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A Phase 1/2/3 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of an Adeno-associated Virus Vector Containing an Expression Cassette of the Human Factor IX Transgene (BBM-H901) Injection in Patients With Hemophilia B

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Trial Profile

A Phase 1/2/3 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of an Adeno-associated Virus Vector Containing an Expression Cassette of the Human Factor IX Transgene (BBM-H901) Injection in Patients With Hemophilia B

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2026

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At a glance

  • Drugs Dalnacogene ponparvovec (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Belief Biomed; Shanghai Xinzhi BioMed

Most Recent Events

  • 19 Mar 2026 According to a Belief Biomed media release, BBM-H901 has been officially approved by the Pharmaceutical Administration Bureau of Macao Special Administrative Region of China for the treatment of adult patients with moderate to severe hemophilia B.
  • 01 Jan 2026 Primary endpoint (Phase 3: Annualized bleeding rate (ABR)) has been met, based on results published in Nature Medicine.
  • 01 Jan 2026 Primary endpoint (Phase 1/2: The incidence of adverse events (AEs) and serious adverse events (SAEs)) has been met, based on results published in Nature Medicine.

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