GRAND PHARMA (00512) announced that its self-developed global innovative radiopharmaceutical conjugate (RDC) GPN01530 has recently received formal approval from the U.S. Food and Drug Administration (FDA) to commence Phase I/II clinical studies for the diagnosis of solid tumors. This marks another significant step in the company's global expansion in the field of nuclear medicine for oncology diagnostics and treatment.

As the company's first self-developed RDC product to receive FDA approval for clinical trials, the successful clearance of GPN01530's clinical study provides an important model for the international development of GRAND PHARMA's nuclear medicine pipeline. It represents a key milestone in the company's global R&D and regulatory progress for oncology diagnostics and treatment, demonstrating its comprehensive capabilities in cutting-edge nuclear medicine technology platforms, international clinical development, and regulatory submissions.

Leveraging its "dual submission in China and the U.S." strategy for global registration, GRAND PHARMA will continue advancing the worldwide R&D and regulatory efforts for GPN01530. Building on this foundation, the company plans to further deepen its globalization strategy in this sector, actively promoting international clinical research and regulatory filings for more self-developed innovative nuclear medicine products. This initiative aims to enhance GRAND PHARMA's core competitiveness and global influence in nuclear medicine for oncology diagnostics and treatment.