The first domestic product! Simcere Pharmaceutical’s new pediatric anti-influenza drug has had its marketing application accepted

On September 3, Simcere Pharmaceutical (02096) announced that its new anti-influenza drug, Madanosovir Granules, developed in collaboration with Jiaxing Andikang Biotechnology Co., Ltd., has had its New Drug Application (NDA) accepted by the National Medical Products Administration (NMPA).

The drug is intended to treat uncomplicated influenza A and B in children aged 2 to 11, making it China’s first innovative anti-influenza drug targeting pediatric patients to successfully complete Phase III clinical trials and apply for market approval.

Madanosovir is a cap-dependent endonuclease inhibitor, which works by inhibiting the cap-dependent endonuclease required for influenza virus replication, thereby blocking the transcription of viral mRNA and precisely suppressing viral replication.

Clinical studies have shown that the drug has good safety in pediatric patients. It can relieve symptoms and clear the virus more quickly and has a low risk of resistance. Its oral efficacy is unaffected by food, with a formulation that is more suitable for children.

Source: Caizhongshe