Recently, the National Medical Products Administration approved the marketing of Selenafil Hydrochloride Tablets (trade name: Angweida), a Class 1 innovative drug applied for by Suzhou Wangshan Wangshui Biological, for the treatment of erectile dysfunction (ED).

It is worth mentioning that it takes effect quickly, takes effect within 30 minutes after oral administration, and has a long duration of efficacy, with a half-life of 8 to 11 hours. In addition, the efficacy of Onvida is not affected when taken with moderate alcoholic beverages, which solves the social dilemma that has plagued ED patients for many years.

Impressive performance

As early as ten years ago, Wangshan Wangshui Biological turned its attention to the ED drug market, which was then monopolized by multinational pharmaceutical companies. The research team drew inspiration from flavonoid natural products and, after numerous screenings and structural optimizations, finally obtained a highly active and highly selective phosphodiesterase 5 (PDE5) inhibitor with independent intellectual property rights.

In clinical trials, Onvida's performance was impressive. Its clinically recommended starting dose is lower than that of the marketed drugs with the same target. After patients took 2.5, 5, and 10 mg of selenafil as needed, the erectile function score (IIEF-EF) was as high as 25.7, 25.6, and 26.1 points, respectively, close to normal levels. These data not only prove the excellent efficacy of Onvida, but also provide strong support for its competitiveness in the market.

What is more worth mentioning is that Onvida has performed well in terms of safety. In the Phase III clinical trial, the incidence of common adverse reactions such as headache and indigestion was lower in the 2.5, 5, and 10 mg dose groups of Onvida. In addition, Onvida has a weak inhibitory effect on other subtypes of PDE, so no or few adverse reactions related to them were found, such as abnormal vision (related to PDE6), back pain and muscle pain (related to PDE11), etc.
The success of Onvida is not accidental. Behind it is the profound accumulation of Wangshan Wangshui Biological in the field of innovative research and development. As a comprehensive integrated biopharmaceutical company, Wangshan Wangshui focuses on three major areas: antiviral, neuropsychiatric, and reproductive health, and has built 9 innovative asset pipelines. In addition to Onvida, Wangshan Wangshui's other pipelines under development are also attracting much attention. For example, VV116 is an RdRp inhibitor that has been approved by China and Uzbekistan for the treatment of COVID-19, with the trade names MindVY and MINDVY. This drug played an important role during the COVID-19 pandemic, demonstrating Wangshan Wangshui's strong research and development capabilities in the antiviral field.

In addition, LV232 is a potential first-in-class dual-target 5-HTT/5-HT3 receptor modulator. With its unique mechanism of action, LV232 can enhance the antidepressant effect while reducing common gastrointestinal side effects. It not only brings new hope to patients with depression, but also further consolidates Wangshan Wangshui's research and development position in the field of neuropsychiatry.

Blue Ocean Market

Erectile dysfunction (ED), as a common male sexual dysfunction disease, has a significantly increased incidence, driving the rapid development of the ED drug market.

According to QYResearch's research data, the global ED drug market size will be approximately US$6.34 billion in 2024, and is expected to reach US$10.05 billion by 2031, with a compound annual growth rate (CAGR) of 7.0% from 2025 to 2031.

In China, the ED drug market is also showing a rapid growth trend. From 2019 to 2023, the scale of China's anti-ED drug market increased from 4.28 billion yuan to 7.89 billion yuan, and is expected to increase from 9.31 billion yuan to 15.7 billion yuan from 2024 to 2028.

The ED drug market is highly competitive and is dominated by the following drugs:

PDE5 inhibitors: This is the most widely used anti-ED drug in clinical practice, including sildenafil, tadalafil, vardenafil, etc. Among them, sildenafil occupies a dominant position in the Chinese market, and tadalafil has continued to expand its market share due to its advantages such as long-lasting efficacy and high safety. In recent years, the rise of Chinese generic drugs has also posed a strong competition to imported drugs. For example, Jin Ge (sildenafil) of Baiyunshan Pharmaceutical and Tadalafil Tablets of Qilu Pharmaceutical have gradually won market recognition with their price advantages and good efficacy.
Traditional Chinese medicine and health food: Traditional Chinese medicine and health food also occupy a certain market share in the Chinese market. Traditional Chinese medicine such as Fufang Xuanju Capsule and Wuzi Yanzong Pill are favored by some patients because of their small side effects and suitability for long-term conditioning.

In the future, with the continuous progress of drug research and development, the expansion of market channels and the increase in patients' demand for treatment, the ED drug market will usher in more development opportunities. At the same time, the rise of Chinese drugs will further change the market competition landscape.

Conclusion

China's new ED drug Onvida is not only a major breakthrough for Wangshan Wangshui Biological, but also an important progress in this field for China's pharmaceutical industry. Its advantages in efficacy, safety and applicability enable it to compete with imported drugs.

However, in order to stand out in this fiercely competitive market, Chinese drugs need to continue to make efforts in market promotion and brand building. I believe that in the near future, Chinese ED drugs will not only break the monopoly of imported drugs, but also provide patients with better and safer treatment options.

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