On September 2, 2025, Simcere Pharmaceutical Group (2096.HK) announced that the New Drug Application (NDA) for the domestically pioneered pediatric anti-influenza virus drug Deunoxavir Marboxil Tblets (Xianlinda Tablets), co-developed with AndiCon Biotech, had been officially accepted by the National Medical Products Administration. It is intended for the treatment of uncomplicated influenza A and influenza B in children aged 2–11 years. This is the first anti-influenza virus innovative drug in China that has successfully completed Phase III clinical trials and been submitted for marketing authorization targeting pediatric patients, and is expected to achieve "cure with one pack" for childhood influenza.
The pivotal Phase III clinical study of Deunoxavir Marboxil in children aged 2–11 years was co-led by Professor Ni Xin, President of Beijing Children's Hospital, Capital Medical University, and Professor Zhao Chengsong, Vice President of the hospital, as principal investigators. This multicenter, randomized, double-blind, double-dummy, positive-controlled study involved 38 clinical trial centers nationwide. In different age subgroups, a "head-to-head" trial design was adopted compared with positive control drugs such as Baloxavir Marboxil for Suspension and Oseltamivir Granules. Clinical studies have shown that Madavervir Granules have potential clinical advantages in pediatric patients, including good safety, faster symptom relief and virus clearance, lower drug resistance risk, oral efficacy not affected by food, and a dosage form more suitable for pediatric patients.
In addition, Deunoxavir Marboxil Tablets have also made progress in the field of influenza prevention. Its indication for post-exposure prevention of influenza A and influenza B in populations aged 2 years and above has obtained implied permission for clinical trials. This makes it the first innovative drug in China to conduct clinical trials on post-exposure prevention of influenza in children aged 2 years and above. After children are exposed to the influenza virus, they are expected to reduce the risk of illness through "one pack for prevention", which is expected to fill the gap in this field.
About Deunoxavir Marboxil Tablets
Marboxil (Xianlinda®) is a cap-dependent endonuclease inhibitor. Its mechanism of action is to inhibit the cap-dependent endonuclease required for influenza virus replication, block viral mRNA transcription, and thereby precisely inhibit virus replication. Clinical studies indicate that it has three core advantages: 1. "One tablet cures" for adult influenza and "one pack cures" for pediatric influenza; 2. It can terminate viral shedding within 24 hours ("virus negativity in one day"); 3. Dual functions of treatment and prevention ("one stone, two birds").