On the 13th of this month, Celltrion is planning to release the results of the global clinical phase 2 of’Recyronaju’ (ingredient name legdanvimab code name CT-P59) at the 2021 High1 Drug Development Symposium hosted by the Korean Pharmacopoeia. news
The results of the Phase 2 clinical trial of Celltrion’s novel coronavirus infection (Corona 19) antibody treatment will be announced at a domestic conference on the 13th.
According to the pharmaceutical and bio industry on the 5th, Celltrion released the results of the global phase 2 clinical trial of’Reekyronaju’ (ingredient name legdanvimab code name CT-P59) at the 2021 High1 New Drug Development Symposium hosted by the Korean Pharmacy Society on the 13th of this month. I am going to do it.
Earlier, Celltrion applied for conditional approval from the Ministry of Food and Drug Safety after completing phase 2 global clinical trials in Rekirona, but did not disclose detailed clinical data. This is because, as the public’s interest is high, it has agreed not to disclose detailed data until there is a separate directive from the Ministry of Food and Drug Safety.
However, even though the introduction of the domestic COVID-19 treatment was made visible, the clear clinical results were raised, and Celltrion decided to announce the results early with the consent of the Ministry of Food and Drug Safety.
According to Celltrion, when Rekirona is administered to patients with mild and moderate corona19, the rate of development into severe patients is significantly reduced. Celltrion’s position is that Rekkirona has enough elements to be recognized for its excellent efficacy and safety by domestic and foreign experts.
Celltrion is expected to present the results of phase 2 clinical trials of Rekirona at an international conference soon.
Meanwhile, the Phase 2 clinical trial was conducted on a total of 327 mild and moderate corona19 patients in Korea, Romania, Spain and the United States. On November 25, last year, the final medication was completed, and on December 29, it applied for conditional permission from the Food and Drug Administration.
Apart from the conditional approval, Celltrion is also planning to conduct phase 3 clinical trials of COVID-19 antibody treatments in more than 10 countries around the world.
Reporter Lee Mi-kyung, Hankyung.com [email protected]
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