GC Green Cross Receives Approval for Phase 1 IND of COVID-19 mRNA Vaccine in Korea

Phase 2 IND Submission Planned for the Second Half of Next Year

GC Green Cross announced on December 19 that its domestic Phase 1 clinical trial protocol (IND) for 'GC4006A', its COVID-19 mRNA (messenger ribonucleic acid) vaccine candidate, has received approval from the Ministry of Food and Drug Safety.

A view of the GC Green Cross headquarters in Yongin, Gyeonggi Province. GC Green Cross

GC Green Cross was recently selected as a company to receive Phase 1 clinical research support under the 'Pandemic Preparedness mRNA Vaccine Development Support Project' led by the Korea Disease Control and Prevention Agency. As this approval was granted quickly following the IND submission in September, the company expects to accelerate development in line with the government's ongoing policy to localize the mRNA vaccine platform. The company stated that it plans to submit the Phase 2 IND in the second half of next year.

The mRNA vaccine platform is not limited to specific infectious diseases; rather, it is a universal technology that enables rapid response to new pathogens and variants in the event of a future pandemic. For this reason, building the capability to independently develop and produce mRNA vaccines domestically is considered a key factor in achieving 'vaccine sovereignty,' ensuring stable vaccine supply even amid potential future global supply chain disruptions.

GC Green Cross explained that this Phase 1 IND approval marks an important first step toward establishing a domestic foundation for mRNA vaccine self-sufficiency.

Lee Jaewoo, Head of Development at GC Green Cross, said, "Based on GC Green Cross's mRNA platform capabilities, we will develop safe and effective vaccines," adding, "Through continuous research and development, we aim to strengthen vaccine sovereignty and contribute to building a robust public health safety net."