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[Press Release, July 17, 2020] MFDS Approves Clinical Trial for a COVID-19 Antibody Treatment Developed in Korea
  • Registration Date 2020-08-23
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[Press Release, July 17, 2020 / unofficial translation ]

MFDS Approves Clinical Trial for a COVID-19 Antibody Treatment Developed in Korea
- A total of 13 COVID-19 treatments and vaccines under clinical trials in Korea -

□ On July 17, the Ministry of Food and Drug Safety (MFDS; Minister Eui-kyung Lee) approved phase 1 clinical trial for the COVID-19 antibody treatment "CT-P59" developed in Korea.

○ This brings the number of ongoing clinical trials for treatments and vaccines in relation to COVID-19 in Korea to 13 (11 treatments, 2 vaccines).

□ The newly approved “CT-P59” is a recombinant antibody treatment being developed as a new drug by “Celltrion,” and phase 1 clinical trial will be conducted on healthy people for safety evaluation.

○ After phase 1 trial verifies safety, phase 2 and 3 trials conducted on patients must confirm safety and efficacy in order to obtain approval.

[Clinical trial phases]
- (Phase 1) A drug is administered to a person for the first time to evaluate safety and pharmacokinetics.
- (Phase 2) After phase 1, the drug is administered to target patients to explore therapeutic effects.
- (Phase 3) After phase 2, the drug is administered to a number of patients to confirm the safety and therapeutic effects.
※ In some cases, "phases 1 and 2" (phase 1/2) or "phases 2 and 3" (Phase 2/3) are conducted simultaneously.

○ The principle of this treatment is to prevent infection by attaching an antibody treatment agent to the spot where the COVID-19 virus binds to human cells.
- For reference, in foreign countries, clinical trials are underway for COVID-19 antibody treatments developed by U.S.-based company L and company R on healthy people or patients.

□ As there is a high public interest in the development of COVID-19 treatments and vaccines, the MFDS will promptly provide information on the status of clinical trials of developed products.

○ The MFDS will also do its best to provide the necessary support to accelerate the development of safe and effective COVID-19 treatments and vaccines and ensure treatment opportunities for the Korean people.

< Attachment > Status of approved COVID-19 clinical trials in Korea (As of July 17, 2020) (Only in Korean)
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  • 7.17 국내 개발 코로나19 항체치료제 임상 승인_Eng.pdf Download

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