[Special Stock] ABL "Early Clinical Approval of COVID-19 Treatment by US FDA Reflects Superior Efficacy and Market Potential"

[Asia Economy Reporter Hyungsoo Park] ABL Bio is showing strong performance. The news that ABL901 (HFB30132A), a novel coronavirus (COVID-19) antibody therapeutic jointly developed with the multinational biotech company HiFi Bio Therapeutics, has received clinical approval from the U.S. FDA appears to have influenced the stock price.

As of 11:22 AM on the 18th, ABL Bio is trading at 36,050 KRW, up 8.58% from the previous day.

Lee Sang-hoon, CEO of ABL Bio, stated, "Receiving early FDA approval after submitting the IND on the 25th of last month is a significant result reflecting the superior efficacy of ABL901."

He added, "ABL Bio will continue to work closely with HiFi Bio to leverage global clinical trials as a stepping stone to rapidly supply the COVID-19 therapeutic worldwide with full commitment."

ABL Bio received Phase 1 clinical trial approval on the 14th (local time). ABL Bio and HiFi Bio plan to complete Phase 1 within a month and then simultaneously initiate global Phase 2/3 clinical trials, including in the U.S. The clinical results are expected in the first half of next year, with commercialization targeted for the summer.

ABL901, developed from the blood of recovered patients, targets the spike protein located on the surface of SARS-CoV-2 to block cell infection. Incorporating half-life extension technology, ABL901 demonstrated efficacy lasting over 3.5 months in both in vitro cell experiments and in vivo monkey animal studies. In toxicity tests on monkeys administered with concentrations higher than the effective dose for humans, no evidence of toxicity was found, indicating safety.

According to ABL Bio, ABL901 has outstanding differentiation in half-life and neutralization against variants, making it highly competitive compared to leading domestic and international antibody therapeutics developers. In particular, by advancing U.S. clinical trials, they see very high market potential as it facilitates smooth expansion of therapeutic supply to the global market.