SEOUL -- South Korea's public health watchdog approved second and third-stage clinical trials to verify the efficacy and safety of a COVID-19 antibody treatment developed by Celltrion, which has vowed to complete preparations for the mass supply of therapeutic antibodies for emergency domestic use by the end of this year.
The Ministry of Food and Drug Safety allowed Celltrion to carry out a Phase 2 clinical study involving 300 patients and a Phase 3 clinical study involving 720 patients. The ministry's approval came after Celltrion's antibody treatment, CT-P59, showed safety and drug tolerance in the first-stage test involving healthy people in August.
South Korea has unveiled a roadmap for the treatment of COVID-19 to develop plasma treatment by the year's end as well as antibody treatment and vaccines next year. The Korea National Institute of Health, a state research body, has selected Celltrion as a cooperation partner to develop vaccines and medicine. In an evaluation test, Celltrion's antibody treatment was found to be effective in neutralizing the mutated strain of the SARS-CoV-2 coronavirus.
Celltrion will carry out clinical trials in the United States and four other countries.
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