Seoul: SK Biopharmaceuticals Co. announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to initiate early-stage clinical trials for its radiopharmaceutical therapy (RPT) drug candidate, SKL35501, and diagnostic imaging agent, SKL35502. This approval represents a significant milestone as it is the first time a South Korean company has been granted investigational new drug (IND) clearance by the FDA for a Phase 1 clinical trial in the innovative field of alpha-emitter-based RPT.

According to Yonhap News Agency, alpha emitters are radioactive isotopes that deliver high-energy radiation over a short distance, targeting cancer cell DNA while minimizing damage to surrounding healthy tissue. The FDA's clearance underscores SK Biopharmaceuticals' capabilities in radiopharmaceutical development. The program reached the global clinical stage approximately 18 months after the technology was licensed from Hong Kong-based Full-Life Technologies.

Furthermore, SK Biopharmaceuticals, a pharmaceutical unit of the South Korean conglomerate SK Group, has also submitted an identical IND application to South Korea's Ministry of Food and Drug Safety, signaling its commitment to advancing the program both domestically and internationally.