[서울=뉴스핌] Reporter Park Da-young = Chong Kun-dang challenged the approval of the second domestic treatment for the new coronavirus infection (Corona 19). On the 8th, the company applied for conditional permission to the Ministry of Food and Drug Safety as a treatment for patients with severe high-risk corona19’Napabeltan’.
Chong Kun Dang’s challenge for the treatment of coronavirus is the second following Celltrion’s’Rekironaju’.
 |
| Chong Kun Dang’Napa Beltan’ [자료=종근당] |
According to the related industry and Chong Kun Dang on the 9th, the conditional approval of the Ministry of Food and Drug Safety is a system that grants marketing authorization as a result of phase 2 clinical trials under the condition of conducting phase 3 clinical trials for diseases without treatment.
Chong Kun Dang’s Napabeltan was previously used as a treatment for pancreatitis. Chong Kun Dang developed a drug re-creation method that adds indications for napabeltan, which was prescribed for the treatment of pancreatitis.
The therapeutic effect against the coronavirus showed meaningful results through phase 2 clinical trials conducted in Russia. It has been confirmed that Napabeltan shortens the duration of corona treatment and shortens the recovery period of symptoms when compared to standard treatment.
The 104 patients who participated in the clinical trial were randomly divided into Napabeltan administration group and standard treatment group and administered for 10 days. As a result, 61.1% of the napabeltan-treated group recovered immediately after administration. The standard treatment group recovered only 11.1%. Compared to the 28 days prior to the clinical phase 2, 94.4% of the napabeltan-treated group and 61.1% of the standard treatment group recovered.
It is also noteworthy that there were no deaths from the Napabeltan medication group. In the standard treatment group, four deaths occurred due to worsening symptoms of Corona 19.
The Ministry of Food and Drug Safety decides whether to grant conditional approval through three-step consultation on corona treatment. These are the verification advisory group, the Central Pharmacy Review Committee (Central Pharmacy Review), and the final inspection committee.
The three stages of reviewing the efficacy and safety of Napa Beltan are expected to take a total of 40 days. Although it took about six months to approve the existing drug, the Ministry of Food and Drug Safety said it would shorten the review period for COVID-19 treatment and vaccine within 40 days.
If licensed, this treatment will become the second domestic treatment, succeeding Celltrion’s Rekirona state in the middle of next month. Earlier, Celltrion’s Rekironaju was granted permission within 38 days after applying for a conditional permit at the end of last year.
Chong Kun Dang is also considering overseas exports, starting with the domestic conditional permit application. It is in discussions with health authorities such as the UK, France and Japan to export Napa Beltan.
In Korea, it plans to proceed with an additional phase 3 clinical trial. Chong Kun Dang submitted a clinical trial plan (IND) while applying for conditional approval. Phase 3 clinical trials are conducted at about 10 domestic hospitals, including Seoul National University Hospital, targeting 600 patients in severely high-risk corona19 patients. It is planning to carry out clinical trials not only in Korea with a small number of patients with severe gastric disorders, but also overseas in order to quickly recruit patients.
An official from Chong Kun Dang said, “Napabeltan is the only drug that has reliably proved its therapeutic effect in the absence of a corona treatment for severely high-risk patients.” I will contribute.”
In addition to Celltrion and Chong Kun Dang, domestic companies developing corona treatment are also accelerating. Analysis says that the sovereignty of COVID-19 treatment is approaching.
In a situation where 300 to 400 people are diagnosed with corona every day, securing a treatment with a certain effect can reduce the burden on medical staff and hospital beds. If the domestically developed therapeutic agent is successfully commercialized, it has the advantage that it can be supplied to the medical field without disruption. For this reason, it has been pointed out in the industry that it is necessary to secure sovereignty over corona treatment and vaccines.
GC Green Cross aims to apply for conditional approval of the blood system drug’GC5131A’ within this month. Daewoong Pharmaceutical’s’Hoy Star Tablet (ingredient name: Camostat mesylate)’ is undergoing phase 2 and 3 clinical trials. Last year, the number of clinical subjects was increased from 80 to 1,000 because statistical significance could not be confirmed in phase 2 clinical trials, and additional clinical trials are in progress.
Bukwang Pharmaceutical, the first Korean company to enter the clinical trial for COVID-19 treatment last year, is analyzing the results after completing phase 2 clinical trials of’Levovir (Clevudin)’. Shinpoong Pharmaceutical recently added three clinical institutions to speed up the phase 2 clinical trial of’Pyramax’. The goal is to complete phase 2 clinical trials by next month.
Meanwhile, Ilyang Pharmaceutical announced that it tried to confirm the corona treatment effect of the leukemia treatment’Supect (ingredient name Radotinib)’ while conducting phase 3 clinical trials in Russia, but the clinical trial failed because it was not able to prove the effect recently.