[사회]Corona 19 Domestic Antibody Treatment Review Start … “Completed in 40 Days”

[앵커]

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

It is the third time in the world that it has requested approval for its use, and the Ministry of Food and Drug Safety plans to complete the review immediately within the next 40 days.

Reporter Park Hong-gu about the report.

[기자]

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

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

It is produced in large quantities by the process of growing 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, Rekyrona is a method in which antibody treatments bind to the site that binds to human cells.

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

Rekironaju is expected to be developed as an injection that is given intravenously over approximately 90 minutes to patients with mild to moderate levels of Corona 19.

Celltrion conducted a phase 2 clinical trial in 327 corona patients19 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 Pharmaceutical Safety plans to verify safety and efficacy based on the data presented above.

[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, as it will only apply to patients with mild or moderate severity.

Experts say there will be limits to reversing the corona epidemic19.

This is YTN Park Hong-gu.

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