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Fanregratinib - HUTCHMED

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Drug Profile

Fanregratinib - HUTCHMED

Alternative Names: ATLED; Fanregratinib tartrate - HUTCHMED; HMPL-453; HMPL-453 tartrate - HUTCHMED

Latest Information Update: 02 Sep 2026

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At a glance

  • Originator Hutchison MediPharma
  • Developer HUTCHMED
  • Class Amides; Amines; Aniline compounds; Antineoplastics; Benzamides; Chlorobenzenes; Ethers; Piperazines; Pyrimidines; 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

  • Registered Cholangiocarcinoma
  • Phase I/II Solid tumours
  • Discontinued Mesothelioma

Most Recent Events

  • 02 Sep 2026 Discontinued - Phase-II for Mesothelioma (Second-line therapy or greater, Late-stage disease) in China (PO) (HUTCHMED Pipeline, September 2026)
  • 01 Sep 2026 Discontinued - Phase-I for Solid tumours (Late-stage disease, Metastatic disease, Second-line therapy or greater) in Australia (PO) (HUTCHMED Pipeline, September 2026)
  • 28 Aug 2026 Registered for Cholangiocarcinoma (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) - First global approval

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