First Offline Prescription Issued for China's Homegrown Class I Innovative Drug for Men's Health

NANJING, China—Yangtze River Pharmaceutical Group's homegrown Class I innovative drug for men's health received its first offline prescription in Jiangsu province, marking the drug's official entry into clinical use.

The drug, tadalafil hydrochloride tablets, represents a new generation of highly selective phosphodiesterase type 5 (PDE5) inhibitors. Through molecular structure optimization, the compound demonstrates enhanced inhibitory activity and selectivity against its target, according to the company.

Unlike existing treatments, the drug is less affected by food and alcohol metabolism, allowing for more flexible dosing, the company said. This offers a new treatment option for patients with erectile dysfunction (ED).

ED is a common condition among adult males. A meta-analysis based on epidemiological surveys shows that the overall prevalence of ED among adult males in China approaches 50%, with rates rising significantly with age. The prevalence is particularly pronounced among men over 40.

Despite the high prevalence, consultation and standardized treatment rates among ED patients remain low. Traditional attitudes, privacy concerns, and medical habits contribute to this gap, but worries about drug efficacy, safety, and treatment experience may be significant factors, according to industry observers.

PDE5 inhibitors, recommended as first-line ED treatment in domestic and international guidelines, are the preferred initial therapy for most patients.

Tadalafil hydrochloride tablets underwent 22 years of systematic research and development, completing more than 20 clinical studies. Phase III clinical trials demonstrated that the drug improves erectile function in ED patients. The research findings were presented at the International Society for Sexual Medicine World Congress in 2026.

The clinical application of tadalafil hydrochloride tablets will bring new support for ED treatment and long-term management in China. Yangtze River Pharmaceutical said it will continue innovation and R&D while collaborating with various sectors of society through health education, screenings, and other initiatives to raise awareness of men's health and improve quality of life for families.