[Asia Economy Reporter Cho Hyun-ui] GC Green Cross's plasma treatment for the novel coronavirus infection (COVID-19) has received 'approval for use under treatment purposes' from the Ministry of Food and Drug Safety. This is the first case worldwide where a COVID-19 plasma treatment under development is used for individual patients rather than participants in clinical trials.
According to the pharmaceutical industry on the 20th, GC Green Cross's COVID-19 plasma treatment 'GC5131A' can now be used to treat COVID-19 patients at Chilgok Kyungpook National University Hospital. This follows the Ministry of Food and Drug Safety's approval the previous day of Chilgok Kyungpook National University Hospital's application for treatment-purpose use of 'GC5131.'
The Ministry of Food and Drug Safety operates a treatment-purpose use approval system that allows the use of unapproved clinical trial drugs for patients with no other treatment options or those with life-threatening severe conditions.
GC Green Cross expects that this approval will expand the use of the treatment in the field.
This approval is separate from clinical trials. GC Green Cross is currently conducting a Phase 2 clinical trial of the COVID-19 plasma treatment on 60 high-risk patients at six hospitals, including Chung-Ang University Hospital and Samsung Seoul Hospital.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
