[Asia Economy Reporter Hyungsoo Park] Korea BNC is showing strong performance. The news that 'Antroquinonol,' a COVID-19 treatment for which manufacturing and sales rights have been secured in Korea and some other countries, received FDA approval to expand the target group for its Phase 2 clinical trial (to include severe patients) appears to have influenced the stock price.
As of 9:30 a.m. on the 31st, Korea BNC is trading at 36,400 KRW, up 16.51% from the previous day.
Antroquinonol was originally developed as an anticancer candidate drug for treating lung cancer, acute leukemia, and pancreatic cancer. Taiwan's Golden Biotech received FDA approval for Phase 2 clinical trials in July last year to develop it as a COVID-19 treatment, and has completed dosing for 80 out of the targeted 174 patients. The original developer, Golden Biotech, submitted a request last month to the FDA to amend the clinical trial protocol to include severe patients. This expands the Phase 2 trial subjects from mild to moderate hospitalized COVID-19 patients to severe patients requiring non-invasive ventilation and high-concentration oxygen.
If the FDA does not reject or raise issues within 30 days of the protocol amendment request, it is automatically approved. Since there were no special objections from the FDA, the amendment was approved. This means the scope of COVID-19 hospitalized patients for Antroquinonol has been expanded from mild and moderate cases to include severe patients. If the Phase 2 clinical trial is successfully completed as planned, an emergency use authorization application is expected based on the clinical results. If approved, the usage scope of Antroquinonol will expand, potentially increasing the target market for the treatment.
Korea BNC secured exclusive manufacturing and sales rights for Antroquinonol in Korea, Russia, Turkey, and Ukraine in January this year and is developing the COVID-19 treatment in cooperation with Golden Biotech.
A company official stated, "After confirming the Phase 2 clinical trial results in the third quarter, if positive, we plan to apply for emergency use authorization from the FDA based on the clinical trial report."
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