 ▲ The appearance of Celltrion’s Corona 19 antibody treatment,’Recyronaju’, released to the media on December 22 last year. (Photo = Yonhap News) © Senior Reporter Jeon Young-tae |
[대한뉴스통신/전영태 선임기자] Celltrion’s’Rekironaju’ (ingredient name Legdanvimab CT-P59) was approved as the first COVID-19 treatment in Korea.
The Ministry of Food and Drug Safety held a final inspection committee composed of internal and external experts on the 5th, and conducted a phase 3 clinical trial on the Corona 19 antibody treatment “Recyronazu 960mg (Regdanvimab),” which Celltrion applied for permission on December 29th last year. It said that the approval was decided on condition of submission of test results.
‘Rekironaju’ is a gene-recombinant neutralizing antibody treatment that selects the neutralizing antibody gene present in the blood of a cure for Corona 19 and inserts (recombines) the gene into a host cell capable of mass production and produces it in large quantities through cell culture.
Subjects to be administered are adult patients with mild and moderate symptoms in high-risk COVID-19 patients. The efficacy and effect of THIS DRUG is the improvement of clinical symptoms in high-risk mild to moderate adult patients (18 years of age or older). The dosage and use of THIS DRUG 40 mg per 1 kg of adult body weight is administered intravenously for 90 minutes (±15 minutes).
‘High-risk group’ refers to a group that is over 60 years old or has an underlying disease (cardiovascular disease, chronic respiratory disease, diabetes, or hypertension).
‘Rekironaju’ is the first corona 19 treatment approved as a domestically developed drug, and the third corona 19 antibody treatment approved by regulatory authorities in the world.
With this permission, if’Rekironaju’ is used in a medical field that requires a treatment in the situation of the Corona 19 pandemic, it is expected to play a meaningful role in overcoming Corona 19 and returning to daily life with a vaccine to be used in the future. .