Korean pharmaceutical companies are accelerating their push into the U.S. market, with a series of new drug application filings to the Food and Drug Administration expected to yield meaningful results this year.
According to industry sources on Wednesday, domestic firms have been submitting NDAs to the FDA in quick succession since the start of 2025.
HK inno.N filed an NDA last month for K-CAB, Korea's 30th domestically developed new drug. The treatment for gastroesophageal reflux disease demonstrated clinical superiority over existing proton pump inhibitor therapies in global Phase 3 trials. HLB has also made its third attempt at securing approval for a liver cancer drug.
ABL Bio received FDA approval to begin Phase 1 clinical trials for ABL206, a bispecific antibody-drug conjugate. SK Biopharmaceuticals also secured Phase 1 approvals for radiopharmaceutical candidate SKL35501 and diagnostic imaging agent SKL35502.
"This year could see improved FDA approval outcomes for the industry," an industry official said. "We'll be watching to see if another Korean drug wins FDA approval for the first time in two years, following Leclaza in 2024."