天坛生物下属企业撤回药品注册申请

Core Viewpoint - TianTan Biological announced the withdrawal of the drug registration application for "Recombinant Human Coagulation Factor VIIa Injection" due to the need for additional clinical trial data for pediatric patients under 12 years old [1][3]. Group 1 - TianTan Biological's subsidiary, Chengdu Rongsheng Pharmaceutical Co., Ltd., submitted the drug registration application to the National Medical Products Administration (NMPA) in January and received an acceptance notice [3]. - Since receiving the acceptance notice, Chengdu Rongsheng has been actively cooperating with the review process [3]. - The company plans to resubmit the drug registration application after completing the necessary clinical data for the pediatric population [1].