Celltrion Applies for Approval of COVID-19 Antibody Treatment... First Domestic Therapy Nears Approval (Comprehensive)

Third COVID-19 Antibody Treatment Application Worldwide
Government "Completion Within 40 Days"... Preparing for US and European Approvals Too

[Asia Economy Reporter Cho Hyun-ui] Celltrion has applied for conditional approval of its COVID-19 antibody treatment 'Rekkironaju' (CT-P59). Celltrion became the third company worldwide, following multinational pharmaceutical companies Lilly and Regeneron, to apply for approval to use a COVID-19 antibody treatment.

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

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

The expected target patients are those with mild to moderate COVID-19. The anticipated dosage and formulation is an injection administered intravenously over 90 minutes. The goal is to prevent organ damage, which is a major factor leading to severe COVID-19, through early diagnosis and early treatment.

"Confirmed Recovery Period Reduction Effect in Phase 2 Clinical Trial"

Rekkironaju demonstrated an effect of shortening the recovery period in COVID-19 patients according to the results of the Phase 2 clinical trial. However, data regarding safety and efficacy remain confidential until separate guidelines are established for objective and rigorous verification. A Celltrion official stated, "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 grounds necessary to apply for conditional approval."

The MFDS aims to thoroughly verify the safety and efficacy of the drug using the 'COVID-19 Vaccine and Therapeutics Dedicated Review Team' and complete the process within 40 days. Kim Sang-bong, Director of the Biopharmaceutical Division at MFDS, explained, "We plan to focus on reviewing treatment effects such as improvement of patient symptoms like fever and cough, reduction in the period for the virus to convert from positive to negative, as well as ensuring safety and quality."

Celltrion applied for approval after completing Phase 2 of a multinational clinical trial that was simultaneously approved for Phases 2 and 3 by the MFDS. Phase 3 will proceed as planned, independent of this approval application. Director Kim said, "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."

[Image source=Yonhap News]

Likely Launch in January Next Year... Overseas Emergency Use Authorization Also Planned

Rekkironaju is expected to be launched in the domestic market around the end of January next year. Celltrion has produced enough supply since September to treat 100,000 domestic patients so that it can be used immediately in medical settings once conditional approval is granted.

Following domestic approval, preparations for overseas expansion are underway. Currently, Phase 2/3 clinical trials have been approved and are ongoing in the United States and Europe, and consultations are being prepared regarding the possibility of emergency use authorization (USA) and conditional approval (Europe) next year. A Celltrion official said, "We plan to apply for emergency use authorization procedures in the US and Europe in January next year," adding, "Based on the Phase 2 results, we intend to induce pre-orders so that we can supply the product as quickly as possible once approval is granted."

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