Daewoong and Chong Kun Dang fail to obtain conditional approval…Green Cross also lacks global clinical results
Celltrion Rekironaju, Ieul, the No. 2 domestic treatment, no news
[서울=뉴스핌] Reporter Jeong Seung-won = The new coronavirus infectious disease (Corona 19) treatment that is being developed by a domestic pharmaceutical and bio company is seldom producing results.
Candidate drugs, which were developed by Celltrion and used in clinical trials after Rekirona, which have been attracting attention as the second and third treatments, are failing to verify their effectiveness in successive clinical trials.
 |
| [인천=뉴스핌] Joint photo interview group = Corona 19 antibody treatment’Rekironaju’ 2021.02.08 [email protected] |
◆ Daewoong·Chong Kundang’s successive failures have led the Green Cross to’red light’
According to the Ministry of Food and Drug Safety on the 7th, 30 places in Korea have been approved for clinical trials as a treatment for Corona 19 so far.
As the Corona 19 epidemic began last year, pharmaceutical companies rushing into the development of treatments, and a total of 29 clinical trials were approved until December of last year.
However, among these treatments, Celltrion has not been effective in clinical trials except for Rekirona, which was developed by Celltrion.
Daewoong Pharmaceutical has failed to prove its effectiveness in Phase 2a clinical trial of Hoystar Tablet, a chronic pancreatitis treatment that is being developed as a treatment for COVID-19.
In the clinical phase 2a results announced in December last year, it did not meet the main endpoint. As a result of clinical phase 2a, Hoystar tablet showed insufficient confirmation of the effect of directly killing the virus.
Chong Kun Dang also conducted phase 2 clinical trials to develop Napabeltan, a protein enzyme inhibitor, as a treatment for Corona 19, but failed to obtain conditional approval from the Ministry of Food and Drug Safety.
The Ministry of Food and Drug Safety concluded that conditional approval is difficult only with the results of phase 2 clinical trials through a meeting of the verification advisory group for Napaveltanju on the 17th. Chong Kun Dang plans to challenge formal approval through phase 3 clinical trials.
GC Green Cross’s blood system drug GC5131A, which is expected to apply for conditional approval during this month, is also expected to have a difficult road.
In February, GC Green Cross completed a clinical trial to evaluate the dose setting, efficacy, and safety of high-immune globulin GC5131A in patients with pneumonia or high-risk patients due to COVID-19 patients.
However, problems arose ahead of the application for conditional permits. A large-scale global clinical trial was conducted for blood treatment at the Corona 19 Blood Treatment Coalition, a gathering of global blood product companies, but it was concluded that the evaluation index for demonstrating the effectiveness of the blood treatment drug was not satisfied in the announcement of the topline on the 2nd (local time) Came out.
The blood system drug used in this clinical trial was provided by a foreign company other than Green Cross, but was manufactured in the same way as the Green Cross blood device drug.
Green Cross has been conducting clinical trials at home and abroad, hoping for conditional approval of GC5131A.
However, as it failed to derive meaningful results in global clinical trials, it became more urgent to prove its effectiveness in domestic clinical trials.
An official from Green Cross said, “The domestic blood system clinical and conditional license application is separate from overseas clinical trials,” and said, “We plan to apply for a domestic conditional license for blood system medicine during this month as scheduled.”
 |
| [시애틀 로이터=뉴스핌] Reporter Kim Sun-mi = Plasma from a cure for COVID-19 was collected at a medical institution located in Seattle, Washington, USA. 2020.08.14 [email protected] |
◆ Shinpoong Pharm. Bukwang Pharm clinical trial in progress…
Other than Green Cross, Shinpoong Pharmaceutical, Bukwang Pharmaceutical, and Donghwa Pharmaceutical are undergoing clinical trials for the development of COVID-19 treatment.
Shinpoong Pharmaceutical announced at a shareholders’ meeting held earlier this month that it has completed the registration of a patient in the phase 2 clinical trial of Piramax, the COVID-19 treatment it is developing.
Shinpoong Pharmaceutical plans to complete phase 2 clinical trials in July and enter phase 3 clinical trials in August. Shinpoong Pharmaceutical is cautious about the application for conditional permission for Piramax.
The antiviral drug clevudine, which Bukwang Pharm is developing as a treatment for COVID-19, is also undergoing phase 2 clinical trials, and Donghwa Pharm is developing DW2008S as a treatment for asthma.
The industry is watching the progress of the development of treatments that have competed since the Corona 19 epidemic last year.
However, there are also voices of concern about the clinical trial of a domestic COVID-19 treatment that has not produced results since Celltrion.
An official in the pharmaceutical industry said, “After Celltrion’s treatment, there are no treatments that show such results in clinical trials,” he said. “Each pharmaceutical company is trying to package the clinical results of its own treatment well, but I am wondering how effective it will be.” .