Celltrion corona antibody treatment approval application’countdown’… Can be administered from January to February next year as early as possible

Celltrion, which is developing a treatment for the novel coronavirus infection (Corona 19), plans to apply for a conditional permit to the Ministry of Food and Drug Safety within this week. If you get permission, it will be available as early as January to February next year.

Celltrion said on the 28th, “We are ready to apply for conditional approval of the antibody treatment’CT-P59′,” and “We plan to apply by the 31st of this month.” Previously, Celltrion Group Chairman Seo Jeong-jin also announced that he plans to apply for conditional approval within this year based on the results up to phase 2 clinical trials. The Ministry of Food and Drug Safety currently has a separate evaluation team dedicated to corona19 vaccine/treatment approval, and aims to shorten the screening period that took more than 180 days to within 40 days. Therefore, if CT-P59 satisfies the screening criteria, it is expected to be used in the medical field from February next year.

The conditional permits enforced by the Food and Drug Administration are similar to the U.S. Food and Drug Administration’s (FDA) emergency use approvals, and if the permit is obtained, drug commercialization and mass production are possible. As a condition of approval, the Ministry of Food and Drug Safety explained that the clinical results should be sure of the effectiveness of the drug, and that it should target patients who do not have an alternative treatment.

When the license is granted by the Ministry of Food and Drug Safety, Celltrion’s antibody therapy will be administered mainly to patients with mild symptoms. An official from Celltrion said, “Corona 19 virus reaches its maximum detection level within a week after infection. It is expected that CT-P59 can reduce the 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 drugs if the organs are damaged due to the severe corona 19 progression. The antibody therapy celltrion is developing is an intravenous injection, which is a method of rapidly delivering the drug to the body by directly administering it to the blood vessel.

Antibody therapy is a biopharmaceutical used as a therapeutic agent by separating the corona 19 antibody formed in the body. It is a new drug for Corona 19, not a drug re-creation used by checking the efficacy of existing drugs like remdesivir. 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 Regeneron’s antibody therapy, “I immediately improved my condition. I felt unbelievable.”

Celltrion began production of CT-P59, which can be treated for about 100,000 domestic Corona19 patients from last September at the Songdo production facility, so that if conditional approval is granted, it can be used immediately in the medical field. Currently, the initial volume production has been completed. In addition, in the near future, it is expected to conduct global phase 3 clinical trials in more than 10 countries around the world. Celltrion has analyzed safety and efficacy data after completing medication for 327 corona19 patients in Global Phase 2 on the 25th of last month.

On the other hand, Celltrion announced on the 27th by text and e-mail that it will ban stock trading of the three Celltrion Group listed companies (Celltrion, Celltrion Healthcare, and Celltrion Pharmaceuticals) until the approval of the Corona 19 antibody treatment. All stock transactions in the name of employees and their family members, stock option events, and employee stock ownership transactions were included in the ban.

The reason Celltrion took tough measures to prevent employees from trading stocks seems to be due to the possibility of violating the Capital Market Act. Stock trading using undisclosed inside information may result in an investigation or prosecution of executives and employees for violations of the Capital Markets Act. In this regard, Celltrion explained, “With the recent development of COVID-19 treatment, the stock trading of employees of the company can be a problem not only of social interest but also of individual legal responsibility.” On the 28th, Celltrion’s stock price ended at 33,500 won, down 4% from the previous day.

Reporters Kwon Yujin and Kim Youngmin [email protected]