SK Biopharmaceuticals RPT Drug Candidate SKL35501 Wins US FDA Phase 1 Approval
SK Biopharmaceuticals has secured US FDA Phase 1 clearance for its RPT drug candidate SKL35501. It's the first Korean firm to enter alpha-emitter RPT trials in the US.
A new era for Korean oncology has arrived in the U.S. market. SK Biopharmaceuticals announced on January 12, 2026, that it's received U.S. regulatory clearance to begin early-stage clinical trials for its radiopharmaceutical therapy (RPT) candidate, SKL35501, and diagnostic agent SKL35502.
First Korean Alpha-Emitter RPT to Enter US FDA Phase 1 Trials
According to the company, this marks the first time a South Korean firm has obtained investigational new drug (IND) clearance from the FDA for a Phase 1 trial in the alpha-emitter-based RPT field. Alpha emitters are revolutionary because they deliver high-energy radiation over a short range, precision-targeting cancer cell DNA while sparing healthy tissue.
Rapid Development and Global Strategy
The program's progression to the global clinical stage took only about 18 months after being in-licensed from Full-Life Technologies. SK Biopharmaceuticals has also submitted a parallel IND application to South Korea's Ministry of Food and Drug Safety, signaling a dual-track regulatory approach.
| Feature | SKL35501 (Therapy) | SKL35502 (Diagnostic) |
|---|---|---|
| Mechanism | Alpha-emitter RPT | Imaging Agent |
| Target | Cancer cell DNA | Tumor visualization |
| Status | US FDA Phase 1 Approved | US FDA Phase 1 Approved |
This milestone comes as SK Biopharmaceuticals enjoys strong momentum. In Q3 2025, the company's net profit jumped over tenfold to 71.4 billion won, highlighting its growing financial strength within the SK Group conglomerate.
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