Recently, the official website of the State Food and Drug Administration announced that the Class 1 new drug Selenafil Hydrochloride Tablets (trade name: Onvida®) applied by Suzhou Wangshan Wangshui Biotechnology was officially approved for marketing for the treatment of male erectile dysfunction (ED).

The research and development of Onvida® began ten years ago. Founded in 2013, Wangshan Wangshui Biopharmaceuticals, as the first biopharmaceutical company incubated by the Suzhou Achievement Transformation Center of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, set its sights on the ED treatment market, which was then monopolized by multinational pharmaceutical companies.

The research team drew inspiration from flavonoid natural products, and after a large number of screening and structural optimization, they finally obtained a highly active and highly selective phosphodiesterase 5 (PDE5) inhibitor with independent intellectual property rights.

In March 2016, the drug obtained a clinical trial approval; in February 2023, it completed the Phase III clinical trial for erectile dysfunction indications, and submitted a new drug application (NDA) in September of the same year; it was finally approved in July 2025. In nearly ten years, the entire process from molecular design to market launch has been completed.

The highlight of Onvida® lies in its wide applicability. It can be used by special groups such as the elderly, patients with mild to moderate liver damage, and patients with mild to severe renal damage, which significantly broadens the applicable boundaries of traditional ED drugs. What is more in line with the Chinese social and cultural scene is that the efficacy of the drug is not affected when taken with a moderate amount of alcoholic beverages. This feature solves the social dilemma that plagues ED patients: "If you want to drink, you can't take medicine, and if you take medicine, you can't drink." According to data

from Didu , the sales of anti-ED chemical drugs in the Chinese market have been increasing year by year in recent years, exceeding 9 billion yuan in 2023. Among them, the retail market accounts for the majority, and it is the absolute main battlefield.
Previously, there were 5 original PDE5 inhibitors launched in the Chinese ED market: sildenafil (October 2002, Pfizer), vardenafil (July 2004, GSK/Bayer), tadalafil (December 2004, Eli Lilly), avanafil, and the first domestically produced Class 1 new drug, eldenafil (December 2021, Yuekang Pharmaceutical). Against

this background, Onvida®, as a domestically produced Class 1 new anti-ED drug, faces challenges in its market prospects.

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