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The government announced on the 15th that the Corona 19 antibody treatment that Celltrion is developing can be used in medical fields in accordance with the approval procedure for therapeutic use of the Ministry of Food and Drug Safety.
According to the Central Defense Countermeasures Headquarters, 41 participants in the phase 2 clinical trials were registered at 12 medical institutions the day before. In addition to the clinical trial, 6502 people registered the plasma donation, of which 496 donated real plasma.
In the case of Celltrion antibody treatment, after completing the analysis of the results of the phase 2 clinical trials, it is expected to continue with the phase 3 clinical trials by applying for conditional approval.
Celltrion antibody treatments can be used off-site after applying for therapeutic purposes to the Ministry of Food and Drug Safety at Asan Hospital in Seoul and receiving approval.
Jun-wook Kwon, head of the 2nd Division of the Central Defense Countermeasures Headquarters, said: “Apart from clinical trials, the Ministry of Food and Drug Safety approved a case for the treatment of (specific) patients in the medical field. I’m doing it. ”
The Ministry of Food and Drug Safety is operating a treatment-use approval system that allows the use of drugs for clinical trials that are not approved for the treatment of life-threatening critically ill patients or other means of treatment. You can request that a hospital use the drug to treat a specific patient.
It can only be used for specific hospitals and patients who have applied for approval for therapeutic use and is independent of clinical trials or conditional approval procedures.
In Korea, Celltrion Antibody Treatment and GC Green Cross Blood Device Treatment have already been approved by the Ministry of Food and Drug Safety for use in Corona 19 patients.
To date, the GC Green Cross blood system treatment has been approved for 22 treatment purposes.
In the case of the national Corona 19 vaccine, clinical trials of two DNA vaccines and one synthetic antigen vaccine were approved, and clinical trials are expected to begin this year.
“We will do our best to secure national vaccines through phase 3 clinical trials in the second half of next year,” said Kwon, head of the second division.
Remdesivir, which was imported especially as a treatment for Corona 19, was supplied to 82 hospitals and 1,567 patients starting at 0 o’clock in the day.
[조성신 기자 [email protected]]