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Fanregratinib - HUTCHMED

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Drug Profile

Fanregratinib - HUTCHMED

Alternative Names: HMPL-453

Latest Information Update: 07 Nov 2025

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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

  • Phase II Cholangiocarcinoma; Mesothelioma
  • Phase I/II Solid tumours

Most Recent Events

  • 03 Nov 2025 HUTCHMED announces intention to submit new drug application to NMPA for Cholangiocarcinoma in first half of 2026
  • 03 Nov 2025 Hutchmed completes enrollment in phase-II clinical trials in Cholangiocarcinoma (Late-stage disease, Second-line therapy or greater, Metastatic disease) in China (PO) (NCT04353375)
  • 28 Aug 2023 Hutchmed completes a phase-I trial in Cholangiocarcinoma (In volunteers) in China (unspecified route) (NCT05930119)

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