Celltrion developed COVID-19 antibody treatment, released on December 22 last year. yunhap news
The results of a phase 2 clinical trial of Celltrion’s novel coronavirus infection (Corona 19) antibody treatment,’Recyronazu’ (ingredient name regdanvimab code name CT-P59) will be disclosed for the first time.
According to the pharmaceutical and bio industry on the 5th, Celltrion will participate in the 2021 High1 New Drug Development Symposium hosted by the Korean Pharmaceutical Association on the 13th of this month and announce the results of the global phase 2 clinical trial of Rekkirona.
Prior to this, Celltrion applied for conditional approval to the Korean Ministry of Food and Drug Safety after completing Phase 2 of the global clinical trial of Rekirona, but did not disclose detailed clinical data.
This is because, at the request of the Ministry of Food and Drug Safety, taking into account the public’s focus on COVID-19 treatment, it has agreed to disclose detailed data until further instructions.
However, even though the introduction of the domestic Corona 19 treatment was made visible, it was decided to announce it early as concerns spread that the clear clinical results were in the dark.
The Pharmaceutical Society for the Healthy Society (Summary) has pointed out that “the government should transparently disclose and evaluate the clinical trial results of Celltrion treatment.”
Celltrion emphasized that Rekironaju has enough elements to be recognized for its excellent efficacy and safety as a COVID-19 treatment by domestic and foreign experts.
An official from Celltrion said, “Rekironaju is expected to prove the initial treatment effect that the company has been talking about by remarkably reducing the rate of development of severe patients when administered to mild and moderate corona19 patients.”
Celltrion plans to announce 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 enter phase 3 clinical trials for COVID-19 antibody treatments in more than 10 countries around the world.
Reporter Lee Ji-young [email protected]