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Risovalisib - HaiHe Biopharma

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Drug Profile

Risovalisib - HaiHe Biopharma

Alternative Names: CYH 33; Haizexin; HH-CYH33; Lysovalicib mesylate hydrate - HaiHe Biopharma; Risovalisib mesilate hydrate - HaiHe Biopharma

Latest Information Update: 01 Apr 2026

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At a glance

  • Originator HaiHe Biopharma; Shanghai Institute of Materia Medica
  • Developer HaiHe Biopharma
  • Class Antineoplastics; Carbamates; Fluorinated hydrocarbons; Morpholines; Piperazines; Pyridines; Pyrroles; Small molecules; Sulfones; Triazines
  • Mechanism of Action 1 Phosphatidylinositol 3 kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Ovarian cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Ovarian cancer
  • Phase II Fallopian tube cancer; Peritoneal cancer; Vascular malformations
  • Phase I/II Growth disorders
  • Phase I HER2 negative breast cancer; Solid tumours

Most Recent Events

  • 31 Mar 2026 Risovalisib is still in phase I trials for HER2-negative breast cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) in China (PO) (NCT04856371) (CTR20210627)
  • 23 Mar 2026 Registered for Ovarian cancer (Late-stage disease, Second-line therapy or greater) in Japan (PO) - First Global Approval
  • 23 Mar 2026 Efficacy data from a phase II trial in Ovarian cancer released by Haihe Biopharma

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