Ginkgo biloba extract has been confirmed as a potential inhibitor of beta-amyloid aggregation, which is known as a major cause of Alzheimer’s dementia.

Professor Yang Young-soon of the Department of Neurology at Soonchunhyang University Cheonan Hospital (Insurance Director, Korean Dementia Association) presented study results confirming the oligomerization-inhibiting effect of Ginkgo biloba extract through amyloid PET scans at a media roundtable hosted by the Korea Medical & Bio Press Association held on 18 May at the Korea Press Center in Jung-gu, Seoul.

The study was conducted on patients with mild cognitive impairment (MCI) who had tested positive on amyloid PET scans. The research team observed and compared, over an 18-month period, a group administered Ginkgo biloba extract and a control group administered conventional cognitive enhancers.

As a result, the group receiving Ginkgo biloba extract showed a tendency toward suppression of beta-amyloid deposition, which is known as a causative substance of dementia. The study is considered significant in that, unlike previous biomarker-based studies, it directly confirmed the degree of amyloid plaque deposition in the brain by using amyloid PET imaging. The study was recently published in the international journal “Journal of Alzheimer’s Disease.”



AriBio announced that it has signed an exclusive licensing agreement with China’s Fosun Pharma for the global development, approval, manufacturing, and commercialization of its oral Alzheimer’s disease drug candidate “AR1001.” The deal is valued at a total of USD 4.7 billion (approximately KRW 7 trillion), making it the largest licensing agreement in the field of Alzheimer’s therapeutics in the history of Korea’s bioindustry.

AriBio will first receive an option fee of USD 60 million (approximately KRW 90 billion), and an additional USD 80 million upon the topline announcement of Phase 3 clinical trial results, for a total upfront payment of USD 140 million (approximately KRW 210 billion). The company has also secured milestone payments tied to approval and commercialization stages, as well as royalties of up to around 20%.

AR1001 is a disease-modifying, oral Alzheimer’s disease treatment candidate belonging to the PDE-5 inhibitor class. A global Phase 3 clinical trial involving more than 1,500 patients is currently under way in the United States, Europe, China, Korea and other regions.

The company stated, “This agreement goes beyond a simple technology transfer and represents recognition of the global new drug development capabilities of a Korean biotech company.”



Stem cell specialist Miracell announced that it has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its stem cell extraction system “Smart M-Cell” and its dedicated kits (BSC Blood Kit and BmSC Bone Marrow Kit). This marks the first time a Korean stem cell extraction system has received FDA 510(k) clearance.

Miracell explained that it obtained clearance for an integrated “single-set configuration” that combines equipment and consumables, thereby simultaneously gaining recognition for its technological capabilities and safety. The FDA 510(k) process is a stringent certification procedure that requires not only substantial equivalence to previously approved products but also scientific proof of safety and effectiveness.

The company stated that Smart M-Cell is designed to minimize cell damage while stably extracting high-concentration stem cells, and that it enables the consistent acquisition of cells of uniform quality regardless of the operator’s level of experience.

Leveraging this clearance, Miracell plans to accelerate the establishment of its US subsidiary and its penetration of the local market. Miracell Chairperson Shin Hyun-soon said, “We will enhance our competitiveness in the global regenerative medicine market by combining FDA-verified technology with our AI platform.”

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