Seoul: SK Biopharmaceuticals Co. announced it has received U.S. regulatory clearance to initiate early-stage clinical trials for its radiopharmaceutical therapy drug candidate SKL35501 and diagnostic imaging agent SKL35502.

According to Lao News Agency, this clearance is significant as it marks the first instance of a South Korean company obtaining investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial in the field of alpha-emitter-based radiopharmaceutical therapy (RPT). Alpha emitters are radioactive isotopes that deliver high-energy radiation over a short range, directly targeting cancer cell DNA while minimizing exposure to adjacent healthy tissue.

SK Biopharmaceuticals highlighted that this approval underscores its capabilities in radiopharmaceutical development, with the program advancing to the global clinical stage approximately 18 months after being in-licensed from Hong Kong-based Full-Life Technologies. The company, a pharmaceutical unit of the South Korean conglomerate SK Group, has also submitted the same IND application to South Korea’s Ministry of Food and Drug Safety.