VIGONVITA-B(02630): The New Drug Application (NDA) for Angweida Sildenafil Citrate Tablets has been accepted by the Department of Health of Hong Kong, China and the Pharmaceutical Administration Bureau of Macau, China

VIGONVITA-B(02630) announced that recently, the New Drug Application (NDA) for its self-developed Class 1 new drug sildenafil citrate tablets (trade name: Angweida, development code: TPN171) for the treatment of erectile dysfunction (ED) has been officially accepted by the Department of Health of the Hong Kong Special Administrative Region, China; the NDA in the Macau Special Administrative Region, China was also officially accepted by the Pharmaceutical Administration Bureau on September 30, 2026. This NDA is primarily based on a multicenter, randomized, double-blind, placebo-controlled parallel-group Phase III clinical study (NCT05188989) of TPN171 for the treatment of erectile dysfunction. The study results showed that TPN171 has significant clinical efficacy and high safety. TPN171, as a highly active and highly selective phosphodiesterase 5 (PDE5) inhibitor with a novel chemical structure, has clinical study results for its ED indication showing rapid onset of action, moderate duration of efficacy, high safety, a broad applicable population, and diverse usage scenarios, demonstrating the potential to become a Best-in-Class drug. TPN171 for the treatment of ED has already been approved for marketing in China (trade name: Angweida) and Uzbekistan (trade name: Onvita). In September 2026, the clinical trial application for TPN171 for the Alzheimer's disease indication was approved by the National Medical Products Administration of China.