Drug Profile

Orelabrutinib - InnoCare Pharma

Alternative Names: BIIB-135; ICP 022; INNOBRUKA; YINUOKAI

Latest Information Update: 31 Aug 2026

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At a glance

Originator InnoCare Pharma
Developer InnoCare Pharma; Zenas BioPharma
Class Amides; Anti-inflammatories; Antineoplastics; Antirheumatics; Eye disorder therapies; Phenyl ethers; Piperidines; Pyridines; Small molecules
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 - Mantle-cell lymphoma
New Molecular Entity Yes

Marketed Chronic lymphocytic leukaemia; Mantle-cell lymphoma; Marginal zone B-cell lymphoma
Preregistration Idiopathic thrombocytopenic purpura; Waldenstrom's macroglobulinaemia
Phase III Diffuse large B cell lymphoma; Multiple sclerosis; Systemic lupus erythematosus
Phase II Lymphoma; Neuromyelitis optica; Non-Hodgkin's lymphoma
Phase I/II B-cell lymphoma; Follicular lymphoma
Discontinued Rheumatoid arthritis

25 Aug 2026 InnoCare Pharma plans a phase III trial for Mantle-cell lymphoma (Second-line therapy or greater, Combination therapy) in China (PO) in October 2026 (NCT07784101)
04 Aug 2026 Orelabrutinib - InnoCare Pharma receives Breakthrough Therapy status for Marginal zone B-cell lymphoma (Combination therapy; Second-line therapy or greater) in China
14 Jul 2026 Efficacy and adverse events data from the phase III trial for Chronic lymphocytic leukaemia released by Bejing InnoCare Pharma

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