First Domestic COVID-19 Treatment Soon in Clinical Trials: "Clinical-Grade Production Completed on the 10th"

GC녹십자 announced on the 20th that it has started producing clinical trial products of the novel coronavirus (COVID-19) plasma treatment 'GC5131A'. The company is developing the plasma treatment in collaboration with the National Institute of Health and manufactures it at the Ochang plant in Cheongju, Chungbuk. <이미지:연합뉴스>

[Asia Economy Reporter Choi Dae-yeol] Clinical trials for a plasma therapy, expected to be the first COVID-19 treatment developed domestically to be released, are set to begin soon.

According to the Central Disease Control Headquarters on the 1st, the plasma therapy being developed by the National Institute of Health and GC Green Cross began production on the 18th of last month. The health authorities anticipate completing the manufacturing process for clinical trials around the 10th of this month. Plasma therapy is a pharmaceutical product made by collecting large amounts of plasma?the liquid component in the blood of COVID-19 recovered patients?and concentrating and formulating neutralizing antibodies that can inactivate the COVID-19 virus through various processes.

The clinical trial plan was submitted to the regulatory authorities on the 29th of last month and is currently under review. The Ministry of Food and Drug Safety, which is conducting the review, has stated it will complete the evaluation as soon as possible, so it is expected not to take long. The plan is to administer the plasma therapy to 60 trial participants to determine the appropriate dosage and verify safety and efficacy. Once the Ministry approves the plan, clinical trials will begin at a total of five hospitals: Samsung Seoul Hospital, Asan Medical Center, Chung-Ang University Hospital, Korea University Ansan Hospital, and Chungnam National University Hospital.

Currently, the only officially approved COVID-19 treatment is the antiviral drug Remdesivir, developed by the American pharmaceutical company Gilead Sciences. However, its use is recommended only in limited situations to reduce the hospitalization period of severe patients. Since the government’s special import approval, it has been prescribed to 106 severe patients across 32 hospitals.

If the plasma therapy under preparation for clinical trials is developed successfully, it will be the first domestically produced COVID-19 treatment. Additionally, under a government national project, Celltrion is developing an antibody therapy. The antibody therapy received approval for Phase 1 clinical trials last month in both South Korea and the United Kingdom, and health authorities expect it to be available for use in the first half of next year. The plasma therapy is expected to apply for Phase 2 clinical trials immediately and could be commercialized by the end of this year, ahead of the antibody therapy.