On July 25, 2025, the official website of the National Medical Products Administration (NMPA) announced that Tanonodafil Hydrochloride Tablets, a Class 1 innovative drug submitted by Yangtze River Pharmaceutical Group, was approved for marketing for the treatment of erectile dysfunction (ED).

Shenzhen Bao'an District Songgang People’s Hospital served as a sub-center for two multicenter clinical trials of this drug:

Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Udenafil Hydrochloride Tablets in the Treatment of Male Erectile Dysfunction

Long-term Safety Study of Tanonodafil Hydrochloride Tablets in Patients with Erectile Dysfunction

The kick-off meeting for the Phase III trial was held on March 29, 2021, and the first informed consent form was signed on June 4, 2021. A total of 23 subjects were enrolled, ranking 11th nationwide among 54 participating centers.

The kick-off meeting for the long-term safety study was held on March 8, 2024, and the hospital completed the enrollment of the first subject nationwide on March 12, 2024, with 12 enrolled subjects, ranking 12th nationwide among 54 centers.

As the Principal Investigator (PI) of the sub-center, Director Liu Yueguang led the urology research team to complete the clinical trials with high quality, winning consistent recognition from the sponsor and the Contract Research Organization (CRO).

Tanonodafil Hydrochloride Tablets (formerly named Udenafil) is a highly selective phosphodiesterase type 5 (PDE5) inhibitor. Structurally analogous to cyclic guanosine monophosphate (cGMP), it competitively blocks the binding between cGMP and PDE5 to inactivate PDE5, reduce the hydrolysis of cGMP, elevate intracellular cGMP concentration, and thereby enhance erectile function.

Previously on July 8, 2025, another Class 1 innovative drug Onvita® (generic name: Semenafil Hydrochloride Tablets, research code: TPN171), co-developed by Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd., Shanghai Institute of Materia Medica, Chinese Academy of Sciences and other institutions with the hospital’s participation, also obtained marketing approval.

Shenzhen Bao'an District Songgang People’s Hospital is a nationally certified institution for drug and medical device clinical trials. It currently covers 13 clinical trial disciplines for pharmaceuticals including a Phase I clinical trial laboratory and 33 disciplines for medical device trials, undertaking more than 100 registration-oriented clinical trial projects for pharmaceuticals, medical devices and in vitro diagnostic reagents.