Celltrion plans to apply for a conditional permission this week for the treatment of COVID-19 antibodies under development.
According to Celltrion on Dec. 29, the company plans to apply for a conditional permission for the antibody treatment "CT-P59" to the Ministry of Food and Drug Safety within this week.
Celltrion Group Chairman Seo Jung-jin said earlier that he plans to apply for conditional approval by the end of this year on the condition that the third phase is implemented based on the results of the second phase of clinical trials.
Celltrion has been analyzing its safety and validity data since it completed taking medication for 327 patients with COVID-19 at the global 2nd phase on Nov. 25.
Celltrion has started production of CT-P59 at Songdo production facilities since September, where about 100,000 patients with COID-19 in Korea can be treated. Medical sites can be used immediately if conditional approval is obtained. It completed production of initial supplies.
It is also planning to launch global three phase soon. It will be carried out in more than 10 countries around the world.
"We will apply for approval to the Ministry of Food and Drug Safety this week," a Celltrion official said. "We are conducting clinical trials day and night around the world to contribute to the end of the COVID-19 crisis, which is spreading rapidly."
The Ministry of Food and Drug Safety plans to reduce the processing period (180 days or more) of the licensing review to within 40 days while operating the COVID-19 vaccine and treatment licensing review team. Accordingly, it could be approved as early as February next year.
