先声药业：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
SIMCERE PHARMA's new drug application (NDA) for the anti-influenza drug Madaxanovir granules, in collaboration with Jiaxing Andikang Biotechnology Co., Ltd., has been accepted by the National Medical Products Administration. This drug is used to treat uncomplicated influenza A and B in children aged 2 to 11 years and is China's first innovative antiviral drug for children, with good safety and multiple clinical advantages
According to the Zhitong Finance APP, SIMCERE PHARMA (02096) announced that on September 3, 2025, the new drug application (NDA) for the anti-influenza drug Madaxinosawei granules (Xianlinda®), developed in collaboration with Jiaxing Andikang Biotechnology Co., Ltd. (Andikang), was accepted by the National Medical Products Administration (NMPA). This drug is intended for the treatment of uncomplicated type A and type B influenza in children aged 2 to 11 years and is the first innovative antiviral drug targeting pediatric patients in China to successfully complete Phase III clinical trials and apply for market approval.
Madaxinosawei is a cap-dependent endonuclease inhibitor. Its mechanism of action involves inhibiting the cap-dependent endonuclease essential for influenza virus replication, thereby blocking the transcription of the virus's own mRNA and precisely suppressing viral replication.
Clinical studies have shown that Madaxinosawei granules have good safety in pediatric patients, faster symptom relief and viral clearance, lower risk of resistance, oral efficacy unaffected by food, and a formulation more suitable for pediatric patients, among other potential clinical advantages
