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[이코노믹리뷰=황진중 기자] It is expected that Celltrion (068270) will be transferred to the Ministry of Food and Drug Safety for approval of the new Corona 19 antibody drug CT-P59 (ingredient name Regdanvimab), which is being developed by itself. Celltrion plans to apply for CT-P59 conditional permit to the Ministry of Food and Drug Safety by the end of the year. The Ministry of Food and Drug Safety will announce the approval within 40 days upon receiving the application. Earlier, the U.S. Food and Drug Administration (FDA) took 33 and 41 days to authorize the antibody treatments for Eli Lilly and Regeneron, respectively.
Woosung Ki, CEO, “Therapeutics are expected to be released at the promised time”
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Celltrion CEO Ki Woo-sung said at the Korea Bio-Investment Conference on the 28th, “I look forward to releasing the Corona 19 treatment (CT-P59) at the time promised.” Celltrion conducted clinical data analysis for about a month after completing phase 2 patient administration on the 25th of last month.
Conditional permission is a system in which, when there is no treatment for a specific disease, a drug in clinical trials is subject to the conditions for proceeding with the phase 3 and marketing is approved only with the results of phase 2.
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Celltrion emphasizes early diagnosis and early treatment in relation to the spread of Corona 19. It seems that the fact that the initial effect of infection can be maximized due to the nature of antibody therapeutics. CEO Ki Woo-sung said, “The corona 19 virus reaches its maximum detection level within a week after infection.” “CP-P59 is expected to reduce the progression of severe disease by focusing on early treatment for mild patients.” Explained.
CT-P59 appears to also work on the mutant Corona 19 virus, which has recently raised concerns. “Researchers have confirmed that the CT-P59 mutant virus has a neutralizing effect,” said Woo-sung Ki, and stressed, “I am afraid that there is a mutation, but I do not think that there is a need to fear yet.” He added, “There is a variation in the UK, and we are testing it together in collaboration with the US.”
Ministry of Food and Drug Safety to announce approval within 40 days upon application
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The Ministry of Food and Drug Safety is planning to shorten the approval review period, which previously took 180 days or more, to process it within 40 days by forming a dedicated evaluation team for the approval of the COVID-19 vaccine and treatment. For the data submitted by the company, the final approval will be given by synthesizing the evaluation results of experts in each field and the advisory opinions of external experts such as the Central Pharmacy Review Committee if necessary.
The Ministry of Food and Drug Safety is using a rolling review, a method of rapid review, so that marketing approval can be obtained quickly while confirming safety.
The pre-review system is a method for pharmaceutical companies to submit key data necessary for product approval, etc. to the regulatory authorities as soon as they are prepared, and the regulatory authorities to review the data received first. In general, non-pandemic situations, pharmaceutical companies prepare all the data for authorization and submit it to regulatory authorities. The main data are pharmaceutical manufacturing and quality control standards (GMP), manufacturing process, standards and test methods (CMC), non-clinical pharmacological toxicity test data, and clinical data.
Regarding the approval of COVID-19 antibody treatment, the FDA’s emergency use approval (EUA) is drawing attention. The FDA gave approval after reviewing the antibody treatments of global pharmaceutical companies Eli Lilly and Regeneron for 33 and 41 days, respectively. The FDA’s approval of the vaccine was even faster. Pfizer-Bioentech’s vaccine, which was carried out up to phase 3, was approved the next day after receiving a recommendation from the Vaccine and Biological Drugs Advisory Committee (VRBPAC) on the 10th of this month after application on November 20th (local time).
An official from the Ministry of Food and Drug Safety said, “We decided to announce the results of the examination within 40 days upon receipt of the application. Depending on the case, it may or may not go through the Central Pharmacy Review Committee. I know that it has not been decided yet.”
“Antibody therapy production capability is important”… Preemptive production from September
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CEO Ki said, “It is difficult to secure production capacity (capa) for the production of COVID-19 antibody therapeutics in the global market. Places that do not have (own production facilities) must do consignment production (CMO). Even taking into account the pandemic situation, validation is necessary, so it will take one to two years as soon as possible.” He emphasized that even if the Corona 19 treatment is commercialized, the amount of supplies that can be supplied will be absolutely insufficient due to the facility.
Celltrion started production of CT-P59, which can be treated by 100,000 domestic Corona19 patients, at the Songdo production facility from last September so that it can be used for treatment purposes immediately in the medical field if the conditional permission of the Ministry of Food and Drug Safety is approved. Finished production.
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Celltrion is planning to produce treatments for up to 1.5 to 2 million people annually for mass supply overseas in the future, and is closely reviewing detailed annual production plans for 2021 to ensure that there is no disruption in the inventory status of existing products and global supply. CEO Ki emphasized, “When the CT-P59 is released, Celltrion will quickly release it through its own production.”
According to the explanation, Celltrion is expected to secure 600,000 liters of capacity to produce existing products and CT-P59. CEO Ki said, “Capa may be very short due to the pandemic.” “It may be necessary to turn one factory into full for the production of COVID-19 treatment. The inside is preparing for that.”
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