China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for an F18 product for use in positron emission tomography (PET) imaging of fibroblast activating protein (FAP)-positive lesions. This marks a significant step forward in the development of innovative diagnostic tools for cancer and other diseases.
Drug Profile and Mechanism of Action
The Category 1 drug, a radioactive in vivo diagnostic drug targeting FAP, sees no similar product marketed or under development in China. FAP, a type II transmembrane serine protease belonging to the prolyl oligopeptidase family, is highly expressed in epithelial tumor-related fibroblasts such as gastric cancer, esophageal cancer, and lung cancer, but has no or low expression in normal tissues and benign tumor stroma. Targeted FAP radionuclide imaging can be used to diagnose a variety of tumors and non-tumor diseases.
Clinical Application and Future Prospects
The product has high specificity and affinity with FAP protein, which can be highly concentrated in tumors with high expression of FAP. It then brings fluoride [18F] to the FAP-positive site in patients with advanced solid tumors, making it applicable to PET imaging of FAP-positive lesions in patients with solid tumors. This innovative approach positions Yantai Dongcheng to address significant unmet medical needs in the diagnosis and management of cancer and other diseases, improving patient outcomes and quality of life.-Fineline Info & Tech
