人民财讯1月23日电，上海医药（601607）1月23日公告，下属上药信谊的马来酸阿伐曲泊帕片收到国家 药品监督管理局颁发的《药品注册证书》，该药品获得批准生产。此外，下属常州制药厂生产的普瑞巴 林胶囊收到新加坡食品药品监督管理局(HSA)颁发的药品注册证书，该药品获得批准上市。 ...

2019年10月，常州制药厂完成普瑞巴林胶囊的研发工作；2021年7月，该药品获得美国食品药品监督管 理局批准文号(详见公司公告临2021-065号)；2025年6月，该药品获得泰国食品药品监督管理局批准上 市。截至本公告日，公司针对该药品在东南亚市场(即泰国、新加坡、马来西亚及菲律宾)上市另投入的 研发费用约人民币219万元。 格隆汇1月23日丨上海医药(601607.SH)公布，近日，公司下属常州制药厂有限公司生产的普瑞巴林胶囊 收到新加坡食品药品监督管理局(HSA)颁发的药品注册证书，该药品获得批准上市。 普瑞巴林胶囊主要用于治疗带状疱疹后神经痛、糖尿病外周神经痛、纤维肌痛和脊髓损伤引起的神经性 疼痛以及癫痫的辅助治疗。 ...

上海医药公告，下属常州制药厂有限公司生产的普瑞巴林胶囊收到新加坡食品药品监督管理局（HSA） 颁发的药品注册证书，该药品获得批准上市。普瑞巴林胶囊主要用于治疗带状疱疹后神经痛、糖尿病外 周神经痛、纤维肌痛和脊髓损伤引起的神经性疼痛以及癫痫的辅助治疗。2019年10月，常州制药厂完成 普瑞巴林胶囊的研发工作；2021年7月，该药品获得美国食品药品监督管理局批准文号；2025年6月，该 药品获得泰国食品药品监督管理局批准上市。截至本公告日，公司针对该药品在东南亚市场（即泰国、 新加坡、马来西亚及菲律宾）上市另投入的研发费用约人民币219万元。 ...

Group 1 - The core project is the B023 cell injection, which has received approval for clinical trials from the National Medical Products Administration (NMPA) for treating inoperable, locally advanced, or metastatic solid tumors that have failed standard treatments [1][2] - B023 is an innovative Class I biological product developed by Shanghai Pharmaceutical Group's subsidiary, with a total research and development investment of approximately 39.26 million RMB [2] - The active component of B023 is invariant natural killer T (iNKT) cells, which can be used universally without causing graft-versus-host disease due to the lack of polymorphism in CD1d among the population [2] Group 2 - As of the announcement date, there are no other drugs with the same indication and type available in the global market [3] - The approval for clinical trials does not significantly impact the company's current operations, and the company will continue to advance the project in accordance with national regulations [3]

Group 1 - The core viewpoint of the article is that Shanghai Pharmaceuticals (601607) is currently operating in an orderly manner, with steady progress in various business segments and stable performance [1] Group 2 - The company has responded to investor inquiries on its interactive platform, indicating confidence in its overall operations [1] - Business operations are reported to be advancing steadily, suggesting a positive outlook for future performance [1] - The company's performance is described as stable, which may indicate resilience in its financial results [1]

Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its self-developed "B023 cell injection" for treating locally advanced or metastatic solid tumors that are inoperable and have no effective treatment options after standard therapy failure [1] Group 1 - The "B023 cell injection" is aimed at patients with locally advanced or metastatic solid tumors [1] - The approval allows the company to conduct clinical trials for a treatment that currently lacks effective options [1] - This development highlights the company's commitment to advancing innovative therapies in oncology [1]

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 ...