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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: 26 May 2025

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At a glance

  • Originator Newave Pharmaceuticals
  • Developer Guangzhou Lupeng Pharmaceutical; Newave Pharmaceuticals
  • Class Antineoplastics; Eye disorder therapies; 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

  • 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)
  • 31 Mar 2025 Guangzhou Lupeng Pharmaceutical announces intention to file NDA application with the NMPA in China for Mantle cell lymphoma in first half of 2026 (Guangzhou Lupeng Pharmaceutical pipeline, March 2025)

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