（一） 产品信息 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法律责任。 北京天坛生物制品股份有限公司下属国药集团武汉生物制药有限公司（以下 简称"天坛武汉"）研制的"人凝血酶原复合物"已完成临床伦理审查、临床入 组前准备等工作，于近日正式开展Ⅲ期临床试验，现将有关信息披露如下： 一、 概况 证券代码：600161 证券简称：天坛生物 公告编号：2025-050 北京天坛生物制品股份有限公司 关于下属企业药品临床试验进展的公告 | 产品 | | 获得临床试验批准 | | 注册 | 剂 | 研发投入 | | --- | --- | --- | --- | --- | --- | --- | | 名称 | 适应症 | 通知书时间和编号 | 规格 | 分类 | 型 | （万元） | | | 本品主要用于治疗先天性和获得 | | | | | | | | 性凝血因子Ⅱ、Ⅶ、Ⅸ和Ⅹ缺乏 | | | | | | | | 症（单独或联合缺陷）包括： | | | | | | | | 1.凝血因子Ⅱ、Ⅶ、Ⅸ和Ⅹ缺乏 | | | | | | | | 症，包 ...

Core Viewpoint - Beijing Tiantan Biological Products Co., Ltd. announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. has received the Drug GMP Compliance Inspection Notice and the updated Drug Production License, indicating the completion of the production site change for the product "Recombinant Human Coagulation Factor VIII" and the potential for expanded production capacity [1][4]. Group 1: GMP Compliance Inspection - Chengdu Rongsheng received the Drug GMP Compliance Inspection Notice from the Sichuan Provincial Drug Administration [1]. - The inspection was conducted from August 18 to August 21, 2025, and concluded that the company complies with the Drug Production Quality Management Standards (2010 revision) and related appendices [2]. Group 2: Drug Production License Changes - The production scope for Chengdu Rongsheng has been updated to include the production of "Recombinant Human Coagulation Factor VIII," limited to registered application use, following the successful GMP compliance inspection [3]. - The production address remains the same: No. 280, Jingyuan Road, Shuangliu District, Chengdu, Sichuan Province [3]. Group 3: Impact on the Company - The product "Recombinant Human Coagulation Factor VIII" was approved for market launch in September 2023, and the production site change was approved in July 2025 [4]. - The completion of the production site change allows for an increase in production scale for the product [4].

证券代码：600161 证券简称：天坛生物 编号：2025-049 北京天坛生物制品股份有限公司 关于下属企业获得《药品GMP符合性检查告知书》及变更 《药品生产许可证》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法律责任。 近日，北京天坛生物制品股份有限公司下属成都蓉生药业有限责任公司（以 下简称"成都蓉生"）收到四川省药品监督管理局颁发的《药品 GMP 符合性检查 告知书》和变更后的《药品生产许可证》。成都蓉生已完成"注射用重组人凝血 因子Ⅷ"产品生产场地变更工作，可实现该产品生产规模扩大。现就相关情况公 告如下： 一、 《药品 GMP 符合性检查告知书》相关信息 检查时间：2025 年 8 月 18 日-2025 年 8 月 21 日 检查结论：符合《药品生产质量管理规范（2010 年修订）》及相关附录规 定。 发证机关：四川省药品监督管理局 二、 《药品生产许可证》变更内容 同意成都蓉生生产地址四川省成都市双流区菁园路 280 号的生产范围治疗 用生物制品（注射用重组人凝血因子Ⅷ）（仅限注册申报使用）变更为治疗用生 物 ...

