MegaPro Biomedical Announces Acceptance of Clinical Study Report for MPB‑1734 Phase 1/2a Trial by Taiwan FDA
Taipei, Taiwan – December 29, 2025
MegaPro Biomedical Co., Ltd. (“MegaPro”, TPEx: 6827), a Taiwan‑based clinical‑stage pharmaceutical company, today announced that the Clinical Study Report (CSR) for the Phase 1/2a clinical trial of MPB‑1734 has been formally accepted for record by Taiwan’s Ministry of Health and Welfare (MOHW) as of December 26, 2025. This milestone marks the successful completion of the Phase 1/2a study and represents an important step forward in the clinical development of MPB‑1734.
MPB‑1734 is a novel oncology formulation of cabazitaxel that does not contain Tween‑80, developed using MegaPro’s proprietary NanoMicelle™ technology platform. The completion and regulatory acceptance of the CSR signify that MPB‑1734 is ready to advance into its next stage of clinical development.
Dr. Yuan‑Hung Hsu, President of MegaPro Biomedical, stated that the Phase 1/2a clinical trial of MPB‑1734 has now been formally completed. Clinical data demonstrated a maximum tolerated dose (MTD) of 25 mg/m², along with significant improvements in common hematologic and gastrointestinal adverse events compared with the reference formulation. In addition, following a meeting with the U.S. Food and Drug Administration (FDA) earlier this year, MPB‑1734 was confirmed to have the potential to pursue a 505(b)(2) regulatory pathway, supported by bioequivalence (BE) studies, which could substantially shorten development timelines.
MegaPro further noted that the Company is currently conducting process scale‑up and manufacturing optimization for MPB‑1734. Upon completion of these activities, MegaPro plans to engage with the FDA to finalize the design of the bioequivalence studies, with the goal of accelerating initiation of BE trials and subsequent NDA submission.
According to statistics published by the World Health Organization (WHO), approximately 1.47 million new cases of prostate cancer are diagnosed globally each year, with around 400,000 deaths annually and a five‑year prevalence of approximately 5.03 million patients. Market analysis from Global Market Insights (2024) estimates that the global prostate cancer drug market has reached approximately USD 12.6 billion, and is projected to grow to USD 29.9 billion by 2034. With its Tween‑80‑free formulation, improved tolerability, and reduced adverse effects, MPB‑1734 is expected to rapidly penetrate and capture market share following commercialization.
Dr. Hsien‑Chih Wang, Chief Executive Officer of MegaPro Biomedical, further commented that the Company will continue to leverage its NanoMicelle™ platform to optimize formulations of hydrophobic drugs and extend the MPB‑1734 development model across additional pipeline assets. By applying a strategy that combines bioequivalence studies with the 505(b)(2) regulatory pathway, MegaPro aims to accelerate regulatory approval of multiple programs. Meanwhile, the Company’s Nanoparticle™ platform continues to advance, with its MRI contrast agent for hepatocellular carcinoma, MPB‑1523, expected to submit a Pre‑IND meeting request for Phase III clinical development in the near term. Licensing discussions for MPB‑1523 are also progressing in parallel to further accelerate commercialization.
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 technologies. The Company operates two proprietary platforms—Nanoparticle™ and NanoMicelle™—and develops innovative diagnostic and therapeutic products.
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, including statements regarding regulatory pathways, clinical development plans, market opportunities, and future business prospects. These statements are based on current expectations and involve risks and uncertainties that could 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.