[사회]Domestic Corona 19 Antibody Treatment Examination Start…”Completed within 40 days”

[사회]Domestic Corona 19 Antibody Treatment Examination Start…”Completed within 40 days”

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[앵커]

The Ministry of Food and Drug Safety has initiated a permit review for the Corona 19 antibody treatment of Celltrion, a Korean pharmaceutical company.

It is the third time in the world to apply for approval for use, and the Ministry of Food and Drug Safety plans to complete the review promptly within the next 40 days.

Reporter Park Hong-gu on the press

[기자]

Celltrion has applied for approval of the use of COVID-19 antibody treatments to the licensing authorities for the third time in the world after US pharmaceutical companies Lily and Regeneron.

This treatment, named “Rekironaju”, is a treatment made by selecting neutralizing antibodies present in the blood of cured people for Corona 19.

It is produced in large quantities through the process of culturing the cells by inserting the neutralizing antibody gene into a host cell capable of mass production.

[김상봉 / 식품의약품안전처 바이오생약국장 : 코로나19 완치자의 혈액에서 항체를 지속적으로 채취할 필요 없이 유전자 재조합된 세포를 이용해 중화항체를 대량 생산할 수 있습니다.]

While the existing treatment, remdesivir, inhibits the replication of the infected Corona 19 virus in cells, Rekirona is a method in which antibody treatments instead bind to the site that binds to human cells.

In this way, even if the virus enters the body, it becomes impossible to penetrate into the cells.

Rekironaju will be developed as an injection that is administered intravenously for about 90 minutes to patients with mild to moderate levels of Corona 19.

Celltrion conducted a phase 2 clinical trial on 327 corona19 patients in Romania, Spain, and the United States, including Korea.

Although the final phase 3 clinical trial of 720 patients remains, the Ministry of Food and Drug Safety plans to verify safety and effectiveness based on the data previously submitted.

[김상봉 / 식품의약품안전처 바이오생약국장 : 신속한 허가심사를 위해 기존 처리기간인 180일 이상을 최대한 단축해서 40일 이내에 처리하는 것을 목표로 추진하고 있습니다.]

However, even if the drug is released early next year, the role will inevitably be limited in that it will only be applied to patients with mild or moderate severity.

Experts say that there will be limits to reversing the corona19 epidemic.

This is YTN Park Hong-gu.

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