The government’s full-fledged approval screening for the antibody treatment for the novel coronavirus infection (Corona 19) developed by Celltrion is underway.
At the COVID-19 briefing of the Central Defense Countermeasure Headquarters on the 29th, the head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, Celltrion applied for an item permission for the COVID-19 treatment “Reekyronaju 960mg (ingredient name Legdanbimab, code name CT-P59)” He said he was going to go into full-scale screening.
‘Rekironaju’ is a genetically modified neutralizing antibody treatment being developed as a new drug by Celltrion.
The main component is a COVID-19 neutralizing antibody, which has been given the international generic name’Regdanvimab’, and selects the neutralizing antibody gene present in the blood of a cure for Corona 19, and uses the selected/collected gene into host cells capable of mass production. It is a biological product produced through the cell culture process by insertion (recombination).
It is possible to mass-produce neutralizing antibodies using genetically recombined cells without the need to continuously collect antibodies from the blood of COVID-19 patients.
Gilead’s’Becluriju (ingredient name remdesivir)’, which was previously licensed as a therapeutic agent, inhibits the replication of the infected Corona 19 virus in cells, while’Rekironazu’ binds human cells on the surface of the Corona 19 virus. Antibody therapy is instead bound to the site, preventing the virus from penetrating into the cell.
The expected target patients for’Rekironaju’ are mild to moderate corona19 patients, and the expected usage is 90 minutes of intravenous administration.
According to Director Kim Sang-bong, the Ministry of Food and Drug Safety significantly shortened the phase 2 clinical trial period to 10 months through close consultation with Celltrion from the beginning of development to application for permission in February.
In order to design a phase 2 clinical trial that can confirm exploratory meaning and therapeutic effect together, the Ministry of Food and Drug Safety has been supporting extended recommendations of target patients and expert advice.
Accordingly, Celltrion completed phase 2 of the multinational phase 2/3 clinical trials approved by the Ministry of Food and Drug Safety and applied for permission. The third phase will proceed as planned regardless of the application for this permit.
“This approval/examination was initiated when Celltrion submitted the application for approval and related data to the Ministry of Food and Drug Safety,” said Director Kim Sang-bong. “The submitted data will be preliminary reviewed by the Office of High-tech Product Licensing Office. After that, experts in each field of the’Corona 19 Vaccine/Treatment Authorization Review Team’ organized in advance will examine the data necessary for approval such as non-clinical, clinical, and quality.”
In addition, he added, “After that, we will synthesize the review opinions to determine the validity of the permit, and to give the final approval after consulting the Central Pharmacy Review Committee composed of external experts.”
Through the submitted data, the COVID-19 vaccine/treatment approval review team checks the treatment effects such as improving the patient’s symptoms such as fever and cough, reducing the period during which the virus transitions from positive to negative, and intensively reviewing aspects of securing safety and quality. do.
In addition, through investigation of the actual condition of the clinical trial, the clinical trial agency (medical institution) will directly check the compliance with the regulations for the overall clinical trial, such as the safety of clinical trial subjects and the reliability of the test results.
A factory condition survey is also conducted. The Ministry of Food and Drug Safety has already conducted a preliminary review of the GMP evaluation data before applying for the item license of’Rekkironaju’. However, the Ministry of Food and Drug Safety said that it plans to conduct a survey on the factory conditions including the results of the preliminary review.
In order to secure the professionalism and objectivity of the evaluation results, consultation is received from external experts. About the validity of the data submitted for the permit review and acceptance in the clinical field, we plan to request external advice from the COVID-19 treatment expert council composed of specialists such as toxicologists and infectious medicine specialists, and finally receive advice from the Central Pharmacy Review Committee. .
“The KFDA plans to proceed with the condition of submitting the results of the current phase 3 clinical trial after approval if only the safety and effectiveness are sufficiently confirmed as a result of the approval review and expert consultation for’Rekironaju’,” said Director Kim Sang-bong. In the case of corona 19 vaccines and treatments, including the applied products, we aim to shorten the existing processing period (180 days or more) for rapid approval and review, and process them within 40 days.”