Grand Pharmaceutical Group Co., Ltd. (Grand Pharma) Pharmaceutical announced that its self-developed, globally innovative radiopharmaceutical drug conjugate (RDC), GPN01530, has received formal clearance from the U.S. Food and Drug Administration (FDA) to initiate Phase I/II clinical studies for the diagnosis of solid tumors.

InnoStar entrusted by Grand Pharma, provided comprehensive Non-clinical safety evaluation and pharmacokinetic studies for GPN01530. The studies were conducted in accordance with NMPA (National Medical Products Administration), ICH, and FDA guidelines within GLP laboratory environments meeting both NMPA and FDA standards. InnoStar professional team, with a scientifically rigorous approach and efficient, precise technical execution, supported GPN01530 in successfully obtaining the FDA's Investigational New Drug (IND) clearance, allowing it to proceed into Phase I clinical trials.

GPN01530 is a small-molecule RDC drug targeting Fibroblast Activation Protein (FAP). FAP is a key marker of Cancer-Associated Fibroblasts (CAFs), which play roles in extracellular matrix remodeling, regulation of tumor cell proliferation, and tumor immune suppression, thereby promoting tumor growth and invasion. It represents a novel, specific target for tumor diagnosis and therapy. Research indicates that FAP is not expressed or is expressed at low levels in normal tissues but is highly expressed in CAFs within the tumor microenvironment and in up to 90% of epithelial tumor tissues. The specific targeting of FAP by GPN01530 offers new potential for the diagnosis and treatment of various malignant tumors.

Currently, the most commonly used PET/CT imaging agent in clinical practice is Fluorine-18 Fluorodeoxyglucose ([18F]FDG), which assesses diseases based on the glucose metabolism levels of lesions. However, its sensitivity is relatively low (40%-68%), limiting its value in early tumor diagnosis. In contrast, FAP-targeted imaging agents hold promise for pan-solid tumor application with high sensitivity, making FAP one of the hottest targets in current radiopharmaceutical research.