GC Biopharma Gets South Korea Approval to Start Phase 1 Trial of mRNA COVID-19 Vaccine

GC Biopharma has received regulatory clearance in South Korea to begin human testing of its mRNA-based COVID-19 vaccine candidate, GC4006A.

The approval was granted by the Ministry of Food and Drug Safety (MFDS) under an Investigational New Drug (IND) application.

A Fast-Tracked Regulatory Green Light

The IND approval came shortly after submission in September, signaling strong regulatory confidence in the program.

GC Biopharma plans to accelerate development in line with the Korean government’s push to localize mRNA vaccine technologies.

• Phase 1 clinical trial approved
• Phase 2 IND planned for the second half of 2026
• Development aligned with national pandemic preparedness goals

About GC4006A and the mRNA Platform

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

mRNA vaccines are seen as a strategic technology because they allow rapid adaptation to new pathogens and viral variants.

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

Key technology features include:

• Proprietary UTR (untranslated region) patents to improve mRNA stability
• Codon optimization to enhance protein production
• Advanced lipid nanoparticle delivery for efficient cellular uptake

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

Government Support for Pandemic Preparedness

GC Biopharma was also selected for Phase 1 clinical research support under the Korea Disease Control and Prevention Agency’s mRNA Vaccine Development Support Project.

This initiative aims to strengthen Korea’s domestic vaccine capabilities for future pandemics.

What the Company Is Saying?

“This IND approval represents a meaningful milestone, demonstrating the robustness and competitiveness of our mRNA platform,” said Jaewoo Lee, Head of Regulatory Science & Product Development at GC Biopharma.

He added that the company will continue expanding the platform’s applications across vaccines and other therapeutic areas.

GC Biopharma’s Broader Strategy

Formerly known as Green Cross Corporation, GC Biopharma has over 50 years of experience in vaccines and plasma-derived therapies.

In 2024, the company successfully entered the US market with Alyglo®, an intravenous immunoglobulin product.

Today, its R&D focus spans:

• mRNA and protein engineering
• Lipid nanoparticle drug delivery
• Rare diseases and immunology & inflammation

Why This Matters?

The Phase 1 approval positions GC Biopharma as a serious domestic player in mRNA vaccine development.

More importantly, it strengthens South Korea’s ability to respond quickly to future infectious disease threats.

As mRNA platforms expand beyond COVID-19, this milestone could have long-term implications well beyond a single vaccine program.

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