[서울=뉴스핌] Reporter Kim Joon-hee = While Celltrion has positively announced the results of phase 2 clinical trials for Corona 19 treatment, CT-P59, which has applied for conditional approval in Korea, Shinyoung Securities raised its target price to 430,000 won in anticipation of development success. .
Lee Myung-sun, researcher at Shinyoung Securities said on the 14th, “It is difficult to directly compare the antibody treatments of Eli Lilly and Regenenone, which were approved for emergency use by the US FDA in November, and the efficacy evaluation of clinical results, but in terms of safety, Rekirona is superior I judge.”
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Researcher Lee said, “However, it is difficult to reflect the hasty results in that the current time is ahead of the domestic approval results, where there are not many corona19 confirmed cases. It is a buying opinion as it is being reborn as a global antibody drug development company from a biosimilar company. I will keep it.”
Celltrion announced the results of phase 2 clinical trials in Rekirona the day before. According to the global clinical results of 327 patients, including mild and severe patients, the incidence of developing severe diseases requiring inpatient treatment showed a tendency to decrease, and the recovery rate was also reduced by 3.4 days.
In particular, in the moderate patient group over 50 years old (including pneumonia), when administered at a fixed dose of 40 mg/kg, clinical recovery was shortened by 6.4 days compared to 13 days in the placebo group. It also revealed that the virus concentration in the body was significantly lower than that of the placebo group due to the rapid decrease in the virus in the body when Rekirona was administered.
In the safety evaluation of Celltrion, unlike its competitors, there were no specific issues overall, and there were no cases of discontinuation of the study due to serious adverse reactions, death, or adverse reactions after administration.
The researcher said, “However, there was a limitation that statistical significance could not be secured except for the patients with moderate illness over 50 years of age in the data of reducing the incidence rate that develops severely as a small-scale clinical trial was conducted for rapid development. It is necessary to secure more reliable data through phase 3 clinical trials.”
Celltrion has already completed the production of Rekirona for 100,000 people. Therefore, it is possible to supply immediately upon domestic conditional approval, and for global supply, we are preparing to apply for emergency use in Europe and the United States and produce for 2 million people.
In addition, in January, it is expected that the clinical results will be presented in thesis and conferences, and applications for emergency use in Europe and the United States will be made. In February, it is expected that the results of domestic conditional permit examination will be released.
“As we focused on the development and production of Rekyrona, our biopharmaceutical sales in the fourth quarter of last year decreased by 26% compared to the third quarter, but there is a possibility that the sales of Humira biosimilar CT-P17 and Rekirona will be added to this year’s results. It has increased,” he predicted.