Domestic 2 Corona Treatment, Will Coming Next Month… Chong Kun Dang, applied for permission from the Ministry of Food and Drug Safety

Input 2021.03.08 11:04

Severe treatment’Napabeltan’… “Proof of treatment effect in clinical trials”
Ministry of Food and Drug Safety to decide whether to permit approval in the middle of next month

Chong Kun Dang (185750)On the 8th, it announced that it has applied for conditional approval of the candidate drug’Napabeltan’ (ingredient name’Napamostat’) to the Ministry of Food and Drug Safety.

The Ministry of Food and Drug Safety decides whether to approve the use of the drug after reviewing it within 40 days from the date of application. In the middle of next month, if permission is granted, Celltrion (068270)Korea’s No. 2 therapeutic agent will be born.

Chong Kun Dang said, “Since August of last year, the result of conducting phase 2 clinical trials of Napabeltan on 104 severely ill patients with Corona 19 in Russia proved that it prevents worsening of symptoms in severely ill patients and significantly reduces the treatment period.” It also has a therapeutic effect,” he explained.

According to Chong Kun Dang, 61.1% of the napabeltan-treated group recovered immediately after administration, showing a significantly higher treatment effect than the control (standard treatment group) 11.1%. After 28 days of the total clinical period, there was a difference in treatment effect between 94.4% of the administration group and 61.1% of the control group. The death cases of severely ill patients also differed between 0 in the administration group and 4 in the control group.

Napabeltan is a drug that is being developed as a severe treatment for Corona 19 by recreating the existing pancreatitis treatment. Instead of Korea, where the number of severely ill patients is small, clinical trials have been conducted in Russia. Recently, a Russian clinical trial company received such results and applied for permission to the Ministry of Food and Drug Safety on the same day. Health authorities such as the UK, France, and Japan are also discussing the export of Napa Beltan.

Conditional approval is a system in which the Ministry of Food and Drug Safety first permits the use of drugs only with the results of phase 2, subject to the completion of phase 3 clinical trials, considering the urgent need of infectious diseases such as Corona 19. Celltrion’s Rekirona state is also currently being used in medical institutions nationwide for this procedure. Chong Kun Dang also submitted a phase 3 clinical plan for 600 severely ill patients to the Ministry of Food and Drug Safety.