SEOUL -- South Korea's drug safety watchdog began evaluating the safety and efficacy of Celltrion's antibody treatment code-named CT-P59, which has been developed as an intravenous injection for patients with mild and moderate symptoms. It would be South Korea's first treatment for COVID-19.
The Ministry of Food and Drug Safety said it would complete the screening of CT-P59 within 40 days. Celltrion has said that CT-P59 shortened the recovery time of patients with no reported side effects, while it eradicated the virus in up to five days, effectively protecting patients with mild symptoms from developing into a severe case.
Celltrion said it has submitted a formal application for CT-P59's conditional marketing authorization (CMA). For second-stage clinical trials, 327 patients with mild-to-moderate symptoms have been enrolled. The company would initiate Phase III clinical trials in more than 10 countries to obtain more comprehensive safety and efficacy results.
"We remain committed to closely working with the regulatory agencies worldwide including the U.S. FDA and the European Medicines Agency (EMA) to ensure that patients around the world have access to safe and effective treatment against COVID-19 as early as possible," Celltrion's medical and marketing division head Kim Ho-ung said in a statement on December 29.
CT-P59 has been developed through a process of extracting a neutralizing gene and recombining it into host cells that can be mass-produced. The high price of antibody drugs has been cited as a disadvantage. Although Celltrion has yet to disclose its price, it has repeatedly promised to supply it at the 'cost' level in South Korea.
Celltrion, a bio firm involved in a state project to find the treatment of COVID-19 patients, has already finished producing CT-P59 that can be used by 100,000 patients. As CT-P59 has the advantage of forming antibodies immediately after administration, medical personnel and other vulnerable people will be able to prevent infections.
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