The Ministry of Food and Drug Safety (Director Kang-rip Kim) announced that Celltrion Co., Ltd.’s COVID-19 treatment’Recyronaju 960mg (Regdanbimab) (code name: CT-P59)’ has initiated a permit review as an application for product approval was received on the 29th.
‘Rekironaju’, which was applied for permission this time, is a genetically modified neutralizing antibody treatment that is being developed as a new drug by Celltrion.
The main component of’Rekirona’ is a COVID-19 neutralizing antibody that has been given the international generic name (Regdanvimab).
Neutralizing antibody genes present in the blood of a cure for Corona 19 are selected, and the selected and collected genes are inserted (recombined) into host cells capable of mass production, and mass-produced through the cell culture process.
Therefore, 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.
‘Becluriju’ (Remdesivir), which was previously approved as a therapeutic agent, inhibits the replication of the infected Corona 19 virus in cells, while’Rekyronazu (Regdanvimab)’ is a human cell on the surface of the Corona 19 virus. Antibody therapy is instead bound to the binding site (receptor binding domain) to prevent the virus from penetrating into the cell.
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| ▲ Celltrion’s new coronavirus infectious disease (Corona 19) antibody treatment’Rekirona’ applied for permission. | ||
The expected target patients for’Rekironaju’ are mild to moderate corona19 patients, and the expected use and formulation is an injection administered intravenously for 90 minutes, and the expected efficacy and effect is the treatment of mild to moderate corona19 patients.
The Ministry of Food and Drug Safety has completed the phase 2 clinical trial period to 10 months through close consultation with the manufacturer from the beginning of development to application for permission in February of this year.
In clinical trials, recommendations for expanding target patients and expert advice were supported so that the design of a phase 2 clinical trial that can confirm exploratory meaning and therapeutic effect can be achieved.
Celltrion Co., Ltd. is applying for approval after completing phase 2 of the multinational clinical trials approved by the Ministry of Food and Drug Safety at the same time, and phase 3 will proceed as planned regardless of this application.
Phase 2 aims to shorten the recovery period for 7 corona19 symptoms such as fever in 327 mild to moderate Corona19 patients, and to shorten the time it takes to transition from positive to negative during virus testing.
Phase 3 is planning to check whether the rate of worsening symptoms such as needing oxygen therapy or hospitalized for 720 mild to moderate Corona 19 patients decreases.
This approval/examination was initiated when Celltrion, a manufacturer, submitted the approval application and related data to the Ministry of Food and Drug Safety’s’Drug Safety Country’ (e-civil petition window, nedrug.mfds.go.kr), as in general drug approval procedures.
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| ▲ The process of action of’Rekkironaju (Regdanbimab)’. | ||
After the submitted data is preliminary reviewed by the high-tech product licensing officer, experts in each field of the’Corona 19 Vaccine/Therapeutic Product Permit Deliberation Team’ organized in advance will review the data necessary for approval such as non-clinical, clinical, and quality.
After that, the review opinions are combined to determine the validity of the permit, and the final approval is given through consultation with the Central Pharmacy Review Committee composed of external experts.
The main data reviewed by Celltrion Inc.’s application for product permission are non-clinical trials, clinical trials, quality, risk management plans, and manufacturing and quality management data.
Non-clinical test data are data that verify toxicity and effectiveness through animal tests before drug administration to humans, and clinical test data are data confirming the safety and effectiveness when administered to humans.
Quality data are data related to the manufacturing process control of the drug and’standards and test methods’ for quality control, and the risk management plan (RMP) includes comprehensive risk mitigation measures such as instructions for use for patients and measures to ensure safe use. This is data on the safety management plan.
Manufacturing·Quality Management Standards (GMP) implementation status evaluation data are 10 kinds of data, including facility·environmental management and quality assurance system related to the item for which the license is applied.
The Ministry of Food and Drug Safety is planning to thoroughly verify the safety and effectiveness by using experts in each field and external experts of the’Corona 19 Vaccine and Treatment License Examination Team’ so that safe and effective COVID-19 treatment can be used by the public.
First of all, it plans to check the treatment effects such as improving the patient’s symptoms such as fever and coughing, and reducing the period for the virus to transition from positive to negative, and focus on the aspects of securing safety and quality.
In addition, we plan to directly check with the clinical trial agency (medical institution) whether or not to comply with the regulations for overall clinical trials, such as the safety of clinical trial subjects and the reliability of test results.
In addition, for this product, the GMP evaluation data were reviewed in advance before the application for product permission, and the factory status survey including the results of the preliminary review will be conducted.
In order to secure the professionalism and objectivity of the evaluation results, we plan to provide external expert advice.
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 consisting of specialists such as toxicologists and infectious medicine specialists, and finally receive advice from the Central Pharmacy Review Committee. .
The Ministry of Food and Drug Safety plans to grant approval on condition that the results of the currently ongoing phase 3 clinical trial are submitted after approval if the safety and effectiveness are sufficiently confirmed as a result of the approval review and expert consultation for the applied product.
The Ministry of Food and Drug Safety aims to shorten the existing processing period (180 days or more) and process it within 40 days for the rapid approval and review of the Corona 19 vaccine and treatment, including the product for this approval.
According to the company’s request, a preliminary review was conducted for some non-clinical, quality and GMP data (11.20~), and the non-clinical data had already been reviewed, and data supplementation was requested for quality and GMP data.
On the other hand, looking at the development status of COVID-19 treatment at home and abroad, in the case of foreign countries, the antibody treatments of Lily and Regeneron are undergoing phase 3 clinical trials, and they were approved for emergency use in the United States.
In addition, existing medicines such as’varicitinib’ (arthritis treatment) are also undergoing clinical trials to add the efficacy and effect of the treatment of Corona 19.
In Korea, clinical trials are ongoing for a total of 15 products (13 ingredients), including’Rekironaju’ and antibody treatments being developed as a treatment for Corona 19.
Currently, Celltrion Co., Ltd. has been approved for Phase 2/3 of clinical trials from the United States and Europe for’Rekirona’. Planning.
This product is the third product that has applied for approval to the licensing authorities after Lily and Regeneron among the COVID-19 antibody treatments that are competing for development worldwide.
An official from the Ministry of Food and Drug Safety said, “If there is an application for permission for a COVID-19 treatment or vaccine that will be developed in the future, we will thoroughly verify the safety and effectiveness and will do our best to allow approval as quickly as possible.”