Nanjing Zenshine Pharmaceuticals Co., Ltd., a China-based small molecule drug developer, has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ZX-7101A, an anti-influenza treatment targeting uncomplicated influenza in adults.
The NDA is supported by data from a multi-center, randomized, double-blinded, placebo-controlled Phase II/III clinical trial involving 900 adults diagnosed with uncomplicated influenza. The study demonstrated that ZX-7101A met its primary therapeutic endpoint, significantly reducing the time to remission of all influenza symptoms compared to the placebo group, with statistically significant results.
Key findings from the study highlighted that ZX-7101A notably expedited the time for influenza virus RNA to test negative, decreased the time for the influenza virus titer to turn negative, and shortened fever relief duration when compared to controls. In terms of safety, ZX-7101A exhibited an excellent safety profile, with the incidence of adverse reactions in the treatment group comparable to that of the placebo group, and no significant gastrointestinal side effects reported.- Flcube.com
