Core Viewpoint - The announcement indicates that the new drug application (NDA) for the influenza treatment, Madaxanovir granules, has been accepted by the National Medical Products Administration (NMPA) in China, marking a significant milestone as it is the first innovative antiviral drug targeting influenza in children to complete Phase III clinical trials and apply for market approval in China [1] Group 1: Drug Development and Approval - The collaboration between the company and Jiaxing Antikang Biotechnology Co., Ltd. focuses on the development of Madaxanovir granules for treating uncomplicated influenza A and B in children aged 2 to 11 [1] - Madaxanovir is a cap-dependent endonuclease inhibitor, which works by inhibiting the replication of the influenza virus through blocking the transcription of the virus's own mRNA [1] Group 2: Clinical Advantages - Clinical studies have shown that Madaxanovir granules demonstrate good safety in pediatric patients, faster symptom relief, quicker viral clearance, lower risk of resistance, and oral efficacy that is unaffected by food [1] - The formulation of Madaxanovir is more suitable for pediatric patients, highlighting its potential clinical advantages over existing treatments [1]
先声药业(02096.HK)：玛氘诺沙韦颗粒新药上市申请(NDA)获国家药品监督管理局受理