MegaPro Biomedical Announces Submission of Pre‑IND Meeting Request for Phase III Clinical Trial of MPB‑1523
Taipei, Taiwan – March 12, 2026
MegaPro Biomedical Co., Ltd. (“MegaPro”, TPEx: 6827), a Taiwan‑based clinical‑stage specialty pharmaceutical company, today announced that its internally developed liver cancer MRI contrast agent, MPB‑1523, is progressing as planned toward a global, multicenter Phase III clinical trial. The Company has submitted a Pre‑IND meeting request to the U.S. Food and Drug Administration (FDA) in preparation for the Phase III study.
MegaPro expects to receive formal feedback from the FDA in the second quarter of 2026, after which it plans to submit the Phase III IND application. In parallel, the Company is also preparing to submit Pre‑IND consultation applications to regulatory authorities in Mainland China, aiming to further accelerate the initiation of Phase III clinical development.
According to MegaPro, the Phase III clinical trial design for MPB‑1523 is based on recommendations from the End‑of‑Phase II meeting with the U.S. FDA. The study will adopt a four‑point imaging assessment scale as the primary efficacy endpoint, comparing MRI images obtained before and after administration of MPB‑1523 within the same subject, thereby reducing inter‑subject variability.
Retrospective analysis of Phase II clinical data demonstrated that post‑administration imaging scores improved by an average of 1.24 points, representing an approximately 60% increase compared with baseline, indicating a statistically and clinically meaningful enhancement in imaging performance.
Upon receipt of FDA Pre‑IND feedback and the planned initiation of Phase III trials in the United States, Taiwan, and Mainland China, MegaPro believes that the robust Phase II data package, together with regulatory guidance, will significantly enhance the program’s attractiveness for global and regional licensing opportunities, strengthening the Company’s long‑term growth momentum.
MegaPro further noted progress in its second core technology platform, NanoMicelle™, with its novel oncology formulation MPB‑1734 (a Tween‑80‑free formulation of cabazitaxel). The Phase I clinical study report for MPB‑1734 was accepted by Taiwan’s Ministry of Health and Welfare in December 2025. Clinical results showed a maximum tolerated dose (MTD) of 25 mg/m², exceeding the currently approved dose of 20 mg/m² for the reference formulation, while also demonstrating significant improvements in common adverse events such as anemia and diarrhea.
The Company is actively advancing process scale‑up for MPB‑1734 and expects completion in the third quarter of 2026. Drug product manufactured under the new process will be used in subsequent bioequivalence (BE) studies.
Leveraging its two proprietary nanotechnology platforms—Nanoparticle™ and NanoMicelle™—MegaPro continues to advance a diversified product pipeline. Supported by the strong Phase II imaging efficacy of MPB‑1523, the Company plans to initiate Phase III clinical trials across the U.S., Taiwan, and China in the second quarter of 2026, further shortening the timeline to commercialization. Meanwhile, MPB‑1734 has demonstrated superior tolerability and safety compared with the reference formulation and is on track to complete process scale‑up in the third quarter.
With steady clinical execution and a well‑defined regulatory strategy, MegaPro is entering a critical inflection point for international licensing and sustainable operational growth, highlighting its compelling long‑term investment potential.
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 focused on the development of niche nanomedicine therapies. The Company operates two proprietary nanotechnology platforms—Nanoparticle™ and NanoMicelle™—and has developed iron‑oxide‑based nanomedicines for both therapeutic and diagnostic applications.
MegaPro’s product pipeline 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, including but not limited to statements regarding future business operations, clinical development plans, regulatory timelines, and commercialization prospects. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including but not limited to market conditions, regulatory outcomes, competition, pricing, currency fluctuations, and other factors beyond the Company’s control. MegaPro undertakes no obligation to update any forward‑looking statements.