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Sovleplenib - HUTCHMED

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Drug Profile

Sovleplenib - HUTCHMED

Alternative Names: HMPL-523; HMPL-523 acetate

Latest Information Update: 16 Mar 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 Immunomodulators; 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

Highest Development Phases

  • Preregistration Idiopathic thrombocytopenic purpura
  • Phase II/III Autoimmune haemolytic anaemia
  • Phase I B-cell lymphoma; Haematological malignancies; Lymphoma; Unspecified
  • Discontinued Lupus vulgaris; Multiple sclerosis; Rheumatoid arthritis

Most Recent Events

  • 05 Mar 2026 HUTCHMED resubmit NDA to NMPA for Idiopathic thrombocytopenic purpura in February 2026
  • 06 Feb 2026 Hutchmed completes a phase I pharmacokinetics trial (In volunteers) in China (PO, Tablet) (NCT07348133)
  • 07 Jan 2026 HUTCHMED announces intention to submit NDA to China National Medical Products Administration for Sovleplenib for Autoimmune haemolytic anaemia in the first half of 2026 (PO)

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