[Asia Economy Reporter Hyungsoo Park] Hyundai Bio is continuing its investment to develop CP-COV03, a broad-spectrum antiviral candidate substance, as a treatment for COVID-19.


At 10:09 AM on the 26th, Hyundai Bio was trading at 31,700 KRW, up 15.48% from the previous day.


On this day, Hyundai Bio announced that it had decided to proceed with the procedure to apply for Emergency Use Authorization (EUA) of CP-COV03 from the U.S. Food and Drug Administration (FDA). Hyundai Bio secured 13.7 billion KRW by selling its stake in Vitabrid Japan, a joint venture for cosmetics sales in Japan, to enter overseas markets.


Hyundai Bio will establish a dedicated corporation in the U.S. with the proceeds from the sale. It plans to proceed with the EUA application process for CP-COV03 with the FDA.


To prepare for the EUA application, Hyundai Bio will soon sign a consulting contract with global Contract Research Organization (CRO) Company I.


When bio or pharmaceutical companies developing new drugs such as COVID-19 treatments establish corporations in the U.S., they may also be selected as recipients of U.S. government policy funding support.


Earlier, Hyundai Bio placed an order for dedicated manufacturing facilities to produce 200,000 doses per month of the COVID-19 treatment (brand name Jepti). Some equipment has already been delivered and is being assembled. Hyundai Bio plans to complete the establishment of all these production facilities at the contract manufacturing pharmaceutical company for CP-COV03 by the end of October.


A Hyundai Bio official said, "We initially ordered production facilities to produce 200,000 doses per month to supply CP-COV03 worldwide, but we can increase the production facilities depending on the situation."


Hyundai Bio is also smoothly securing the main raw materials, niclosamide and magnesium oxide (MgO), to support the smooth mass production of CP-COV03. To protect intellectual property rights, patent applications have been completed for the entire core technology, including the manufacturing principles and processes of drugs with niclosamide as the main ingredient, not only in major advanced countries such as the U.S., Europe, and Japan but also across all continents including Africa, South America, Southeast Asia, and the Middle East.



Hyundai Bio expects that if Jepti is approved for use as the "first purely domestic antiviral drug," South Korea will join the ranks of countries possessing antiviral drugs, greatly contributing to the "establishment of pharmaceutical sovereignty." In 2020, Hyundai Bio succeeded for the first time in the world in increasing the bioavailability of niclosamide up to 43 times through its proprietary drug delivery system (DDS) technology. Subsequently, Hyundai Bio developed Jepti and successfully completed both preclinical and Phase 1 clinical trials.


This content was produced with the assistance of AI translation services.

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