GC Biopharma Files IND for Phase 1 Trial of COVID-19 mRNA Vaccine Candidate GC4006A

GC Biopharma Files IND for Phase 1 Trial of COVID-19 mRNA Vaccine Candidate GC4006A

By, Admin 23 September 2025

GC Biopharma (006280.KS) has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS), South Korea. The application seeks approval for a Phase 1 clinical trial of its mRNA vaccine candidate GC4006A for COVID-19.

Project Background

  • Development accelerated in April 2025.
  • Korea Disease Control and Prevention Agency (KDCA) selected GC Biopharma to lead its “mRNA Vaccine Development Support Project for Pandemic Preparedness.”
  • KDCA aims to localize mRNA vaccine production by 2028.
  • GC Biopharma pledged full resources and expertise to support this goal.

Clinical Trial Plans

  • Phase 1 will test safety and immunogenicity of GC4006A.
  • Target group: healthy adult volunteers.
  • IND approval is expected by end of 2025.
  • First administrations planned in early 2026.

Preclinical Findings

  • Non-clinical studies showed robust humoral immune response, producing antibodies comparable to existing vaccines.
  • GC4006A also triggered a strong cellular immune response, effectively targeting infected cells.

mRNA-LNP Platform

GC4006A is built on GC Biopharma’s mRNA-LNP (Lipid Nanoparticle) platform, in development since 2019. This platform supports end-to-end mRNA vaccine development. The Phase 1 trial will demonstrate platform capabilities and support the goal of 100-day pandemic response readiness.

Company Statement

“GC Biopharma is the first Korean company with a full in-house mRNA drug development capacity,”

  • Jae Uk Jeong, Head of R&D.

“Our COVID-19 mRNA vaccine is only the beginning. We will expand applications to multiple diseases.”

Expansion Plans

The company intends to apply its mRNA-LNP platform across diverse pipelines:

  • Rare genetic diseases
  • Chronic inflammatory conditions
  • Anticancer immunotherapies
  • Vaccines

GC Biopharma is also exploring co-development and technology transfer partnerships with global pharma companies.

About GC Biopharma

  • Headquartered in Yong-in, South Korea.
  • Formerly known as Green Cross Corporation.
  • Over 50 years of expertise in plasma derivatives and vaccines.
  • Expanded global presence with Alyglo® (IVIG) US launch in 2024.
  • Core R&D capabilities in protein engineering, mRNA, and lipid nanoparticle delivery.
  • Focus: rare diseases and immunology & inflammation (I&I).

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