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Orelabrutinib - InnoCare Pharma

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Drug Profile

Orelabrutinib - InnoCare Pharma

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

Latest Information Update: 29 Dec 2025

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At a glance

  • Originator InnoCare Pharma
  • 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

Highest Development Phases

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

Most Recent Events

  • 23 Dec 2025 Zenas BioPharma plans a phase III trial for Multiple Sclerosis in March 2026 (NCT07299019)
  • 14 Dec 2025 InnoCare Pharma plans a phase III trial for systemic lupus erythematosus
  • 14 Dec 2025 Center for Drug Evaluation (CDE) of NMPA approves Orelabrutinib for systemic lupus erythematosus

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