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S. Korea starts review of Celltrion's COVID-19 treatment

All News 15:53 December 29, 2020

SEOUL, Dec. 29 (Yonhap) -- South Korea's drug safety agency said Tuesday that it has launched a review on Celltrion Inc.'s coronavirus treatment in a move that could potentially lead to manufacturing and sales of the drug.

The move came just hours after the South Korean pharmaceutical giant filed for conditional approval of CT-P59, an anti-COVID-19 monoclonal antibody treatment, with the Ministry of Food and Drug Safety.

Celltrion has completed a phase two clinical trial of the antibody treatment.

This photo provided by South Korean pharmaceutical company Celltrion Inc. shows its coronavirus antibody treatment substance. (PHOTO NOT FOR SALE) (Yonhap)

Celltrion has said that CT-P59 shortened the recovery time of patients with no reported side effects. The company also said that the drug kills the coronavirus within 4-5 days, effectively protecting patients with mild symptoms from developing into a severe case.

The ministry said it plans to approve CT-P59 on the condition that Celltrion submit results of an ongoing phase three clinical trial after approval once the safety and efficacy of the treatment are fully demonstrated.

The ministry said it plans to wrap up the process within 40 days.


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