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HM 15421

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Drug Profile

HM 15421

Alternative Names: GC-1134A; HM-15421; LA-GLA; Long-acting alpha-galactosidase - Hanmi Pharmaceutical/GC Biopharma; Long-acting GLA - Hanmi Pharmaceutical/GC Biopharma

Latest Information Update: 21 Mar 2025

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At a glance

  • Originator GC Biopharma; Hanmi Pharmaceutical
  • Class Enzymes; Recombinant proteins
  • Mechanism of Action Alpha-galactosidase replacements
  • Orphan Drug Status

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

    Yes - Fabry's disease
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Fabry's disease

Most Recent Events

  • 05 Mar 2025 GC Biopharma plans phase-I/II trial for Fabry's disease in USA, Argentina and South Korea (SC) in April 2025 (NCT06858397)
  • 04 Feb 2025 Phase-I/II clinical trials in Fabry's disease in USA (SC), before February 2025 (GC Biopharma pipeline, February 2025)
  • 03 Sep 2024 Hanmi Pharmaceutical files an IND application with the US FDA in USA for Fabry's disease prior to September 2024

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