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上海莱士:人纤维蛋白原获得《药品注册证书》
Ge Long Hui· 2026-01-30 10:11
Core Viewpoint - Shanghai Raas (002252.SZ) announced that its wholly-owned subsidiary, Tonglu Biopharmaceutical Co., Ltd., has recently received a Drug Registration Certificate from the National Medical Products Administration for its product, Human Fibrinogen [1] Company Summary - Tonglu Biopharmaceutical's product, Human Fibrinogen, is derived from healthy human plasma, which is isolated, purified, and treated for virus removal and inactivation before being freeze-dried [1] - The indication for this product is congenital fibrinogen deficiency or reduction [1]
上海莱士(002252.SZ):人纤维蛋白原获得《药品注册证书》
Ge Long Hui A P P· 2026-01-30 10:09
格隆汇1月30日丨上海莱士(002252.SZ)公布,全资子公司同路生物制药有限公司("同路生物")于近期 收到国家药品监督管理局签发的《药品注册证书》,药品名称:人纤维蛋白原。人纤维蛋白原系由健康 人血浆,经分离、提纯,并经病毒去除和灭活处理、冻干制成。同路生物本产品适应症为先天性纤维蛋 白原减少或缺乏症。 ...
上海莱士:多款产品列入2024年医保目录
Sou Hu Cai Jing· 2025-10-30 01:07
Core Viewpoint - Shanghai Laishi (002252) has confirmed that several of its products have been included in the 2024 National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List [2] Group 1: Product Inclusion in Medical Insurance - The following products from Shanghai Laishi and its subsidiaries are included in the medical insurance directory: human albumin, intravenous human immunoglobulin (PH4), human fibrinogen, prothrombin complex, coagulation factor VIII, human immunoglobulin, tetanus human immunoglobulin, and rabies human immunoglobulin [2]
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
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]
天坛生物:关于下属企业获得药物临床试验批准通知书的公告
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]
天坛生物(600161.SH):下属企业获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-30 09:30
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]
天坛生物:天坛昆明获批开展“人纤维蛋白原”临床试验
Zhi Tong Cai Jing· 2025-09-30 09:28
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]
天坛生物(600161.SH):天坛昆明获批开展“人纤维蛋白原”临床试验
智通财经网· 2025-09-30 09:26
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]
天坛生物:下属企业获得药物临床试验批准通知书
Ge Long Hui· 2025-09-30 09:12
Core Viewpoint - Tian Tan Biological Products Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for "human fibrinogen" [1] Company Summary - Tian Tan Kunming, a subsidiary of Tian Tan Biological Products, is the entity that obtained the clinical trial approval [1]
天坛生物:“人纤维蛋白原”获得药物临床试验批准通知书
Core Viewpoint - TianTan Biological (600161) has received approval from the National Medical Products Administration for clinical trials of "human fibrinogen" to treat congenital fibrinogen deficiency or lack [1] Company Summary - TianTan Kunming, a subsidiary of TianTan Biological, has been granted a Clinical Trial Approval Notice for the drug "human fibrinogen" [1] - The drug is indicated for conditions such as congenital fibrinogen deficiency or lack [1]