Simcere’s anti-influenza drug NDA accepted by NMPA

Simcere Pharmaceutical Group announced on September 3, 2025, that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Deunoxavir Marboxil Granules (Xianlinda). This anti-influenza drug, jointly developed with Jiaxing AnDiCon Biotech Co., Ltd., is for treating uncomplicated influenza A and B in pediatric patients aged 2 to 11 years.

Deunoxavir Marboxil Granules is China's first pediatric anti-influenza virus innovative drug to successfully complete Phase III clinical trials and achieve regulatory acceptance. The drug functions as a cap-dependent endonuclease inhibitor, blocking viral mRNA transcription and suppressing replication.

Clinical studies highlight several potential advantages, including favorable safety profiles in pediatric patients, faster symptom relief, quicker viral clearance, lower resistance risk, and no impact of food intake on oral drug efficacy. The dosage form is also better suited for pediatric use.