“Fosaprepitant Dimeglumine for Injection” obtains FDA ANDA Approval

Release time:2021-03-29

Recently,“Fosaprepitant Dimeglumine for Injection” (brand name “Shanqi”), a drug developed by the Group used for the prevention of nausea and vomiting caused by chemotherapy, has obtained approval of abbreviated new drug application (“ANDA”, i.e. United States generic drug application) from the United States Food and Drug Administration (“FDA”).

This product is another “three applications with three approvals” variety of the Group which has been approved for launch in the three major international markets of China, the United States, and Europe. Fosaprepitant Dimeglumine for Injection is a neurokinin-1 (NK-1) receptor antagonist and a prodrug of aprepitant. It is clinically used to prevent nausea and vomiting caused by chemotherapy drugs. The product is a powder intravenous injection, with affirmative efficacy, high safety, and broad clinical use. Compared with oral aprepitant, the use of injections can provide greater flexibility and convenience for some patients with disease-related nausea who cannot accept oral medication. The product has become a necessary antiemetic drug for prescription combination for the treatment of tumors.

The approval of Fosaprepitant Dimeglumine for Injection in the United States is another achievement of the Group’s internationalization strategy, which once again proves the Group’s determination and ability to enter the overseas high-end market. The launch of this product will further accelerate the Group’s process of expanding into the international market for oncology drugs and pave the way for the subsequent overseas market promotion of a series of high-end generic drugs.