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Chong Kun Dang wins first overseas approval for phase 3 trial of COVID-19 treatmentBy Shim Woo-hyun
Published : Sept. 30, 2021 - 17:39
Drugmaker Chong Kun Dang said Thursday that it has received an approval from the Ministry of Health of Ukraine to conduct a phase 3 clinical trial of their COVID-19 treatment candidate, Nafabeltan.
Ukraine is the first foreign country to authorize the final-stage trial of the South Korean pharmaceutical company’s self-developed COVID-19 treatment.
In Korea, Chong Kun Dang received an approval from the Ministry of Food and Drug Safety in April.
Ukraine is one of the seven foreign countries that the firm is planning to run the test in, with the others being Brazil, India, Thailand, Russia, Argentina, and Peru.
Chong Kun Dang will evaluate efficacy and safety of Nafabeltan through double-blind studies with a total of 600 COVID-19 patients at high risk for progression to severe COVID-19 cases.
Nafabeltan inhibits the activity of the spike protein of COVID-19. The company expects the treatment candidate to be effective against the existing COVID-19 variants, including the delta and lambda variants.
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