SEOUL, Dec. 29 (Yonhap) – The Ministry of Food Safety and Medicines announced on Tuesday that it has launched a review of the treatment of the novel coronavirus (Covid-19) from Celltrion Inc. in an initiative that could potentially lead to the manufacturing and sale of the drug.
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The move came just hours after the South Korean pharmaceutical giant requested conditional approval of CT-P59, an anti-Covid-19 monoclonal antibody treatment, from the ministry.
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Celltrion has completed a Phase 2 clinical trial of antibody therapy.
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Celltrion said CT-P59 shortened recovery time for patients with no reported side effects. The company also said the drug kills the coronavirus within four to five days, effectively protecting patients with mild symptoms so they don’t develop severe cases.
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The department said it plans to approve CT-P59 on the condition that Celltrion submit the results of an ongoing Phase 3 clinical trial after approval once the safety and efficacy of the treatment are fully demonstrated. .
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The ministry said it plans to complete the process within 40 days.
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