Core Viewpoint - The announcement highlights the acceptance of the new drug application for the influenza treatment drug, Madaxanovir granules, by the National Medical Products Administration (NMPA) in China, marking a significant milestone for the company and the pediatric antiviral market in China [1] Group 1: Drug Development and Approval - The new drug application (NDA) for Madaxanovir granules, developed in collaboration with Jiaxing Andikang Biotechnology Co., has been accepted by NMPA on September 3, 2025 [1] - Madaxanovir is the first innovative antiviral drug targeting influenza in children aged 2 to 11 years in China to complete Phase III clinical trials and submit for market approval [1] Group 2: Mechanism of Action - 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 3: Clinical Advantages - Clinical studies indicate 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 is particularly suitable for pediatric patients, enhancing its potential market appeal [1]
先声药业(02096)：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