China-based Grand Pharmaceutical Group Limited (HKEX: 00512) announced receipt of US FDA Fast Track Designation (FTD) for GPN01530-2, a fibroblast activation protein (FAP)-targeted small molecule radionuclide-drug conjugate (RDC), for the diagnosis of solid tumors. The designation potentially positions GPN01530-2 for rolling New Drug Application (NDA) review and more frequent FDA interactions as the company advances a Phase I/II clinical study in the US.
GPN01530-2 targets FAP, a marker highly expressed on cancer-associated fibroblasts (CAFs) in approximately 90% of epithelial tumor tissues but absent or low in normal tissue. The agent is designed for PET/CT diagnostic imaging and incorporates a structurally optimized FAP ligand intended to increase tumor uptake while reducing background signal — a design distinction from earlier fibroblast activation protein inhibitor (FAPI)-class tracers such as 68Ga-FAPI-46. The current standard, 18F-fluorodeoxyglucose (18F-FDG), carries reported sensitivity of only 40–68% in solid tumor imaging, according to Grand Pharma.
Investigator-initiated study data in 35 patients with solid tumors, published in the Journal of Controlled Release, reported that 68Ga-GP01 — the active imaging component of GPN01530-2 — detected more lesions and achieved higher tumor-to-background ratios than both 68Ga-FAPI-46 and 18F-FDG. The company reported zero adverse events within six hours post-injection across all patients and described rapid background clearance and sustained lesion uptake.
Fast Track status allows more frequent interactions with the US FDA and makes GPN01530-2 eligible for rolling review, under which completed sections of a future NDA could be submitted before the full application if agreed with the agency.