Domestic COVID-19 Plasma Therapy Soon in Clinical Trials... Development Within the Year?

GC Green Cross to Produce Formulation This Week
CELLTRION Prepares for Global Clinical Trials

Minister of Health and Welfare Park Neung-hoo visited GC Green Cross in Yongin-si, Gyeonggi-do, which is developing a plasma treatment for the novel coronavirus disease (COVID-19), in May to inspect the research facilities.<이미지:연합뉴스>

[Asia Economy Reporter Choi Dae-yeol] A novel coronavirus disease (COVID-19) treatment being developed domestically will enter clinical trials starting this week. If the development process proceeds smoothly, health authorities expect it to be available as early as the end of this year or the beginning of next year. Since there is expected to be a shortage of clinical trial participants in Korea, options to conduct trials jointly with countries experiencing a high number of patients are also being discussed.

According to the Central Disease Control Headquarters and related industries on the 13th, GC Green Cross plans to produce the formulation for the plasma treatment clinical trial currently under development within this week. Plasma treatment is a therapy that utilizes immune antibodies found in the plasma of recovered COVID-19 patients, and the government and the company are jointly developing a treatment formulated from this plasma.

Development had been slow due to a shortage of plasma, but recently, encouraged by health authorities, 375 recovered patients have expressed their willingness to donate plasma, and 171 have actually donated. Phase 1 clinical trials have been waived, allowing the trial to proceed directly to Phase 2. Previously, the Shincheonji Church of Jesus, which was a hotspot for the outbreak in the Daegu and Gyeongbuk regions, also expressed willingness to donate plasma from about 500 people, which is expected to secure enough supply for commercialization after clinical trials.

Similarly, Celltrion’s antibody treatment, which is being developed as a national project, has also declared that it will enter clinical trials this week. Seo Jung-jin, chairman of the Celltrion Group, recently stated in a lecture that clinical trials on humans would begin on the 16th. According to the Ministry of Food and Drug Safety, the clinical trial plan for the antibody treatment developed by Celltrion is currently under review. The government is actively supporting the development of treatments and vaccines at a pan-governmental level, so a decision is expected to be made sooner than usual.

The company is reportedly considering conducting clinical trials simultaneously in countries such as the United Kingdom, where there are many COVID-19 patients, due to the expected shortage of participants in Korea. The antibody treatment is also expected to have preventive effects, but whether it is actually effective will be determined through clinical trials.

Currently, the only COVID-19 treatment officially approved in major countries is Remdesivir, developed by the American pharmaceutical company Gilead Sciences. Originally developed as a treatment for Ebola virus infection, it was repurposed and recognized as a COVID-19 treatment. In the US and Korea, it is approved for limited use to reduce hospitalization duration in severe patients. According to health authorities, Remdesivir has been administered to 42 severe or critical patients domestically, with 9 showing improvement. However, it is unclear whether this improvement is due to the drug’s efficacy, other symptomatic treatments, or the patients’ immune response.

Fifteen patients showed no significant change in symptoms, and three worsened. Until early this month, the number of severe and critical patients in Korea was in the mid-30s, but as of the previous day, it decreased to 19, about half. Health authorities stated that it is still premature to determine whether this reduction is due to the effect of Remdesivir.

This content was produced with the assistance of AI translation services.