Wangshan Wangshui-B (02630): The marketing registration application (NDA) for Onvidia® Simenafil hydrochloride tablets was accepted by the Hong Kong Department of Health, China and the Macau Drug Administration

^{Zhitong Finance App News, Wangshan Wangshui-B (02630) issued an announcement. Recently, the Group's self-developed new drug simenafil hydrochloride tablets (trade name: Onvidia®, R&D code: TPN171) for the treatment of erectile dysfunction (ED) indications in the Hong Kong Special Administrative Region of China has been officially accepted by the Hong Kong Department of Health; the NDA for the Macau Special Administrative Region of China has also been officially accepted by the Drug Administration on September 30, 2026.}

This NDA is mainly based on a multi-center, randomized, double-blind, placebo-controlled phase III clinical study (NCT05188989) of TPN171's indications for erectile dysfunction. The study results showed that TPN171 had remarkable clinical efficacy and high safety.

As a highly active, highly selective phosphodiesterase 5 (PDE5) inhibitor with a novel chemical structure, TPN171 has the potential to become a best-in-class (best-in-class) drug with rapid efficacy, moderate duration of efficacy, high safety, wide range of applications, and diverse usage scenarios.

^{TPN171, which is used to treat ED indications, has been approved for marketing in China (trade name: Onvita®) and Uzbekistan (trade name: Onvita®), respectively.} In September 2026, the application for clinical trials of TPN171 for Alzheimer's disease was approved by the China National Drug Administration.