By Fineline Cube 
China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate Anruiwei (onradivir) in adult patients with simple influenza A. This approval marks a significant step forward in the treatment options available for influenza A patients.
Onradivir Mechanism and Innovation
Onradivir is described as the world’s first influenza RNA polymerase PB2 protein inhibitor. It has a clear mechanism of action and global proprietary intellectual property rights. The drug’s innovative approach to targeting the influenza virus sets it apart in the field of antiviral therapies.
Clinical Trial Results
Results from the Phase III study demonstrated that onradivir was superior to the placebo in terms of the primary endpoint of time to alleviation of seven symptoms (TTAS) and secondary endpoint indicators. These included single system or single symptom relief time, and virological indicators such as viral load reduction, virus conversion time, and the proportion of virus conversion subjects. Statistically significant differences were achieved in these measures.
Comparison with Oseltamivir
Onradivir is also the only anti-influenza drug in China to have undergone Phase III clinical trials head-to-head against oseltamivir. In this study, onradivir shortened the median TTAS and fever relief time by nearly 10% compared to oseltamivir, highlighting its potential as a more effective treatment option.-Fineline Info & Tech