Celltrion's regdanvimab is first COVID-19 MAb authorized by Korean MFDS

20 September 2021

South Korea’s Celltrion Healthcare (Kosdaq: 068270) saw its shares gain more than 3% to 275,500 won today, after it revealed over the weekend that the Korean Ministry of Food and Drug Safety (MFDS) approved its regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19.

The drug is indicated for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition (the obese, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19.

This marks the first time a monoclonal antibody (MAb) treatment for COVID-19 has received a full approval to treat patients with COVID-19 from the Korean MFDS.

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