SK Biopharmaceuticals has received Investigational New Drug (IND) approval from the US FDA for its novel radiopharmaceutical therapeutic agent, SKL35501, and its diagnostic imaging agent, SKL35502. This marks the first time a Korean company has received FDA Phase 1 clinical trial approval in the alpha-emitting radionuclide therapy (RPT) field. SKL35501 targets the protein NTSR1 and is applicable to various cancers, including colorectal, prostate, and kidney cancers. SKL35502 serves as a companion diagnostic tool, identifying patients eligible for treatment by confirming NTSR1 expression. This innovative approach integrates diagnosis and treatment into a single platform, embodying the concept of Theranostics. The global radiopharmaceutical market is projected to grow to approximately 10 billion USD (about 13 trillion KRW) by 2030. Building on this FDA approval, SK Biopharmaceuticals plans to pursue technology transfer and co-development with global pharmaceutical companies, while also conducting domestic clinical trials. The industry views this approval as a milestone for Korea's radiopharmaceutical sector, anticipating further opportunities given the high barriers to entry. Source: