SK Bioscience's COVID-19 Vaccine 'GBP510' Successful in Phase 3 Clinical Trial... Approaching Product Approval

Clinical Results for 4,037 Adults Aged 18 and Over
Proven Superiority Compared to Control Vaccine
Application for MFDS Approval Submitted After Securing Safety Data

SK Bioscience GBP510.

[Asia Economy Reporter Lee Gwan-joo] SK Bioscience's COVID-19 vaccine candidate 'GBP510,' developed in-house, has shown superior performance compared to the control group AstraZeneca (AZ) vaccine in Phase 3 clinical trials, increasing the likelihood of success for the first domestically produced vaccine.

On the 25th, SK Bioscience announced that the Phase 3 clinical trial analysis of GBP510, a synthetic antigen-based COVID-19 vaccine candidate developed in-house, confirmed superior immune responses compared to the control vaccine. GBP510 is a COVID-19 vaccine candidate jointly developed by SK Bioscience and the Antigen Design Research Institute (IPD) at the University of Washington School of Pharmacy, supported by the Bill & Melinda Gates Foundation (BMGF) and the Coalition for Epidemic Preparedness Innovations (CEPI). It incorporates GlaxoSmithKline (GSK)'s adjuvant AS03.

SK Bioscience conducted Phase 3 clinical trials involving 4,037 adults aged 18 and over at 16 domestic clinical institutions including Korea University Guro Hospital, as well as in five overseas countries: Thailand, Vietnam, New Zealand, Ukraine, and the Philippines. The results demonstrated the superiority of GBP510 (two doses at 4-week intervals) over the control AZ vaccine in terms of immunogenicity. GBP510 significantly increased neutralizing antibodies, which prevent COVID-19 infection, compared to the control vaccine. Additionally, the 'seroconversion rate,' indicating the proportion of participants whose neutralizing antibody levels increased fourfold or more after GBP510 vaccination, was significantly higher than that of the control vaccine.

SK Bioscience plans to apply for product approval from the Ministry of Food and Drug Safety as soon as safety data is secured within this week. Upon final approval, it will secure 'vaccine sovereignty' as Korea's first COVID-19 vaccine and enable independent vaccine exports.

Ahn Jae-yong, CEO of SK Bioscience, said, “The current achievement was possible thanks to the united support of the government, health authorities, international organizations, research institutions, and global companies, as well as the wholehearted encouragement of the Korean people.” He added, “Through the successful development of GBP510, we will create a new turning point in global epidemic prevention and fulfill our mission to establish Korea as a vaccine sovereign nation.”

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