[Pangyo Bio & Medical] SK Bioscience to apply for domestic approval of its covid-19 vaccine, “SKYCovione, GBP510”

SK Bioscience announced on the 29th that it applied for approval at the Ministry of Food and Drug Safety of its covid-19 vaccine, “SKYCovione, GBP510.”

The name of product is finalized as “SKYCovione.” If approved, it will become South Korea’s first Covid-19 vaccine.

SKYCovione is a synthetic antigen Covid-19 vaccine. It received development funding from the Bill and Melinda Gates Foundation and the Coalition for Infectious Disease Prevention Vaccine.

A global pharmaceutical company GSK’s immune-boosting agent was applied, and it was jointly developed with the Antigen Design Research Institute at the University of Washington in the U.S.

SK Bioscience has secured immunogenicity and safety data from phase 3 clinical trials.

Neutralizing antibodies that induce prevention by neutralizing the infection of COVID-19 when vaccinated twice with SKYCovione were formed 2.93 times higher than the control vaccine.

The antibody conversion rate (subjects whose neutralized antibodies have more than quadrupled) when getting SKYCovione vaccination was 98%, more than 10 percentage points higher than the antibody conversion rate of the control vaccine. Even in the elderly aged 65 or older, the antibody conversion rate was 95%. That of the control vaccine is 79 per cent.

SKYCovione will be supplied to countries around the world through “COVAX Facility” after getting a domestic approval.

In addition, SK Bioscience plans to obtain an emergency use authorization for SKYCovione by country from the World Health Organization (WHO) Emergency Use Listing (EUL) and Europe.

Ahn Jae-Yong, CEO of SK Bioscience said, “We will do our best to continue to cooperate with global organizations and companies to grow as an innovative bio company on the global stage.”

Source: Pangyo Techno Valley Official Newsroom

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