The first novel coronavirus infection (Corona 19) treatment developed by a Korean company achieved successful results in clinical trials. Accordingly, commercialization will be possible as early as this month.
Celltrion announced on the 13th that it had confirmed the effect in the phase 2 clinical trial of the Corona 19 antibody treatment “Recyronaju” (ingredient name regdanvimab CT-P59), which applied for conditional permission from the Ministry of Food and Drug Safety. Professor Um Joong-sik of Gachon University Gil Hospital said in the ‘2021 High1 New Drug Development Symposium’ held this afternoon, “Rekkironaju reduced the incidence of severe patients requiring inpatient treatment by 54% in all patients and 68% in moderately ill patients over 50 years old compared to the placebo group. “The recovery period was shortened by more than 3 days compared to the placebo group,” he explained.
Rekirona is a therapeutic agent developed by recombining with host cells capable of mass production after selecting and collecting the neutralizing antibody gene present in the blood of a cure for Corona 19. Mass production is possible through cell culture without constant supply of antibodies. As for similar treatments,’LY-CoV555′ developed by Lily, an American pharmaceutical company, and’REGN-COV2′ developed by Regeneron, were approved for emergency use by the US Food and Drug Administration (FDA).
Celltrion filed an application for conditional approval of Rekkirona state to the Ministry of Food and Drug Safety on the 29th of last month. In this process, data were submitted for Phase 1 clinical trials and 327 mild to moderate patients administered to 32 healthy people and 18 mild Corona19 patients, respectively.
The Ministry of Food and Drug Safety has shortened the review period to a maximum of 40 days for rapid approval of the Corona 19 treatment. Accordingly, the approval of Rekkirona should be decided by the 7th of next month at the latest, but the government has already pledged to decide whether to approve it in January. If conditional permission is obtained, it will become the first domestic COVID-19 treatment. After submitting the results of phase 3 clinical trials, the formal product approval step will be taken.
It is expected to speed up the overseas emergency use approval process while releasing successful phase 2 clinical data. The company plans to conduct related consultations with the US FDA and the European Medicines Agency (EMA) to allow various countries to use Leckirona.
Celltrion started developing a treatment for Corona 19 in March last year, confirmed its efficacy in an animal efficacy test, entered the first phase of clinical trials in July, and started producing initial quantities in September. The amount secured in advance is 100,000 people, and this year, it is expected to produce 2 million people and supply them both at home and abroad.