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MegaPro Biomedical Advances Lead MRI Contrast Agent to Phase III; Pre-IND for US Market Planned for 2026 Q1Dec 18, 2025

MegaPro Biomedical (巨生醫) announced on the 17th that its self-developed MRI contrast agent for liver cancer, MPB-1523, is progressing into a multi-national, multi-center Phase III clinical trial. The company plans to submit a Pre-IND (Investigational New Drug) consultation to the US FDA in the first quarter of next year.

Technical Advantages of MPB-1523:

  • Heavy Metal-Free: Unlike traditional agents, it uses PEGylated iron oxide nanoparticles, making it safer for patients with renal or hepatic impairment.
  • Triple-Contrast Imaging: When paired with TrueFISP MRI sequences, it provides a high-resolution view of vascular structures, tumor thrombi, and liver background, offering a non-invasive tool for diagnosing vascular invasion.
  • Market Expansion: Beyond primary and metastatic liver cancer, the company aims to expand indications to pre-cancerous lesion monitoring, significantly increasing its market value.

MegaPro Biomedical is currently in licensing talks with several pharmaceutical companies, viewing MPB-1523 as a core driver for its mid-to-long-term revenue growth.

Resource: 巨生醫肝癌MRI顯影劑推進三期 明年Q1啟動美國Pre-IND