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Sovleplenib - HUTCHMED

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Drug Profile

Sovleplenib - HUTCHMED

Alternative Names: HMPL-523; HMPL-523 acetate

Latest Information Update: 17 Jun 2026

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At a glance

  • Originator Hutchison MediPharma
  • Developer Hutchison MediPharma; HUTCHMED
  • Class Amines; Anti-inflammatories; Antianaemics; Antineoplastics; Antirheumatics; Morpholines; Piperidines; Pyrazines; Pyridones; Small molecules; Sulfones
  • Mechanism of Action Syk 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
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Autoimmune haemolytic anaemia; Idiopathic thrombocytopenic purpura
  • No development reported B-cell lymphoma; Haematological malignancies; Lymphoma; Unspecified
  • Discontinued Lupus vulgaris; Multiple sclerosis; Rheumatoid arthritis

Most Recent Events

  • 12 Jun 2026 Updated efficacy and adverse events data from the phase II/III ESLIM-02 trial in Autoimmune haemolytic anaemia released by HUTCHMED
  • 29 Apr 2026 Preregistration for Autoimmune haemolytic anaemia (Treatment-resistant) in China (PO)
  • 29 Apr 2026 NMPA accepts NDA for Sovleplenib for Autoimmune haemolytic anaemia and grants priority review

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