How is Celltrion Corona antibody treatment different from existing treatments?

▲ Corona 19’Rekironaju ‘ⓒCelltrion Antibody Treatment

Celltrion’s ‘Rekironaju 960 mg’, which has entered conditional approval review for the first time as a home treatment against COVID-19, is a genetically modified neutralizing antibody treatment.

The neutralizing antibody genes present in the blood are selected from a cure for Corona 19, and the selected and harvested genes are inserted (recombined) into host cells capable of mass production and are mass produced through a cell culture process. .

Corona 19 neutralizing antibodies are antibodies that can neutralize the Corona 19 virus.

Thus, it is possible to mass-produce neutralizing antibodies using genetically recombined cells without the need to continuously collect antibodies from the blood of COVID-19 patients.

In the case of ‘Remdesivir’, which is a previously approved treatment, it inhibits the replication of the infected Corona 19 virus in cells, while the Rekyrona strain binds the antibody treatment to the binding site of the human cell on the virus surface Crown 19. Prevents penetration into the cell.

The intended target patients for Rekirona are patients with Corona 19, which ranges from mild to moderate. Patients receive intravenous administration over 90 minutes.

◆ Significantly reduced to 10 months for development and 4 months for permit selection

The development period for Rekkirona has significantly shortened the phase 2 clinical trial period to 10 months through close consultation between the Ministry of Food and Drug Safety and Celltrion.

The Ministry of Food and Drug Safety aims to shorten the existing treatment period (180 days or more) and process it within 40 days for speedy approval and review of Corona 19 vaccines and treatments, including Rekirona.

Consequently, it is expected to ship in February next year if the permitting process for Rekkirona proceeds smoothly.

Separately, the Phase 3 clinical trial of Rekirona will proceed as planned.

Phase 3 of the clinical trial plans to see if the rate of worsening of symptoms, such as the need for oxygen therapy or hospitalization, decreases in 720 patients with mild to moderate Corona 19.

Celltrion is currently in the process of receiving approval for phase 2 and 3 clinical trials for Rekirona from the United States and Europe, and plans to move forward abroad through consultations on whether it is possible to obtain approval for emergency use (EE USA) or conditional approval (Europe) starting next year. .

An official from the Ministry of Food and Drug Safety said: “Recyronaju is the third product that has applied to licensing authorities for approval after Lily and Regeneron among COVID-19 antibody treatments competing for development worldwide.” . If there is a permit request, we will thoroughly verify safety and effectiveness, while doing our best to allow approval as quickly as possible. ”