[Asia Economy Reporter Oh Ju-yeon] GC Green Cross is discontinuing its COVID-19 plasma treatment development project.
On the 4th, GC Green Cross announced that it voluntarily withdrew its application for approval of the COVID-19 plasma treatment submitted to the Ministry of Food and Drug Safety.
On the same day, the company stated, "Based on the initial Phase 2 clinical trial results of Zicoviddic conducted at 13 domestic clinical trial institutions, we applied for domestic product approval and have been under review by the Ministry of Food and Drug Safety. The Ministry recommended submitting additional clinical results that can confirm the treatment efficacy after internal review of the submitted clinical trial data and meetings with the 'COVID-19 Treatment Safety and Efficacy Verification Advisory Group.' We accepted the review opinion and voluntarily withdrew the product approval application," the company explained.
Zicoviddic is a plasma fraction treatment made by concentrating antibodies contained in the plasma of recovered COVID-19 patients at high concentrations.
GC Green Cross applied to the Ministry of Food and Drug Safety on April 30 for approval of Zicoviddic as a COVID-19 treatment, but it was concluded that approval was not possible.
The Ministry recommended submitting additional clinical trial results that can confirm treatment efficacy, and GC Green Cross accepted the review opinion and decided to withdraw the product approval application. Instead, they plan to support the use of Zicoviddic for COVID-19 treatment purposes in medical settings.
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