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注射用重组人凝血因子VIIa
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天坛生物:关于下属企业撤回药品注册申请的公告
Zheng Quan Ri Bao· 2025-11-19 13:35
Core Viewpoint - TianTan Biological announced that its subsidiary Chengdu Rongsheng Pharmaceutical will submit a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, following the receipt of the acceptance notice [2] Group 1 - The product's marketing authorization application has been accepted by the NMPA, with acceptance number CXSS2500005 [2] - Chengdu Rongsheng is actively working on the review process and has been requested to provide additional clinical trial data for pediatric patients under 12 years old [2] - As a result of the need for additional data, Chengdu Rongsheng has submitted a request to withdraw the drug registration application and plans to resubmit it after completing the necessary clinical data [2]