À̹ÌÁö È®´ë [Photo provided by Celltrion Inc.]
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of two monoclonal antibody therapies to treat Covid-19 symptoms including Regkirona (regdanvimab) developed by Korean biotech firm Celltrion Inc.
According to its disclosure on Friday, the CHMP recommended the use of Regkirona for treatment of adult patients with a confirmed infection caused by Covid-19 that could develop into a more serious phase.
U.S. biotech firm Regeneron¡¯s Ronapreve antibody therapy for Covid-19-infected patients also received CHMP recommendation for its application in at-risk patients aged 12 or older.
This is the first time a monoclonal antibody therapy has received a positive opinion from the CHMP. If approved by the European Commission (EC), the two therapies will be used as a treatment for the first time in Europe, where the virus is spreading faster than ever.
Celltrion filed for marketing authorization of Regkirona with the EMA in early October. The EC is expected to give its green light to the therapy in one to two months.
Shares of three Celltrion Group companies all rose Friday on the imminent launch of Korea¡¯s first home developed Covid-19 therapy in Europe.
Kospi-listed Celltrion shares gained 2.12 percent to trade at 217,000 won ($184.23) by midday Friday. Kosdaq-listed Celltrion Pharm rose 2.83 percent to 119,800 won, and Celltrion Healthcare up 1.05 percent to 86,600 won.
By Pulse
[¨Ï Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]