GC Biopharma said Monday it has submitted an investigational new drug (IND) application to Korea’s Ministry of Food and Drug Safety for a phase 1 trial of its Covid-19 mRNA vaccine candidate GC4006A.

Development picked up after the company was selected in April for the Korea Disease Control and Prevention Agency’s pandemic-preparedness mRNA vaccine program, which targets domestic mRNA capability by 2028, the company said.

The phase 1 study will evaluate safety and immunogenicity in healthy adults. GC Biopharma expects IND clearance within the year and plans to begin first dosing in early 2026.

Preclinical data showed GC4006A generated humoral and cell-mediated immune responses comparable to marketed vaccines and demonstrated safety and protective efficacy, according to the company.

GC4006A stems from GC Biopharma’s in-house mRNA-LNP platform, which the company has built since 2019 to handle end-to-end mRNA drug development. “Among domestic pharmaceutical companies, we are the first to internalize the end-to-end process for mRNA drug development,” said Jeong Jae-uk, executive vice president of R&D.

The company said platform validation could enable a 100-day response to future pandemics and that it is exploring expansion into rare genetic and chronic inflammatory diseases, cancer immunotherapy, and additional vaccines, alongside potential co-development and tech-transfer deals.