[Asia Economy Reporter Hyungsoo Park] While the KOSDAQ market is plunging, Hyundai Bio's stock price is soaring. Expectations for the oral antiviral drug for COVID-19 (CP-COV03) appear to be influencing the stock price.


As of 11:02 AM on the 14th, Hyundai Bio is trading at 34,200 KRW, up 18.54% from the previous trading day.


Hyundai Bio announced that the 'Monte Carlo (multiple probability) simulation' results for Phase 2 clinical trials confirmed that CP-COV03 maintains the maximum effective blood drug concentration (EC99) that suppresses Omicron virus replication by more than 99% within the Noael limit throughout the 5-day dosing period.


To find the optimal dosage and administration method of CP-COV03 in Phase 2 clinical trials, they recently requested a drug evaluation system development team from the Ministry of Food and Drug Safety to conduct simulations based on preclinical data and Phase 1 clinical trial results.


The simulation results showed that CP-COV03 can safely cure the disease without side effects from toxicity accumulation even when repeatedly administered for 5 days to COVID-19 patients participating in Phase 2 clinical trials. Hyundai Bio also plans to verify the cure status after 3 days of dosing in Phase 2.


The EC99 (effective concentration 99) concentration corresponds to the IC100 (inhibitory concentration 100) concentration that suppresses 100% of virus replication. Pfizer's Paxlovid has been disclosed in papers to maintain concentrations above EC90 in the human body.


Hyundai Bio plans to submit the simulation results to the Ministry of Food and Drug Safety to apply them in Phase 2 clinical trials. Since Tamiflu, which was a 'game changer' during the H1N1 flu outbreak, only Pfizer's antiviral drug is known to have continuously maintained blood drug concentrations above EC90 during repeated dosing periods.


Dr. Jin Geun-woo, head of Hyundai Bio's research institute, said, "It is difficult to maintain EC99 within the Noael limit because the maximum drug concentration increases the more the drug is repeatedly administered over 5 days. CP-COV03 has confirmed maintaining EC99 throughout the 5-day dosing period."



Among antiviral drugs for COVID-19, only Pfizer's Paxlovid continuously maintains IC100 (EC99) concentrations during the dosing period. It is known to be difficult to achieve without support from cutting-edge technology.


This content was produced with the assistance of AI translation services.

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