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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: 04 Feb 2026

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

Most Recent Events

  • 30 Jan 2026 Phase-III clinical trials in Mantle-cell lymphoma (Monotherapy, Second-line therapy or greater) in China (PO) (NCT07377578)
  • 28 Jan 2026 Guangzhou Lupeng Pharmaceutical plans a phase I pharmacokinetic trial (In volunteers) in China (PO, Tablets) in March 2026 (NCT07374224)
  • 21 Jan 2026 Newave Pharmaceutical plans the phase III ROCKET-CLL trial in Chronic lymphocytic leukemia (Second-line therapy or greater) (NCT07342478)

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