· 609,000 doses of advance purchased SKYCovione™ will be sequentially supplied based on the vaccination plan of the KDCA

· EMA has started review of Conditional Marketing Authorization for SKYCovione™(SKYCovion™) in Europe

· Starting in South Korea, SK will expand the vaccine’s global supply

[2022, Sep, 2] Seoul, South Korea- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, announced that the first Korean COVID-19 vaccine, ‘SKYCovione™’, began to be shipped from SK’s vaccine manufacturing plant, L-HOUSE in Andong. The initial volumes to be distributed for domestic use are about 609 thousand doses.

SK bioscience signed an advance purchase agreement (APA) with the Korean government for 10 million doses of ‘SKYCovione™.’ The vaccine will be supplied sequentially for domestic use based on the request of the Korea Centers for Disease Control and Prevention (KDCA).

Duck-soo Han, Prime Minster of South Korea said “The shipment of the Korea’s first COVID-19 vaccine, SKYCovione™, is a valuable achievement through close cooperation between SK bioscience, the Korean government as well as domestic and international initiatives. The government will continue to support SK bioscience to contribute overcoming the pandemic and further accelerate the development of new Korean vaccines.”

Andrew Chey, Vice Chairman of SK discovery said “Our mission as a vaccine company was to develop a COVID-19 vaccine to contribute overcoming the pandemic and strengthen global public health. Starting with SKYCovione™, which was able to be developed with the help of numerous domestic and international initiatives, we will further expand our partnerships and investment in R&D to respond to the next pandemic.”

Jaeyong Ahn, CEO of SK bioscience said, “With the shipment of SKYCovione™ today, we have finally achieved the two-track strategy based on global CDMO and joint-development of COVID-19 vaccine. We as a global innovative partner of vaccine and biotech, will not stop at today´s achievements, but continuously work with various global initiatives to preemptively respond to new pandemics.”

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 the 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 clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.

SKYCovione™ also showed cross-neutralizing activity against Omicron variant BA.1 when administered as a booster. The results of the Phase I/II clinical trial, conducted with 81 healthy adults who received a booster dose of SKYCovione™ 7 months after the second dose of SKYCovione™, showed that the neutralizing antibody titres against the Omicron variant BA.1 were 25 times the titers observed two weeks after two primary doses.

Further, SK bioscience is conducting heterologous and homologous booster clinical trials of SKYCovione™.

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.

Recently, SK bioscience submitted an application for a Conditional Marketing Authorization (CMA) of SKYCovione™(SKYCovion™) to the Medicines and Healthcare products Regulatory Agency(MHRA) and the European Medicines Agency (EMA). SK bioscience also plans to quickly apply for Emergency Use Listing (EUL) to the World Health Organization (WHO). If the EUL is obtained, SKYCovione™ will be made available to the COVAX Facility for procurement and equitable allocation worldwide, if required.