Celltrion to apply for conditional nod for Covid-19 treatment

Celltrion said it has completed the administration of drugs for its global phase 2 clinical trial of CTP59, a Covid-19 treatment, and plans to apply for its conditional approval after confirming the trial's intermediate results.

The announcement comes after the company received approval from the Ministry of Food and Drug Safety to conduct phase 2 and 3 clinical trials for the treatment on Sep. 17. Since then, the company has been conducting phase 2 clinical trials at Korean medical institutions and in foreign countries, including the U.S., Spain and Romania.

The phase 2 clinical trial evaluated the efficacy and safety of CT-P59 on 327 mild and moderate Covid-19 patients. The company divided the subjects into three groups -- a placebo-treated group, a low-dose group, and a high-dose group.

Celltrion has completed drug administration for phase 2 clinical trial of CT-P59, its Covid-19 treatment candidate. (Celltrion)

Celltrion said it plans to derive phase 2 clinical trials' interim results as soon as possible, consult related agencies, including the Ministry of Food and Drug Safety, and apply for conditional approval for CT-P59.

The company started the production of CT-P59 in September to use the treatment immediately in the medical field if it receives conditional approval.

"We plan to manufacture about 100,000 vials and has already finished the manufacturing of initial dose," the company said.

After completing the phase 2 clinical trial, the company will also conduct global phase 3 clinical trials soon.

Celltrion will conduct phase 3 clinical trials in more than 10 countries and further verify the efficacy and safety of CT-P59 identified in phase 2 on a wider range of patients.

"We will also speed up winning the final approval of CT-P59 through a clinical process that adheres to the regulations for new drug approval by regulatory agencies around the world," the company said. "Celltrion plans to provide treatments for 1.5 to 2 million people worldwide annually."

The company is carefully reviewing detailed plans for next year's annual production to ensure that there is no disruption in the manufacturing of its existing products and global supply, it added.

In a recent interview with the vernacular Hankyoreh newspaper, Celltrion CEO Suh Jung-jin expressed confidence to make Korea a “coronavirus-free country” next May, thanks to the successful development of Covid-19 treatments by then.