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▲ On the 22nd, a researcher is looking at a COVID-19 antibody treatment in a laboratory at Incheon Celltrion Plant 2, which is developing an antibody treatment for a novel coronavirus infection (Corona 19). yunhap news |
[에너지경제신문=이나경 기자] Celltrion is expected to apply for emergency use of CT-P59, a Corona 19 antibody treatment, to the Korea Centers for Disease Control and Prevention this week as early as possible. In the situation where the vaccine supply is slow, interest is drawing on whether the first Korean COVID-19 treatment will be born.
According to industry sources on the 23rd, Celltrion is expected to apply for emergency use approval of CT-P59 to the Korea Centers for Disease Control and Prevention as early as this week based on the results of phase 2 clinical trials. Celltrion Chairman Seo Jeong-jin previously emphasized several times that he would apply for emergency use approval within this year. The emergency use approval system is a system that allows temporary manufacturing, sales, and use of diagnostic reagents requested by the Ministry of Food and Drug Safety in cases where a diagnostic reagent is urgently needed due to fear of an infectious disease pandemic, but there is no licensed product in Korea. Whether or not to approve emergency use is decided by the Ministry of Food and Drug Safety, and the approval is usually decided within 40 days. According to this standard, Celltrion treatment will be commercially available in January of next year.
Medical authorities and governments are also looking forward to Celltrion’s antibody treatment. Prime Minister Jeong Sye-gyun visited Celltrion in Songdo, Incheon on the 22nd, and urged them to find a research team and speed up the development of treatments. Prime Minister Jeong received a report on the development of the COVID-19 treatment from Celltrion Chairman Seo Jeong-jin, and inspected the Corona 19 treatment research center and production facility at Celltrion Plant 2. Prime Minister Jung said, “I sincerely hope that the clinical trial of the treatment will be successfully completed and the timely approval will be given to the people.”
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▲ Prime Minister Jeong Sye-gyun visited Incheon Celltrion Plant 2, which is developing an antibody treatment for a novel coronavirus infection (Corona 19) on the 22nd, and listens to the explanation of the treatment from Celltrion Chairman Seo Jeong-jin. yunhap news |
On this day, Nak-yeon Lee and Democratic Party representative also attended the Supreme Council’s meeting held at the National Assembly, saying, “In a few days, approval for conditional use of domestic drugs will be received by the Ministry of Food and Drug Safety, and the next procedure will proceed”, putting weight on the possibility of developing a treatment.
Celltrion has completed recruiting and administering patients for global phase 2 clinical trials of CT-P59, a corona19 antibody treatment, on the 25th of last month. The 327 participants were classified into a placebo-treated group, a low-dose group, and a high-dose group to confirm efficacy, safety, and appropriate dosage. In particular, with the recent approval of CT-P59 for therapeutic use from the Ministry of Food and Drug Safety, expectations for the first treatment are increasing. Currently, the medication has been completed to 300 patients on site. The therapeutic use is a system approved by the Ministry of Food and Drug Safety so that drugs under clinical trials can be used in emergency patients with life-threatening or no alternative treatment means. In hospitals and medical centers, drugs to be administered to patients are applied for and approved by the Ministry of Food and Drug Safety.
An official from Celltrion said, “It has not yet been decided whether the application for approval for emergency use of the corona treatment will proceed within this week,” and “the plan to complete the application for approval within the year has not changed.”
Meanwhile, according to the Ministry of Food and Drug Safety, there are a total of 11 COVID-19 treatments that are undergoing phase 2 clinical trials in Korea as of this day, and among them, Celltrion’s CT-P59 and Daewoong Pharmaceutical’s DW1248 (Camostat) that have completed phase 2 clinical trials are 2 It’s a species.