MegaPro Biomedical’s Dual Technology Platforms Enter Value‑Harvesting Phase
Taipei, Taiwan – August 5, 2025
MegaPro Biomedical Co., Ltd. (“MegaPro”, TPEx: 6827), a Taiwan‑based clinical‑stage pharmaceutical company, today announced that its two proprietary technology platforms—Nanoparticle™ and NanoMicelle™—are entering a critical value‑harvesting phase, supported by clear regulatory pathways and advancing clinical programs.
MegaPro stated that its liver‑specific MRI contrast agent MPB‑1523 is expected to submit a Pre‑IND meeting request for a Phase III clinical trial by the end of this year, paving the way for a planned 505(b)(1) New Drug Application (NDA) submission in 2028. In parallel, the Company’s novel oncology formulation MPB‑1734, following completion of process scale‑up, will proceed with bioequivalence (BE) studies, with the goal of submitting a 505(b)(2) NDA in 2028. Together, these milestones mark the transition of MegaPro’s dual nanotechnology platforms into a phase of tangible value realization.
Dr. Yuan‑Hung Hsu, President of MegaPro Biomedical, commented:
“MegaPro has established a dual‑platform strategy spanning both 505(b)(1) and 505(b)(2) regulatory pathways, with a strategic focus on diagnostic imaging and innovative oncology formulations to address significant unmet medical needs globally. After more than a decade of research, development, and clinical validation, this year represents a key inflection point as the Company enters its value‑harvesting phase.”
MPB‑1523 is one of only two liver‑specific MRI contrast agents available worldwide. Utilizing a unique PEGylated iron‑oxide nanoparticle technology, MPB‑1523 differentiates malignant liver lesions through differential uptake by Kupffer cells. Phase II clinical studies have demonstrated significantly superior image contrast compared with the marketed agent Primovist®.
In addition to its application in patients with impaired renal function and the diagnosis of hepatocellular carcinoma (HCC), MPB‑1523 has potential applications in metastatic liver cancer, portal vein invasion imaging, and monitoring of pre‑malignant liver lesions, underscoring its strong clinical and commercial value.
MPB‑1734, a Tween‑80‑free novel formulation developed under the NanoMicelle™ platform, is a 505(b)(2) reformulation of the approved anticancer drug Jevtana® (cabazitaxel). The product is being developed for indications including prostate cancer and head and neck cancer. Leveraging NanoMicelle™ technology, MPB‑1734 may potentially bypass conventional Phase II and Phase III trials, relying instead on bioequivalence studies to support regulatory approval under the 505(b)(2) pathway. MegaPro has also identified additional candidate drugs containing Tween‑80 and plans to initiate preclinical animal studies to evaluate further development opportunities.
Dr. Hsien‑Chih Wang, Chief Executive Officer of MegaPro Biomedical, added:
“Several of MegaPro’s products have now advanced into Phase III clinical trials or bioequivalence studies, demonstrating strong licensing potential. MPB‑1523 offers expanded applications across primary and metastatic liver cancers as well as pre‑malignant lesion monitoring, while MPB‑1734 and the NanoMicelle™ platform present a compelling Tween‑80‑free commercial model with the potential to achieve faster regulatory approval. As Phase III and BE studies commence and licensing discussions become more tangible, MegaPro is well positioned to enter a golden period of value creation for shareholders, standing out in the capital markets as a rare biopharmaceutical company with dual platforms, a diversified pipeline, and global 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 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), 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 pathways, licensing potential, 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 results, market conditions, competition, and other factors beyond the Company’s control. MegaPro undertakes no obligation to update any forward‑looking statements.