About BBM
Company Profile

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. The Biologics License Application (BLA) of a gene

therapy for the treatment of adult patients with hemophilia B, BBM-H901 (generic name: Dalnacogene Ponparvovec Injection), has been approved by the NMPA of China.


BBM-H901 is the first approved hemophilia B gene therapy 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. 


Management Team
Dr. Xiao Xiao

Co-founder
Chairman & CSO

Dr. Jane Zheng

Co-founder
CEO

Dr. Zengmin Du

 VP, CMC

Dr. Wei Jiang

VP, Operation

Zuquan Xie

VP, Commercial

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
January

Investigational New Drug (IND) application of BBM-D101 (DMD) was accepted by U.S. FDA.


March

Investigational New Drug (IND) application of BBM-A101 (Osteoarthritis) was accepted by the CDE, NMPA.


April

BBM-H901 (generic name: Dalnacogene Ponparvovec Injection, Hemophilia B) New Drug Application (NDA) was approved by CDE, NMPA.


April

Investigational New Drug (IND) application of BBM-D101 (DMD) was accepted by the CDE, NMPA.


January

Dosing of the first subject in BBM-H803(Hemophilia A) registrationalclinical 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.

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).

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.

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.

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.

October

Belief BioMed Rodent Animal Experiment Center officially commenced.


November

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

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.

2025
2024
2023
2022
2021
2020
2019
2018
Awards & Recognitions

Since its establishment, Belief BioMed has increasingly gained recognition from the industry for its comprehensive strength. By 2024, it has won approximate 40 various corporate awards, including Hurun 2024 Global Unicorn List, the 2023 Shanghai Key Service Unicorn Enterprises, the 2022 China Unicorn Enterprises, the 2022 Top 100 Shanghai Hard Core Technology Enterprises, the Excellence Award in the 2022 National Disruptive Technology Innovation Competition sponsored by the Ministry of Science and Technology of China. Moving forward, Belief BioMed will continue to forge ahead with a steadfast commitment and an unwavering dedication to becoming a global leader in gene therapy development, so as to bring more innovative treatments for patients around the world.