Belief BioMed (BBM) is an industry-leading, high-tech company that integrates the development, manufacturing and clinical application of gene therapy products. The company is committed to providing innovative and more effective gene therapies for genetic disorders, neurodegenerative diseases, age-related degenerative diseases and some major malignant diseases through safe and efficient virus vector technology. The company is headquartered in Shanghai, China, with offices or R&D and manufacturing centers in Beijing, Suzhou, Hong Kong and North Carolina, USA.
BBM has developed hundreds of key vector technologies and owns dozens of world-leading patented technologies, including the world-leading HEK293 cell suspension serum-free culture process and full-scale chromatography purification process, and has established the first commercial production platform for clinical used gene therapy drugs in China. The company has been building up its capabilities in a variety of fields including novel AAV capsids targeting different tissues, efficient transgene expression cassette design, advanced clinically-used vector manufacturing process, and innovative clinical development pathways. It has also established an extensive R&D pipeline covering a wide range of major, unmet clinical needs in therapeutic areas such as hemophilia, Parkinson's disease, arthritis, lysosomal storage disorders, hereditary neuromuscular diseases, oncology, ophthalmology, and degenerative diseases of the elderly. Several product pipelines have entered clinical studies or IND filings, and clinical data have been collected showing that the drug candidates have good safety and efficacy profiles.
The 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’s wholly owned subsidiary Shanghai Belief-Delivery BioMed Co., LTD., was officially approved by China National Medical Products Administration (NMPA). It is the first gene therapy under development for treatment of hemophilia, and the efficacy and safety data of the clinical study are so far very positive. 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.