Core Viewpoint - TianTan Biological announced that its subsidiary Chengdu Rongsheng Pharmaceutical has received the GMP compliance inspection notice and the updated drug production license from the Sichuan Provincial Drug Administration, allowing for an expansion in the production scale of "Recombinant Human Coagulation Factor VIII" [1] Group 1 - Chengdu Rongsheng has completed the site change for the production of "Recombinant Human Coagulation Factor VIII" [1] - The GMP compliance inspection was conducted from August 18 to August 21, 2025, and concluded that the company meets the relevant regulations [1] - The updated drug production license allows for the production of therapeutic biological products (Recombinant Human Coagulation Factor VIII) at the new address in Chengdu, Sichuan Province [1]

Core Viewpoint - Beijing Tiantan Biological Products Co., Ltd. announced that its subsidiary, Kunming Blood Products Co., Ltd., has received the Clinical Trial Approval Notice from the National Medical Products Administration for the clinical trial of "Human Fibrinogen" [1] Group 1: Product Information - The product "Human Fibrinogen" is set to undergo clinical trials following the approval [1] Group 2: Market Situation - The domestic market information is sourced from the National Medical Products Administration's official website [1] - International market details were not disclosed in the announcement [1] Group 3: Approval Process - The product must complete several steps including clinical trials, submission of drug marketing authorization application, review by the National Medical Products Administration, and obtaining a drug registration certificate before it can be produced and marketed [1]

Core Viewpoint - TianTan Biological announced the approval of a clinical trial for "human fibrinogen" by the National Medical Products Administration [1] Group 1 - TianTan Biological's subsidiary, Kunming Blood Products Co., Ltd., received the clinical trial approval notice [1] - The approval allows the company to conduct clinical trials for "human fibrinogen" [1]

Core Viewpoint - Tian Tan Biological Products Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of "human fibrinogen" [1] Group 1 - Tian Tan Kunming, a subsidiary of Tian Tan Biological, is authorized to conduct clinical trials for "human fibrinogen" [1]

Core Viewpoint - Tian Tan Biological (600161.SH) has received approval from the National Medical Products Administration for clinical trials of its "human fibrinogen" product, marking a significant step towards potential market entry [1] Group 1 - Tian Tan Biological's subsidiary, China National Pharmaceutical Group Kunming Blood Products Co., Ltd. (referred to as "Tian Tan Kunming"), has been granted the Clinical Trial Approval Notice for "human fibrinogen" [1] - The product will need to complete clinical trials, submit a drug marketing authorization application, pass the review by the National Medical Products Administration's Drug Evaluation Center, and obtain a drug registration certificate before it can be produced and sold [1]

Core Viewpoint - Tian Tan Biological (600161.SH) has received approval from the National Medical Products Administration for clinical trials of its "human fibrinogen" product, marking a significant step towards potential market entry [1] Group 1: Company Developments - Tian Tan's subsidiary, Kunming Blood Products Co., Ltd., has been granted the Clinical Trial Approval Notice for "human fibrinogen" [1] - The company must complete several steps, including conducting clinical trials, submitting a drug marketing application, and obtaining necessary approvals before production and sales can commence [1] Group 2: Regulatory Environment - The approval from the National Medical Products Administration is a crucial regulatory milestone for the company [1] - The process includes clinical trials, review by the drug evaluation center, and final approval from the National Medical Products Administration [1]

证券代码：600161 证券简称：天坛生物 公告编号：2025-048 北京天坛生物制品股份有限公司 关于下属企业获得药物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法律责任。 近日，北京天坛生物制品股份有限公司下属国药集团昆明血液制品有限公司 （以下简称"天坛昆明"）获得国家药品监督管理局签发的《药物临床试验批准通 知书》，同意天坛昆明开展"人纤维蛋白原"临床试验。现将有关信息披露如下： 一、 概况 （一） 产品信息 | 产品 | 适应症 | 可以开展临床试验 | | | | 规格 | 注册 | 剂型 | 研发 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 名称 | | 的时间及证书编号 | | | | | 分类 | | 投入 | | | 先天性纤维蛋白原减少或 | 2025 年 月 | 9 | 28 | 日， | 0.5g(25m1)/ | 治疗用生 | 注射剂 | | | | 缺乏症。 | 2025LP02528 | ...