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Yesterday, the official website of the State Food and Drug Administration showed that the avanafil tablets declared by Haisco according to registration classification 3 (domestic applicants imitated the overseas listing but the original research was not listed in the domestic market) have been approved for marketing by NMPA (approval number: National Medicine Standard H20213212 , Sinopharm Zhunzi H20213213), it will be the first imitation of this product after it is marketed.
Avanafil is a generic drug product developed by Hesco.
According to the "Guidelines for the Management of Erectile Dysfunction (2018) issued by the American Urological Association (AUA)", the recommended oral PDE5 inhibitors for ED mainly include sildenafil, tadalafil, vardenafil, and avana non.
Avanafil was originally a drug developed by Vivus Corporation of the United States authorized by Japan’s Tanabe Mitsubishi Pharmaceutical Co.
At present, in addition to Haisco, which has been approved for listing, Shanghai Huilun Jiangsu Pharmaceutical is in the stage of listing application.
There are three types of PDE5 inhibitors currently on the market in the domestic ED market: tadalafil, sildenafil and vardenafil, among which Eli Lilly's tadalafil and Pfizer sildenafil account for the main market share.