Avanafil

Male erectile dysfunction (ED) is a reproductive system disease with a high incidence among adult males. According to statistics, its global prevalence rate exceeds 20%, and shows an upward trend with age, which seriously affects the quality of life of patients and family relationships. Avanafil belongs to the highly selective phosphodiesterase 5 (PDE5) inhibitor. By specifically inhibiting the activity of PDE5, it reduces the degradation of cyclic guanosine monophosphate, relaxes the smooth muscle of the corpus cavernosum, and promotes blood perfusion to achieve erection. Compared with similar drugs, it has higher selectivity for PDE5, takes only 15 minutes to take effect, and has a lower incidence of adverse reactions, providing a new treatment option for patients who have poor response or intolerance to other PDE5 inhibitors.

The global market size of ED therapeutic drugs had exceeded 7.5 billion US dollars in 2023, among which PDE5 inhibitors account for more than 90% of the market share. As a new generation product, avanafil has a compound annual growth rate of 18% in the past three years, which is significantly higher than that of traditional varieties such as sildenafil and tadalafil. In terms of the domestic market, with the improvement of the awareness rate of ED patients and the enhancement of self-payment ability, the terminal sales of avanafil exceeded 1.2 billion yuan in 2023. At present, more than 15 pharmaceutical companies have been approved for generic preparations. After the implementation of centralized procurement, the price has dropped by more than 80%, which further promotes the penetration of the primary market, and the demand for upstream API maintains an annual growth rate of more than 30% simultaneously.

The original research enterprise of avanafil is Japan's Tanabe Mitsubishi Pharma, and the original research trade name is "Stendra". The expiration date of the US compound patent is 2021, and the core patent in China expired in 2020. The approved dosage form of the original research product is oral tablet, with specifications including 50mg, 100mg and 200mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs (Fourth Batch)*. In terms of domestic API registration, nearly 20 enterprises have obtained A status for their avanafil APIs through CDE registration, which can be legally supplied for preparation production, and 18 domestic avanafil oral preparations have been approved for marketing. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for avanafil API, covering all categories such as starting material impurities, intermediate impurities and degradation impurities involved in the synthesis route. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA. Most products have sufficient spot inventory. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the full-scenario needs of pharmaceutical companies for process R&D, quality research and routine quality testing.