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The European Medicines Agency has announced a “rolling review” of Celltrion’s COVID-19 treatment is underway. The monoclonal antibody regdanvimab (also known as CT-P59 and Regkirona Inj) has already undergone early human trials. The South Korean Ministry of Food and Drug Safety granted conditional approval of the treatment in early February. The antibody treatment has shown efficacy against several variant strains.
The company has begun Phase 3 clinical trials in South Korea and plans to expand into over 10 countries.
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