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CelltrionⒸ Provided by Celltrion
Celltrion, known as the largest biological company in the country, announced that it completed the recruitment and administration of patients for phase 2 clinical trials of an antibody treatment for novel coronavirus (Corona 19) infection at 4 a.m. 25. Celltrion said today: “We plan to apply for a conditional approval after confirming the intermediate results of the phase 2 clinical trial soon.”
The Ministry of Food and Drug Safety (Ministry of Food and Drug Safety) also revealed that if a request for conditional approval is received on this day, it will form a dedicated team with top experts to significantly shorten the time required for approval and review. It looks like it can be used in
Recruitment and management of 327 clinical patients completed
“Recruit 10% more for stable clinical risk”
Celltrion was previously approved for phase 2 and 3 clinical trials of CT-P59, a corona 19 antibody treatment, from the Ministry of Food and Drug Safety on September 17, and has been conducting phase 2 clinical trials in countries such as the United States, Romania and Spain, as well as in the main national medical institutions. .
In phase 2 clinical trials, the efficacy and safety of CT-P59 is being evaluated for patients with mild and severe COVID-19, and Celltrion has successfully secured 327 subjects, more than 300 patients in clinically planned phase 2. A Celltrion official explained: “In the case of clinical patients, approximately 10% of the recruiting staff are recruited additionally, but additional patients were recruited for stable clinical trials.”
Celltrion classified subjects for phase 2 clinical trials into △ placebo-treated group baja low-dose group dosis high-dose group, and plans to confirm the efficacy, safety, and appropriate dose of CT-P59 through data analysis.
In particular, Celltrion announced that it plans to obtain interim results for phase 2 clinical trials as soon as possible, consult closely with related institutions such as the Ministry of Food and Drug Safety, and apply for a conditional permit for CT-P59.
The Ministry of Food and Pharmaceutical Safety is also in a position to significantly shorten the time required for permits and detection through the “Accelerated GO Program”, which is used for rapid and reliable detection.
The Food and Drug Safety Ministry said: “We will thoroughly verify the safety of COVID-19 vaccines and treatments in consideration of the Corona 19 national crisis. By forming a dedicated team, we will dramatically reduce the time required for permits and examinations.”
Therefore, if the phase 2 clinical trial proceeds as smoothly as the phase 1 clinical trial, the treatment is expected to be available in late December this year or early January next.
In addition, Celltrion is CT-P59, which can be treated by 100,000 Corona19 home patients at Songdo production facilities since last September, so that antibody treatments can be used immediately at medical sites if approved. conditional approval from the Ministry of Food and Drug Safety. It announced that production has started and initial production has been completed.
Celltrion will also begin phase 3 global clinical trials soon. Phase 3 clinical trials will take place in 10 countries around the world. Phase 3 clinical trials are conducted to further verify the efficacy and safety of CT-P59 identified in phase 2 clinical trials across a broader range of patients.
Celltrion also plans to produce treatments for up to 1.5 to 2 million people annually for mass supply abroad.
A Celltrion official said: “We are conducting day and night clinical trials in the global field for a successful global clinical trial of a domestic antibody treatment that may contribute to the end of the COVID-19 pandemic, which continues to spread to the third and fourth epidemics “. Thanks to the effort and dedication of the medical staff active in the field, we will do everything possible to complete the development of treatments so that people can return to their daily lives in a short time obtaining significant results as soon as clinical phases 2 and 3 of CT-P59 run smoothly. said.
Meanwhile, Celltrion president Seo Seong-jin appeared on tbs’Kim Eo-jun’s News Factory ‘the day before and announced that a request for conditional approval of CT-P59, which is being developed, is imminent. He said: “Antibody therapy should be a public good of the country,” he said.
Reporter Seung-Hoon Lee
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