智飞生物(300122.SZ)：撤回儿童型四价流感病毒裂解疫苗和流感病毒裂解疫苗的注册申请

Core Viewpoint - The company, Zhifei Biological, has decided to withdraw its registration applications for two pediatric influenza vaccines after receiving a termination notice from the National Medical Products Administration, aiming to enhance clinical evidence and align with market demand for high-quality vaccines [1]. Group 1: Vaccine Development - Zhifei Biological's subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., received a notice to terminate the registration applications for the pediatric quadrivalent influenza virus split vaccine and the influenza virus split vaccine [1]. - The company had submitted these applications for children aged 6 months to 35 months in September and October 2024, respectively, and both applications were accepted by the regulatory authority [1]. - Clinical trial results indicated that the immunogenicity data for the entire population was overall superior to that of the already marketed control vaccines, meeting the preset research standards with good safety profiles [1]. Group 2: Strategic Decision - Due to the variability of influenza viruses and the unique immune system characteristics of children, the company decided to withdraw the registration applications after careful evaluation [1]. - The company plans to steadily advance supplementary research to continuously improve the clinical evidence chain and pursue the listing application process [1].