Belief BioMed Inc. (BBM) is a biotech company that integrates the research & development, manufacturing and clinical application of gene therapy products. The company is committed to providing innovative and more effective gene therapies for severe genetic and chronic diseases through safe and efficient viral vector technology.
BBM has developed hundreds of key vector technologies, including HEK293 cell suspension serum-free culture process and full-scale chromatography purification process, and has established the commercial production platform for gene therapy drugs in China. The company has been building up its capabilities in a variety of fields including novel adeno-associated virus (AAV) capsids targeting different tissues, efficient transgene expression cassette design, and advanced clinical-grade vector manufacturing process. It has also established an extensive R&D pipeline covering a wide range of major, unmet medical needs in therapeutic areas such as hemophilia, Parkinson's disease, arthritis, neuromuscular disease, etc. Several product pipelines have entered clinical studies or submitted IND filings.
In 2021, the Clinical Trial Application (CTA) for BBM-H901, an AAV gene therapy drug for prevention of bleeding in adult male patients with hemophilia B, which was independently developed and manufactured by Belief BioMed, was officially approved by China National Medical Products Administration (NMPA). It is the first gene therapy under development for treatment of hemophilia in China. In 2022, the results of clinical studies related to BBM-H901 were successively published in two prestigious international journals, i.e. The Lancet Haematology and New England Journal of Medicine. In the same year, BBM-H901 was granted Orphan Drug Designation (ODD) by U.S. Food and Drug Administration (FDA), and Breakthrough Therapy Designation (BTD) by China Center for Drug Evaluation (CDE), NMPA.
