Asian Tech Press (Mar. 16) -- South Korean drugmaker SK Bioscience Co. has submitted an application to the UK drug regulator for an emergency use authorization (EUA) of its COVID-19 vaccine candidate.
SK Bioscience said in a statement that it has commenced a rolling review submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA), seeking rapid approval of the COVID-19 vaccine candidate GBP510.
GBP510, developed by a biotechnology subsidiary of South Korean conglomerate SK Group, is the country's first homegrown vaccine candidate that has entered the last phase of its clinical trial.
The company said it plans to produce an interim result of its GBP510 trials in the first quarter of the year and seek approval from South Korea's drug authorities in the first half of 2022.
SK Bioscience also aims to submit review documents for GBP510 to the European Medicines Agency (EMA) with the UK MHRA in the first half of this year, followed by plans to obtain Emergency Use Listing (EUL) from the WTO and emergency approval in overseas countries.