Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) has received approval from the National Medical Products Administration for its self-developed B023 cell injection, a Class I innovative biological product aimed at treating inoperable locally advanced or metastatic solid tumors that have failed standard treatments [1] Group 1: Product Development - The B023 cell injection is developed by Shanghai Pharmaceuticals' subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd [1] - The core component of B023 is invariant natural killer T (iNKT) cells, which are a type of non-classical T cell with a constant T cell receptor (TCR) [1] - iNKT cells can be used in allogeneic applications without causing graft-versus-host disease (GvHD) due to the lack of polymorphism in the CD1d molecule in the human population [1] Group 2: Financial Investment - As of the date of the announcement, the total research and development investment for the B023 project has reached approximately 39.2584 million RMB [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for its self-developed B023 cell injection, marking a significant advancement in innovative biopharmaceuticals targeting late-stage or metastatic solid tumors that are not amenable to surgery [1] Group 1: Product Development - B023 cell injection is classified as a Class I innovative biopharmaceutical, specifically designed for patients with locally advanced or metastatic solid tumors that have failed standard treatments and lack effective therapeutic options [1] - The core component of B023 is invariant natural killer T (iNKT) cells, which are a type of non-classical T cell with a constant T cell receptor (TCR) that can be applied universally without causing graft-versus-host disease (GvHD) [1] - The project has been entirely developed by Shanghai Pharmaceuticals' subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., and the company holds complete intellectual property rights for the product [1] Group 2: Financial Investment - As of the date of the announcement, the total research and development investment for the B023 project has reached approximately 39.2584 million RMB [1] - There are currently no other products with the same indication and type available in the global market, highlighting the uniqueness of B023 [1]

香港交易及結算所有限公司和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分內容而產生或因依賴該 等內容而引致的任何損失承擔任何責任。 （於中華人民共和國註冊成立的股份有限公司） （股份代碼：02607） 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 醫 藥 集 團 股 份 有 限 公 司 （「 本 公 司 」） 在 上 海 證 券 交 易 所 網 站 (http://www.sse.com.cn)刊登的《上海醫藥集團股份有限公司關於 B023 細胞注射液獲得臨 床試驗批准通知書的公告》僅供參閱。 承董事會命 上海醫藥集團股份有限公司 楊秋華 董事長 中國上海，2026 年 1 月 21 日 於本公告日期，本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明 先生；非執行董事為張文學先生；以及獨立非執行董事為顧朝陽先生、霍文遜先 生、王忠先生及萬鈞女士。 * 僅供識別 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Ho ...

证券代码：601607 证券简称：上海医药 编号：临2026-005 上海医药集团股份有限公司 关于 B023 细胞注射液获得临床试验批准通知书的公告 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个别及连带责任。 近日，上海医药集团股份有限公司（以下简称"上海医药"或"公司"）下 属上海医药集团生物治疗技术有限公司（以下简称"上药生物治疗"）自主研发 的"B023 细胞注射液"（以下简称"该项目"）收到国家药品监督管理局（以下 简称"国家药监局"）核准签发的《药物临床试验批准通知书》，现将有关情况公 告如下： 一、该项目基本信息 项目名称：B023 细胞注射液 剂型：注射剂 申请事项：境内生产药品注册临床试验 受理号：CXSL2500924 通知书批号：2026LP00112 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 10 月 23 日受理的 B023 细胞注射液符合药品注册的有关要求，同意开展不可 手术的经标准治疗失败的、无有效治疗方式的局部晚期或转移性实体瘤的临床试 验。 二、该项目研发及注册情况 ...

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its self-developed B023 cell injection [1] Group 1: Product Development - B023 cell injection is an innovative Class I biopharmaceutical developed and produced by Shanghai Pharmaceuticals Biotherapy, targeting locally advanced or metastatic solid tumors that are inoperable and have no effective treatment options after standard therapy failure [1] - The core component of B023 is invariant natural killer T (iNKT) cells, which are a type of non-classical T cell with a constant T cell receptor (TCR) [1] - Human iNKT cells have TCR chains TCRvα24 and TCRvβ11, which recognize lipid antigens presented by MHC class I molecule CD1d [1] Group 2: Clinical Implications - CD1d is non-polymorphic in the population, allowing for the allogeneic application of iNKT cells without causing graft-versus-host disease (GvHD), making it a universal cell type [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for its innovative biological product "B023 Cell Injection" for clinical trials, targeting late-stage or metastatic solid tumors that have failed standard treatments [1] Group 1: Company Developments - The project is classified as a Class I innovative biological product and aims to address a significant unmet medical need in oncology [1] - The company has invested approximately 39.26 million RMB in the research and development of this product [1] - There are currently no similar products available on the market for the same indication globally [1] Group 2: Industry Context - The approval of the clinical trial notification is a significant step in the long and costly process of new drug development, which often faces risks related to research progress and clinical trial outcomes [1] - The company indicated that this approval will not have a major impact on its operational performance [1]

Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Biologicals, has received the Clinical Trial Approval Notice from the National Medical Products Administration for its self-developed "B023 Cell Injection" [1] Group 1: Product Development - B023 Cell Injection is an innovative Class I biological product developed and produced by Shanghai Pharmaceuticals Biologicals, with the core component being invariant natural killer T cells (iNKT) [1] - The clinical intended use for B023 is for locally advanced or metastatic solid tumors that are inoperable and have failed standard treatments, with no effective treatment options available [1] - As of the announcement date, the project has accumulated research and development expenses of approximately 39.2584 million RMB [1] Group 2: Market Position - There are currently no other drugs on the global market with the same variety and indication as B023 Cell Injection [1]

Group 1 - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Isavuconazole sulfate raw material [1][3] - The drug Isavuconazole sulfate is a triazole antifungal agent, which is a prodrug that converts to the active metabolite Isavuconazole in the body [4] - The company has invested approximately RMB 5.1287 million in the research and development of this drug [4] Group 2 - The approval indicates that the raw material meets the domestic drug registration requirements and can be sold in the domestic market [6] - The total procurement amount for Isavuconazole sulfate formulations in mainland China hospitals in 2024 is RMB 304.291 million [5] - The company has increased its stake in Shanghai Shanshi Group Financial Co., Ltd. from 30% to 40% through the acquisition of a 10% equity stake for approximately RMB 143 million [9][10]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the active pharmaceutical ingredient (API) Sulfate Isavuconazole, indicating compliance with domestic drug registration requirements and enabling market sales in China [1] Group 1: Company Developments - The approval of Sulfate Isavuconazole API signifies that the product meets the necessary regulations for drug registration in China [1] - This achievement provides valuable experience for the company in future API submissions [1] - The current approval is not expected to have a significant impact on the company's operating performance for the period [1]

Core Viewpoint - Shanghai Pharmaceuticals announced the approval of the active pharmaceutical ingredient Sulfate Isavuconazole for production by its subsidiary, Upjohn Kangli (Changzhou) Pharmaceutical Co., Ltd, by the National Medical Products Administration of China [1] Group 1: Company Information - The approved drug, Sulfate Isavuconazole, is a triazole antifungal agent and a prodrug of Isavuconazole, which is rapidly converted into its active metabolite in the body by plasma esterases [1] - The drug is developed in collaboration with Astellas Pharma and Basilea Pharmaceutica, and it was approved for use in the United States in 2015 for the treatment of invasive aspergillosis and mucormycosis in adults [1] Group 2: Industry Context - Isavuconazole works by inhibiting the biosynthesis of ergosterol, thereby disrupting the formation of fungal cell membranes, similar to other triazole antifungal agents [1]