Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for clinical trials of its self-developed B019 injection, aimed at treating refractory systemic lupus erythematosus [2]. Company Summary - B019 injection is a chimeric antigen receptor T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [2]. - The drug has previously been approved for clinical trials for two other indications: relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma, with approvals granted in October 2023 and December 2024, respectively [2].

Core Viewpoint - Shanghai Pharmaceuticals (601607) has received approval from the National Medical Products Administration for its self-developed drug "B019" to conduct clinical trials for refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 is a chimeric antigen receptor (CAR) T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual promoter vector, allowing T-cells to express two independent CARs that can bind to CD19 or CD22 proteins on B lymphocytes without interference [1] Group 2: Clinical Trial Approvals - Clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma have been approved by the National Medical Products Administration in October 2023 and December 2024, respectively [1]

Core Viewpoint - Shanghai Pharmaceuticals (02607) has received approval from the National Medical Products Administration for its self-developed drug "B019" to conduct clinical trials for refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 is a chimeric antigen receptor (CAR) T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual promoter vector, allowing T-cells to express two independent CARs that can bind to CD19 or CD22 proteins on B lymphocytes without interference [1] Group 2: Clinical Trial Approvals - Clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma were approved by the National Medical Products Administration in October 2023 and December 2024, respectively [1]

Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its self-developed B019 injection, targeting refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 injection is a chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD22, designed for treating refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual-synonymous vector to express two independent CARs on T-cells, allowing for simultaneous binding to CD19 or CD22 proteins on B lymphocytes without interference [1] - The clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma were approved by NMPA in October 2023 and December 2024, respectively [1] Group 2: Financial Investment - The project has incurred approximately RMB 149,000 in research and development expenses for the new indication as of the date of the announcement [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。 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Holding Co., Ltd. * （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 B019 新適應症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，2025 年 7 月 30 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 一、该项目基本信息 药物 ...

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its self-developed B019 injection, targeting refractory systemic lupus erythematosus [1] Group 1 - B019 injection is a chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD22, designed for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual-synonymous vector to express two independent CARs on T-cells, allowing for simultaneous binding to CD19 or CD22 proteins on B lymphocytes without interference [1] - Clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma were approved by the NMPA in October 2023 and December 2024, respectively [1]

证券代码：601607 证券简称：上海医药 编号：临2025-076 上海医药集团股份有限公司 关于 B019 新适应症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。 二、该项目研发及注册情况 B019 注射液是靶向 CD19 和 CD22 的嵌合抗原受体自体 T 细胞注射液，拟用 于治疗难治性系统性红斑狼疮。B019 的嵌合抗原受体结构采用一个双顺反子载 体结构，可以在 T 细胞上表达两个独立的嵌合抗原受体，在互不影响的情况下分 别结合 B 淋巴细胞表面表达的 CD19 或 CD22 蛋白，以发挥治疗作用。B019 注射 1 液用于治疗复发或难治性急性 B 淋巴细胞白血病、复发或难治性 B 细胞非霍奇金 淋巴瘤这两个适应症的临床试验申请已分别于 2023 年 10 月、2024 年 12 月获得 国家药监局批准。 该项目由上药生物治疗自主研发，并拥有完全知识产权。截至本公告披露日， 在前 2 个适应症的基础上，该项目在新适应症已累计投入研发费用约 14.90 万元 人民币。 近日，上海医药 ...

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 drug "B019" for the treatment of refractory systemic lupus erythematosus [1] Group 1 - B019 injection is a chimeric antigen receptor T-cell injection targeting CD19 and CD22, aimed at treating refractory systemic lupus erythematosus [1] - The project has accumulated research and development expenses of approximately 149,000 RMB for this new indication [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。 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Holding Co., Ltd. * 证券代码：601607 证券简称：上海医药 编号：临 2025-075 （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硫酸沙丁胺醇注射液通過仿製藥一致性評價的公 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，2025 年 7 月 29 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 ...

关于硫酸沙丁胺醇注射液通过仿制药一致性评价的公告 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"公司"）下属上海禾丰制药 有限公司（以下简称"上药禾丰"）的硫酸沙丁胺醇注射液（以下简称"该药品"） 收到国家药品监督管理局（以下简称"国家药监局"）颁发的《药品补充申请批 准通知书》（通知书编号：2025B03280），该药品通过仿制药质量和疗效一致 性评价。 一、该药品基本情况 药品名称：硫酸沙丁胺醇注射液 剂型：注射剂 规格：1ml：0.5mg（按 C13H21NO3计） 注册分类：化学药品 申请人：上海禾丰制药有限公司 药品批准文号：国药准字 H20258131 审批结论：本品通过仿制药质量和疗效一致性评价。 证券代码：601607 证券简称：上海医药 编号：临 2025-075 上海医药集团股份有限公司 二、该药品相关的信息 硫酸沙丁胺醇注射液主要用于治疗支气管哮喘或喘息型支气管炎等伴有支 气管痉挛的呼吸道疾病。2024 年 2 月，上药禾丰就该药品新增规格合并仿制药 一致 ...