Grand Pharma's Self-Developed Global Innovative FAP-Targeting RDC Drug GPN01530 Receives FDA IND Approval for U.S. Clinical Trials
SHANGHAI SECURITIES NEWS, China Securities Net (Reporter: Zhang Xue) — Grand Pharmaceutical Group Limited ("Grand Pharma") announced on December 17 that its self-developed, global innovative Radionuclide Drug Conjugate (RDC) targeting Fibroblast Activation Protein (FAP), GPN01530, has recently received official approval from the U.S. FDA to commence Phase I/II clinical trials for the diagnosis of solid tumors.
GPN01530 is Grand Pharma's first self-developed RDC product to be approved by the FDA for clinical research. The company stated that this approval marks a significant milestone in its "Go Global" strategy and provides a vital template for the international development of its radiopharmaceutical pipeline.
FAP (Fibroblast Activation Protein) is a key marker of cancer-associated fibroblasts (CAFs). It promotes tumor growth and invasion by participating in extracellular matrix remodeling, tumor cell proliferation regulation, and immunosuppression. It has emerged as a novel, highly specific target for tumor diagnosis and therapy.
Leveraging its R&D expertise in the nuclear medicine field, Grand Pharma has optimized the structure of the FAP ligand in GPN01530 to increase uptake in tumor tissues while reducing uptake in normal tissues. Preclinical results indicate that compared to other FAP ligands, GPN01530 demonstrates rapid tumor targeting, higher tumor uptake, and superior pharmacokinetic properties.
The early-stage research for the GPN01530 project was conducted entirely independently at Grand Pharma's Chengdu Radiopharmaceutical Base, utilizing its proprietary radiochemical labeling and animal molecular imaging platforms. This one-stop process included labeling technology development, animal imaging studies, and the production and testing of registration batches via a GMP-compliant production line. Furthermore, GPN01530 is the first self-developed product to enter the FDA clinical stage from the Chengdu base since it began operations in June this year.

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