GC Pharma's headquarters building in Yongin, Gyeonggi Province (GC Pharma)
Local demand for biotech company GC Pharma‘s experimental plasma treatment against the new coronavirus remains even after the company failed to receive conditional use approval here, according to industry sources Tuesday.
According to sources, Kyungpook National University Hospital on Friday received an emergency use authorization for the treatment, just three days after the Ministry of Food and Drug Safety rejected GC Pharma‘s application for conditional use.
In South Korea, experimental drugs still undergoing clinical trial are sometimes authorized for emergency treatment use when they could be used for diseases that are life-threatening and there is no other option. This is different from the more general conditional use approval or regular approval from the ministry.
To date, GC Pharma’s plasma treatment has been granted approvals to treat a total of 46 patients since it was first used at Kyungpook National University Hospital in October last year.
In South Korea, there is only one COVID-10 treatment developed by a domestic company. Celltrion received conditional approval for its antibody treatment Rekirona in February.
GC Pharma‘s COVID-19 treatment, if it was approved, would have become the country’s second COVID-19 treatment.
In its rejection, the Ministry of Food and Drug Safety cited the view of an advisory panel that the drug candidate has failed to prove its effectiveness in a second-phase clinical trial conducted on 63 patients.
The ministry then said it would help GC Pharma to design follow-up clinical trials, but the company hinted that it may not pursue further studies.
The company said it would consult with medical institutions and health authorities to use the treatment more efficiently, instead of pushing for an approval.
GC Pharma’s plasma treatment is a hyperimmune globulin drug that uses blood plasma taken from patients who have fully recovered from COVID-19.
By Shim Woo-hyun (firstname.lastname@example.org