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).
