03

2024y01m

Good News | Belief BioMed Successfully Completed Dosing of First Subject in the Registrational Clinical Trial for Hemophilia A

Shanghai, China, 3rd January, 2024—— Belief BioMed Group (BBM), an industry-leading biotech company focusing on innovative gene therapies, announced the completion of first subject dosing in its registrational clinical trial (CTR20233400) of BBM-H803, a…

18

2023y10m

Belief BioMed and Takeda China Announced Exclusive Commercial Partnership in the Field of Hemophilia B，Bringing Innovative Gene Therapy to Chinese Patients

(Shanghai, China, October 17, 2023) – Belief BioMed Inc. announced today that it has signed an exclusive cooperation agreement with Takeda China. According to the agreement, Belief BioMed will grant Takeda China the exclusive license for the commercializa

23

2023y04m

Belief BioMed Announces a Key Milestone of Dosing Completion for All Subjects in its Registrational Clinical Trial of BBM-H901

Shanghai, China, 24th April, 2023 —— Belief BioMed Group (BBM), an industry-leading biotech company focusing on innovative gene therapies, announced today the completion of patient dosing in its Phase III Registrational Clinical Trial (CTR20212816) of BB…

22

2022y12m

Belief BioMed’s Second AAV-based Gene Therapy Drug Candidate was Granted Orphan Drug Designation by the FDA

Belief BioMed (BBM, Company) announced today that its self-developed and manufactured BBM-H803 injection was granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia A on December 21, 2022. It i

27

2022y10m

The Case Report of Belief BioMed’s Hemophilia B Gene Therapy Drug Candidate BBM-H901 Published in The New England Journal of Medicine

A case report of Total Knee Arthroplasty after Gene Therapy for Hemophilia B (HB) is published in the world’s leading medical journal, The New England Journal of Medicine, via correspondence, reporting the world’s first total knee arthroplasty (TKA) afte…

24

2022y08m

Belief BioMed’s AAV-based Gene Therapy Drug Candidate Receives China CDE’s Breakthrough Therapy Designation

Belief BioMed (BBM, Company) announced today, that China Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to the BBM-H901 injection, the AAV vector gene therapy dr

17

2022y08m

Belief BioMed’s AAV-based Gene Therapy Drug Candidate was Granted Orphan Drug Designation by the FDA

Belief BioMed (BBM, Company) announced today, that its self-developed and manufactured BBM-H901 injection has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B. It is the first gene

20

2022y05m

Clinical Trial Results of Belief BioMed's Hemophilia B Gene Therapy Drug Candidate BBM-H901 Published in The Lancet Haematology

The early phase clinical trial results of BBM-H901, the first intravenously injectable hemophilia B gene therapy product developed and tested in Asia, are published in The Lancet Haematology, a top international journal in hematology. https://www.thelance

30

2021y12m

Belief BioMed Completed Dosing of the First Subject in the Registrational Gene Therapy Clinical Trial for Hemophilia B

On December 30th, 2021, Belief BioMed Group（BBM）announced that it has successfully dosed the first subject in the registrational gene therapy clinical trial by intravenous (IV) infusion of BBM-H901, an adeno-associated virus (AAV) vector expressing facto…

10

2021y08m

Belief Biomed’s Gene Therapy for Hemophilia B Receives NMPA IND Approval: First Intravenous Infusion Gene Therapy for Rare Disease in China

On August 10th, 2021，Belief Biomed announced that China’s National Medical Products Administration (NMPA) has cleared the IND (Investigational New Drug) application for Belief Biomed’s BBM-H901. This marks the first IND approval for Intravenous （i.v.）…