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Rocbrutinib - Newave Pharmaceutical

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Drug Profile

Rocbrutinib - Newave Pharmaceutical

Alternative Names: HS-10561; LP-168; NWP-775

Latest Information Update: 17 Sep 2025

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At a glance

  • Originator Newave Pharmaceuticals
  • Developer Guangzhou Lupeng Pharmaceutical; Newave Pharmaceuticals
  • Class Alcohols; Alkenes; Amides; Aniline compounds; Antineoplastics; Cyclic ethers; Cyclopentanes; Eye disorder therapies; Ketones; Piperazines; Pyridines; Pyrroles; Skin disorder therapies; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Mantle-cell lymphoma
  • Phase I B-cell lymphoma; Chronic urticaria; Diffuse large B cell lymphoma; Idiopathic thrombocytopenic purpura; Marginal zone B-cell lymphoma; Multiple sclerosis; Neuromyelitis optica
  • Preclinical Chronic lymphocytic leukaemia
  • No development reported Cancer

Most Recent Events

  • 17 Sep 2025 Chemical structure information added.
  • 26 May 2025 University of Cincinnati plans a phase II trial for Chronic lymphocytic leukaemia (Second line therapy or greater, Combination therapy) in USA in June 2025 (NCT06978088)
  • 31 Mar 2025 Phase-I development is ongoing in China (Guangzhou Lupeng Pharmaceutical pipeline, March 2025)

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