"从实验室到临床，我们用了15年。如果资金能跟上，这款药或许能早几年救更多人。"当博生吉医药创 始人杨林博士看到PA3-17注射液获准进入关键性II期临床试验的通知时，这位在中国最早提出肿瘤细胞 疗法概念的科学家，语气里满是感慨。2024年，安科生物参股的博生吉及博生吉安科收到国家药监局审 评中心的会议纪要，标志着这款全球首款靶向CD7的自体CAR-T细胞治疗产品向上市迈出关键一步，但 这一步，比预期晚了太久。 2010年，杨林博士创办博生吉，彼时细胞免疫治疗在国内尚属空白领域。他带领团队率先攻坚CD7阳性 血液淋巴系统恶性肿瘤这一难题——这类疾病复发难治，传统疗法疗效有限，而CD7靶点的研发更是 因"CAR-T细胞相互残杀""肿瘤细胞残留"等技术难关，让全球众多团队望而却步。博生吉自2012年起深 耕CD7单域抗体研发，历经免疫毒素、CAR-NK等技术路径探索，最终突破性地采用非基因编辑策略， 解决了安全性与疗效的平衡问题，前期临床试验中更是取得了100%客观缓解率、近90%完全缓解率的 优异数据。 在医药创新的赛道上，杨林博士的"灰头土脸"是中国科研者坚守的缩影。当PA3-17注射液最终走向市场 时，我们 ...

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。 ...

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 - Anke Biotech (300009.SZ) announced that its affiliated companies, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the key Phase II clinical trial of PA3-17 injection, a targeted CAR-T cell therapy for adult relapsed and refractory CD7-positive hematological malignancies [1] Group 1 - The PA3-17 injection is the world's first targeted CD7 autologous CAR-T cell therapy product to receive clinical trial approval [1] - The product utilizes advanced genetic engineering technology to modify the patient's own T cells, enabling them to specifically recognize and kill CD7-positive tumor cells [1] - The approval marks a significant milestone for Boshengji Anke in the development of innovative cancer therapies [1]

Core Viewpoint - Anke Biotech (300009.SZ) announced that its affiliated companies, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd., received approval from the National Medical Products Administration for the key Phase II clinical trial of PA3-17 injection, a targeted CAR-T cell therapy product for treating adult relapsed and refractory CD7-positive hematological malignancies [1]. Group 1 - Anke Biotech's affiliated companies have received a communication meeting minutes from the National Medical Products Administration regarding the PA3-17 injection [1]. - PA3-17 injection is the world's first targeted CD7 autologous CAR-T cell therapy product that has received approval for clinical trials [1]. - The product is specifically designed for the treatment of adult patients with relapsed and refractory CD7-positive hematological malignancies [1].

Financial Performance - In the first half of 2025, the company achieved operating revenue of CNY 1,292.19 million, a year-on-year decrease of 0.51% [3] - The net profit was CNY 374.55 million, down 11.61% year-on-year, while the net profit attributable to shareholders was CNY 366.52 million, a decrease of 11.92% [3] - The net cash flow from operating activities increased by 53.75% to CNY 316.42 million [3] - The main business of biological products saw a year-on-year growth of 7.49%, with sales of the injection drug Trastuzumab "Ansatin" increasing by 298% [3] Business Strategy and Market Development - The company is optimizing sales channels and strategies to enhance market development amid intensified competition and fluctuating market demand [3] - Plans for the second half of the year include optimizing business structure, increasing market expansion efforts, and enhancing internal management and resource integration [3] Growth in Specific Product Lines - The growth hormone segment has seen a year-on-year increase in new patient enrollment, with water-based injections accounting for over 40% of the segment's revenue [3][4] - The company is collaborating with Weisheng Pharmaceutical on the long-acting growth hormone "Longpei Growth Factor," expected to be approved in the second half of 2025 [5] Innovative Drug Development - The company is advancing its self-developed innovative drugs, including: - "HuA21 Injection," targeting HER2, currently in Phase III clinical trials [8] - "AK2024 Injection," also targeting HER2, has received clinical approval [8] - "HK010 Injection," a dual-target drug, is progressing well in Phase I trials [8] - "AK2017 Injection," a recombinant human growth hormone, is in Phase II trials [8] - The company is also involved in various collaborative projects, including mRNA drug development and CAR-T therapies [9] Future Financial Outlook - The company anticipates a slight increase in sales and R&D expenses over the next two years due to the rise in clinical trials and new product launches [10] - Overall, the company aims to achieve a recovery growth target for the full year of 2025, supported by product market promotion and sales activities [10][11]

Core Viewpoint - Anke Bio (300009) announced that its affiliated companies, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd., have developed PA3-17 injection, which has been included in the list of proposed breakthrough therapies by the National Medical Products Administration (NMPA) [1] Group 1 - PA3-17 injection is the world's first targeted CD7 autologous CAR-T cell therapy product that has received clinical trial approval for treating adult relapsed/refractory T-lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) [1]