SEOUL, Jan. 12 (Korea Bizwire) — South Korea’s pharmaceutical giant Celltrion Inc. said Tuesday that its anti-COVID-19 monoclonal antibody treatment has shown higher treatment efficacy compared to its two rival candidates.
The Korean Ministry of Food and Drug Safety is currently reviewing conditional approval of Celltrion’s CT-P59, also known as Regdanvimab, a move that could potentially lead to manufacturing and sales of the first homegrown treatment.
Celltrion said the treatment has shown higher efficacy compared to two COVID-19 treatment candidates developed by U.S. pharmaceutical firms — Eli Lilly and Regeneron Pharmaceuticals.
The U.S. Food and Drug Administration previously issued Emergency Use Authorization (EUA) for novel coronavirus-neutralizing antibody treatment candidates by the two firms.
Celltrion said it will present the top-line data of the global phase-two clinical trial during a forum Wednesday.
The trial study enrolled 327 patients with mild-to-moderate symptoms of COVID-19 to evaluate the efficacy and safety of CT-P59 in combination with the standard of care in patients with the infection.
The company also plans to submit an application for EUA and for Conditional Marketing Authorization to the European Medicines Agency (EMA) for CT-P59 in the coming months.