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Belief BioMed’s BBM-D101 Receives FDA Orphan Drug and Pediatric Rare Disease Designations for DMD
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Belief BioMed has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Pediatric Rare Disease Designation (RPDD) for its gene therapy drug, BBM-D101 injection, indicated for the treatment of Duchenne muscular dystrophy (DMD). BBM-D101: A Pioneering rAAV Gene Therapy for Duchenne Muscular DystrophyBBM-D101…
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Belief BioMed Partners with Bayer’s AskBio to Explore New Gene Therapies
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Belief BioMed Inc. (BBM), a Chinese biopharmaceutical company specializing in gene therapy, has announced a strategic partnership with Asklepios BioPharmaceutical, Inc. (AskBio), a wholly-owned subsidiary of Bayer AG. This collaboration aims to harness the potential of new gene therapies. The agreement will see the companies pool their expertise and resources…
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Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
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The Center for Drug Evaluation (CDE) has indicated on its website that the market application for BBM-H901, a gene therapy treatment for hemophilia B developed by Belief BioMed Group (BBM), a Shanghai-based specialist in gene therapy, is on track for priority review. BBM-H901, co-developed with Japan’s Takeda, is an adeno-associated…
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Belief BioMed and Takeda’s Hemophilia B Gene Therapy BBM-H901 Accepted for NMPA Review
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Belief BioMed Group (BBM), a Shanghai-based gene therapy specialist, and Takeda have announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for BBM-H901, a gene therapy for hemophilia B. This development marks a significant milestone for the treatment, which is being designed…
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Belief BioMed Group Initiates Clinical Study for Hemophilia A Gene Therapy BBM-H803 in China
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Belief BioMed Group, a Shanghai-based gene therapy specialist, has announced the first subject dosing in a regulatory clinical study for its in-house developed adeno-associated virus (AAV) gene therapy, BBM-H803, for the treatment of hemophilia A in China. This marks a significant step forward in addressing the unmet medical need for…
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Belief BioMed Partners with Takeda for BBM-H901 Commercialization in Asia
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Shanghai-based gene therapy specialist Belief BioMed Group (BBM) has announced a strategic partnership with Japan’s Takeda Pharmaceutical Company (TYO: 4502), granting Takeda commercialization rights for its investigational product, BBM-H901. This agreement encompasses the territories of mainland China, Hong Kong, and Macau. Financial details of the partnership have not been disclosed.…
