Drug Profile

Zanubrutinib - BeOne Medicines

Alternative Names: BGB-3111; BRUKINSA

Latest Information Update: 05 Mar 2026

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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

22 Jan 2026 Phase-III clinical trials in Chronic lymphocytic leukaemia (Combination therapy, First-line therapy) in South Korea, Australia (PO) (NCT07277231)
22 Jan 2026 BeOne Medicines initiates enrolment in a phase-III trial in Chronic lymphocytic leukaemia (Combination therapy, First-line therapy) in New Zealand (PO) (NCT07277231)
09 Jan 2026 BeiGene completes the Phase-II clinical trials in Marginal zone B-cell lymphoma, Mantle-cell lymphoma, Waldenstrom's macroglobulinaemia (Second-line therapy or greater) in USA (PO) (NCT04116437)

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