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MegaPro Biomedical Achieves Preliminary Alignment with U.S. FDA on Phase III Clinical Development Plan for MPB-1523

MegaPro Biomedical held a Type C meeting with the U.S. Food and Drug Administration (FDA) on April 14, 2026, to discuss the manufacturing specifications and Phase III clinical trial design of MPB-1523. The Company received the official meeting minutes on May 15, 2026. A summary of the key points is as follows:

FDA Feedback on CMC and Trial Readiness:
(1) The U.S. FDA acknowledged the appropriateness of the Critical Quality Attributes (CQA), control strategy, and non-compendial analytical methods for both the drug substance and drug product of MPB-1523. The currently manufactured batches are considered adequate to support the initiation of Phase III clinical trials.
(2) The Company has reached preliminary alignment with the FDA on the overall Phase III clinical trial design, including key elements such as efficacy endpoints, sample size, and patient enrollment process. The FDA also provided relevant recommendations, which the Company will incorporate into its subsequent Phase III clinical trial planning and regulatory submission.

MPB-1523 Market Overview:
Currently, the liver MRI diagnostic market is dominated by gadolinium-based contrast agents, among which Primovist is a leading product. According to market research, global sales of Primovist reached approximately USD 130 million in 2023 and continue to grow in the United States and China. However, due to the presence of heavy metals, these products have usage limitations in patients with impaired renal function.
MPB-1523 does not contain heavy metals and is expected to offer improved safety and imaging performance, allowing for a broader patient population. In addition to penetrating the existing market, MPB-1523 also holds potential for expansion into other diagnostic applications.

In terms of demand, the Company estimates that:

The diagnostic demand for primary liver cancer in Asia is approximately 1.75 million cases annually.
The demand for liver metastasis detection in Asia is approximately 6.21 million cases annually.
Combined demand in Europe and the United States exceeds 10 million cases annually.

Overall, the global potential diagnostic demand is estimated to be approximately 8 to 10 million cases per year. Considering that around 20% of patients have impaired renal function, there is increasing demand for alternative contrast agents. The total addressable market is therefore estimated to reach approximately USD 300 million.

For further details, please refer to the official disclosure on the Market Observation Post System (MOPS).

MegaPro Biomedical's Cell Therapy Product MPB‑2354 Selected as Top 8 Finalist in the Healthcare Sector at SelectUSA Tech

MegaPro Biomedical Co., Ltd. (“MegaPro Biomedical”, TPEx: 6827) today announced that its proprietary, nanotechnology‑enabled cell therapy product MPB‑2354 has been selected as a Top 8 finalist in the Healthcare sector at the 2026 SelectUSA Tech Startup Competition, part of the SelectUSA Investment Summit organized by the U.S. Department of Commerce.

MegaPro Biomedical is scheduled to join the delegation led by Taiwan’s Ministry of Economic Affairs to the United States in early May, where the company will participate in related SelectUSA activities and engage with startup ecosystems and international investors in Los Angeles, San Francisco, and Silicon Valley. This recognition reflects the strong evaluation of MegaPro Biomedical’s nanotechnology platform in terms of innovation, clinical development potential, and global market positioning by U.S. government and professional review panels.

MPB‑2354 is an allogeneic adipose‑derived stem cell therapy developed based on MegaPro Biomedical’s proprietary nanoparticle technology platform, and is uniquely combined with MRI contrast imaging technology. The product demonstrates dual functionality, offering both anti‑inflammatory therapeutic effects and real‑time in vivo imaging capability, representing a meaningful advancement in addressing key challenges in cell therapy. Through MRI‑based tracking, clinicians can monitor cell localization, retention, and status after administration, thereby enhancing quality control and safety assessment in cell‑based treatments.

In addition, MPB‑2354 is compatible with a wide range of cell therapy products, including mesenchymal stem cells (MSCs), T cells, and dendritic cells (DCs), without altering the intrinsic characteristics of the cells. This compatibility enables potential future integration with various existing and emerging cell therapy modalities.

MegaPro Biomedical noted that MPB‑2354 is currently advancing through preclinical development in accordance with its established R&D and regulatory roadmap. Selection into SelectUSA is expected to further strengthen the company’s understanding of the U.S. biomedical ecosystem and clinical resources, and will serve as an important reference for evaluating future U.S. clinical trials, strategic partnerships, and market entry strategies. The company will prudently assess opportunities related to U.S. presence establishment, regulatory advancement, clinical development, and strategic collaborations as part of its international expansion strategy.

MegaPro Biomedical will continue to focus on the development of its nanoparticle technology platform, aiming to build a globally differentiated cell‑visualization technology platform. The company has established a diversified pipeline including MPB‑1523 MRI contrast agent for hepatocellular carcinoma, MPB‑2043 MRI contrast agent for lymph node imaging, and MPB‑2354 cell therapy product. Going forward, MegaPro Biomedical plans to further integrate nanoparticle technology with cell therapies, actively pursue international market opportunities and strategic partnerships, and continue to build long‑term R&D value and sustainable growth momentum.

About MegaPro Biomedical

MegaPro Biomedical (TPEx: 6827) was established in 2014 as a spin‑off from the Industrial Technology Research Institute (ITRI). The company is a specialty pharmaceutical developer focused on niche nanomedicine technologies. MegaPro Biomedical operates two proprietary nanotechnology platforms—nanoparticles and nanomicelles—and has developed nanometer‑scale iron oxide products.

The company’s product portfolio includes MPB‑1514 (injectable iron supplement 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 anticancer drug formulation).

For more information, please visit:

https://www.megaprobio.com/

Forward‑Looking Statements

This press release contains forward‑looking statements that involve risks and uncertainties. Except for statements of historical fact, all statements regarding MegaPro Biomedical’s future operations, business outlook, plans, and prospects are forward‑looking statements. Actual results may differ materially due to various factors, including but not limited to price fluctuations, actual demand, exchange rate movements, market competition, regulatory and legal changes, global economic and financial conditions, political risks, cost estimates, and other risks beyond the company’s control. These forward‑looking statements are based on current expectations, and the company undertakes no obligation to update them in the future.

MegaPro Biomedical Announces On‑Track Progress of Global Phase III Clinical Trial Program for MPB‑1523

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.