Celltrion Corona Antibody Treatment Market Entry Countdown

The Corona 19 antibody treatment (CT-P59) being developed by Celltrion will be administered for the first time in Korea to Corona 19 patients. In a briefing on the 15th, Kwon Jun-wook, Head of Headquarters 2nd Division of Central Defense Response, said: “Treatment with domestic antibodies has been approved by the Ministry of Food and Pharmaceutical Safety on the 11th for treatment purposes for treating patients separately from clinical trials.” According to industry, Asan Hospital in Seoul applied for approval from the Ministry of Food and Drug Safety to prescribe Celltrion antibody treatment for confirmed corona19 patients at the hospital and received approval on the 11th. According to Kwon, the CT administration -P59 will begin as soon as the Institutional Review Board (IRB) completes the related procedures for its prescription at Asan Hospital.

Approval for use for therapeutic purposes is granted by the Ministry of Food and Drug Safety to be used under the responsibility of an individual physician for the treatment of seriously life-threatening patients or without adequate means of treatment for diseases such as Corona 19. CT-P59 is expected to be used as the first corona19 antibody treatment in Korea with conditional approval from the Ministry of Food and Drug Safety shortly after completing phase 2 clinical medication on 25th last month. This is because if CT-P59 is administered to a corona19 hospitalized patient at Asan Hospital for effect, the effect of a treatment developed by a national company is tested. Approval for use for treatment purposes is a different procedure than emergency approval for use by Celltrion and the government. Celltrion is currently analyzing the results of phase 2 after completing the clinical administration of phase 2 of CT-P59. When Celltrion requests approval for emergency use (conditional approval), the Ministry of Food and Drug Safety will decide whether to allow it within 40 days. Consequently, if Celltrion requests the approval of the Ministry of Food and Drug Safety within this year, the drug will be launched no later than the end of January after obtaining approval from the Ministry of Food and Drug Safety. Celltrion President Seo Jeong-jin once said of the efficacy of antibody treatment: “It can clear all coronaviruses from the body in 4-5 days after administration.”

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