BPM’s Cross-Ethnic DKD Clinical Study Published in Top-Tier American Journal of Nephrology

Bio Preventive Medicine Corp. ("BPM", Stock Code: 6810) announced today the publication of the world’s first multinational, cross-ethnic, long-term clinical study integrating data from Taiwan and Europe. The research validates that DNlite-IVD103 can precisely prevent and monitor Diabetic Kidney Disease (DKD) in Type 2 diabetes. This groundbreaking study was officially published in the American Journal of Nephrology (AJN), a premier journal in the field of nephrology, and was co-correspondingly authored by Dr. Lee-Ming Chuang, a leading diabetes authority at National Taiwan University Hospital, and Dr. Stephen Bakker, a renowned kidney transplant expert at the University Medical Center Groningen (UMCG) in the Netherlands.

International Recognition from the World's Largest Healthcare Market

The American Journal of Nephrology is a highly rigorous, peer-reviewed, top-tier international journal focused on timely and hotly debated topics in basic science and clinical research. Papers accepted for publication undergo strict evaluation and debate by the editorial board, making them highly respected within the nephrology community. The publication of DNlite-IVD103’s research in AJN signifies that its scientific analysis and clinical data for the early prevention and monitoring of rapid renal decline have once again received international validation. Earning recognition from the medical community in the United States—the world's largest pharmaceutical market—not only strengthens DNlite-IVD103's global commercialization momentum but also serves as the ultimate stepping stone for its next phase: entering the US market.

Bridging the Gap in Current DKD Guidelines

Dr. Karen Tseng, Chairman and CEO of BPM, stated that historically, it was believed that diabetic kidney disease progressed linearly from normal to microalbuminuria, then macroalbuminuria, and ultimately to kidney failure. However, actual clinical practice paints a different picture. Furthermore, the estimated Glomerular Filtration Rate (eGFR) in some patients can drop rapidly and drastically to renal failure without any prior warning signs. In short, there is a critical management gap in the current clinical care guidelines for diabetic kidney disease.

The AJN paper, titled "Urinary Fetuin-A Fragments Predict Progressive eGFR Decline in Two Independent Type 2 Diabetes Cohorts of Different Ethnicities", reveals that even among diabetic patients who have normal albumin levels and are misclassified as "low risk," DNlite-IVD103 can detect the risk of kidney deterioration early. Crucially, this threshold (cut-off) can be directly applied to Caucasian populations. Dr. Tseng highlighted that this is the world's first cross-ethnic follow-up validation spanning over a decade, covering both Taiwanese and European populations, and conducted by regional Key Opinion Leaders (KOLs). This singular, outstanding achievement places BPM significantly ahead of its international competitors.

A Precision Diagnostic Tool with Established Regulatory Approvals

DNlite-IVD103 has already secured In Vitro Diagnostic (IVD) market authorizations in the European Union and Malaysia. It is the world's first ELISA test designed to prevent rapid renal decline. By non-invasively detecting urinary biomarkers, it can effectively predict and monitor the deterioration of a diabetic patient's kidney function over the subsequent 5 years. By integrating other clinical indicators, DNlite-IVD103 precisely stratifies DKD risk into low, medium, and high categories. It generates comprehensive reports offering tailored monitoring frequencies and care recommendations for physicians.

Seizing the US Opportunity and FDA Pathways

In late June, the U.S. FDA granted De Novo marketing authorization to UK-based Renalytix for its KidneyIntelX test for DKD detection and monitoring. KidneyIntelX utilizes blood biomarkers combined with key features from a patient's electronic health record. This milestone indicates that the FDA has begun to acknowledge that current DKD care guidelines fall short of patient needs and is actively establishing prognostic testing categories to assess CKD progression. This paradigm shift will lead global healthcare professionals and DKD patients into a new era of disease management—and provides a perfect strategic window for DNlite-IVD103 to re-enter the US market.

The diabetic population in the US stands at approximately 37 million, with the government spending over $114 billion annually on related medical expenditures. To elevate care quality and reduce healthcare burdens, the US government has been actively promoting the transformation of kidney disease care to achieve early prevention and detection.

Following the guidance of regulatory consultants, BPM will initiate communications with the FDA to restart the marketing authorization application process in the US market. Concurrently, BPM will pursue strategic partnerships with US healthcare companies to commercialize DNlite-IVD103, aiming to capture massive new opportunities in the co-management of diabetic kidney disease.

Reference:「Urinary Fetuin-A Fragments Predict Progressive eGFR Decline in Two Independent Type 2 Diabetes Cohorts of Different Ethnicities」：https://karger.com/ajn/article/doi/10.1159/000534514/864551/Urinary-Fetuin-A-Fragments-Predict-Progressive