About BBM | Belief Biomed Inc

Company Introduction

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.

Vision And Mission

Our Vision

To become a leader in the field of gene therapy in China, providing innovative treatments for patients in the world.

Our Mission

To bring cutting-edge gene therapies to patients that are accessible and affordable.

Key Milestones

2016

Belief BioMed core team set up

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) , 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.