Novo Nordisk's Subcutaneous Hemophilia A Drug Mim8 Granted Clinical Trial Approval in China for Pediatric Patients

The latest public announcement from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) indicates that Mim8, a Class 1 novel therapeutic biological product developed by Novo Nordisk, has received implicit approval for clinical trials. The proposed indication is routine prophylactic treatment in pediatric patients (<12 years of age) with hemophilia A (congenital factor VIII deficiency), with or without factor VIII inhibitors, to prevent bleeding episodes or reduce their frequency.

It is reported that Mim8 is a next-generation bispecific antibody targeting FIXa and FX, developed by Novo Nordisk. It is a subcutaneous prophylactic treatment for patients with hemophilia A, with or without inhibitors, and is currently in Phase 1/2 clinical trials.

According to publicly available information from Novo Nordisk, as a FVIIIa mimetic, Mim8 promotes the binding of FIXa to FX on the surface of activated phospholipids and enhances the proteolytic activity of FIXa (i.e., its ability to activate FX), thereby mimicking the function of FVIIIa in vivo.