MegaPro Biomedical Co., Ltd. (hereinafter referred to as “MegaPro Biomedical”; stock code: 6827), a company focused on the research and development of nanomedicine and innovative imaging agents, today announced that it has recently achieved important progress in international regulatory communication and market outreach. In addition to obtaining the communication meeting minutes from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for MPB-1523, its hepatocellular carcinoma MRI contrast agent, as an important reference for subsequent Phase III clinical trial planning in China, MegaPro Biomedical’s General Manager, Dr. Yuan-Hung Hsu, recently participated in the 2026 China Pharmaceutical Innovation and Research Development Association Investment Conference (CPIC) in Shanghai, where he introduced the latest R&D achievements of RegenTrace™ (MPB-2354), the company’s cell therapy tracking platform, to the international industry and investment communities, continuing to expand global collaboration opportunities.
MPB-1523, MegaPro Biomedical’s flagship drug candidate and MRI contrast agent for hepatocellular carcinoma, has recently formally obtained the communication meeting minutes from China’s CDE. During the meeting, CDE experts provided specific recommendations regarding preclinical research data and the design of future Phase III clinical trials in China. The Company will continue to refine the Phase III clinical trial protocol based on the relevant feedback, which will serve as an important basis for the Company’s subsequent application to China’s regulatory authority for Phase III clinical trials. MegaPro Biomedical stated that receipt of the CDE meeting minutes represents another step forward in the regulatory advancement of MPB-1523 in China. The Company will concurrently advance its clinical development plans in China and the United States, and expects to initiate the U.S. FDA Phase III IND application in the third quarter of this year, continuing to promote the product’s global clinical development progress.
Separately, General Manager Dr. Yuan-Hung Hsu recently led the team to Shanghai to participate in the 2026 China Pharmaceutical Innovation and Research Development Association Investment Conference (CPIC), where he presented the latest R&D achievements of RegenTrace™ (MPB-2354), the Company’s cell therapy tracking platform, during the conference roadshow. The presentation introduced the platform’s technological applications to international pharmaceutical companies, clinical experts, and investment institutions at the event.
MegaPro Biomedical stated that RegenTrace™ can be applied to cell therapy products such as mesenchymal stem cells (MSCs) and CAR-T cells, providing high-resolution, non-invasive MRI-based in vivo cell tracking technology to assist in observing the distribution, homing, and survival of cells in the body. The platform previously completed animal-study validation in collaboration with Stanford University in the United States and won first place in the “Health Tech” category at the 2026 SelectUSA Investment Summit, demonstrating its potential for international collaboration and technology licensing.
The General Manager stated that, as cell therapy continues to develop rapidly worldwide, demand for tracking and monitoring cells in the human body has received increasing attention. RegenTrace™ is built around MRI molecular imaging technology and is expected to provide more comprehensive imaging information during the cell therapy development process. Looking ahead, the Company will continue to seek collaboration with international pharmaceutical companies and research institutions to promote the application of the platform technology in global markets.
MegaPro Biomedical further noted that the receipt of China CDE communication meeting minutes for MPB-1523, together with the completion of the international CPIC roadshow for RegenTrace™, will support the Company’s continued advancement of product development and expansion of overseas partnerships. Going forward, the Company will continue to deepen its focus on nanomedicine delivery and advanced imaging technologies, advancing the development of several core product lines, including MPB-1523, MPB-1734 (a new formulation oncology drug for prostate cancer), and MPB-2043 (an MRI contrast agent for lymph node staging), and steadily moving toward its goal of obtaining product approvals in major markets such as the United States, Europe, and China by 2028.
About MegaPro Biomedical:
MegaPro Biomedical (stock code: 6827) was established in 2014 as a spin-off from the Industrial Technology Research Institute (ITRI). It is a new drug technology company primarily engaged in the development of niche nanomedicine products. The Company owns two nanotechnology platforms—nanoparticles and micelles—and has developed nano iron oxide products. Its most advanced products are an injectable iron supplement for iron-deficiency anemia and a contrast agent for liver cancer imaging. MegaPro Biomedical’s product portfolio currently includes MPB-1514, an iron supplement for iron-deficiency anemia; MPB-1523, an MRI diagnostic contrast agent for hepatocellular carcinoma; MPB-2043, an MRI diagnostic contrast agent for lymph node staging; RegenTrace™ (MPB-2354), a cell therapy product; and MPB-1734, a new formulation anti-cancer drug.
For more information, please visit the Company’s official website: https://www.megaprobio.com/
Disclaimer:
Disclaimer: This document and the related information released concurrently contain forward-looking statements. Except for statements of historical facts, all statements regarding MegaPro Biomedical’s (hereinafter referred to as the “Company”) future business operations, possible future events, and outlook, including but not limited to forecasts, targets, estimates, and operating plans, are forward-looking statements. Forward-looking statements are subject to various factors and uncertainties that may cause actual results to differ materially, including but not limited to price fluctuations, actual demand, exchange rate changes, market share, market competition, changes in legal, financial, and regulatory frameworks, international economic and financial market conditions, political risks, cost estimates, and other risks and variables beyond the Company’s control. These forward-looking statements are based on current projections and assessments, and the Company undertakes no obligation to update them in the future.