Technology & Platform
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.
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. Passed the NMPA inspection in 2023 and obtained the drug production license. 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.
15000m2
Commercial production site for gene therapies
2000L
Maximum production capacity for a single batch
Product Pipeline
Belief BioMed has established an extensive R&D pipeline covering a wide range of unmet medical needs in therapeutic areas such as hemophilia, DMD, Parkinson's disease, osteoarthritis, etc. April 8 2025, BBM-H901 (generic name: Dalnacogene Ponparvovec Injection), has been officially approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with moderate to severe hemophilia B (congenital coagulation factor IX deficiency).
Rare diseases
| Candidate | Indication | Current progress | Pre-clinical | IIT | IND | PhI | PhII | PhIII | BLA | Marketed |
| BBM-H901 | Hemophilia B | Marketed BTD ODD/RPDD ATMP | April 8 2025, BBM-H901 (generic name: Dalnacogene Ponparvovec Injection), has been officially approved by the National Medical Products Administration (NMPA) | |||||||
| BBM-H803 | Hemophilia A | PhI/II | Phase III in 2025 | |||||||
| BBM-D101 | Duchenne Muscular Dystrophy (DMD) | IND ODD/RPDD PhI | Phase III in 2025 | |||||||
Chronic diseases
| Candidate | Indication | Current progress | Pre-clinical | IIT | IND | PhI | PhII | PhIII | BLA | Marketed |
| BBM-P002 | Parkinson's Disease | PhI | ||||||||
| BBBM-A101 | Osteoarthritis | PhI | ||||||||
| BBM-C101 | Cervical Intraepithelial Neoplasia (HPV) | IIT | Phase I in 2025 (plan) | |||||||
Note: BTD: Break-through Designation; ODD: Orphan Drug Designation; RPDD: Rare Pediatric Disease Designation; ATMP: Advanced Therapy Medicinal Product
Marketed Product
According to the "Regulations on the Administration of Drug Instructions and Labels" (Order No. 24) issued by the National Medical Products Administration (NMPA), once the drug instruction has been approved for revision, pharmaceutical manufacturers are required to immediately notify the relevant pharmaceutical distribution enterprises, user institutions, and other departments of the changes. To ensure that relevant entities and healthcare professionals receive the most up - to - date instruction information promptly, our company is announcing the latest instruction information as required by these regulations. The following content is provided exclusively for healthcare professionals.