The Center for Drug Evaluation (CDE) has indicated on its website that the market application for BBM-H901, a gene therapy treatment for hemophilia B developed by Belief BioMed Group (BBM), a Shanghai-based specialist in gene therapy, is on track for priority review. BBM-H901, co-developed with Japan’s Takeda, is an adeno-associated virus (AAV) gene therapy that has been granted priority status due to its classification as a ‘clinically urgently needed in-shortage drug, and innovative drug and modified drug for the prevention and treatment of major infectious diseases and rare diseases.’ This follows the therapy’s previous breakthrough therapy designation in China.- Flcube.com
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