[Asia Economy Reporter Hyungsoo Park] Korea BNC is showing strong momentum day after day. It appears that the news of the Taiwan Food and Drug Administration (FDA) granting emergency approval for the use of Antroquinonol, a COVID-19 treatment candidate substance applied for by National Taiwan University Hospital, for 100 patients with mild to moderate COVID-19 infections has influenced the stock price.
As of 9:14 AM on the 6th, Korea BNC is trading at 12,900 KRW, up 15.7% from the previous day. The stock has maintained a strong trend even after soaring to the daily price limit the day before.
Emergency use authorization is a system that allows clinical trial drugs to be used for treatment purposes outside of clinical trials when there is a life-threatening emergency or serious illness, or when there is no satisfactory or equivalent alternative treatment. In Taiwan, the only drug approved under special conditions to treat COVID-19 patients is Gilead’s Remdesivir. Although Antroquinonol is not officially approved as a product, it has become the first oral treatment approved in Taiwan to treat COVID-19 besides the injectable Remdesivir.
Currently, in the United States, injectable Remdesivir, Regeneron’s antibodies, Lilly’s Bamlanivimab, Etesevimab, GSK’s Sotrovimab, and Roche’s Actemra (Tocilizumab) injections have received emergency use authorization. In Korea, injectable Remdesivir and Celltrion’s Regkirona have conditional approval for phase 3 clinical trials.
A company official explained, "The emergency use authorization of Antroquinonol for 100 patients with mild to moderate COVID-19 at National Taiwan University Hospital, besides Remdesivir, can be seen as a judgment that the safety and efficacy of the treatment drug are valid." He added, "It appears to be due to the urgent need for its use as COVID-19 confirmed cases rapidly increase in Taiwan."
Regarding the status of the phase 2 clinical trial currently underway with approval from the U.S. FDA, the official stated, "On the 3rd of last month, the second DMC results for 80 subjects who received the drug confirmed the efficacy and safety of Antroquinonol for patients hospitalized with mild to moderate COVID-19 virus infection." He added, "Consent and approval were granted to continue recruiting subjects and conducting the clinical trial without any changes to dosage or the clinical trial protocol."
The clinical trial was approved by the U.S. FDA in July of last year. It is a randomized, double-blind, placebo-controlled trial where 200 mg of the test drug is orally administered daily for 14 days. The primary endpoint is the probability of survival without progressing to severe disease requiring invasive mechanical oxygen therapy on day 14. It is known that the trial was also recommended to expand the subject selection criteria from mild to moderate hospitalized COVID-19 patients to severe patients requiring non-invasive ventilation and high-flow oxygen.
A representative of Golden Biotech, a Taiwanese partner company of Korea BNC, introduced, "The antiviral, anti-inflammatory, and anti-pulmonary fibrosis effects of Antroquinonol have been confirmed through in vitro and animal experiments. The treatment efficacy and safety for patients hospitalized with pneumonia due to COVID-19 infection with mild to moderate symptoms have been positively confirmed through the second result analysis of 80 subjects in phase 2 clinical trials without any changes to dosage or clinical trial protocol." Furthermore, the representative stated, "After confirming the phase 2 clinical trial results in the third quarter, if positive, we plan to apply for emergency use authorization from the U.S. FDA."
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