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▲ Celltrion Corona 19 treatment, Rekironaju. yunhap news |
[에너지경제신문 이나경 기자] Celltrion has been unable to laugh even after approval of a new coronavirus infection (Corona 19) treatment for the first time in Korea. This is because the Ministry of Food and Drug Safety’s Central Pharmacist Review Committee (hereinafter referred to as the Central Pharmacopoeia) has been recognized for only half of the safety and efficacy of Celltrion’s Corona 19 antibody treatment’Rekironaju’, and recommended that it be used only for some patients. Accordingly, Chong Kun Dang, Daewoong Pharmaceutical, Green Cross, and other latecomers of Corona 19 treatment are drawing attention to which patients they will apply for permission.
◇ Central Pharmacopoeia, Celltrion treatment group restricted… Experts “Natural Results”
According to the industry on the 31st, the Central Pharmacopoeia announced on the 27th that it could approve the product subject to the submission of the results of the phase 3 clinical trial for Rekkirona. On that day, the Central Pharmacopoeia recommended limiting the group of patients to be administered, saying that it is difficult to conclude the clinical significance of Rekkirona for mild patients, unlike the previous verification advisory group. The specific recommended ranges are high-risk, mild and moderately ill patients, and among mild patients, the elderly or those with underlying diseases who are at high risk of developing severe can be used at the discretion of the medical staff. Previously, the verification advisory group said that Rekyronaju is effective in preventing worsening of symptoms in mild and moderately ill patients with Corona 19, but the Central Pharmacopoeia is difficult to interpret that this effect is effective only with the results of phase 2 clinical trials.
Experts also pointed out that it is appropriate to brake the central commitment to Rekkirona. Kim Shin-woo, a professor of infectious medicine at Kyungpook National University Hospital, said, “Since patients with mild symptoms who do not enter the risk group are generally able to recover without the need for a treatment, the judgment is a natural result.” “If there is a research result, it is expected that the area of use will be wider.”
Kim Woo-ju, a professor of infectious medicine at Korea Daeguro Hospital, said, “Celltrion antibody treatment can be administered to moderately ill patients, even if they are not old or have no underlying disease. I am concerned that the range is too comprehensive.” The biggest problem is that the wife does not disclose relevant clinical data and the list of advisory and review committees.”
Currently, Rekirona state only leaves the results of the final examination committee’s review, which is the final gateway to permitting. The approval is expected to be completed in early February after passing the final inspection committee. Celltrion has prepared 100,000 people’s worth at its production facility in Songdo, Incheon since September last year so that the drug can be marketed immediately after approval, and is preparing for emergency use approval in the US and Europe.
◇ After Celltrion… ‘Daewoong-Green Cross-Chong Kun Dang’ 3rd wave match expected
GC Green Cross, Daewoong Pharmaceutical, and Chong Kun Dang are among the latecomers imminent to develop treatments after Celltrion. All of these companies are currently completing phase 2 clinical trials and analyzing the results. GC Green Cross is currently drawing results after completing phase 2 clinical trials for the blood system drug’GC5131A’, which can be administered to severely ill patients. It plans to apply for conditional permits as soon as the results come out. As clinical trials have been conducted for severely ill patients, there is a high possibility that conditional approval is also severe.
Daewoong Pharmaceutical is developing’Hoystar tablet’, which is used as a treatment for chronic pancreatitis and reflux esophagitis after gastric resection, as a treatment for COVID-19 for mild patients. The results of the previous phase 2a are currently being analyzed, and the clinical trial plans for phases 2b and 3 were approved by the Ministry of Food and Drug Safety on the 25th to finally confirm the treatment effect.
Chong Kun Dang is also developing anticoagulant and acute pancreatitis drug’Napabeltan’ as a corona treatment through a drug re-creation method. The main treatment targets are high-risk patients with severe patients. Chong Kun Dang plans to apply for a phase 3 clinical approval application and conditional approval to the Ministry of Food and Drug Safety early next month based on the results of phase 2 clinical trials in Russia.
Meanwhile, in Korea, 15 companies, including Celltrion, have begun developing COVID-19 treatments.
Reporter Lee Na-kyung [email protected]