SK bioscience Receives Marketing Authorization of COVID-19 Vaccine from UK MHRA

• The MHRA's Marketing Authorization for SK bioscience COVID-19 vaccine is valid in the United Kingdom.
• SKYCovion™ is the world's first-ever vaccine developed utilizing the RoseTTAFold, a software tool that uses deep learning.
• SK bioscience has applied for an Emergency Use Listing from the World Health Organization, for enabling equitable access of vaccine in the world.

SEONGNAM, South Korea, May 30, 2023 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, has announced today the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization (MA) for SK bioscience's COVID-19 vaccine SKYCovion™ (brand name in Korea: SKYCovione™) as a primary series for strong immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. It becomes the 8th COVID-19 vaccine authorized by the UK's independent medicines regulator. The authorization covers England, Scotland, and Wales.

The MHRA's decision is based on data from the Phase III trial that showed the vaccine induced neutralizing antibody responses against SARS-CoV-2 parental strain and had a standard safety and reactogenicity profile after administered as a primary vaccination of two doses.

Jaeyong Ahn, CEO of SK bioscience said, "We are delighted with the MHRA's authorization of Korea's first COVID-19 vaccine SKYCovion. This is the result of our commitment to protecting and promoting global public health. We are confident it will be the milestone to solidify our position in the global market amid the transition of the pandemic to the endemic phase."

SKYCovion, the protein-based vaccine developed with GSK's pandemic adjuvant, can be stored between 2-8 degrees Celsius, making it suitable to use in countries where ultra-low cold chain channels are not available. This helps achieving the vaccine equity and vaccination coverage in low-income countries.

SK bioscience has also applied for an Emergency Use Listing (EUL) from the World Health Organization (WHO) and Marketing Authorization (MA) from the European Medicines Agency (EMA).

SKYCovion is jointly developed with the Institute for Protein Design (IPD) from the University of Washington School of Medicine. The development of SKYCovion has been supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union's Horizon 2020 Programme, and its pre-clinical trials have been funded by the Bill & Melinda Gates Foundation.

SKYCovion is the world's first-ever vaccine developed using the RoseTTAFold, a software tool that uses deep learning to quickly and accurately predict protein structures based on limited information. The RoseTTAFold was designed as a three-track neural network developed by the University of Washington.

SK bioscience is expanding its portfolio to secure its competitiveness in the endemic phase of the pandemic by developing 1) universal pan-sarbecovirus vaccines funded by CEPI, 2) polyvalent vaccines, and conducting the pre-clinical trials for 3) mRNA vaccine platform development funded by CEPI and the Bill & Melinda Gates Foundation.

About SK bioscience

SK bioscience is a global innovative vaccine and biotech company, standing committed to global pandemic preparedness in vaccine development and manufacturing to create more equitable access to vaccines. In leveraging strengths on cutting-edge vaccine development technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. Under collaborations of domestic and international governments, regulatory agencies, healthcare providers, doctors and medical experts, SK bioscience has firmly established globally certified R&D and manufacturing technologies. All of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions.

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Media Contact:
Changhyun Jin (jin99@sk.com)
Jeannie S. Pak (J.pak@sk.com)
Tae-Gyun Kim (taegyunkim@sk.com)  

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