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 one of the novel specific targets in the field of tumor diagnosis and treatment. Grand Pharmaceutical stated that GPN01530-2, by optimizing the FAP ligand structure, has improved drug uptake in tumor tissues while reducing uptake in normal tissues.

Preclinical study results show that compared with other FAP ligands, GPN01530-2 exhibits rapid tumor targeting, higher tumor uptake, and superior pharmacokinetic properties. Completed investigator-initiated trials (IIT) in humans demonstrate that the product has a favorable safety profile, with rapid background clearance and strong, sustained lesion uptake; compared with the commonly used clinical PET/CT imaging agent fluorine [18F]-fluorodeoxyglucose (18F-FDG), it shows superior clinical image contrast and positive lesion detection rates.

According to the announcement, the early-stage research of the GPN01530-2 project was completed relying on the radiochemistry labeling platform and animal molecular imaging platform of Grand Pharmaceutical's Chengdu Nuclear Medicine Base, covering labeling process development, animal imaging studies, as well as registration batch production and testing and release conducted on the GMP production line. This project is also the first self-developed product from the Chengdu Nuclear Medicine Base to enter the FDA clinical stage since the base commenced operations.

Grand Pharmaceutical stated that the FDA Fast Track mechanism is designed to accelerate and facilitate the review of new drugs intended for serious or life-threatening conditions and with the potential to address unmet medical needs. After receiving Fast Track designation, the candidate drug may engage in more frequent communications with the FDA when eligible, and may have the opportunity to receive support such as Priority Review and Rolling Review, thereby accelerating the development and marketing process.

In terms of the market, the announcement cited statistical data stating that the global radiopharmaceutical market size has grown from USD 5 billion in 2018 to USD 9.7 billion in 2024, and is expected to reach USD 57.3 billion by 2035; the Chinese radiopharmaceutical market size has grown from RMB 3.6 billion in 2018 to RMB 7.4 billion in 2024, and is expected to reach RMB 75.8 billion by 2035.

Grand Pharmaceutical stated that the FDA Fast Track designation for GPN01530-2 marks new progress in the company's global R&D and registration layout in the nuclear medicine anti-tumor diagnosis and treatment segment. The company will continue to advance the global clinical development and registration of this product through the "China-U.S. dual filing" pathway. However, the company also cautioned that the product is still in the R&D stage, and uncertainties remain regarding whether it will ultimately receive marketing approval and achieve commercialization.

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