Belief BioMed and Takeda China Secure NMPA Approval for BBM-H901 (AAV-FIX), China’s First Hemophilia B Gene Therapy
SHANGHAI, April 10, 2025 /PRNewswire/ — Belief BioMed (BBM) and Takeda China today announced the National Medical Products Administration (NMPA) approval of BBM-H901 (Dalnacogene Ponparvovec Injection) for the treatment of adult patients with moderate to severe hemophilia B. This approval signifies a major milestone, as BBM-H901 is the first domestically developed hemophilia B gene therapy in China, with Takeda China responsible for its commercialization.
BBM-H901 is a gene therapy that utilizes a recombinant adeno-associated virus (rAAV) vector to deliver an optimized human coagulation factor IX (FIX) gene directly to liver cells. This single-dose approach enables sustained FIX protein production, significantly reducing or eliminating the need for frequent intravenous FIX infusions, the standard treatment for hemophilia B. Clinical trial results demonstrated a substantial reduction in annualized bleeding rates and a significant increase in FIX activity levels.
“This approval represents a transformative advancement for hemophilia B patients in China, offering the potential for a significantly improved quality of life,” stated Dr. Xiao Xiao, Co-founder, Chairman, and Chief Science Officer of BBM. “We are committed to collaborating with Takeda China to ensure rapid access to this innovative therapy.” “We are honored to partner with Belief BioMed to bring this groundbreaking AAV-based gene therapy to patients in China,” said Sean Shan, Senior Vice President of Takeda Pharmaceutical and President of Takeda China. “This approval underscores our dedication to providing innovative treatment options for patients with rare diseases.”
https://www.prnewswire.com/news-releases/belief-biomed-and-takeda-china-jointly-announced-bbm-h901-dalnacogene-ponparvovec-injection-chinas-first-hemophilia-b-gene-therapy-was-officially-approved-302425572.html
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