人福医药:子公司撤回重组质粒-肝细胞生长因子注射液药品注册申请

Core Viewpoint - The company announced the withdrawal of its drug registration application for a new biological product aimed at treating severe lower limb ischemic diseases, indicating a proactive approach to meet regulatory and technical requirements [1] Group 1: Company Actions - The company’s subsidiary, Guanggu Renfu, received a termination notice from the National Medical Products Administration regarding its application for the recombinant plasmid-hepatocyte growth factor injection [1] - The company has decided to voluntarily withdraw the application and will improve research materials before reapplying [1] Group 2: Financial and Development Insights - The cumulative research investment for the drug development has reached approximately 160 million yuan [1] - The company expects that this withdrawal will not have a significant impact on its current financial performance [1] Group 3: Industry Context - The development cycle for pharmaceutical products is long and involves multiple stages, which introduces uncertainties [1] - The company commits to timely information disclosure in accordance with regulatory requirements [1]

HWHG-人福医药:子公司撤回重组质粒-肝细胞生长因子注射液药品注册申请 - Reportify