Celltrion: "Rekkironaju, 'FDA Approval' Antibody Treatment Shows Exceptional Effectiveness"

[Asia Economy Reporter Cho Hyun-ui] Celltrion announced that its COVID-19 antibody treatment 'Rekkironaju' has demonstrated equal or superior efficacy compared to the emergency use authorized antibody treatments from Eli Lilly and Regeneron in the United States.

On the 12th, Kwon Ki-seong, Head of Research and Development at Celltrion, stated at the forum "Dialogue with the Future: The Path to a COVID-19 Clean Nation," jointly hosted by Democratic Party lawmakers Lee Kwang-jae, Hwang Hee, and Shin Hyun-young, "The Phase 2 clinical trial results showed equal or better outcomes compared to Eli Lilly and Regeneron antibody treatments in several aspects, including shortened virus reduction time, time to recovery, and the proportion of patients requiring hospitalization."

The COVID-19 antibody treatments from Eli Lilly and Regeneron are products that have each received emergency use authorization from the U.S. Food and Drug Administration (FDA). Regeneron's antibody treatment was used last year to treat former U.S. President Donald Trump's COVID-19 infection.

Celltrion's Rekkironaju focuses on preventing organ damage, a major factor leading to severe COVID-19, through early diagnosis and early treatment. Head Kwon explained, "When inflammation progresses in the lungs, the viral load is not high, so administering the treatment as quickly as possible, within 7 days, ensures definite effectiveness."

Celltrion will disclose the Phase 2 clinical trial results containing this information at the academic conference "2021 High1 New Drug Development Symposium," hosted by the Korean Pharmaceutical Association, at 6 p.m. on the 13th.

Having submitted a conditional approval application for Rekkironaju to the Ministry of Food and Drug Safety on the 29th of last month, Celltrion has also initiated procedures to obtain emergency use authorization in the United States and Europe.

Head Kwon expressed, "Eli Lilly and Regeneron treatments are insufficient even for use within the U.S., so it is difficult for them to be exported overseas," adding, "Once the Phase 2 clinical trial results of Rekkironaju are released, overseas export routes will actively progress." He also revealed, "We are currently in discussions with specific countries regarding the export of Rekkironaju."

Meanwhile, Rekkironaju will be supplied free of charge domestically upon approval. On the same day, Lee Nak-yeon, leader of the Democratic Party, stated, "The Celltrion treatment, to be launched at the end of this month, will be supplied free of charge just like vaccines."