先声药业:玛氘诺沙韦颗粒新药上市申请获NMPA受理

Core Viewpoint - The announcement highlights the acceptance of the new drug application (NDA) for the influenza treatment drug, Madaxanovir granules (Xianlinda®), by the National Medical Products Administration (NMPA) in China, marking it as the first innovative antiviral drug targeting influenza in children aged 2 to 11 years to complete Phase III clinical trials and apply for market approval [1] Company Summary - The collaboration between the company and Jiaxing Antikang Biotechnology Co., Ltd. focuses on the development of Madaxanovir, an innovative antiviral drug for treating uncomplicated influenza in children [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] Clinical Research Summary - Clinical studies indicate that Madaxanovir granules demonstrate good safety in pediatric patients, faster symptom relief and viral clearance, lower risk of resistance, and oral efficacy that is unaffected by food, making it more suitable for pediatric patients [1]