Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that its radioactive diagnostic drug, 18F-LNC1007 injection, has successfully passed a safety review conducted by the US Food and Drug Administration (FDA). This clearance paves the way for the drug to commence a Phase I clinical trial in Australia.
The 18F-LNC1007 injection is designed to target fibroblast activating protein (FAP) and integrin alpha-v beta-3, which are biomarkers associated with the diagnosis of FAP and alpha-v beta-3 positive adult solid tumors. FAP, a type II transmembrane serine protease, is highly expressed in various epithelial tumor-associated fibroblasts, while alpha-v beta-3 is known to play a significant role in tumor growth, invasion, and metastasis. The drug has demonstrated the ability to significantly prolong tumor uptake time, enhance tumor targeting efficiency, and provide excellent tumor imaging quality. It holds the potential to become a non-invasive tracer for the clinical diagnosis of patients with FAP and/or alpha-v beta-3-positive tumors.- Flcube.com
