Hyundai Bio Signs Contract with Korea's No.1 CRO Meditip for Emergency Use Authorization Application of COVID-19 Treatment

[Asia Economy Reporter Jang Hyowon] Hyundai Bio (CEO Oh Sang-gi) announced on the 22nd that it has signed a service contract with 'Medtip,' a specialized agency for regulatory approval related to the Ministry of Food and Drug Safety (MFDS), to apply for emergency use authorization of 'CP-COV03,' which is currently undergoing Phase 2 clinical trials for COVID-19 treatment.

In South Korea, to apply for emergency use authorization for a new drug candidate in the clinical stage, prior consultation with the MFDS and the Korea Disease Control and Prevention Agency is mandatory.

Hyundai Bio also stated that it is in discussions with IQVIA, a local consulting firm in the U.S., to hold a Pre-IND meeting (pre-application consultation) with the FDA to apply for emergency use authorization of CP-COV03 in the United States.

Medtip, a specialized consulting firm for regulatory approval and pharmaceutical development, is the largest domestic company handling overseas regulatory approvals not only for the MFDS but also for the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Hyundai Bio explained that it signed the regulatory approval agency contract with Medtip to apply for emergency use authorization of CP-COV03 as quickly as possible as a COVID-19 treatment.

Hyundai Bio said that the reason for actively initiating the emergency use authorization application process for CP-COV03 both domestically and internationally is that the blood sampling performance for pharmacokinetics (PK) analysis of participating patients in the ongoing COVID-19 clinical trial has approached the target.

Pharmacokinetics refers to examining the changes in drug concentration in the blood over time to understand how a drug administered to the body moves within it. The blood sampling target for Hyundai Bio in this clinical trial is 60 people, and it is expected to be completed within this month.

By obtaining blood drug concentration data through blood sampling and comparing it with virus concentration, antiviral efficacy can be assessed, providing strong grounds to proceed with the emergency use authorization application process even before the clinical trial ends.

In particular, once the blood drug concentration of CP-COV03 is identified through blood sampling, it will provide evidence to estimate antiviral efficacy against viruses other than COVID-19, making it core data for the broad expansion of uses of CP-COV03 as a universal antiviral agent.

The main ingredient of CP-COV03, niclosamide, has been shown by cell efficacy tests from leading global research institutions to have antiviral efficacy against dozens of viral diseases; however, effective blood drug concentrations in animals or humans have not yet been demonstrated.

Jin Geun-woo, head of research at Hyundai Bio, said, "If the correlation between blood drug concentration confirmed through PK analysis and virus concentration is revealed, the efficacy of CP-COV03 against various viruses including COVID-19 can be predicted," adding, "In that case, CP-COV03 could be born as the world's first universal antiviral agent, similar to penicillin as the first universal antibiotic."

Hyundai Bio is accelerating the final stages of the ongoing COVID-19 clinical trial to establish CP-COV03 as the world's first universal antiviral agent capable of immediately responding not only to COVID-19 but also to the next pandemic and twin-demic (simultaneous outbreak of COVID-19 and influenza).

Oh Sang-gi, CEO of Hyundai Bio, said, "Although endemic is frequently mentioned recently, infectious disease experts worldwide commonly point out that endemic does not mean the end of COVID-19," adding, "We plan to expedite the emergency use authorization application process for CP-COV03, a universal antiviral agent, as much as possible."

CEO Oh emphasized, "There is still practically no COVID-19 treatment with confirmed efficacy and safety," and added, "Given the concerns about the next pandemic and twin-demic, I am confident that there is no game-changing COVID-19 treatment like CP-COV03."