Drug Profile

Zanubrutinib - BeOne Medicines

Alternative Names: BGB-3111; BRUKINSA

Latest Information Update: 12 Dec 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

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

08 Dec 2025 Efficacy and adverse events data from phase III ALPINE trial for Chronic lymphocytic leukaemia released by BeOne Medicines
08 Dec 2025 Efficacy and adverse events data from phase III SEQUOIA trial in Chronic lymphocytic leukaemia released by BeOne Medicines
06 Nov 2025 BeOne Medicines anticipates Orphan Drug Designation (ODD) and regulatory submission in Japan for the treatment of marginal zone B-cell lymphoma in first half of 2026

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