Hyundai Bio Initiates Emergency Use Authorization for COVID-19 Treatment and Considers Fast Track for Monkeypox

Published 26 Aug.2022 09:54(KST)

[Asia Economy Reporter Hyungsoo Park] Hyundai Bio announced on the 26th that it has decided to proceed with the procedure to apply for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 treatment candidate CP-COV03.

To enter the global market including the U.S., Hyundai Bio secured funds in advance for global expansion by selling 13.7 billion KRW worth of shares in Vitabrid Japan, its joint venture for cosmetics sales in Japan.

Hyundai Bio will establish a dedicated corporation in the U.S. with the proceeds from the sale. While proceeding with the EUA application process for CP-COV03 with the FDA, the company also plans to explore applying for a fast track designation for CP-COV03 as a treatment for monkeypox. It is reported that some of the funds will be used for global clinical trials of the so-called "pain free" anticancer drug Polytaxel, which is scheduled to start in Australia within this year.

The company plans to soon sign a consulting contract with global CRO I to prepare in advance for the EUA application of CP-COV03 to the FDA.

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