GC Biopharma Secures South Korea IND Approval for Phase 1 mRNA COVID-19 Vaccine Trial

GC Biopharma Secures South Korea IND Approval for Phase 1 mRNA COVID-19 Vaccine Trial

By, Admin 23 December 2025

GC Biopharma has cleared an important regulatory milestone in South Korea’s mRNA vaccine push. The Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug (IND) application for GC4006A, the company’s mRNA-based COVID-19 vaccine candidate.

This approval allows GC Biopharma to initiate Phase 1 clinical trials.

What Is GC4006A?

GC4006A is a COVID-19 vaccine candidate developed using GC Biopharma’s proprietary mRNA-LNP platform.

Key characteristics include:

  • mRNA-based vaccine technology
  • Lipid nanoparticle (LNP) delivery system
  • Designed for rapid response to viral variants

mRNA vaccines are viewed as strategic assets beyond COVID-19, especially for future pandemics.

Why This Approval Matters?

The IND approval was granted shortly after submission in September, highlighting regulatory confidence in the platform.

This move aligns closely with the Korean government’s initiative to localize mRNA vaccine manufacturing.

GC Biopharma plans to:

  • Begin Phase 1 clinical development
  • Submit a Phase 2 IND in the second half of 2026

Platform Strength: mRNA-LNP Technology

GC Biopharma’s platform is designed to enhance both protein expression and durability.

It integrates:

  • Proprietary UTR patents to improve mRNA stability
  • Codon optimization for efficient protein production
  • Advanced LNPs for improved delivery efficiency

Notably, GC Biopharma is the first Korean company to independently manage the full mRNA vaccine lifecycle, from discovery to manufacturing.

Government and Institutional Backing

The company was also selected for Phase 1 clinical research support under the KDCA’s
mRNA Vaccine Development Support Project for Pandemic Preparedness.

This backing reinforces GC Biopharma’s role in national vaccine readiness.

What the Company Is Saying?

Jaewoo Lee, Head of Regulatory Science & Product Development, highlighted the broader implications. According to him, the approval validates the competitiveness of the company’s mRNA platform.

GC Biopharma plans to explore applications beyond vaccines, spanning multiple therapeutic areas.

Bigger Picture: GC Biopharma’s Growth Trajectory

GC Biopharma brings over 50 years of experience in vaccines and plasma-derived therapies.

Recent highlights include:

  • Successful US launch of Alyglo® in 2024
  • Expansion into rare diseases and immunology
  • Continued investment in protein, mRNA, and LNP technologies

Bottom Line

This IND approval positions GC Biopharma as a serious player in Korea’s mRNA ecosystem. More importantly, it strengthens the foundation for pandemic-ready vaccine platforms with global relevance.

Phase 1 data will be the next critical inflection point.

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