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SK bioscience and GSK Announce Biologics License Application Approval of SKYCovione™ in Republic of Korea

2022.06.29

SKYCovione will be ready to enter into domestic vaccine markets after passing the national lot release procedure.

SK Bioscience is preparing for license applications at international regulatory agencies.

Clinical trial for a booster vaccine is being conducted.

SK bioscience announced that ‘SKYCovione,’ South Korea’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant has been authorized by the Korean Ministry of Food and Drug Safety (KMFDS). South Korea has become one of the few countries in the world to have both a domestically developed COVID-19 vaccine and a treatment.

 

SKYCovione™ is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant. The development of SKYCovione™ has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union´s Horizon 2020 Programme.

 

The results of the Phase III clinical trial, collected in 4,037 adults over 18-year-old, showed that SKYCovione™ induced neutralizing antibody responses, against the SARS-CoV-2 parental strain. The neutralizing antibody titres increased about 33 times compared to before the injection and were 3 times that of AstraZeneca´s Vaxzevria™, the control vaccine used in the study, 2 weeks after the second dose.

 

In addition, the proportion of participants who seroconverted, (with a greater than four-fold increase in neutralizing antibody titres compared to baseline), was 98.06% in the SKYCovione™ group. In participants over 65 years, the neutralizing antibody titres were 2.7 times than after vaccination with the control vaccine, and the antibody conversion rate was also higher (95.3% versus 79.2%).

 

In addition, the proportion of participants who seroconverted, (with a greater than four-fold increase in neutralizing antibody titres compared to baseline), was 98.06% in the SKYCovione™. The neutralizing antibody titres was nearly 3 times that of the control vaccine in participants over 65, and the antibody conversion rate was also higher than that of the control vaccine, exceeding 95%.

 

In terms of safety, SKYCovione™ overall showed a clinically acceptable safety profile. Most of the adverse reactions that occurred after injection were mild or moderate, and transient. The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.

 

SK bioscience will apply for authorizations at other selected regulatory agencies for distribution of SKYCovione™, including through the COVAX Facility and for emergency use listing (EUL) to the World Health Organization (WHO).

 

SK bioscience is currently planning heterologous and homologous booster clinical trials of SKYCovione™ and booster trials for adolescents and children to expand the vaccination age group for wider prevention in the era when most people have already been exposed to COVID-19 vaccine or virus.

 

SKYCovione™ is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, hepatitis B, and HPV. SKYCovione™ can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it is particularly suitable for use in low-income settings without the need for ultra-cold chain facilities.

 

The market expects that SKYCovione™ will accelerate securing of Korea´s vaccine sovereignty and reducing dependence on vaccine imports. According to ‘Global Vaccine Markets and Korea´s Vaccine Imports and Exports’ report published by Biotechnology Industry Organization in March, South Korea´s vaccine imports amounted to $2.355 billion, which was 4.5 times the export value ($519 million). Experts explain that the export volume, which was only $183 million in 2017, has nearly tripled due to the contract manufacturing of COVID-19 vaccines, but there is still a large gap between imports and exports, so securing a domestic vaccine will be crucial.

 

SK bioscience is also accelerating to establish a preventive platform to respond the next pandemic era.

 

SK bioscience has extended a research study to confirm the preventive effect of SKYCovione™ against COVID-19 variants including Omicron by utilizing the SKYCovione™’s platform.

 

Separately, in collaboration with CEPI, SK bioscience initiated the development of a vaccine candidate effective for the entire Sarbecovirus group to establish a broader protection system against COVID-19 variants and SARS in the future. Last April, SK bioscience also initiated preclinical development of an innovative binder protein compound designed to prevent and treat COVID-19 when sprayed into nasal passages with support by international organizations and in collaboration with world-renowned research institutes, such as International AIDS Vaccine Initiative (IAVI), Bill & Melinda Gates Foundation and IPD.  

 

Jaeyong Ahn, CEO of SK bioscience said, “The development of Korea’s first COVID-19 vaccine was achieved based on the efforts of the government and members who have been working hard all day and night. We will continue to work with various global organizations based on our own research and manufacturing technologies to preemptively respond to new pandemics.”