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Fidasimtamab - Hanmi Pharmaceutical/Innovent Biologics

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Drug Profile

Fidasimtamab - Hanmi Pharmaceutical/Innovent Biologics

Alternative Names: anti-PD-1/anti-Her2 bispecific antibody - Hanmi Pharmaceutical/Innovent Biologics; BH-2950; IBI-315; PD-1/Her2 BsAB - Hanmi Pharmaceutical/Innovent Biologics

Latest Information Update: 11 Mar 2025

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At a glance

  • Originator Hanmi Pharmaceutical; Innovent Biologics
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • 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 I Solid tumours

Most Recent Events

  • 11 Mar 2025 Fidasimtamab is still in phase I development for Solid-tumours(Combination therapy, Late-stage disease, Second-line therapy or greater) in China (Parenteral) (NCT04162327) (Hanmi Pharmaceutical Pipeline, March 2025)
  • 11 Mar 2025 Fidasimtamab is still in phase I development for Solid-tumours(Monotheray, Late-stage disease, Second-line therapy or greater) in China (Parenteral) (NCT04162327) (Hanmi Pharmaceutical Pipeline, March 2025)
  • 28 Jan 2025 No recent reports of development identified for phase-I development in Solid-tumours(Combination therapy, Late-stage disease, Second-line therapy or greater) in China (Parenteral)

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