Chong Kun Dang (CEO Kim Young-joo) announced on the 8th that it has applied to the Ministry of Food and Drug Safety for conditional approval and phase 3 clinical approval of’Napabeltan (ingredient name Napamostat)’ as a treatment for COVID-19 for severely high-risk patients.
Chong Kun Dang said that it conducted phase 2 clinical trials on 104 severely ill patients with Corona 19 in Russia last year, preventing worsening of symptoms in severely high-risk patients, and significantly improving the treatment period and treatment rate.
In particular, it is expected that treatment mechanisms will be applied to the mutations of viruses found abroad, so that it can actively respond to the spread of various mutant viruses.
In addition, he stressed that four cases of death due to worsening symptoms of Corona 19 occurred in the standard treatment group, but did not occur in the Napabeltan-treated group, confirming the possibility of Napabeltan as a drug that prevents the death of high-risk patients.
Based on the results of phase 2 clinical trials, the company said that it is in consultation with a number of countries such as the UK, France, Japan, and Russia to supply Napa Beltan. 19 It is said that it is to enable rapid export of therapeutic agents.
An official from Chong Kun Dang said, “Napabeltan is the only drug that has reliably proved its therapeutic effect in the absence of a cure for COVID-19 for severely high-risk patients.” It will greatly contribute to the prevention.”
Meanwhile, Chong Kun Dang announced that it has also submitted a large-scale phase 3 clinical trial plan along with the application for conditional approval from Napa Beltan. The third phase of the clinical trial targets about 600 severely high-risk patients, and is conducted at more than 10 institutions including Seoul National University Hospital in Korea, and plans to promote global clinical trials for rapid recruitment of clinical patients.
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