The domestically produced Sildenafil Hydrochloride Tablets (trade name: Onweida) have been officially approved for market launch：（prescription drug）
Key approval information:
Approval Date:
Obtained approval from the National Medical Products Administration (NMPA) on July 8, 2025, and officially announced to the public on July 11.
R&D unit:
jointly developed by Chinese Academy of Sciences Shanghai Institute of Materia Medica, Chinese Academy of Sciences Xinjiang Institute of Physical and Chemical Technology, and Suzhou Wangshan Wangshui Biomedical Co., Ltd.
Drug positioning:
Belonging to Class 1 innovative drugs, it is a phosphodiesterase 5 (PDE5) inhibitor with a completely new chemical structure, mainly used for the treatment of male erectile dysfunction (ED).
Core clinical advantages:
- Rapid onset of action:
It can take effect within 30 minutes after oral administration, supporting "on-demand use".
- Lower dose:
The clinically recommended starting dose (2.5mg) is lower than that of similar marketed drugs, and the incidence of adverse reactions is lower at high activity levels.
- Widely applicable:
The drug has a long duration of efficacy (half-life of 8-11 hours), and can be used by special populations such as the elderly and patients with mild to moderate liver and kidney damage. It does not affect the efficacy when taken with moderate alcohol.
The innovative inspiration for this original drug comes from the traditional Chinese medicine herb, Epimedium.
Five original PDE5 inhibitors have been launched in the domestic ED market
国内ED市场已有5款原研PDE5抑制剂上市
- Sildenafil (October 2002, Pfizer) 西地那非（2002年10月，辉瑞）
- Vardenafil (July 2004, GSK/Bayer) 伐地那非（2004年7月，GSK/拜耳）
- Tadalafil (December 2004, Eli Lilly) 他达拉非（2004年12月，礼来）
- Afanafine and the first domestically produced Class 1 new drug, Edinafine (December 2021, Yuekang Pharmaceutical) 阿伐那非以及首款国产1类新药爱地那非（2021年12月，悦康药业）
- Sildenafil Hydrochloride (July 10, 2025, Wangshan Wangshui Biopharmaceutical) 盐酸司美那非 （2025年7月10日，旺山旺水生物医药）
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