Hyundai Bioscience will go straight to the US with its broad-spectrum antiviral drug candidate to treat monkeypox. Hyundai Bioscience has decided to submit a request for a fast track processing to the U.S. Food and Drug Administration (FDA) for CP-COV03, an oral antiviral medicine for the treatment of monkeypox, which it developed as a treatment for COVID-19. Hyundai Bioscience's decision came after it learned, through a US law firm that specializes in biotechnologies, that CP-COV03 may be granted a fast track processing under the Animal Rule.

Animal Rule is sort of a fast-track adopted by the U.S. FDA for new drugs (e.g., smallpox or monkeypox), as an alternative to conventional clinical trials, allowing approval of new drugs and biological products based on efficacy data obtained solely from animal testing in situations infeasible or unethical to conduct clinical testing on humans. TPOXX is a treatment for smallpox developed with efficacy established from animal testing by Siga Technologies, a US pharmaceutical company, and the FDA approved it as a treatment for smallpox in 2018 under Animal Rule. There are 12 other new drugs the FDA applied the animal rule pathway for granting marketing authorization.