[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 8th that its COVID-19 vaccine under development (GLS-5310) will begin Phase 1/2a clinical trials in the second half of the year to quickly confirm the vaccine's safety and immunogenicity, and will evaluate the vaccine's efficacy through Phase 2b clinical trials in the first half of next year. The company aims to obtain emergency use authorization from the Ministry of Food and Drug Safety in the first half of 2022 and supply the vaccine domestically.


The company stated, "The COVID-19 vaccine (GLS-5310) was developed in collaboration with the National Institute of Health, adding antigens different from the spike antigen to enhance preventive ability against the COVID-19 virus, differentiating it from existing vaccine developers. We are actively utilizing extensive preclinical and clinical development know-how from multiple novel infectious disease preventive DNA vaccines, including the Phase 1/2a clinical trial experience of the MERS DNA vaccine (GLS-5300) completed domestically, aiming for rapid and successful vaccine development."


A company representative also said, "For effective quarantine and suppression of domestic COVID-19 infections, we are preparing a mass production plan for vaccines that can be supplied domestically alongside the research and development of the COVID-19 preventive vaccine." He added, "After completing the qualification evaluation of the new factory by the second half of next year, we plan to start production of GLS-5310 for national stockpile vaccines and produce 30 million doses exclusively for domestic supply by the first half of 2022."



Meanwhile, on the 3rd, the government announced that it will actively support promising domestic companies to secure vaccines by next year. The COVID-19 preventive DNA vaccine (GLS-5310) developed by GeneOne Life Science was designated as a strategic item among the three major vaccine pipelines, as the government judged it to be a vaccine capable of entering clinical trials within the year, and has begun support for commercialization.


This content was produced with the assistance of AI translation services.

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