About BBM | Belief Biomed Inc

Company Introduction

Founded in May 2018, Belief BioMed (BBM) is an industry leader in gene therapy product development, production and clinical application. BBM is committed to the development of safe and efficient adeno-associated virus based gene therapies. AAV vector technology provides more effective innovative gene therapy for genetic diseases with gene defects, neurodegenerative diseases, age-related degenerative diseases and some major malignant diseases. Headquartered in Shanghai, the group also has offices and production centers in Beijing, Suzhou, Hong Kong and North Carolina.

The company has developed hundreds of key technologies of AAV vectors, and owns dozens of world-leading patent technologies, including the world-leading HEK293 cell suspension serum-free culture process and full-chromatography large-scale purification process, and established the first commercialized production platform of clinical-grade AAV gene therapy drugs in China. The company has carried out a comprehensive layout in the fields of new capsids targeting different tissues of AAV, efficient design of transgenic expression boxes, advanced clinical-grade vector manufacturing process, innovative clinical development paradigm and so on. At the same time, it has also established a rich R&D pipeline for the treatment of hemophilia, Parkinson's disease, lysosomal storage disease, hereditary neuromuscular diseases, ophthalmology and degenerative diseases of the elderly, and many other major and unmet clinical needs. Multiple product pipelines have entered various pre-clinical studies or IND applications and have collected clinical data showing good safety and efficacy.

Mission And Vision

Our Mission

Make gene therapy drugs available, affordable and healable.

Our Vision

To become the pioneer leading China’s gene therapy industry, to bring China’s gene therapy drugs to the world.

Key Milestones

2016

Belief BioMed was founded

2017

High productivity cell line established

2018

CMC research and development center established, the production of hemophilia B IIT drug is completed

2019

Experimental Rodent Animal Center officially put into use, hemophilia B IIT officially launched, drug administration in primates Parkinson’s disease model, and 50L process put into production

2020

The Shanghai office, as the global headquarter and clinical research development center, officially opened; the 5,000m ² production and research base officially opened (Shanghai Minhang Science and Technology Park of ECUST); the 300m² non-human primate experiment center officially opened; hemophilia B submitted pre-IND to NMPA CDE; and two MNC License out contracts were signed; One year’s data from primate model of Parkinson’s disease; 200L manufacturing process was locked down and applied in the batch production.

2021

On May 14, 2021, BBM-H901as the first Hemophilia gene therapy drug and the first AAV IND gene therapy drug for rare disease intravenous administration in China, was successfully submitted and accepted by NMPA CDE. The construction of 15,000m ² commercial production and manufacturing center officially started (Shanghai Harbor Free Trade Zone Intelligent Manufacturing Park), and the 500L process put into operation.
On August 6, 2021, BBM-H901 injection (AAV gene therapy drug used to prevent haemophilia B in adult male patients) independently developed by Shanghai Belief-Delivery BioMed Co., Ltd., a wholly-owned subsidiary of Belief BioMed, was approved by National Medical Products Administration (NMPA) to enter the registered clinical trial stage.
On November, a subsidiary of Belief BioMed, also won the approval of special funds for the development of strategic emerging industries in Shanghai.
On December, Belief BioMed Completed Dosing of the First Subject in the Registrational Gene Therapy Clinical Trial for Hemophilia B.

2022

On May, Clinical results for Belief BioMed’s developing hemophilia B gene treatment BBM-H901 published in authoritative hematology journal The Lancet Haematology.