YONGIN, South Korea —December 22, 2025— GC Biopharma announced today that the South Korean Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug (IND) application for a Phase 1 clinical trial of GC4006A, an experimental mRNA vaccine candidate for COVID-19. This regulatory milestone positions the company to accelerate development in alignment with national policy initiatives aimed at the localization of mRNA vaccine technology.
Advancing a Proprietary mRNA-LNP Platform
The GC4006A candidate is built upon GC Biopharma’s specialized mRNA-LNP (Lipid Nanoparticle) platform. This technology is designed to enhance both the intensity and the durability of protein expression through several key technical innovations:
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Proprietary UTR Patents: Optimized untranslated regions to maximize translation efficiency.
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Codon Optimization: Advanced genetic engineering to ensure robust protein production within the body.
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High-Efficiency LNP: A sophisticated delivery system engineered to transport the mRNA safely and effectively into target cells.
Strategic Alignment and Timeline
The approval follows an IND submission in September, reflecting a rapid regulatory turnaround. GC Biopharma is currently receiving support from the Korea Disease Control and Prevention Agency (KDCA) as part of the “mRNA Vaccine Development Support Project for Pandemic Preparedness.” The company has outlined a clear development roadmap, targeting a Phase 2 IND submission in the second half of 2026.
“This approval demonstrates the robustness and competitiveness of the mRNA platform,” stated Jaewoo Lee, Head of Regulatory Science & Product Development. “The goal is to extend the applicability of this platform technology across various therapeutic areas beyond infectious diseases.”
Future Pandemic Readiness
Beyond the current COVID-19 landscape, the successful development of GC4006A serves as a validation of a critical infrastructure technology. Because mRNA platforms allow for rapid reprogramming to address emerging pathogens and viral variants, this project is considered essential for future global health security. GC Biopharma intends to leverage this platform to create a domestic pipeline that can respond immediately to future pandemic threats.
Source:
https://www.prnewswire.com/news-releases/gc-biopharma-secures-ind-approval-for-phase-1-clinical-trial-of-covid-19-mrna-vaccine-in-korea-302648479.html
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