[Asia Economy Reporter Jang Hyowon] Medipron's stock price is on the rise following the news that the advanced entry and post-evaluation system for all in vitro diagnostic devices will be fully implemented in the first half of this year.
As of 10:54 AM on the 16th, Medipron is trading at 4,090 KRW, up 4.2% compared to the previous day.
Medipron, a new drug development bio company, developed a dementia diagnostic kit (QPLEX Alz Plus Assay) that can assist in confirming the accumulation of amyloid beta in the brain through joint research and development with the in vitro diagnostic device company Quantametrics, and obtained product approval from the Ministry of Food and Drug Safety in July last year.
Currently, clinical trials are being conducted at Seoul National University Hospital and Samsung Medical Center, and based on the results, an application for new medical technology evaluation was planned. With the implementation of the 'advanced entry and post-evaluation' system, rapid market launch of the product is now possible, and direct benefits are expected.
The 'advanced entry and post-evaluation' system for in vitro diagnostic devices is a system by the Ministry of Food and Drug Safety that temporarily allows sales of new medical devices approved for product licensing to enable rapid market entry, and later supports normal sales through performance and product evaluation. Previously, even after passing MFDS approval, new medical technology evaluation was required.
An official from the Korea Health Industry Development Institute stated, "We are also consulting with the Health Insurance Review and Assessment Service to ensure that products launched during the advanced entry and post-evaluation period can receive health insurance coverage."
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