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Risovalisib - HaiHe Biopharma

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Drug Profile

Risovalisib - HaiHe Biopharma

Alternative Names: CYH 33; HH-CYH33

Latest Information Update: 21 Nov 2025

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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

  • Preregistration Ovarian cancer
  • Phase I/II Growth disorders
  • Phase I Breast cancer; Gynaecological cancer; Prostate cancer; Solid tumours
  • Preclinical Squamous cell cancer

Most Recent Events

  • 16 Oct 2025 Risovalisib licensed to Taiho Pharmaceutical in Japan
  • 01 Aug 2025 Preregistration for Ovarian cancer (Second-line therapy or greater, Late-stage disease, Recurrent) in Japan (PO)
  • 01 Jun 2025 Risovalisib - HaiHe Biopharma receives Orphan Drug status for Ovarian cancer in Japan

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