Celltrion requests approval this week for corona treatment … Tomorrow as soon as possible

Celltrion is expected to apply for conditional approval of the COVID-19 antibody treatment, which is being developed tomorrow, as soon as possible. If approved, it will be marketed among the COVID-19 treatments developed in the country.

According to industry sources on the 28th, Celltrion plans to apply for a conditional permit for treatment with COVID-19 ‘CT-P59’ antibodies this week. Celltrion will submit safety and efficacy data based on the results of phase 2 clinical trials.

Conditional approval is a system that allows drugs that can be expected to treat serious diseases on the condition that the necessary data for approval, such as phase 3 clinical trials, are submitted post-marketing.

Celltrion has analyzed the safety and efficacy data after completing the medication of 327 corona19 patients in Global Phase 2 on the 25th of last month.

Celltrion started production of CT-P59, which can be treated by 100,000 Corona19 household patients at its Songdo production facility, starting in September, so if conditional approval from the Ministry of Food and Drug Safety is approved, can be used immediately for therapeutic purposes. Currently, initial production has been completed.

Celltrion will also begin phase 3 global clinical trials soon. Phase 3 clinical trials will be conducted in more than 10 countries around the world, and the efficacy and safety of CT-P59 identified in phase 2 will be further verified at background across a broader range of patients. Celltrion will also accelerate the approval process for the final product CT-P59 through a clinical process that conforms to regulations for the approval of new drugs by regulatory agencies around the world.

Celltrion plans to produce treatments for up to 1.5 million to 2 million people per year for mass supply in the future, and is carefully reviewing the detailed plans for next year’s annual production to ensure there are no disruptions in inventory status. of existing products and global supply.

A Celltrion official said: “For the successful global clinical trial of a domestic antibody treatment that may contribute to the end of the Corona 19 crisis, which continues to spread into the 3rd and 4th epidemics, Celltrion executives and employees are conducting day and night clinical trials around the world. ” .