Company Overview | Belief BioMed Inc.

Company Introduction

Belief BioMed Inc. (BBM) is a globally innovative biotech 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 severe genetic and chronic diseases through safe and efficient viral vector technology.

BBM has developed hundreds of key vector technologies, including HEK293 cell suspension serum-free culture process and full-scale chromatography purification process, and has established the commercial production platform for gene therapy drugs in China. The company has been building up its capabilities in a variety of fields including novel adeno-associated virus (AAV) capsids targeting different tissues, efficient transgene expression cassette design, and advanced clinical-grade vector manufacturing process. It has also established an extensive R&D pipeline covering a wide range of unmet medical needs in different therapeutic areas such as hemophilia, DMD, Parkinson's disease, osteoarthritis, etc. Several product pipelines have entered clinical studies or submitted IND filings.

BBM-H901 is the first gene therapy product indicated for hemophilia B for which a new drug application (NDA) has been submitted in China. Previously, it was granted Breakthrough Therapy Designation (BTD), and its NDA was granted a Priority Review Designation, by the China Center for Drug Evaluation (CDE), NMPA. BBM-H901 has also received an Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA). The clinical study results for this product have been published in two prestigious international journals - The Lancet Haematology and the New England Journal of Medicine - and were also announced in an oral presentation at the ISTH 2024 Congress, as well as in a poster presentation at the ASH 2024 Conference.

Vision And Mission

Our Vision

To be a global leader in gene therapy with innovative treatments for patients worldwide.

Our Mission

To make cutting-edge gene therapy drugs that are accessible and affordable.

Key Milestones

2018

May - Belief BioMed group was established.

October - Belief BioMed CMC Center was established.

December - Belief BioMed AAV 15L cell culture suspension process was put into production.

2019

October - Belief BioMed Rodent Animal Experiment Center officially.

November - BBM-H901 (Hemophilia B) Investigator-initiated Trial (IIT) 1001 was officially started; Dosing of the first subject was accomplished.

2020

April - Belief BioMed AAV 200L cell culture suspension process was put into production.

October - Belief BioMed Min-hang R&D Center officially commenced.

October - Belief BioMed Non-human Primate (NHP) Animal Experiment Center officially commenced.

2021

January - Dosing of all subjects in BBM-H901 (Hemophilia B) Investigator-initiated Trial (IIT) was completed.

April - Investigational New Drug (IND) application of BBM-H901 (Hemophilia B) was accepted by the CDE, NMPA.

May - Belief BioMed AAV 500L cell culture suspension process was put into production.

August - The pivotal phase III trial of BBM-H901 (Hemophilia B) was approved by the CDE, NMPA.

December - Dosing of the first subject in BBM-H901 (Hemophilia B) pivotal phase III trial was accomplished.

2022

May - BBM-H901 (Hemophilia B) clinical study results were published in the prestigious international journal The Lancet Haematology.

July - BBM-H803 (Hemophilia A) Investigator-initiated Trial (IIT) was officially started; Dosing of the first subject was accomplished.

August - Belief BioMed Commercial Manufacturing Center in the Lin-gang Special Area, with an area of 15,000 square meters, officially commenced.

August - BBM-H901 (Hemophilia B) was granted Orphan Drug Designation (ODD) by U.S. FDA.

August - BBM-H901 (Hemophilia B) was granted Breakthrough Therapy Designation (BTD) by the CDE, NMPA.

September - BBM-A101 (Osteoarthritis) Investigator-initiated Trial (IIT) officially started; Dosing of the first subject in IIT was accomplished.

October - BBM-H901 (Hemophilia B) clinical study results were published in the prestigious international journal New England Journal of Medicine.

December - BBM-H803 (Hemophilia A) was granted Orphan Drug Designation (ODD) by U.S. FDA.

2023

January - Belief BioMed AAV 2000L cell culture suspension process was put into production.

April - Dosing of all subjects in the phase III registrational trial of BBM-H901 (Hemophilia B) was completed.

April - Dosing of the first subject in BBM-H901 (Hemophilia B) Investigator-initiated Trial (IIT) 1002 was accomplished.

July - Investigational New Drug (IND) application of BBM-H803 (Hemophilia A) was accepted by the CDE, NMPA.

September - Belief BioMed and ThermoFisher reached a strategic cooperation agreement in gene therapy R&D, manufacture and commercialization.

October - Belief BioMed and Takeda China reached Hemophilia B exclusive commercialization partnership in China.

November - Mianyi Biopharmaceuticals, a subsidiary of Belief BioMed, received certifications of Environmental Management System (ISO14001) and Occupational Health and Safety Management System (ISO45001).

2024

January - Dosing of the first subject in BBM-H803 (Hemophilia A) registrational clinical trial was accomplished.

January - Mianyi Biopharmaceuticals, a subsidiary of Belief BioMed, was granted the Drug Manufacturing License “C” by Shanghai Drug Administration.

June - BBM-H901 (Hemophilia B) clinical study results were given a podium presentation at the ISTH 2024 conference.

July - Shanghai Xinzhi BioMed, a subsidiary of Belief BioMed, was granted Drug Manufacturing License “B” by Shanghai Drug Administration.

July - BBM-H901 (Hemophilia B) New Drug Application (NDA) was accepted by CDE, NMPA.

August - BBM-H901 (Hemophilia B) New Drug Application (NDA) was granted a Priority Review Designation by the CDE, NMPA.

September - Belief BioMed to Collaborate with AskBio to Explore the Potential of New Gene Therapies.

October - BBM-H901 (Hemophilia B) was granted Rare Pediatric Disease Designation (RPDD) by U.S. FDA.

October - BBM-H803 (Hemophilia A) was granted Rare Pediatric Disease Designation (RPDD) by U.S. FDA.

October - BBM-H901 (Hemophilia B) was granted Advanced Therapy Medicinal Product (ATMP) Designation by EMA.

November - BBM-D101 (DMD) was granted Orphan Drug Designation (ODD) & Rare Pediatric Disease Designation (RPDD) by U.S. FDA.

December - BBM-H901 (Hemophilia B) clinical study results were given a poster presentation at the ASH 2024 conference.