Celltrion Inc. has officially asked South Korean health authorities to approve the emergency use of a Covid-19 antibody treatment candidate, which is still undergoing clinical trials.
A formal application for CT-P59's conditional marketing authorization was submitted to South Korea's Ministry of Food and Drug Safety on Tuesday, the biopharmaceutical company said.
The potential Covid-19 drug, if approved, would be available at hospitals for clinical purposes only, Celltrion said.
It remains to be seen how long the ministry's review will take, but local media say it usually takes a month or so in the country.
Celltrion says it will seek similar emergency-use approvals from U.S. and European health authorities in the coming months.
Celltrion, which has completed its phase 2 clinical trial of the potential drug, plans to present the top-line data of its phase 2/3 clinical trials in the first half of 2021.
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