SK Bioscience has set about to win approvals for its Covid-19 vaccine, Skycovione, from the U.K. and other countries to enter global markets.

SK Bioscience has applied for conditional marketing authorization of its Covid-19 vaccine to the U.K. regulator.
SK Bioscience has applied for conditional marketing authorization of its Covid-19 vaccine to the U.K. regulator.

SK Bioscience said Friday that it applied for conditional marketing authorization (CMA) to U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) for the global authorization of Skycovione.

Skycovione has undergone the rolling review of MHRA since March to receive fast approval and will enter into the process of winning approval through the application of conditional nods, including the phase 3 data the company has secured lately.

SK Bioscience also aims to introduce the first homegrown vaccine in the fast-growing global Covid-19 vaccine market by applying for conditional approval from the European Medicines Agency (EMA) and registering on WHO’s Emergency Use Listing (EUL), the company said.

“We took the first step to introduce a safe and immunogenic homegrown Covid-19 vaccine in the Covid-19 vaccine market dominated by global pharma.” SK Bioscience CEO Ahn Jae-yong said. “We will do our best to help the world return to normalcy through the COVAX Facility while demonstrating Korea’s technology by getting conditional approval from the U.K. and registering on the WHO’s EUL.”

Korea’s first homegrown vaccine, developed through collaboration with the University of Washington, has proved safe and immunogenic through phase 3 clinical trials conducted on about 4,000 people 18 and over in five countries.

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