The Ministry of Food and Drug Safety announced on the 29th that an application for product permission was received for Celltrion’s Corona 19 treatment, Rekironaju 960mg (regdanvimab codename CT-P59).
Rekirona, which was applied for permission this time, is a genetically modified neutralizing antibody treatment under development by Celltrion as a new drug, and its main ingredient is a Corona 19 neutralizing antibody given the international generic name Regdanvimab. Corona 19 neutralizing antibodies are antibodies that can neutralize (neutralize) the Corona 19 virus.
This can be produced through a cell culture process by selecting the neutralizing antibody gene present in the blood of a cure for Corona 19 and inserting (recombining) the selected and collected gene into a host cell capable of mass production.
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.
Completion of Phase 2 clinical trials for patients with COVID-19 from mild to moderate
Becluriju (Remdesivir), which was previously approved as a therapeutic agent, inhibits the replication of the infected Corona 19 virus in cells, while Rekirona strain (Regdanvimab) is a receptor on the surface of the Corona 19 virus. Binding Domain) instead binds to the antibody therapy to prevent the virus from penetrating into the cell.
The Ministry of Food and Drug Safety said, “The expected target patients of Rekirona are mild to moderate corona19 patients. 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. “I explained.
“The reason that the phase 2 clinical trial was drastically shortened to 10 months was because the Ministry of Food and Drug Safety had in close consultation with the manufacturer from the beginning of development in February to application for permission.” “Phase 2 clinical trial was designed to confirm exploratory meaning and therapeutic effect together. We also provided recommendations for expanding target patients and providing expert advice.”
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.
The Ministry of Food and Drug Safety said, “After a preliminary review by the high-tech product license officer for the data submitted in the future, experts in each field of the pre-configured Corona 19 vaccine/treatment approval review team will review the data necessary for approval such as non-clinical, clinical, and quality He said, “After that, we will synthesize the review opinions to determine the validity of the approval, and we plan to finalize the approval after consulting the Central Pharmacy Review Committee composed of external experts.”
He added, “We will thoroughly verify the safety and effectiveness by using experts in each field and external experts of the Corona 19 vaccine/treatment license examination team so that safe and effective COVID-19 treatment can be used by the public.”
What is the permit/examination process? Overall review including non-clinical, manufacturing and risk management
Permit/examination data include non-clinical trials, clinical trials, quality, risk management plans, and manufacturing/quality control 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 on the manufacturing process control, standards and test methods for quality control of the drug, and the risk management plan (RMP) is a comprehensive safety management that includes risk mitigation measures such as instructions for use for patients and measures to ensure safe use. It is data about the plan.
The data on the evaluation of the implementation status of manufacturing and quality management standards (GMP) are 10 types of data, including facility and environment management, and quality assurance system related to the item for which permission is applied.
The Ministry of Food and Drug Safety said, “We plan to confirm treatment effects such as improving patient symptoms such as fever and coughing, and reducing the period for the virus to transition from positive to negative, and to focus on the aspects of securing safety and quality.” “We plan to check compliance with regulations for overall clinical trials, such as the reliability of the results, and conduct a factory condition survey including the preliminary review results.”
In addition, it plans to request external advice from the COVID-19 treatment expert council composed of specialists such as toxicologists and infectious medicine specialists regarding the validity of the submitted data and acceptance in the clinical field, and finally receive advice from the Central Pharmacy Review Committee.
The Ministry of Food and Drug Safety is a policy that, if safety and effectiveness are sufficiently confirmed as a result of the approval review and expert consultation for the applied product, it is subject to permission to submit the results of the ongoing phase 3 clinical trial after approval. In particular, unlike the existing treatment period of more than 180 days, it is expected to be processed within 40 days for rapid approval and review as it is a Corona 19 vaccine and treatment.
Meanwhile, in Korea, a total of 15 products (13 ingredients) are undergoing clinical trials, including Rekironaju and antibody treatments being developed as a treatment for Corona 19. In addition to Korea, Rekirona has been approved for phase 2/3 clinical trials from the United States and Europe, and plans to advance overseas through consultations on the availability of emergency use approval (USA) and conditional approval (Europe) from next year.
In the case of foreign countries, the antibody therapy products of Lily and Regeneron are undergoing phase 3 clinical trials, and they were approved for emergency use in the United States.