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Inchon Celltrion, which is developing an antibody treatment for a new coronavirus infection (Corona 19), first introduced the corona 19 treatment at its second factory. [뉴스1]
Celltrion, which is developing a treatment for the new coronavirus infection (Corona 19), plans to apply for conditional approval from the Ministry of Food and Drug Safety within this week. If you get permission, it will be available from January to February next year.
Celltrion said on the 28th: ”We are ready to apply for conditional approval of ‘CT-P59’ antibody treatment” and “I plan to apply before the 31st of this month.” Earlier, Celltrion Group Chairman Seo Jeong-jin also announced that he plans to apply for conditional approval within this year based on the results until Phase 2 clinical trials. The Ministry of Food and Drug Safety is currently targeting shorten the detection period that took more than 180 days to 40 days by forming a separate evaluation team dedicated to the approval of Corona 19 vaccine and treatment. Therefore, if CT-P59 meets the detection criteria , is expected to be used in the medical field from February next year.
The conditional permits required by the Food and Drug Administration are similar to the US Food and Drug Administration (FDA) emergency use approval, which allows for mass marketing and production of drugs. As a condition for approval, the Ministry of Food and Drug Safety explained that clinical results must be sure of the effectiveness of the drug and that it should be aimed at patients who do not have an alternative treatment.
“For mild patients … I can reduce the rate of severe progression.”
When licensed by the Ministry of Food and Drug Safety, Celltrion antibody therapy will be administered primarily to patients with mild symptoms. A Celltrion official said: “Corona 19 virus reaches its maximum detection level one week after infection. It is hoped that CT-P59 can reduce progression to severe patients by focusing on early treatment for mild patients.” said. It is explained that this is a principle that prevents deterioration through treatment because it is difficult to treat with medications if the organs are damaged by severe progression of the crown 19. The antibody therapy that Celltrion is developing is an intravenous injection, which it is a method of rapidly delivering the drug to the body by delivering it directly into the blood vessel.
Antibody therapy is a biopharmaceutical that is used as a therapeutic agent by separating the corona 19 antibody formed in the body. It is a new drug for Corona 19, it does not recreate a drug that is used by testing the effectiveness of an existing drug such as remdesivir. The antibody treatments developed by Eli Lilly and Regeneron were used in medical fields after receiving emergency approval from the FDA last month. After President Trump, who had been infected with Corona 19 in October, received the Regeneron antibody treatment, “my condition immediately improved. I felt amazing. ”
Celltrion started production of CT-P59, which can be treated for around 100,000 Corona19 household patients since last September at the Songdo production plant, so that if conditional approval is granted, it can be immediately used in medical fields. Currently, the initial production volume has been completed. In addition, in the near future, it plans to conduct phase 3 clinical trials globally in more than 10 countries around the world. Celltrion has analyzed the safety and efficacy data after completing the medication of 327 corona19 patients in Global Phase 2 on the 25th of last month.
Employees ‘stock trading ban’
Celltrion headquarters in Songdo-dong, Yeonsu-gu, Incheon. News 1
On the other hand, Celltrion announced on the 27th by text message and email that it will prohibit the trading of shares of the three companies listed in the Celltrion Group (Celltrion, Celltrion Healthcare and Celltrion Pharmaceuticals) until the approval of the treatment with Corona 19 antibodies. All stock transactions on behalf of employees and their families, stock option events, and employee stock ownership transactions were included in the ban.
The reason Celltrion took strict measures to prevent its employees from trading shares appears to be due to the possibility of violating the Capital Market Law. Trading in shares using undisclosed inside information may result in an investigation or prosecution of executives and employees for violations of the Capital Markets Law. In this regard, Celltrion explained, “With the recent development of the COVID-19 treatment, the trading of shares of company employees can be a problem not only of social interest but also of individual legal responsibility.” On the 28th, Celltrion’s share price ended at 33,500 won, down 4% from the previous day.
Reporters Kwon Yujin and Kim Young-min [email protected]
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