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Olafertinib - Checkpoint Therapeutics/Suzhou NeuPharma

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Drug Profile

Olafertinib - Checkpoint Therapeutics/Suzhou NeuPharma

Alternative Names: CK-101; RX 518

Latest Information Update: 28 Jul 2025

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At a glance

  • Originator Suzhou NeuPharma
  • Developer Checkpoint Therapeutics; Suzhou NeuPharma
  • Class Amides; Aniline compounds; Antibodies; Antineoplastics; Fluorobenzenes; Piperazines; Quinazolines; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists
  • Orphan Drug Status

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

    Yes - Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Non-small cell lung cancer

Most Recent Events

  • 28 Jul 2025 No recent reports of development identified for phase-I development in Non-small-cell-lung-cancer(Combination therapy) in Unknown (PO)
  • 30 May 2025 Checkpoint Therapeutics has been acquired by Sun Pharmaceutical Industries
  • 30 Jun 2022 Checkpoint Therapeutics completes a phase I/II trial in Non-small cell lung cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA, Australia, Poland, New Zealand, Thailand (PO) (NCT02926768) (EudraCT2017-001265-24)

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