On the 8th, Chong Kun Dang applied for conditional approval and phase 3 clinical approval of’Napa Beltan’ as a treatment for COVID-19 for severely high-risk patients with the Ministry of Food and Drug Safety.
Chong Kun Dang completed a phase 2 clinical trial of Napa Veltan in Russia last year for 104 severely high-risk patients with COVID-19, and applied for conditional approval and a plan for approval of phase 3 clinical trials with the Ministry of Food and Drug Safety.
As a result of the phase 2 clinical trial, 61.1% of patients in the test group administered napabeltan for 10 days reached recovery, showing superior effects compared to 11.1% in the standard treatment group.
After 28 days, the total clinical period, 94.4% of patients treated with napabeltan and 61.1% of the standard treatment group recovered.
Four cases of death due to worsening symptoms of Corona 19 occurred in the standard treatment group, but no Napabeltan treatment group occurred.
Chong Kun Dang plans to conduct phase 3 clinical trials on 600 patients with severe high-risk groups at more than 10 institutions including Seoul National University Hospital in Korea. Global clinical trials are also promoted for rapid patient recruitment.
Chong Kun Dang expects to be able to respond to the spread of various mutant viruses by applying treatment mechanisms to the COVID-19 virus mutation.
This is the second time that the Ministry of Food and Drug Safety has initiated a review of the approval of a domestically developed COVID-19 treatment, following Celltrion’s’Recyronaju’. Rekirona is licensed only for the treatment of mild or moderately ill patients in high-risk groups.
A Chong Kun Dang official said, “Napa Beltan is the only drug that has proven its therapeutic effect in the absence of a COVID-19 treatment for severely high-risk patients.”
Meanwhile, the Ministry of Food and Drug Safety has shortened the approval review period, which took the existing 6 months, to less than 40 days for Corona 19 treatments and vaccines. Ⓒ Safe Times
Copyright holder © Unauthorized reprinting and redistribution of the press is prohibited to create a world where anyone can live with confidence.