The innovative global radiolabeled drug GPN01530-2, independently developed by Yuanda Pharmaceutical (00512), has been granted Fast Track designation by the FDA.

According to an announcement by Chinas Grand Pharmaceutical Group (00512), its self-developed globally innovative radiolabeled drug conjugate (RDC) GPN01530-2 for the diagnosis of solid tumors has recently been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). The FDA established the Fast Track program to expedite the review processes for new drugs that intend to treat serious or life-threatening diseases for which there are currently no effective treatment options and that demonstrate the potential to address unmet medical needs for these conditions. Candidates awarded Fast Track status may qualify for more frequent interactions with the FDA, priority reviews (if relevant criteria are met), and rolling review of New Drug Applications, thereby accelerating the development and market entry of these drugs. Previously, GPN01530-2 had received FDA approval to conduct Phase I/II clinical studies for the diagnosis of solid tumors. This successful acquisition of FTD status marks another significant milestone in the groups global research and registration layout for its nuclear medicine oncology treatment segment, fully affirming the group's comprehensive strengths in building a cutting-edge nuclear medicine technology platform, international clinical development, and registration submissions. The group will leverage the dual submissions international registration pathway between China and the U.S. to continuously advance the global research and registration work for GPN01530-2, and based on this, further deepen the global development strategy of this segment, actively promoting international clinical research and registration submissions for more self-developed innovative nuclear medicine products, thereby continuously enhancing the groups core competitiveness and international influence in the field of nuclear medicine oncology treatment.