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Fanregratinib - HUTCHMED

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Drug Profile

Fanregratinib - HUTCHMED

Alternative Names: HMPL-453

Latest Information Update: 05 Jan 2026

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At a glance

  • Originator Hutchison MediPharma
  • Developer Hutchison MediPharma; HUTCHMED
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Type 1 fibroblast growth factor receptor antagonists; Type 3 fibroblast growth factor receptor antagonists; Type-2 fibroblast growth factor receptor antagonists
  • 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 Cholangiocarcinoma
  • Phase II Mesothelioma
  • Phase I/II Solid tumours

Most Recent Events

  • 29 Dec 2025 Preregistration for Cholangiocarcinoma (Late-stage disease, Metastatic disease, Second-line therapy or greater, Inoperable/Unresectable) in China (PO)
  • 29 Dec 2025 Updated efficacy data from a phase II trial in Cholangiocarcinoma released by HUTCHMED
  • 03 Nov 2025 HUTCHMED announces intention to submit new drug application to NMPA for Cholangiocarcinoma in first half of 2026

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