GC Biopharma, a leading biopharmaceutical company, unveiled that South Korea's Ministry of Food and Drug Safety (MFDS) has approved its application to start a Phase 1 clinical trial for its COVID-19 mRNA vaccine, named GC4006A.
The approval came quickly after the company submitted the application in September. GC Biopharma plans to speed up development in line with the South Korean government's efforts to localize mRNA vaccines. The company also plans to submit a Phase 2 application in the second half of 2026.
GC4006A is developed using GC Biopharma's mRNA-LNP platform, which helps create vaccines that can instantly respond to new viruses and variants in future pandemics.
Recently, GC Biopharma was also selected to receive Phase 1 clinical research support from South Korea's Korea Disease Control and Prevention Agency (KDCA) under a project to support mRNA vaccine development for future pandemics.
The company is the first in Korea to manage the entire process of making mRNA vaccines, from discovery to production. GC Biopharma is based in Yong-in, South Korea, and has over 50 years of experience in developing vaccines and plasma-based treatments. The company is expanding globally, with plans to launch Alyglo® (an intravenous immunoglobulin) in the U.S. in 2024.
Executive Statement
According to Jaewoo Lee, Head of the Regulatory Science & Product Development Division at GC Biopharma, this IND approval represents a meaningful milestone, demonstrating the robustness and competitiveness of their mRNA platform. They will continue to explore the applicability of the platform technology across various therapeutic areas, including vaccines.