Vector System
Belief BioMed has established its own original adeno-associated virus (AAV) capsid development platform, Capsidx®, and has developed a variety of novel engineered AAV capsids with independent intellectual property rights, that can target different tissues, including the liver, muscles, and neurons. Compared to conventional AAV capsids, the novel AAV capsids have higher transduction efficiency, better tissue-specificity, and lower immunogenicity.
Product Pipeline
BBM has established an extensive R&D pipeline covering a wide range of unmet medical needs in therapeutic areas such as hemophilia, hereditary muscle disease, Parkinson's disease, osteoarthritis, etc. Several product pipelines have entered clinical studies or submitted IND filings. The NDA of BBM-H901, a gene therapy for the treatment of adult patients with hemophilia B, has been accepted by the NMPA of China.
In-house Manufacturing
Belief BioMed has developed hundreds of key vector technologies, including HEK293 cell suspension serum-free culture process and full-scale chromatography purification process. BBM has established a commercial production site with an area of 15,000sqm for gene therapies. Its equipment and facilities have completed various verifications, and comply with Good Manufacturing Practice (GMP) standards. It has multiple plasmid, drug substance, and fill finish production lines, as well as a comprehensive quality control platform, the site can meet the needs of gene therapy drug production at different stages from preclinical to commercial, and for different scales with a maximum production capacity of up to 2000L for a single batch.