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Zanubrutinib - BeOne Medicines

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Drug Profile

Zanubrutinib - BeOne Medicines

Alternative Names: BGB-3111; BRUKINSA

Latest Information Update: 02 Jul 2025

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At a glance

  • Originator BeiGene
  • Developer BeOne Medicines; Medison Pharma
  • Class Amides; Antineoplastics; Phenyl ethers; Piperidines; Pyrazoles; Pyrimidines; Small molecules; Urologics
  • Mechanism of Action Agammaglobulinaemia tyrosine kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Waldenstrom's macroglobulinaemia; Mantle-cell lymphoma; Follicular lymphoma; Chronic lymphocytic leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Waldenstrom's macroglobulinaemia
  • Phase III B-cell lymphoma
  • Phase II/III Membranous glomerulonephritis
  • Phase II CNS cancer; Diffuse large B cell lymphoma; Lupus nephritis; Lymphoma; SARS-CoV-2 acute respiratory disease
  • Phase I/II Haematological malignancies; Solid tumours

Most Recent Events

  • 25 Jun 2025 BeOne Medicines expects approval for tablet formulation of Zanubrutinib from European Commission in 2025
  • 25 Jun 2025 BeOne Medicines intends to convert zanubrutinib from capsules to tablets in regions outside China in 2025
  • 25 Jun 2025 CHMP issues a positive opinion recommending approval of a new film-coated tablet formulation of Zanubrutinib for all approved indications

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