SK Biopharm wins FDA approval for Phase 1 trial of alpha-emitter cancer therapy

CAR-T Digest - August 2020

Weekly Digest - January 2026

12 January 2026: SK Biopharm wins FDA approval for Phase 1 trial of alpha-emitter cancer therapy

SK Biopharm announced that it has received U.S. FDA approval for an investigational new drug application to initiate a Phase 1 clinical trial of its alpha-emitter radiopharmaceutical therapy SKL35501 alongside the companion imaging diagnostic agent SKL35502, marking the first FDA Phase 1 IND approval for an alpha-emitter–based RPT obtained by a domestic company
This clearance positions SK Biopharm to enter first-in-human global development of an actinium-225 theranostic pair, reflecting growing momentum behind targeted alpha therapies that can deliver high-energy radiation directly to cancer cells while minimizing damage to surrounding healthy tissue
Following the approval, the company plans to advance clinical development with the United States as the central hub, while simultaneously submitting the same protocol to Korea’s Ministry of Food and Drug Safety and conducting parallel trials in both countries to accelerate timelines
The Phase 1 study will enroll patients with advanced solid tumors that highly express the NTSR1 receptor and have failed existing treatments, initially evaluating safety and dose levels before expanding into tumor types showing early signs of efficacy, using a strategy that pairs targeted treatment with real-time diagnostic confirmation.
Building on its entry into the radiopharmaceutical space through in-licensing from Full-Life Technologies and securing radionuclide supply partnerships across the US and Europe, SK Biopharm views this FDA approval as a key step toward establishing radiopharmaceutical therapy as a new growth pillar alongside its existing CNS business