S. Korea disapproves homegrown blood plasma therapy for COVID-19

Biotech company GC Pharma failed Tuesday to get conditional approval for its experimental plasma treatment against the new coronavirus. 

The Ministry of Food and Drug Safety rejected GC Pharma's application for the drug, GC5131A, submitted late last month, after an advisory panel of experts found its second-phase clinical trial involving 63 patients failed to prove its remedy effect.

The agency concluded that there were no meaningful differences between the control group and experimental group. It also said the trial was conducted on a small number of subjects and that they did not receive the same dose of the drug.

If approved, it could be the country's first blood plasma cure for the deadly disease.

During the trial, three members of the test group died. Two of the deaths were found to be unrelated to the drug, and the remaining case's relation with the drug could not be determined, according to the MFDS.

The agency promised to support GC Pharma to design follow-up clinical trials, but the firm hinted that it will not pursue further trials.

"We will have the drug be used more efficiently at medical institutions, rather than hastily push for an approval," GC Pharma said in a statement.

"We will have close consultations with health authorities about future plans and announce them transparently."

The treatment is a type of hyperimmune globulin drug that uses blood plasma taken from people who have fully recovered from COVID-19. 

GC Pharma earlier said it has completed the production of its third batch, meaning the treatment candidate is expected to be available at medical institutions immediately.

Experimental drugs under clinical trial are sometimes granted approval for emergency usage from the Ministry of Food and Drug Safety in cases where diseases are life-threatening and there is no other treatment option. 

So far, South Korea has one homegrown COVID-19 treatment.
Biopharmaceutical company Celltrion Inc. won conditional approval of its antibody treatment for COVID-19, named Rekirona.

In mid-March, Chong Kun Dang Pharmaceutical Corp.'s acute pancreatitis drug failed to get conditional approval as a treatment for the novel coronavirus. (Yonhap)