GC Biopharma Secures IND Approval for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea

Published: Tuesday, December 23, 2025 at 3:56 am

GC Biopharma Receives Approval for COVID-19 mRNA Vaccine Trial

GC Biopharma, a global biopharmaceutical company, has received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for a Phase 1 clinical trial of its COVID-19 mRNA vaccine candidate, "GC4006A." The approval follows the company's IND submission in September, marking a swift progression for the project. The company plans to submit a Phase 2 IND in the second half of 2026.

The vaccine candidate is developed using GC Biopharma's proprietary mRNA-LNP (Lipid Nanoparticle) platform. This technology is seen as crucial for rapid responses to emerging pathogens and viral variants, extending its potential beyond the current pandemic. The company's platform utilizes its own patents, codon optimization technology, and advanced delivery efficiency to enhance protein expression.

GC Biopharma was also recently selected for Phase 1 clinical research support under the Korea Disease Control and Prevention Agency (KDCA)'s "mRNA Vaccine Development Support Project for Pandemic Preparedness." Company representatives have stated that the IND approval is a significant milestone, demonstrating the strength of their mRNA platform. GC Biopharma is the first company in Korea to independently manage the entire process of mRNA vaccine development, from discovery to manufacturing.

The company, formerly known as Green Cross Corporation, has a long history in biopharmaceutical development, including plasma derivatives and vaccines. They are expanding their global presence, including a successful US market entry in 2024. GC Biopharma is focused on innovation, leveraging its research and development capabilities in protein engineering, mRNA, and lipid nanoparticle drug delivery platforms to develop treatments for rare diseases and immunology and inflammation.

BNN's Perspective:

This development is a positive sign for South Korea's efforts to become self-sufficient in vaccine production. While the timeline for Phase 2 is still a few years out, the rapid approval of the Phase 1 trial suggests a streamlined regulatory process and a commitment to advancing this critical technology. The focus on mRNA technology, which can be adapted to address new variants, is a forward-thinking approach to pandemic preparedness.

Keywords: GC Biopharma, COVID-19 vaccine, mRNA vaccine, clinical trial, IND approval, South Korea, MFDS, GC4006A, mRNA-LNP, Lipid Nanoparticle, vaccine development, pandemic preparedness, KDCA, biopharmaceutical, vaccine technology

Full Story