South Korean pharmaceutical and biotech companies seeking entry to the world’s largest drug market, the United States, are increasingly filing for U.S. approvals.
According to the industry on Feb. 8, HK inno.N said it filed a new drug application, or NDA, with the Food and Drug Administration last month for K-CAB, South Korea’s 30th domestically developed new drug. K-CAB treats gastroesophageal reflux disease. In a global Phase 3 trial, it showed clinical superiority over proton pump inhibitors, or PPIs, an existing class of treatments.
HLB has again approached the FDA with a liver cancer drug, its third attempt. In mid-January, HLB’s U.S. subsidiary Elevar Therapeutics and partner Hengrui Pharmaceuticals filed an NDA for rivoceranib and a biologics license application, or BLA, for camrelizumab, respectively. In the same month, the company also requested an NDA for lirafugratinib as a second-line treatment for bile duct cancer.
Companies are also moving through earlier steps, including submitting and winning approval of investigational new drug applications, or INDs. ABL Bio said it submitted an IND to the FDA in late January to begin a Phase 1 trial of ABL209, a bispecific antibody-drug conjugate, or ADC, candidate. The company plans to start Phase 1 trials of ABL209 and another bispecific ADC candidate, ABL206, at the same time around midyear and release early data next year. ABL206 received FDA IND clearance in January.
SK Biopharmaceuticals, which is expanding its radiopharmaceutical therapy, or RPT, business, said it received Phase 1 approval in January for RPT candidate SKL35501 and imaging agent SKL35502.
PharmaResearch said its nano cancer drug PRD-101 received Phase 1 approval last week. The company, known for strength in aesthetics, plans to expand into cancer treatment based on PRD-101.
Vivozon said it received clinical approval for VVZ-2471, a non-opioid oral painkiller candidate. The company plans to develop it in South Korea as a treatment for neuropathic pain and in the United States as a treatment for opioid addiction.
With companies accelerating FDA work, the industry expects more South Korean new drugs to reach the U.S. market this year. The Korea Biotechnology Industry Organization said the FDA approved 46 new drugs last year. The list included drugs developed by Chinese and Japanese companies, but none from South Korea.
* This article has been translated by AI.
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