GC Biopharma Submits IND Application for COVID-19 mRNA Vaccine

YONGIN, South Korea – September 22, 2025 – GC Biopharma has taken a significant step in the development of its COVID-19 vaccine candidate, GC4006A. The company announced today that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) in South Korea to begin a Phase 1 clinical trial.

The company’s development of GC4006A has been fast-tracked since April 2025, when it was selected by the Korea Disease Control and Prevention Agency (KDCA) to lead a national project aimed at localizing mRNA vaccine production by 2028.

In a previously conducted non-clinical study, GC4006A demonstrated a strong humoral immune response, with antibody levels comparable to those of existing vaccines. It also showed a robust cellular immune response, which is crucial for targeting infected cells.

According to GC Biopharma, the upcoming Phase 1 clinical trial will not only test the safety and immunogenicity of GC4006A in healthy adults but also serve as a crucial validation of its proprietary mRNA-LNP (Lipid Nanoparticle) platform. This platform enables the company to manage the entire mRNA vaccine development process in-house, from start to finish. The company aims to use this technology for a rapid response to future pandemics, potentially within 100 days of an outbreak.

If the IND application is approved by the end of 2025, the company plans to begin administering the vaccine in early 2026.

Jae Uk Jeong, Head of R&D at GC Biopharma, stated that the company is the “first in Korea to establish a full in-house capacity of mRNA drug development” and that the COVID-19 vaccine is just the beginning. The company plans to expand the platform’s application to a wide range of therapeutic areas, including rare genetic diseases, chronic inflammatory diseases, and oncology.