[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 Note
A revolutionary change in the treatment of Alzheimer's disease is imminent. Expensive brain imaging tests, which previously required a two-month wait, are now on the verge of being replaced by simple blood draws. Intravenous (IV) infusion therapies, which tied patients to hospitals for one hour every two weeks, are about to be replaced by self-injections that can be completed in just 15 seconds. As the physical, spatial, and temporal limitations of diagnosis and treatment are eliminated, the target population for therapy is expanding from dementia patients to ordinary people who have no symptoms yet but are at risk. However, the infrastructure to conduct these tests, clear criteria to screen out false positives, and systematic methods of distributing costs are not yet in place. The Asia Business Daily examines the emerging paradigm shift in dementia treatment and how we should prepare for it.

① Testing Takes Two Months, Administration Takes an Hour: A Sea Change Is Coming to Treatment Sites

② Blood Tests and SC Formulations: 'Door of Opportunity' Opening for K-Bio

③ Surging Demand Expected Amid Challenges Related to 'False Positives and Reimbursement'

The phosphorylated tau protein (p-tau217), a standard biomarker, is emerging as a core area of competition in the Alzheimer's blood testing market. While global companies have taken the lead by securing antibodies, reagents, and dedicated equipment to measure p-tau217, domestic companies are attempting to enter the market by measuring the same biomarker using their own antibodies and analysis devices.

According to the industry on September 9, the number of FDA-approved Alzheimer's blood tests has increased to four since May last year, when Fujirebio's Lumipulse was approved. Of these, two products were co-developed by Roche and Eli Lilly. The Elecsys p-tau217, approved last month, is the first test to use a single biomarker to assess amyloid pathology in the brain.

P-tau217 refers to the modified 217th amino acid position of the tau protein, which supports neural cells. When amyloid accumulates in the brain, p-tau217 is released into the bloodstream, allowing for the assessment of amyloid accumulation without the need for brain imaging. Because amyloid-targeting therapeutics only work in patients with amyloid buildup in the brain, identifying eligible patients is a prerequisite for treatment. As this can now be determined with just a blood test, pharmaceutical companies have been quick to adopt these assays.

Pharmaceutical companies are using blood tests to confirm amyloid pathology in participants during clinical trials for amyloid-targeting therapeutics. By first screening patients with blood tests and then administering positron emission tomography (PET) scans only to those who need them, they can reduce both costs and procedural complexity. In Korea, there is also ongoing discussion about using p-tau217 in relevant clinical practice guidelines.

Korean companies are pioneering the market with differentiated biomarkers. PeopleBio has commercialized "AlzOn," which measures the abnormal aggregation of amyloid protein. QuantaMatrix has developed "AlzPlus," which simultaneously measures four biomarkers involved in amyloid generation and inhibition. AlzPlus has received item approval from the Ministry of Food and Drug Safety and has undergone a New Health Technology Assessment. It is currently used as a non-reimbursed service.

However, an important challenge remains: accumulating clinical evidence for tests using new biomarkers. This is because there is relatively little evidence tied to international clinical guidelines or large-scale clinical studies. As a result, domestic companies are also working to develop tests that use their own technology to measure standardized biomarkers such as p-tau217. Some companies are comparing the results derived from their devices to existing test or PET scan results to demonstrate clinical efficacy. An official from a Korean diagnostic company said, "The accumulation of international evidence that medical professionals refer to will ultimately be for standard biomarkers. Without securing tests measuring these standard biomarkers, it will be difficult to survive in the long run."

The adoption of overseas tests is also underway. LabGenomics is working with Daewoong Bio to introduce Fujirebio's Lumipulse in Korea and is also running a contract testing business through its U.S. subsidiary, QDx Pathology. Kang Sung-hoon, director of the Alzheimer's Prevention Center at Korea University Guro Hospital, predicted, "Although many companies are entering, the market will ultimately be reorganized around a small number of tests that offer both clinical efficacy and cost/accessibility advantages."

Key Challenge for SC Injection: Formulation Technology to Overcome the 2ml Barrier

Competition over formulations has also begun in the therapeutic arena. "Rekemvi iClick," the subcutaneous injection (SC) formulation of Rekemvi, is delivered using an auto-injector once per week, requiring only about 15 seconds to administer. In July, the FDA expanded its approval from just maintenance therapy to include the initial treatment phase as well, based on demonstrated similarity in drug exposure to the intravenous formulation. Rekemvi iClick increases the antibody concentration without utilizing a dispersion enzyme; the drug is formulated at 200mg per ml, with 250mg divided into two doses of 1.25ml each. The conventional maximum volume for subcutaneous administration, without special technology, is generally 2ml; Rekemvi iClick stays within this limit.

Technology to address the 2ml per-injection limit for subcutaneous administration is emerging as a key entry point for Korean companies. First, formulation technology to increase drug concentration and thus reduce volume is highlighted. However, as higher concentrations make the drug more viscous, technology for auto-injectors that can handle such viscosity is also required. In addition, dispersion enzymes that temporarily loosen subcutaneous tissue and thus increase the possible injection volume are gaining attention.

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

Domestic formulation platform company Alteogen is expected to establish its presence with a platform employing dispersion enzymes. Using hyaluronidase-type enzymes, this technique promotes the diffusion of drugs in subcutaneous tissue, enabling larger injection volumes. Until now, such technology has mainly been used to convert high-dose anticancer therapies to subcutaneous injections. Recently, its range of applications has expanded to autoimmune diseases. An Alteogen representative said, "For central nervous system disorders administered via injection and requiring higher doses, our technology can be used to formulate subcutaneous injections."

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