(Provided by Chong Kun Dang)
It is known that Chong Kun Dang’s plan to seek a treatment for the novel coronavirus infection (Corona 19) has failed. Following Celltrion, which developed the first domestic treatment, the second domestic product, which raised expectations, did not receive permission from the authorities.
This is due to the judgment that Chong Kun Dang’s Napabeltanju (ingredient name Napamostat mesylate) has not been proven effective in the treatment of Corona 19 in the first expert consultation procedure of the Ministry of Food and Drug Safety.
According to the Ministry of Food and Drug Safety on the 17th, it was concluded that Chong Kun Dang’s Napaveltanju could not be approved only with the results of the currently submitted phase 2 clinical trial, so no further expert advice and approval/examination procedures are in progress.
In the case of COVID-19 treatments and vaccines, the Ministry of Food and Drug Safety is undergoing a process of consulting an external expert’triple’ leading to the verification advisory group, the central pharmacist review committee, and the final inspection committee for objective and transparent approval and review.
As the first step, the verification advisory group, came up with an opinion that the validity was not proved, the second step for approval and review, the Central Pharmacy Tribunal, was decided not to be held.
Instead, the Ministry of Food and Drug Safety plans to support the faithful design and implementation of a phase 3 clinical trial plan in Napa Beltan Province. The verification advisory group recommended the submission of additional clinical trial data to confirm the effectiveness of Napaveltan’s COVID-19 treatment.
Chong Kun Dang’s Napabeltanju is a prescription drug used as a treatment for pancreatitis, and after completing a phase 2 clinical trial in Russia, it applied for conditional approval from the Ministry of Food and Drug Safety on the 8th of this month. It applied for permission to change to add COVID-19 treatment to the efficacy and effectiveness of Napa Beltan.
As Chong Kun Dang applied for an item permission, there was high expectation that the second domestic Corona 19 treatment after Celltrion would be released. This is because GC Green Cross, Daewoong Pharmaceutical, and other domestic companies that have completed phase 2 clinical trials of Corona 19 have applied for permission beforehand.
In fact, on the news that the expert consultation process began on that day, the stock price of Chong Kun Dang ended at 195,000 won, up 16.42% from the previous day.
However, it is expected that there will be a lot of disappointment inside and outside the industry as the conditional permits are canceled immediately at the judgment of the verification advisory group.
Chong Kun Dang said that although it had not expected the results of the verification advisory group’s meeting at all, it will faithfully conduct a phase 3 clinical trial to prove the effect of COVID-19 treatment.
An official from Chong Kun Dang said, “We will submit data that can confirm the effect of COVID-19 treatment requested by the Ministry of Food and Drug Safety through a clinical phase 3 test.”