[서울=뉴스핌] Reporter Park Da-young = Celltrion is planning to apply for conditional approval of’CT-P59′, an antibody treatment for novel coronavirus infection (Corona 19), to the Ministry of Food and Drug Safety this week. When Celltrion applies for a permit, the Ministry of Food and Drug Safety is expected to give approval around the beginning of February next year unless there is any abnormality after review. It can be used immediately in the medical field after obtaining approval from the Ministry of Food and Drug Safety.
According to industry sources on the 28th, Celltrion plans to apply for CT-P59 conditional permission from the Ministry of Food and Drug Safety within the region. Conditional authorization is a system that grants marketing authorization as a result of phase 2 clinical trials under the condition of conducting phase 3 clinical trials for diseases without treatment.
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| [인천=뉴스핌] Reporter Jeong Il-gu = On the afternoon of the 22nd, the Celltrion novel coronavirus infection (Corona 19) antibody treatment’CT-P59′, which is undergoing clinical trials at Celltrion Plant 2, Yeonsu-gu, Incheon, is being released. 2020.12.22 [email protected] |
Celltrion Group Chairman Seo Jeong-jin said he plans to apply for conditional approval of CT-P59 for phase 2 clinical trials within this year. Earlier, Celltrion completed the medication for 327 patients with mild or moderate corona19 in global clinical phase 2 on the 25th. In phase 1 clinical trials, CT-P59 was confirmed to have safety and rapid virus reduction effects in mild patients with Corona 19. The company plans to submit data on phase 2 clinical trials to the Ministry of Food and Drug Safety within this week.
An official from Celltrion said, “We are going to apply for approval from the Food and Drug Administration this week.”
Celltrion CT-P59 can be prescribed to corona19 confirmed patients in medical settings if the Ministry of Food and Drug Safety obtains conditional approval for phase 2 clinical trials. Celltrion has finished producing CT-P59 for 100,000 people in preparation for conditional approval.
When Celltrion completes the application for a permit this week, it will be reviewed by the Ministry of Food and Drug Safety, and whether to approve the permit will be decided in early and mid-February. The Ministry of Food and Drug Safety has decided to drastically shorten the evaluation period for product approval for Corona 19 vaccines and treatments from 180 days to within 40 days.
An official from the Ministry of Food and Drug Safety said, “We have been conducting a preliminary review on the treatment for Celltrion. The goal is to decide whether to approve the use after completing the review in the beginning of mid-February. As there are many changes, the approval timing may be different. It is expected,” he said.