[New Paths in Dementia Treatment]② Blood Tests and SC Formulations: "Opening the Door of Opportunity" for K-Bio

Domestic Diagnostics Companies Take On p-tau217 Standardization

Limits to Differentiated Biomarkers: Securing Clinical Evidence Is Critical

Transition to Subcutaneous Injection Draws Attention to High-Concentration Formulations and Dispersio

Editor's NoteA groundbreaking shift is imminent in Alzheimer's disease treatment. Expensive brain imaging tests—which previously required a two-month wait—could soon be replaced by simple blood draws, while intravenous infusion therapies that tied patients to hospitals for an hour every two weeks may soon give way to subcutaneous self-injections completed in just 15 seconds. When the physical, spatial, and temporal barriers to diagnosis and treatment are overcome, the eligible recipients will expand from patients already suffering from dementia to include the general population who are asymptomatic but at risk. However, there is still a lack of testing infrastructure to support this change, no established criteria for filtering out false positives, nor a reimbursement system to share costs. The Asia Business Daily examines how the paradigm shift in dementia treatment is unfolding and what preparations are required.

① Drastic Changes Ahead: Two-Month Testing and Hour-Long Administration in Current Treatment Sites

② Blood Tests and Subcutaneous Formulations: A 'Window of Opportunity' for K-Bio

③ Amid Soaring Demand: The Issues of 'False Positives and Reimbursement'

The phosphorylated tau protein (p-tau217), a standard biomarker, is emerging as the key competitive axis in the Alzheimer's disease blood test market. While global companies have taken the lead by launching antibodies, reagents, and specialized equipment to measure p-tau217, domestic companies are entering the market by using their own antibodies and analyzers to measure the same biomarker.

According to industry sources on September 9, the U.S. Food and Drug Administration (FDA) has approved four Alzheimer's blood tests, starting with Fujirebio's Lumipulse in May of last year. Of these, two are jointly developed by Roche and Eli Lilly. The recently approved Elecsys p-tau217 is the first test to assess brain amyloid pathology using a single biomarker.

p-tau217 is a modified version of the tau protein at position 217, which supports neural cells. When amyloid builds up in the brain, it is released into the blood; by measuring its concentration, amyloid accumulation can be assessed without the need for brain imaging. Because amyloid-targeting therapies are effective only in patients with brain amyloid buildup, identifying eligible patients is a prerequisite for treatment. As this determination can now be made with just a blood draw, pharmaceutical companies have been quick to adopt these tests.

Pharmaceutical companies are using blood tests to confirm amyloid pathology among clinical trial participants for amyloid-targeted therapies. Instead of conducting positron emission tomography (PET) scans on all patients, a blood test is first used for primary screening, followed by PET for selected cases, thereby reducing costs and streamlining procedures. In Korea, the use of p-tau217 in clinical guidelines is also under discussion.

Domestic companies are pioneering the market with differentiated biomarkers. PeopleBio has commercialized 'AlzOn,' which measures abnormal aggregation of amyloid protein. QuantaMatrix has developed 'AlzPlus,' which simultaneously measures four markers involved in amyloid production and inhibition. AlzPlus is currently being used as a non-reimbursable item, having received product approval from the Ministry of Food and Drug Safety and passing the new health technology assessment.

However, the challenge with tests using new biomarkers is accumulating sufficient clinical evidence, as they are less established in international guidelines and large-scale clinical studies. As a result, domestic companies are also developing tests that measure standard biomarkers such as p-tau217 using their own technology. Some companies are validating the clinical effectiveness of their results by comparing measurements from their own devices with existing tests or PET results. An official at a Korean diagnostics company said, "What ultimately becomes the reference for healthcare providers are the standard biomarkers. In the long run, it will be difficult to survive without securing tests that measure these standards."

International test adoption is also underway. LabGenomics is working with Daewoong Bio to introduce Fujirebio's Lumipulse to the Korean market, while also operating a contract testing business through its U.S. subsidiary, QDx Pathology. Kang Sunghoon, director of the Alzheimer's Disease Prevention Center at Korea University Guro Hospital, commented, "Many companies are entering the market, but it will eventually consolidate around a few tests that offer clinical effectiveness, reasonable pricing, and accessibility."

Formulation Technologies to Overcome the 2 ml Subcutaneous Injection Barrier

Competition over formulations is also heating up in Alzheimer's treatments. Rekemvi iClick, the subcutaneous formulation of Rekemvi, is administered once a week with an auto-injector and takes about 15 seconds to deliver. In July, the FDA expanded its approval from only maintenance therapy to include initial treatment. This was based on confirmation that it offers drug exposure similar to intravenous administration. Instead of using a diffusion enzyme, Rekemvi iClick achieves a higher antibody concentration. The drug is formulated at 200 mg per milliliter and administered in two doses of 1.25 ml (250 mg total). With 2 ml being the physiologically feasible injection volume without additional technology, the formulation keeps administration within this limit.

The technology to address the roughly 2 ml limit for subcutaneous injection is expected to be an entry point for domestic companies. Key approaches include formulation techniques to concentrate the drug and reduce its volume. As higher concentrations increase the solution's viscosity, making injection more difficult, advancements in auto-injector technology to handle this challenge are also essential. Diffusion enzymes, which temporarily loosen subcutaneous tissue and thereby allow for a greater injectable volume, are attracting attention as well.

Rekemvi iClick, the subcutaneous (SC) formulation of the Alzheimer's disease treatment Rekemvi. Eisai

Korean formulation platform company Alteogen is expected to establish its position with a platform that utilizes diffusion enzymes. By using hyaluronidase enzymes to assist in drug diffusion within subcutaneous tissues, the maximum injectable volume can be increased. Until now, this technique has mostly been applied to the subcutaneous delivery of high-dose cancer drugs, but its scope is expanding to cover autoimmune diseases. An Alteogen representative said, "Our technology can also be used to create subcutaneous formulations for drugs administered in large doses by injection, even for central nervous system diseases."

This content was produced with the assistance of AI translation services.