Drug Profile

Zanubrutinib - BeOne Medicines

Alternative Names: BGB-3111; BRUKINSA

Latest Information Update: 21 May 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 - Marginal zone B-cell lymphoma; 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

12 May 2026 PMDA accepts NDA for zanubrutinib for Marginal zone B-cell lymphoma for review (BeOne Medicines pipeline, May 2026)
31 Mar 2026 Preregistration for Marginal zone B-cell lymphoma (Second-line therapy or greater) in Japan (PO), prior to March 2026
31 Mar 2026 Zanubrutinib - BeOne Medicines receives Orphan Drug status for Marginal zone B-cell lymphoma (Second-line therapy or greater) in Japan, prior to March 2026

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