Celltrion Applies for COVID-19 Antibody Treatment Approval... MFDS to Complete Review Within 40 Days

[Asia Economy Reporters Heungsun Kim and Hyunui Cho] Celltrion has applied for conditional approval of its COVID-19 antibody treatment 'Rekkironaju' (CT-P59).

The Ministry of Food and Drug Safety (MFDS) stated on the 29th, "Celltrion submitted an application for marketing authorization of Rekkironaju to the MFDS today."

Rekkironaju is a recombinant neutralizing antibody treatment developed as a new drug by Celltrion. It is produced by selecting neutralizing antibodies present in the blood of recovered COVID-19 patients, inserting the genes into host cells capable of mass production, and producing them through cell culture processes.

Phase 2 clinical trial results confirmed that Rekkironaju shortens the recovery period of COVID-19 patients. A Celltrion official said, "After analyzing detailed data from Phase 2 through evaluations by domestic and international experts and internal assessments, we judged that we have sufficiently secured the evidence necessary to apply for conditional approval."

However, data regarding the safety and efficacy of Rekkironaju will remain confidential until separate guidelines are issued at the request of the MFDS. This is to ensure objective and rigorous verification and evaluation by national institutions.

The expected target patients for Rekkironaju are those with mild to moderate COVID-19 symptoms. The anticipated dosage and formulation is an intravenous injection administered over 90 minutes.

The MFDS plans to thoroughly verify the safety and efficacy of the drug by utilizing the 'COVID-19 Vaccine and Treatment Approval Review Team.' The goal is to complete the process within 40 days for rapid approval and review.

Celltrion has completed Phase 2 of a multinational clinical trial, which was approved simultaneously with Phase 3 by the MFDS, and is applying for approval. Phase 3 will proceed as planned regardless of this approval application.

Kim Sangbong, Director of the Bio-Pharmaceutical Division at the MFDS, stated, "If safety and efficacy are sufficiently confirmed, we plan to grant approval on the condition that the results of the ongoing Phase 3 clinical trial are submitted after approval."

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