SK Bioscience Submits Phase 3 Clinical Trial Plan for COVID-19 Vaccine... "Aiming for Commercialization in the First Half of Next Year"

[Asia Economy Reporter Yoo Hyun-seok] SK Bioscience announced on the 28th that it has submitted the clinical phase 3 trial plan for its COVID-19 vaccine candidate (GBP510) to the Ministry of Food and Drug Safety.

SK Bioscience plans to select the final candidate after considering the clinical results of another candidate (NBP2001) and then proceed with the full-scale clinical phase 3 trial for the COVID-19 vaccine. This clinical trial plan was proactively submitted to accelerate the development of the COVID-19 vaccine.

The phase 3 clinical trial of GBP510 will be conducted on 4,000 healthy adults at multiple institutions, including 14 domestic institutions in Korea. Immunogenicity indicators such as neutralizing antibodies and the presence of side effects will be evaluated.

Starting in Korea, SK Bioscience will sequentially submit clinical phase 3 trial applications in Europe, Southeast Asia, and other regions in collaboration with the International Vaccine Institute (IVI). The goal is to commercialize the vaccine in the first half of next year.

GBP510 is a COVID-19 vaccine candidate jointly developed with the Antigen Design Institute at the University of Washington in the United States, supported by the Bill & Melinda Gates Foundation and the international private organization CEPI (Coalition for Epidemic Preparedness Innovations).

Last year, it was selected as the first target of CEPI's 'Wave2' project (next-generation COVID-19 vaccine), which was launched to support differentiated COVID-19 vaccine candidates.

Once efficacy and safety are proven and it is commercialized, hundreds of millions of doses will be supplied worldwide through the international vaccine procurement project 'COVAX facility'.

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