[Market Focus] Sorouks Rises on FDA Approval of Fujirebio Alzheimer's Blood Test... Spotlight on Collaboration with Aribio

Sorouks is showing strong performance. This is believed to be influenced by the news that the 'Lumipulse' blood test, developed by Fujirebio Diagnostics, has received official approval from the U.S. Food and Drug Administration (FDA).

As of 9:24 a.m. on May 19, Sorouks was trading at 3,765 KRW, up 3.86% from the previous day.

According to foreign media reports, on May 16 (local time), the FDA officially approved the 'Lumipulse' blood test developed by Fujirebio Diagnostics. Lumipulse diagnoses the accumulation of amyloid plaques in the brain by measuring the concentrations of two proteins in plasma that are associated with Alzheimer's disease.

Alzheimer's disease is the most common cause of dementia. It is characterized by the abnormal accumulation of amyloid proteins in the brain, which form plaques and lead to the destruction of nerve cells, resulting in a gradual decline in cognitive function. Currently, amyloid deposition is recognized as a key pathological mechanism, and early detection of this process is considered crucial for diagnosis.

Until now, diagnosis of Alzheimer's disease has largely relied on high-cost and complex imaging tests or invasive procedures, such as cerebrospinal fluid analysis via lumbar puncture, magnetic resonance imaging (MRI), and computed tomography (CT). In particular, lumbar puncture involves pain and a risk of infection, which has posed a significant burden for patients.

In contrast, Lumipulse is a test that requires only a simple blood draw. As a result, it is expected to significantly improve accessibility and utility in clinical settings. The FDA stated that this approval will provide a faster and easier diagnostic pathway, especially for patients admitted to specialized treatment centers with signs of cognitive decline.

Meanwhile, Aribio announced on April 28 that it had successfully provided Fujirebio with plasma and cerebrospinal fluid (CSF) samples from patients in the AR1001 Phase 3 clinical trial, achieving a milestone necessary for dementia biomarker development.

Fujirebio is a global leader in the field of high-quality in vitro diagnostics (IVD). The company is focused on developing biomarkers for pathological evaluation of amyloid, the main cause of Alzheimer's disease. Over the past 25 years, Fujirebio has led the commercialization of innovative neurodegenerative disease biomarkers, and in May 2022, it received the first FDA approval for an Alzheimer's in vitro diagnostic method.

Aribio has completed the recruitment and enrollment of more than 1,150 early Alzheimer's disease patients in the AR1001 global Phase 3 clinical trial (POLARIS-AD). Through this, the company has extensively collected plasma and cerebrospinal fluid samples from participants during and after the 52-week treatment period, establishing a global-scale sample biobank.

Aribio is currently pursuing a merger with Sorouks. The merger date for the two companies is set for August 1.