[Asia Economy Reporter Hyunseok Yoo] Mediphron Divity announced on the 24th that it completed the submission of supplementary materials to the Ministry of Food and Drug Safety on the 23rd for the approval of the product license of the ‘Alzheimer's Disease Early Diagnosis Auxiliary Medical Device’ (hereinafter referred to as the ‘early diagnosis device’), developed jointly with Quantamatrix.
Mediphron is developing Alzheimer's dementia treatments, early diagnosis devices, and non-narcotic analgesics as its main pipelines. In particular, the company has strategically focused on developing the early diagnosis device and concentrated its capabilities so that it can serve as a ‘cash cow’ before the commercialization of the dementia treatment it is developing.
A company official stated, “Currently, Alzheimer's disease diagnosis mainly uses expensive imaging equipment called ‘Amyloid PET’ or cerebrospinal fluid tests through lumbar puncture, but both methods have raised issues such as high costs and concerns about side effects. However, the early diagnosis device jointly developed by Mediphron and Quantamatrix only requires a simple test with a small amount of blood, and it is significantly cheaper than PET, offering excellent price competitiveness.” He added, “In the future, early screening and disease prediction are expected to reduce medical costs and have preventive effects.”
The company plans to apply for ‘New Medical Technology Certification’ immediately after the product license approval of the early diagnosis device is obtained. Among Mediphron’s main pipelines, the topical non-narcotic analgesic (MDR-652) also plans to accelerate clinical development by completing the submission of supplementary materials for IND approval of Phase 1 clinical trials within May.
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