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CelltrionAnnounced the results of phase 2 clinical trials of Rekirona, a COVID-19 antibody treatment, on the 13th. The average recovery period of all clinical patients was 5.4 days, which was 3.4 days shorter than that of 8.8 days in the placebo group. The recovery period for middle-aged patients over 50 years old was 6.6 days. It was reduced by 6.4 days compared to the 13-day recovery period in the placebo group.
No serious adverse reactions occurred in the safety evaluation.
Researcher Byung-Hwa Han said, “Global launch and sales contracts are possible only with the published clinical results.”Celltrionand Celltrion HealthcareIt is the basis for raising the value of the company.”
CelltrionApplied for conditional permission from the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety is in the position that if the evaluation result is positive, it may consider product approval early next month as a condition of proceeding with the third phase.
The company plans to apply for emergency use approval for Rekirona to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) this month or next month. One researcher predicted that exports would start at the same time after obtaining approval for overseas emergency use within the second quarter.
The export volume is estimated at 600 billion won this year and 300 billion won next year. This is assuming an estimated unit price of 2 million won per person and 300,000 this year and 150,000 next year.
Researcher Byung-Hwa Han said, “Corona 19 treatment is sold under a contract between the pharmaceutical company and the government, and the standard for comparison with competing drugs will be the efficacy and price.” did.
Reporter Park In-hyuk [email protected]
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