[코로나19] Vaccine treatment, finish within 40 days for stability.

[서울=뉴스프리존]Reporter Park Na-ri = With the number of confirmed cases of coronavirus infectious disease-19 (COVID-19) appearing in Korea every day, there is a high interest in vaccines, and the Ministry of Food and Drug Safety said Celltrion’s Corona 19 antibody treatment “Rekkironaju” It was announced on the 29th that it had begun a permit review for codename CT-P59).

This is due to Celltrion’s application to the Ministry of Food and Drug Safety for an item license of Rekkirona. The Ministry of Food and Drug Safety plans to complete the approval process within 40 days.

‘Rekironaju’ 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 (draft) called Regdanvimab.It selects the neutralizing antibody gene present in the blood of a cure for Corona 19, and selects and collects the gene It is inserted (recombined) into host cells capable of mass production and produced in large quantities through the cell culture process.

The International Non-proprietary Name (INN) is the name of a drug substance determined by the World Health Organization (WHO), and it is a very important step in drug development because almost all countries, including Europe and the United States, use INN for prescription. Corona 19 neutralizing antibody refers to an antibody that can neutralize (neutralize) the Corona 19 virus.

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. The Ministry of Food and Drug Safety explained that by binding the antibody therapeutic agent to the receptor binding domain instead, it prevents the virus from penetrating into the cell.

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 Corona 19 patients.
The Ministry of Food and Drug Safety 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.

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 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 is expected to 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.

The submitted data will be preliminary reviewed by the high-tech product licensing officer, and then 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 synthesized to determine the validity of the approval, and the final approval is given through consultation with the Central Pharmacy Review Committee composed of external experts.

The main data reviewed by Celltrion’s application for product approval 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 about 10 types, including facility·environmental management and quality assurance system related to the item for which the license is applied.

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The Ministry of Food and Drug Safety said, “We will 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.”

It plans to check treatment effects such as improving patient symptoms such as fever and coughing and reducing the period during which the virus transitions from positive to negative, and focus on the aspects of securing safety and quality.
It is a policy to directly check with the clinical trial agency (medical institution) whether to comply with the regulations for the overall clinical trial, such as the safety of clinical trial subjects and the reliability of test results.

In addition, for this product, preliminary review was conducted on GMP evaluation data prior to application for product permission, and the factory status survey including the results of the preliminary review is planned.

In order to secure the professionalism and objectivity of the evaluation results, we plan to provide advice from external experts. About the validity of the data submitted for the permit review and the acceptance in the clinical field, we plan to request external advice from the COVID-19 treatment expert consultative group consisting of toxicologists and infectious physicians, 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 on some non-clinical, quality and GMP data from November 20, and non-clinical data have already been reviewed, and data supplementation has been requested for quality and GMP data.

Meanwhile, the Ministry of Food and Drug Safety explained the current status of the development of COVID-19 treatments at home and abroad.

In the case of foreign countries, the antibody therapy products of Lilly and Regeneron are undergoing phase 3 clinical trials, and they were approved for emergency use in the United States.

In addition, existing drugs such as’baricitinib’ (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.

Celltrion is currently undergoing clinical approval for Phase 2/3 of’Rekirona’ from the US and Europe, and plans to advance overseas through consultation on whether it is possible to obtain emergency use approval (US) or conditional approval (Europe) from next year. Are doing.

This product is the third product that has applied for approval from the licensing authorities after Lily and Regeneron among the COVID-19 antibody treatments that are competing for development worldwide.

The Ministry of Food and Drug Safety said, “If there is an application for approval of a COVID-19 treatment or vaccine that will be developed in the future, we will thoroughly verify the safety and effectiveness and do our best to allow approval as quickly as possible.”

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