GIGA Biomedical's MPB-1523 Receives CDE Meeting Minutes, Plans U.S. Phase III IND Filing in Q3

GIGA Biomedical (6827-TW) announced today (28) that its liver cancer MRI contrast agent MPB-1523 has obtained meeting minutes from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), serving as a key reference for planning its Phase III clinical trials in China. Additionally, the company plans to initiate a Phase III Investigational New Drug (IND) application with the U.S. FDA this quarter.

GIGA Biomedical stated that the recent CDE communication meeting provided specific expert feedback on preclinical data and the proposed Phase III clinical trial design in China. The company will refine its Phase III clinical trial protocol based on these recommendations, advancing its regulatory pathway in China.

The company emphasized its dual-track development strategy, progressing clinical programs simultaneously in both China and the United States. It aims to initiate the U.S. FDA Phase III IND submission in the third quarter of 2025, accelerating the global clinical development of MPB-1523.

Meanwhile, CEO Dr. Yuan-Hung Hsu recently attended the 2026 China Pharmaceutical Innovation and Investment Conference (CPIC) in Shanghai, where he presented the latest R&D progress of RegenTrace (MPB-2354), a cell therapy tracking platform, to international industry leaders and investors, further expanding opportunities for global collaboration.

Looking ahead, GIGA Biomedical will continue to focus on nanomedicine delivery and advanced imaging technologies, advancing key pipeline products including MPB-1523, MPB-1734 (a novel formulation for prostate cancer), and MPB-2043 (a lymph node MRI contrast agent). The company targets regulatory approvals in major markets such as the U.S., Europe, and China by 2028.