▲ A bio pharmaceutical company, GC Pharma

A biopharmaceutical company, GC Pharma, failed to get conditional approval for its plasma therapy, submitted late last month. According to the Ministry of Food and Drug Safety, they determined that GC Pharma failed to prove its remedy effect.

▲ GC Pharma`s plasma therapy was misfired in the conference.

On May 11th, the panels held a conference to review the effect of the plasma therapy, called GC5131A. In the conference, five experts participated and were determined to misfire the therapy. According to the meeting, they said that GC Pharma failed to prove its remedy effect because there was no prominent difference between the experimental group and control group. Also, the number of subjects who participated in the clinical tests was too small, and its distribution was not regular.

▲ the Ministry of Food and Drug Safety approved the plasma treatment for the purpose of healing and emergency.

On May 14th, the Ministry of Food and Drug Safety approved the plasma treatment for the purpose of healing and emergency. The approval system for treatment purposes is a system to use clinical trial medication which does not verify the safety and effectiveness of the plasma treatment. The approval system for treatment purposes is applied to the patients who have a serious illness and also to the patients who have a disease that does not have any replaceable treatment, and COVID-19 belongs to the latter. After the conference, there are some opinions that GC Pharma supplying their plasma therapy rather than challenging it to third clinical tests in the industry.

After the determination of the misfire of the plasma therapy, GC Pharma stated that they would not rush to their pressing matter and new drug application. Rather, they were determined that they would do their best to supply their therapy in an emergency situation, which shows their attitude to using their treatment for the purpose of healing.

May 16th, 2021, by Kwak Chae Hyeon