[Special Stock] Mediphron Receives MFDS Approval for Dementia Diagnostic Kit... 'Applicable to High-Risk Groups'

[Asia Economy Reporter Hyungsoo Park] Mediphron Divity, a new drug development bio company, is showing strong performance. The news that the 'in vitro diagnostic medical device that helps confirm the accumulation of beta-amyloid in the brain' (dementia diagnostic kit), developed jointly with Quantamatrix, a specialized in vitro diagnostic device company, has received product approval from the Ministry of Food and Drug Safety (MFDS) appears to have influenced the stock price.

At 9:14 AM on the 22nd, Mediphron is trading at 5,390 KRW, up 12.06% from the previous day. After hitting the daily price limit the day before, it has maintained a sharp rise for two consecutive days.

The dementia diagnostic kit approved by the MFDS measures multiple biomarkers in the blood to confirm the accumulation of beta-amyloid in the brain, which serves as an indicator for Alzheimer's disease diagnosis. This combines Mediphron's proprietary technology related to biomarkers with Quantamatrix's multi-marker diagnostic platform technology.

CEO Nogiseon of Mediphron introduced, "The dementia diagnostic kit overcomes the limitations of single blood biomarkers by measuring multiple biomarkers and applying a unique algorithm to determine the accumulation of beta-amyloid in the brain."

He added, "Unlike existing products that target severe dementia patients, this kit can be applied not only to patients with cognitive impairment but also to asymptomatic high-risk groups (elderly), differentiating it from existing diagnostic technologies."

Mediphron and Quantamatrix plan to promptly complete the ongoing new medical technology evaluation process to accelerate the market launch of the dementia diagnostic kit. The new medical technology evaluation is a system conducted by the Korea Health Industry Development Institute under the Ministry of Health and Welfare, separate from the MFDS product approval, to assess newly developed innovative medical devices like the dementia diagnostic kit. Passing this evaluation will allow it to be the first dementia diagnostic kit to be marketed domestically. The kit has also received export approval from the MFDS, raising expectations for entry into the global dementia market as well as the domestic market.

Mediphron expects that selling the diagnostic kit will serve as a cash cow because it is cheaper and more convenient than existing diagnostic methods. They plan to create a virtuous cycle by reinvesting in expanding new pipelines, including the clinical phase 1 trial of a non-narcotic analgesic and dementia therapeutics, as well as collaborating with NewMice, the world's first developer of atherosclerosis diagnostic and therapeutic agents.

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