Celltrion, 2021 High1 Drug Development Symposium
Announced Phase 2 Global Clinical Clinical Trial for Antibody Therapy’Rekirona’
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Celltrion (068270)The results of phase 2 clinical trials of the novel coronavirus infection (Corona 19) antibody treatment under development will be released on the 13th of this month.
According to the industry and Celltrion on the 5th, Celltrion plans to announce the results of the global clinical phase 2 of the antibody treatment’Rekironaju’ at the 2021 High1 New Drug Development Symposium hosted by the Korean Pharmacy Society on the 13th of this month.
Rekironaju is an intravenous antibody treatment made by selecting neutralizing antibodies in the blood of patients cured of Corona 19. Currently, Celltrion has completed phase 2 of the global clinical trial in Rekirona and has applied for conditional approval to the Korean Ministry of Food and Drug Safety. Phase 2 clinical trials were conducted on a total of 327 mild and moderate corona19 patients in Korea and Romania, and medication was completed on November 25 of last year. Initially, the Ministry of Food and Drug Safety and Celltrion were discussing the timing of the release of detailed data after the phase 2 clinical trial was over. In addition, Celltrion plans to present the results of phase 2 clinical trials of Rekirona at an international conference in the future.
Meanwhile, Celltrion applied for conditional permission from the Ministry of Food and Drug Safety on December 29 of last year. If the conditional permit is finally approved, Songdo, Incheon is already producing initial quantities so that it can be used directly on site.
Apart from the conditional approval, Celltrion is also planning to enter phase 3 clinical trials for COVID-19 antibody treatments in more than 10 countries around the world.
/ Reporter Jihye Seo [email protected]
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