SIMCERE PHARMA (02096) announced that on September 3, 2025, the New Drug Application (NDA) for martenoxavir granules (Xin Lin Da®), an anti-influenza drug developed in collaboration with Jiaxing Antikang Biotechnology Co., Ltd. (Antikang), has been accepted by the National Medical Products Administration (NMPA). The drug is indicated for the treatment of uncomplicated influenza A and B in children aged 2 to 11 years, marking it as China's first innovative anti-influenza drug targeting pediatric patients to successfully complete Phase III clinical trials and submit for market approval.

Martenoxavir is a cap-dependent endonuclease inhibitor. Its mechanism of action involves inhibiting the cap-dependent endonuclease essential for influenza virus replication, blocking the transcription of viral mRNA, thereby precisely suppressing viral replication.

Clinical studies have demonstrated that martenoxavir granules exhibit favorable safety profiles in pediatric patients, with faster symptom relief and viral clearance, lower drug resistance risk, and potential clinical advantages including oral efficacy unaffected by food intake and a dosage form more suitable for pediatric patients.