Hyundai Bio “Concluded an advisory contract with a global CRO for advancing into the US”

General-purpose antiviral drug candidate ‘CP-COV03’

Hyundai Bio recently acquired a global clinical trial agency (CRO) for emergency use approval and fast-track application to the U.S. Food and Drug Administration (FDA) for ‘CP-COV03’, a general-purpose antiviral drug candidate, as a treatment for COVID-19 and monkey pox. It announced on the 2nd that it has signed an advisory contract with IQVIA.

With this contract, Hyundai Bio plans to cooperate with CP-COV03 to quickly apply for emergency use approval to the FDA as a treatment for various viral diseases such as COVID-19 and monkey pox.

In addition, the company plans to establish ‘Hyundai Bioscience USA’ (tentative name) after Chuseok, a corporation that will apply for emergency use approval for CP-COV03 in the United States and conduct follow-up clinical related tasks.

A Hyundai Bio official said, “The help of an experienced global CRO is essential to apply for emergency use approval or fast track to the FDA, so we signed a contract with a world-class CRO this time. We plan to close it as soon as possible,” he said.

Reporter Jang Bom-i [email protected]

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