Chong Kun Dang has applied for conditional permission from the Ministry of Food and Drug Safety for the COVID-19 treatment’Napabeltan (ingredient name Napamostat mesylate)’, which is being developed by Chong Kun Dang. It is expected to be used in the field next month, as the deadline for approval by the Ministry of Food and Drug Safety for Corona 19 treatment is up to 40 days.
The Ministry of Food and Drug Safety announced on the 8th that it has entered into a review of approval for a change to add the efficacy of COVID-19 treatment to Napabeltan, a treatment for pancreatitis.
It is the second time that the Ministry of Food and Drug Safety entered into the approval review for a treatment for Corona 19 developed in Korea, following Celltrion’s antibody treatment’Recyrona’ (ingredient name Legdanvimab). If Rekirona is intended for mild, high-risk or moderately ill patients, Napaveltan is primarily targeted for the severely high-risk group.
Chong Kun Dang completed a phase 2 clinical trial of Napa Veltan in Russia last year on 104 patients in severely high-risk corona19 patients. Clinical findings Among high-risk patients receiving napabeltan, 61.1% improved their symptoms within 10 days of receiving treatment.
Only 11.1% of patients who received standard treatment during the same period improved their symptoms. After 28 days of treatment, the symptom improvement rate of the napabeltan-treated group was 94.4%, which was higher than that of the standard treatment group (61.1%) during the same period. The period to reach recovery (average 10 days) was also faster than the standard treatment group (14 days). There were also 4 deaths in the standard treatment group, but not in the Napabeltan-treated group.
Chong Kun Dang is planning to conduct a phase 3 clinical trial on 600 patients with severe high-risk groups at more than 10 domestic institutions, including Seoul National University Hospital. An official from Chong Kun Dang said, “Nappabeltan is also effective against the mutant virus, which is currently popular,” and “We are also discussing ways to export to various countries such as Britain, France and Japan.
Reporter Oh Sang-heon [email protected]
Ⓒ Hankyung.com prohibits unauthorized reproduction and redistribution