Shown above is the molecular structure of niclosamide. Hyundai Bioscience strives to apply for emergency use authorization in Korea and the United States for its oral drug for COVID-19, which is made of niclosamide. Photo courtesy of Hyundai Bioscience

Hyundai Bioscience will apply for emergency use of COVID-19 drug

Korea’s biopharmaceutical company Hyundai Bioscience said on Sept. 6 that it would apply for emergency use of its COVID-19 treatment to the country’s medical authority late this month.

The oral drug is tentatively named CP-COV03, composed of niclosamide, which has been used to deal with tapeworm infestations for decades.

“The first-phase trial was done earlier this year, and the second-phase test is now underway. We will apply for an emergency use authorization later this month or early next month,” Hyundai Executive Vice President Jason Kim said.

“If we get the regulatory green light, we expect that Korean patients will be able to take the drug within this year.”

Kim said that Hyundai Bioscience would take the same measure in the United States late this year.

Originally, the Food and Drug Administration (FDA) did not issue an emergency use authorization that much. But the FDA changed its stance due to the virus pandemic.

Included in the examples are Pfizer and Moderna vaccines as well as Gilead Science’s remdesivir.

“Scientists are aware that niclosamide is very effective in dealing with COVID-19. But its problem has been very low bioavailability. Simply put, the human body fails to absorb the material,” Kim said.

“But we have technologies to drastically improve the bioavailability. As niclosamide is a tried-and-tested substance, it will give great ammunition to grapple with the coronavirus once its bioavailability is enhanced.”

Kim noted said that the technologies gained patents in major countries across the world.

“Niclosamide is a broad-spectrum antiviral drug, which acts on host cells rather than the virus. Hence, it can have effects on many other viruses in addition to current or future variants of COVID-19,” Kim said.

“As a result, many other viruses would come under control thanks to the new drug, which we hope will be able to get an emergency use authorization both at home and abroad.”

Niclosamide was discovered in the late 1950s. It is currently included in the World Health Organization’s list of essential medicines.
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