Celltrion Corona 19 Antibody Treatment, Phase 2 Clinical Results on the 13th

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(Seoul = Yonhap News) Reporter Jandi Kim = Celltrion[068270]The results of a phase 2 clinical trial of the antibody treatment for the novel coronavirus infection (Corona 19) of’Recyronaju’ (ingredient name regdanvimab code name CT-P59) will be released for the first time on the 13th of this month.

According to the pharmaceutical and bio industry on the 5th, Celltrion decided to participate in the 2021 High1 New Drug Development Symposium hosted by the Korean Pharmacy Society on the 13th of this month to announce the results of the global clinical phase 2 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, detailed data has been agreed to be closed until further instructions.

However, even though the introduction of the domestic COVID-19 treatment was made visible, the clear clinical results were decided to be announced early as concerns spread that there was no doubt.

The Pharmaceutical Society for the Healthy Society (Simple Medicine) has pointed out that “the government should transparently disclose and evaluate the clinical trial results of Celltrion treatment.”

An official from Celltrion explained, “The company and the Ministry of Food and Drug Safety have been in close consultation with the early disclosure of clinical data,” and “Recently, with the approval of the Ministry of Food and Drug Safety, we decided to present at this conference, which is the first to participate.”

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 lowering the rate of development into 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.

Phase 2 clinical trials were 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.

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2021/01/05 06:03 sent

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