About BBM | Belief Biomed Inc

Company Introduction

Belief BioMed Group (BBM) was founded in September 2016, is a leading innovative pharmaceutical company that combines gene therapy drug R&D, manufacturing platforms and clinical transformation. The Company established offices，R&D centers and manufacturing in China Shanghai, Beijing, Suzhou, Hong Kong and North Carolina. BBM is committed to providing innovative therapies for single gene disorder diseases, neurodegenerative diseases and malignant diseases through adeno-associated virus (AAV) vector technology.

BBM has its own patents for a variety of AAV vectors, as well as dozens of new capsids with extremely specific tissue tropism. BBM invented recombinant AAV packaging technology has been widely used in the field of AAV gene therapy. BBM has extremely rich pipelines, that covering a variety of major and unmet clinical needs such as hemophilia, Parkinson's disease, Lysosomal storage disease, Hereditary neuromuscular disease, Hereditary muscle diseases, Ophthalmology disease and so on. Several pipelines launched the investigator initiated clinical trial and entered Investigational New Drug (IND) application stage. The available clinical data showed that the drugs had significant safety and efficacy. BBM successfully developed the world's leading serum-free suspension culture process based on HEK 293 cells (200L and 500L processes have been successfully put into production) and the large-scale purification process based on chromatography.

On August 6th, 2021, China’s National Medical Products Administration (NMPA) has cleared the IND (Investigational New Drug) application for Belief BioMed’s BBM-H901 using prophylactic treatment of hemophilia B in adult male. This is the first IND approval for AAV gene therapy for Hemophilia in China, and the first intravenous infusion gene therapy for rare diseases in China.

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 6th, 2021, China’s National Medical Products Administration (NMPA) has cleared the IND (Investigational New Drug) application for Belief BioMed’s BBM-H901, then official registration clinical trial has been initiated.