Guangdong Zhongsheng Pharmaceutical Co.,Ltd. (002317.SZ) has announced that its controlling subsidiary, Guangdong Zhongsheng Ruichuang Biotech Co., Ltd., recently received formal acceptance from China's National Medical Products Administration (NMPA) for a clinical trial application. This application seeks to expand the indications of its self-developed Class 1 innovative drug, Onradivir Tablets, to include treatment for patients with influenza A who are at high risk of complications.

The NMPA has issued the official Acceptance Notice for this proposed new indication. Onradivir Tablets, recognized as the world's first influenza RNA polymerase PB2 protein inhibitor, holds a distinct mechanism of action and global independent intellectual property rights. The drug was granted market approval by the NMPA in May 2025.

With this latest submission, the company plans to initiate a Phase III clinical study to evaluate the efficacy and safety of Onradivir Tablets in treating participants aged 12 years and older with confirmed influenza A virus infection and who present a high risk for influenza-related complications. This trial aims to assess the drug's potential to mitigate severe outcomes in this vulnerable patient population.