MFDS Advisory Panel: "Chong Kun Dang COVID-19 Treatment Fails to Prove Efficacy... Additional Clinical Trials Needed"

[Asia Economy Reporter Lee Seon-ae] Chong Kun Dang's COVID-19 treatment 'Napabeltan Injection' (active ingredient Nafamostat Mesylate) failed to prove its therapeutic effect according to expert advisory results.

The Ministry of Food and Drug Safety announced on the 17th that the first expert advisory meeting on the approval of Napabeltan for COVID-19 treatment, the 'Verification Advisory Group,' concluded that efficacy was not proven.

The Verification Advisory Group reviewed the Phase 2 clinical trial data conducted in Russia and concluded that the clinical improvement time was 11 days for both the test group and the control group, showing no difference and thus failing to prove efficacy. The time for virus test results to convert from positive to negative was also 4 days for both groups, with no difference.

The Verification Advisory Group stated that the Phase 2 clinical trial results alone are insufficient to recognize the therapeutic effect of this drug and that additional clinical trials confirming the effect are necessary.

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