、获得药品注册批准等。本次获 药品注册申请受理不会对集团现阶段业绩产生重大影响。 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 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 ...

北京商报讯(记者王寅浩实习记者宋雨盈)9月24日，复星医药（600196）发布公告称，公司控股子公司 复星凯瑞(上海)生物科技有限公司就布瑞基奥仑赛注射液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。 公告显示，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)处于桥接临床试验阶段。 ...

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]

格隆汇9月24日丨复星医药(600196.SH)公布，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。 ...