Drug Profile

Zanubrutinib - BeOne Medicines

Alternative Names: BGB-3111; BRUKINSA

Latest Information Update: 12 Aug 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

05 Aug 2026 Beigene announces intention to submit regulatory applications in U.S., Europe, China and Japan for Mantle-cell lymphoma (First line therapy) in the second half of 2026
30 Jun 2026 Efficacy and adverse events data from phase III trial in Mantle-cell lymphoma released by BeOne Medicines
08 Jun 2026 BeOne Medicines plans a phase II trial for Chronic Lymphocytic Leukemia (First line therapy, Newly diagnosed, Combination therapy) and Small Lymphocytic Lymphoma (First line therapy, Newly diagnosed, Combination therapy) in China (PO) (NCT07682415)

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