Core Viewpoint - The announcement highlights the acceptance of the New Drug Application (NDA) for the influenza drug, Madaxanovir Granules (Xianlinda), by the National Medical Products Administration (NMPA) in China, marking a significant milestone for the company and the industry in pediatric antiviral treatments [1] Company Summary - The company has collaborated with Jiaxing Andikang Biotechnology Co., Ltd. for the development of Madaxanovir Granules [1] - This drug is specifically designed for treating uncomplicated Type A and B influenza in children aged 2 to 11 years [1] - Madaxanovir Granules is noted as the first innovative antiviral drug targeting pediatric patients in China to successfully complete Phase III clinical trials and submit for market approval [1] Industry Summary - The acceptance of the NDA represents a breakthrough in the antiviral drug market for children in China, addressing a significant unmet medical need [1] - The development of pediatric-specific antiviral treatments is becoming increasingly important in the healthcare landscape, particularly in response to seasonal influenza outbreaks [1]

Core Viewpoint - The announcement highlights the acceptance of the new drug application (NDA) for the influenza treatment drug, Madaxin (玛氘诺沙韦颗粒), 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 Details - Madaxin is a cap-dependent endonuclease inhibitor that works by inhibiting the replication of the influenza virus, blocking the transcription of the virus's own mRNA, thereby precisely suppressing viral replication [1] - Clinical studies indicate that Madaxin shows good safety in pediatric patients, faster symptom relief and viral clearance, lower risk of resistance, oral efficacy unaffected by food, and a dosage form more suitable for pediatric patients [1]

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]