On October 12th, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that Novartis' application for the listing of Busizumab injection has been accepted, but the specific indications have not yet been disclosed.
Public data show that brucizumab is a new generation of fundus disease treatment drug targeting to inhibit VEGF, which has previously been approved internationally for the treatment of wet age-related macular degeneration (wAMD, also known as nAMD) and diabetes macular edema (DME). In China, the first listing application for this product was accepted in August last year, and this is the second listing application for this product in China.
Busizumab has been approved for the treatment of nAMD and DME in dozens of countries worldwide, but in China, it has not yet received formal approval from the National Medical Products Administration. But Novartis' public information shows that it has previously been approved for clinical urgent use in designated medical institutions in the Greater Bay Area through the "Hong Kong Macau Medical Device Connect" policy. According to the official website of the China Drug Clinical Trial Registration and Information Disclosure Platform, Novartis has completed at least three Phase 3 clinical trials of buxolizumab in China.