SK Biopharmaceuticals wins U.S. approval for clinical trials of drug candidate
(KPL/Yonhap) SK Biopharmaceuticals Co. said Monday it has received U.S. regulatory clearance to begin early-stage clinical trials of its radiopharmaceutical therapy (RPT) drug candidate SKL35501 and diagnostic imaging agent SKL35502.
The clearance marks the first time that a South Korean company has obtained investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial in the alpha-emitter-based RPT field, the company said in a press release.
Alpha emitters are radioactive isotopes that deliver high-energy radiation over a short range, directly damaging cancer cell DNA while limiting exposure to surrounding healthy tissue.
The company said the approval highlights its radiopharmaceutical development capabilities, noting the program advanced to the global clinical stage about 18 months after being in-licensed from Hong Kong-based Full-Life Technologies.
The pharmaceutical unit of South Korean chip-to-construction conglomerate SK Group has also submitted the same IND application to South Korea's Ministry of Food and Drug Safety.