APRINOIA Therapeutics is advancing into the early diagnosis market for dementia. On June 25, company founder Ming-Kuei Jang stated that the presence of Tau protein is highly correlated with neurodegeneration and disease progression, making it a gold standard for early diagnosis. APRINOIA’s lead imaging agent, APN-1607, enables visualization of Tau protein deposition in the brain and is currently undergoing regulatory review in Taiwan, China, the United States, and Japan. Taiwan may become the first market to approve the product.

Originally planning to go public in the U.S. last year, APRINOIA withdrew its IPO due to unfavorable market conditions and has since restructured into two core business units. The diagnostics unit, approaching commercialization, is being prepared for an IPO in Taiwan as early as next year, while the therapeutics division remains focused overseas, with strategic partnership discussions currently underway.

Jang emphasized that dementia is not a single disease, but encompasses various subtypes such as Alzheimer’s disease, frontotemporal dementia (as in the case of Bruce Willis), and Lewy body dementia (which affected Robin Williams). Accurate differentiation of these conditions requires imaging to observe abnormal protein distributions in the brain.

He further explained that Tau protein is the key biomarker for early diagnosis. While amyloid-beta may begin accumulating before Alzheimer’s symptoms appear, Tau is directly linked to neuronal damage and symptom progression, making it a critical indicator for determining when to initiate treatment.

After a decade of development and over $100 million in investment, APRINOIA successfully created the world’s first PET imaging agent targeting Tau protein—APN-1607. The product has undergone large-scale clinical studies involving over 4,600 subjects and has been featured in more than 70 peer-reviewed scientific publications. Regulatory submissions are underway in multiple countries.

According to Jang, APN-1607 is currently under review as a diagnostic product in Taiwan, China, the U.S., and Japan, with clinical data collected from more than 350 patients. In China, the final patient enrollment for clinical trials has been completed, and the company is now working with distributors and regulators to evaluate the path for market approval. In Taiwan, safety and efficacy data have been submitted to the Ministry of Health and Welfare, and the product is expected to be among the first of its kind to gain approval locally.

To address limited imaging resources for early screening, APRINOIA is also collaborating with Japan’s QST to co-develop a portable, head-mounted PET scanner. This innovation is expected to significantly lower the barriers to early screening and help expand access to dementia diagnostics.

Resource: 新旭攻失智症早期診斷商機