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| ▲ This photo provided by SK Bioscience Co. shows its vaccine manufacturing plant in Andong, 270 kilometers southeast of Seoul. (PHOTO NOT FOR SALE) (Yonhap) |
SK Bioscience-Britain
SK Bioscience submits application for COVID-19 vaccine candidate in Britain
By Kim Han-joo
SEOUL, March 16 (Yonhap) -- South Korean drugmaker SK Bioscience Co. said Wednesday it has submitted an application for an emergency authorization of its COVID-19 vaccine candidate in Britain.
SK Bioscience said it has submitted the application for marketing authorization of GBP510 through an expedited rolling review to Britain's Medicines and Healthcare products Regulatory Agency.
The rolling review is a new system for marketing authorization applications by the MHRA and is intended to streamline the development of new medicine.
GBP510, under development by an affiliate of South Korea's family-controlled conglomerate SK Group, is the country's first homegrown vaccine candidate to enter the last phase of its clinical trial.
SK Bioscience said it aims to produce an interim result of its GBP510 trials in the first quarter of the year and seek emergency approval from South Korea's drug authorities in the first half of 2022.
SK Bioscience also aims to seek marketing authorization from European drug authorities in the first half as well.
The company also eyes commercialization of GBP510 through the World Health Organization's global vaccine COVAX Facility project after receiving a vaccine prequalification from WHO by the end of the year.
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