SK Biopharm Receives FDA IND Approval for Alpha-Emitter RPT New Drug

Accelerating Next-Generation Anticancer RPT Development Strategy

SK Biopharm announced on January 12 that it has received approval from the U.S. Food and Drug Administration (FDA) for Phase 1 Investigational New Drug (IND) applications for its new radiopharmaceutical therapy (RPT) drug candidate 'SKL35501' and imaging diagnostic agent 'SKL35502'.

SK Biopharm

This approval marks the first time a Korean company has received FDA Phase 1 IND approval in the alpha-emitter-based RPT field. It took about a year and a half for SK Biopharm to enter the global clinical stage after introducing this pipeline from Full-Life Technologies, demonstrating the company's RPT development capabilities.

Based on this FDA IND approval, SK Biopharm is simultaneously pursuing global clinical development centered in the United States and has also submitted the same IND to the Ministry of Food and Drug Safety in Korea, where it is currently under review. The company plans to accelerate the development of global anticancer drugs by conducting clinical trials in both the U.S. and Korea in parallel.

This Phase 1 clinical trial targets patients with advanced solid tumors expressing NTSR1, which are associated with high unmet medical needs. It will be the first-in-human, open-label, multi-center clinical trial conducted in both Korea and the United States, primarily enrolling patients who have failed or relapsed after existing standard treatment options. The trial will initially determine the safety and biologically active dose range through dose escalation, and then proceed to dose optimization and expansion phases for cancer types in which efficacy is observed, following the clinical protocol.

SK Biopharm entered the RPT field for the first time in July 2024 by introducing this pipeline from Full-Life Technologies. In November of last year, the company added a second RPT pipeline, and has been expanding its RPT portfolio step by step through a combination of inorganic growth strategies and in-house research and development. In addition, SK Biopharm has signed supply agreements for actinium-225 (225Ac) with three global radioisotope (RI) producers: TerraPower in the United States, PanTera in Belgium, and Eckert & Ziegler in Germany. Through these efforts, the company is sequentially building an RPT value chain that encompasses pipeline acquisition, research and development, and raw material procurement.

Lee Donghun, CEO of SK Biopharm, stated, "This FDA IND approval is a significant milestone for SK Biopharm as we begin full-scale global clinical development in the RPT field. We will strategically foster RPT as a next-generation anticancer pipeline and systematically expand our medium- to long-term growth engines by combining AI-based research and development capabilities."