MegaPro Biomedical Announces On‑Track Progress of Global Phase III Clinical Trial Program for MPB‑1523
Taipei, Taiwan – December 17, 2025
MegaPro Biomedical Co., Ltd. (“MegaPro”, TPEx: 6827), a Taiwan‑based clinical‑stage pharmaceutical company, today announced that progress of its global, multicenter Phase III clinical trial program for MPB‑1523, a proprietary MRI contrast agent for liver cancer, is proceeding as planned. The Company expects to submit a Pre‑IND meeting request to the U.S. Food and Drug Administration (FDA) in the first quarter of next year, marking another important milestone in the commercialization strategy for MPB‑1523.
MegaPro is currently conducting interviews with physicians at hospitals expected to participate in the Phase III trial. This advancement represents a key step forward in the global development and commercial positioning of MPB‑1523.
MPB‑1523 is currently the only liver cancer MRI contrast agent on the market that does not contain heavy metals. The product is based on a PEGylated iron‑oxide nanoparticle technology. After reviewing the Phase II clinical results of MPB‑1523, a leading clinical expert in liver cancer imaging in Mainland China noted that, when used in combination with TrueFISP MRI sequences, MPB‑1523 enables a highly distinctive “triple‑contrast imaging pattern”—simultaneously visualizing bright vascular structures, intermediate‑signal tumor thrombi, and reduced background liver signals resulting from MPB‑1523 uptake—thereby providing superior lesion differentiation.
According to MegaPro, these imaging characteristics allow for more intuitive assessment of vascular invasion in liver cancer, offering clinicians a novel, non‑invasive diagnostic tool with high practical value and advantages not previously achievable with conventional contrast agents. The expert further indicated that current clinical imaging observations support the potential for systematic evaluation of vascular invasion in the upcoming Phase III clinical trial.
Importantly, MPB‑1523 remains suitable for use in patients with hepatic or renal impairment, a population for whom existing contrast agents are often contraindicated. As such, MPB‑1523 is expected to address a significant unmet clinical need while offering substantial market potential.
In addition, MegaPro has completed all clinical design and manufacturing information requested by the FDA during the End‑of‑Phase II meeting. Following receipt of formal Pre‑IND feedback, the Company plans to submit Phase III IND applications sequentially in the United States, Taiwan, and Mainland China. MegaPro is also actively engaged in licensing discussions with multiple pharmaceutical companies and anticipates that MPB‑1523 will become a key driver of the Company’s future revenue growth.
MegaPro noted that the global, multicenter Phase III program is progressing as expected due to the Company’s adherence to high regulatory standards across multiple jurisdictions, including the United States, China, and Taiwan. In parallel, MegaPro continues to optimize its manufacturing processes to ensure compliance with GMP requirements across these markets.
Based on current clinical data, MegaPro further expects that upon entering the Phase III IND stage, the potential indications for MPB‑1523 may be expanded from primary and metastatic liver cancer to include monitoring of pre‑malignant liver lesions, thereby elevating its clinical utility from an adjunctive diagnostic tool to a predictive diagnostic solution. Such expansion would significantly enhance the product’s value proposition and market reach, accelerating commercialization and strengthening the Company’s long‑term revenue and profitability outlook.
About MegaPro Biomedical
Founded in 2014 as a spin‑off from the Industrial Technology Research Institute (ITRI), MegaPro Biomedical Co., Ltd. (TPEx: 6827) is a clinical‑stage pharmaceutical company specializing in the development of niche nanomedicine technologies. The Company operates two proprietary platforms—Nanoparticle™ and NanoMicelle™—and focuses on innovative diagnostic and therapeutic solutions.
MegaPro’s product portfolio includes MPB‑1514 (injectable iron therapy for iron‑deficiency anemia), MPB‑1523 (MRI contrast agent for hepatocellular carcinoma), MPB‑2043 (MRI contrast agent for lymph node staging), MPB‑2354 (cell therapy product), and MPB‑1734 (novel oncology formulation).
For more information, please visit: https://www.megaprobio.com/
Forward‑Looking Statements
This press release contains forward‑looking statements regarding clinical development timelines, regulatory submissions, potential indication expansion, licensing activities, and future business prospects. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially, including regulatory outcomes, clinical trial results, market conditions, competition, and other factors beyond the Company’s control. MegaPro undertakes no obligation to update any forward‑looking statements.