Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) granted a Conditional Marketing Authorisation (CMA) for the emergency use of Regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment candidate. The CMA allows for emergency use of CT-P59 in adult patients aged 60 years and over, or with at least one underlying medical condition (cardiovascular, chronic respiratory disease, diabetes, high blood pressure) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. The CMA is based on Part 1 of the Phase II/III trial which showed; Patients treated with CT-P59 reporting a significantly reduced risk of COVID-19 related hospitalization and oxygenation up to Day 28; Progression rates to severe COVID-19 were reduced by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over; and a significantly shortened time to clinical recovery in CT-P59 treated patients (40 mg/kg) ranging from 3.4 to 6.4 days quicker compared with placebo. A global Phase III clinical trial is currently recruiting and expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19 in more than 10 global sites to evaluate efficacy and safety results of CT-P59. Celltrion is set to demonstrate clinical efficacy against COVID-19 in both UK and South African variants and the results to be expected in the coming days.