The Ministry of Food and Drug Safety decided to grant permission on the condition that Celltrion submits the results of third-stage clinical trials. It is the world's third COVID-19 antibody treatment that has been verified by regulators. CT-P59 takes the form of an intravenous injection that is directly injected into the vein for 90 minutes.
However, administration is limited to patients with mild or moderate symptoms in a high-risk group of people who are over 60 or have at least one of cardiovascular disease, chronic respiratory disease, diabetes or high blood pressure. The company has already finished producing CT-P59 that can be used by 100,000 patients.
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. The company would seek CT-P59's Emergency Use Authorization in the United States and Europe.
CT-P59 (regdanvimab) 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.
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