On May 21, Aribio announced that it has established a foundation to become a leading company in the global Alzheimer's market, following the U.S. Food and Drug Administration (FDA)'s world-first approval of Fujirebio's blood-based Alzheimer's diagnostic test, Lumipulse, alongside its own oral therapeutic, AR1001.
The technology approved by the FDA detects Alzheimer's disease at an early stage by measuring the ratio of 'tau protein (pTau217)' to 'beta-amyloid protein (1-42)' in plasma. This is a groundbreaking method that can replace the existing high-cost positron emission tomography (PET) scans or invasive cerebrospinal fluid (CSF) tests. In particular, Lumipulse can automatically process 120 samples per hour, increasing its utility in hospitals and research institutions. Clinical trials involving 499 patients with cognitive impairment demonstrated a positive predictive value (PPV) of 91.7% and a negative predictive value (NPV) of 97.3%, thereby proving its diagnostic accuracy.
An Aribio representative stated, "This is more than just an approval of a diagnostic technology. It signifies the arrival of an era in which early Alzheimer's diagnosis can be achieved with a single drop of blood." The company added, "This will become a turning point, establishing Alzheimer's screening as a routine procedure much like cholesterol or diabetes testing." Furthermore, Aribio explained, "The Alzheimer's treatment market has the potential for explosive growth, and the demand for AR1001 is expected to increase rapidly in line with this trend."
A particularly noteworthy aspect of this approval process is the strategic partnership between Fujirebio and Aribio. A significant portion of the blood and cerebrospinal fluid samples used in the Lumipulse diagnostic evaluation was obtained from participants in AR1001 clinical trials. This demonstrates that Aribio's clinical design and data quality met the standards required by the FDA.
A company official emphasized, "Aribio has moved quickly by designing both diagnostics and therapeutics together, demonstrating differentiated competitiveness in the market compared to big pharma. The fact that Fujirebio selected our new drug development and clinical infrastructure as an official channel clearly establishes Aribio's position in the future dementia market, where diagnostics and therapeutics will be integrated."
Aribio is actively conducting a global Phase 3 clinical trial (POLARIS-AD) involving more than 1,150 participants across major countries, including the United States, Europe, China, and Korea, with final results expected to be announced in 2026. AR1001 is an oral Alzheimer's therapeutic belonging to the PDE5 inhibitor class, and it suppresses disease progression through multiple mechanisms, including neuroprotection, inhibition of tau protein hyperphosphorylation, and increased cerebral blood flow.
If early diagnostic environments like Lumipulse become widespread, demand for early-stage oral therapeutics such as AR1001 is expected to increase sharply. In particular, ease of administration and a differentiated mechanism of action are anticipated to be key factors driving market share expansion.
An Aribio representative stated, "The FDA approval of Lumipulse is a milestone that will change the paradigm in both Alzheimer's diagnosis and treatment. Through the synergy between AR1001's robust clinical data and diagnostic technology, we will grow into a platform company that encompasses both diagnosis and treatment in the global market." The representative further emphasized, "This strategic partnership is a symbolic case demonstrating that a technology-based new drug development company can rival major pharmaceutical companies, going beyond simple product collaboration."
Meanwhile, Aribio is currently pursuing a merger with listed company Solux, accelerating its transformation into a comprehensive bio company based on both diagnostic and therapeutic pillars.
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