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Grand Pharma's FAP-targeted diagnostic radiopharmaceutical GPN01530-2 receives FDA Fast Track designation

Grand Pharma's FAP-targeted diagnostic radiopharmaceutical GPN01530-2 receives FDA Fast Track designation

On August 9, 2026, Grand Pharmaceutical issued a voluntary announcement stating that its self-developed global innovative radionuclide drug conjugate GPN01530-2 has recently been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of solid tumors. Previously, the product had already been approved by the FDA to conduct Phase I/II clinical studies for the diagnosis of solid tumors. GPN01530-2 is a small-molecule radionuclide drug conjugate (RDC) targeting fibroblast activation protein (FAP). Data shows that FAP is not expressed or is lowly expressed in normal tissues, but is highly expressed in tumor-associated fibroblasts within the tumor microenvironment of various cancers, and is considered a novel specific target in the field of tumor diagnosis and treatment...

2026-08-10

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