China News Service, February 5th. According to Korea Broadcasting International (KBS), the Final Verification Committee of the Korean Food and Drug Safety Agency decided to approve the new coronavirus antibody treatment developed by South Korea’s Celltrion company based on the submission of Phase III clinical trial results. Emergency use authorization application for the drug "CT-P59".
Data map: On December 14, 2020, Seoul, South Korea, medical staff tested citizens for the new coronavirus.
According to reports, on the morning of the 5th local time, the Food and Drug Safety Department held a final verification committee meeting in Osong, Chungbuk to decide whether to approve the use of "CT-P59" and made the above decision.
The final verification committee passed the meeting on the same day, comprehensively tested the review results of the Food and Drug Safety Department and the opinions put forward by the two consultation meetings, agreed with the consultation results of the Central Pharmacist Review Committee, and decided to submit the Phase III clinical trial results as a condition for approval Use "CT-P59".
According to the report, when the final verification committee introduced the reasons for making the above decision, Celltrion had submitted the main materials required for approval of clinical trials and non-clinical trials, quality and hazard management plans, manufacturing and quality management. After in-depth discussions and on-site investigations in various fields related to effectiveness, it was determined that there was no problem in approving the use of "CT-P59".
As a result, the new coronavirus antibody treatment drug "CT-P59" developed by South Korea's Celltrion became the first approved drug for new coronavirus treatment in Korea.