Shinshin Pharmaceutical Leads Domestic Microneedle Development... "Will Enter Overseas Markets After First Commercialization of Pharmaceuticals in Korea"

Transdermal drug delivery platform company Shinshin Pharmaceutical announced on the 14th that it conducted a technology exchange at a microneedle seminar for members of the Korea Pharmaceutical Technology Research Association.

The seminar was attended by factory managers, research directors (CTOs), heads of development departments from domestic pharmaceutical companies, and executives who are currently pharmacists. Woo-Young Lee, head of Shinshin Pharmaceutical’s research institute and an expert in the TDDS (Transdermal Drug Delivery System) field, presented Shinshin Pharmaceutical’s proprietary microneedle technology at the seminar and shared the development status of pipelines of domestic and international companies with the attendees. He emphasized the necessity of developing microneedle formulations in terms of expanding the portfolio of transdermal drugs and the growth potential of related markets both domestically and internationally.

Shinshin Pharmaceutical is developing microneedle pharmaceuticals based on accumulated TDDS technology in transdermal formulations. To maximize drug delivery efficacy, the company independently developed microsphere technology that reduces the particle size of poorly soluble drugs and converts them into an amorphous form. They have also established technological barriers through patent applications related to bioavailability enhancement and microneedle compositions.

Based on the secured microsphere technology, Shinshin Pharmaceutical is accelerating the commercialization of the country’s first microneedle pharmaceuticals. According to the guidelines for developing soluble microneedle pharmaceuticals established by the Ministry of Food and Drug Safety (MFDS) at the end of last year, the company plans to design standards and test methods to obtain rapid approval. Shinshin Pharmaceutical recently completed process setting for producing soluble microneedle pilot products through collaboration with Nicomedical and is currently conducting tests with prototypes.

A Shinshin Pharmaceutical official stated, “First- and second-generation transdermal formulations have a high residual drug amount in the skin and a long drug absorption delay time, and there are limitations in the delivery process of peptide drugs. Therefore, the development of third-generation microneedles, the next-generation formulation, is necessary to improve these issues,” adding, “Through the commercialization of the country’s first microneedle pharmaceuticals, we will contribute to adding microneedle formulations to the Korean Pharmacopoeia.”

He continued, “In addition to the formulation registration of microneedles, we plan to consult with the MFDS regarding the ‘Korean Good Manufacturing Practice (KGMP)’ for pharmaceuticals,” and added, “After selling microneedle pharmaceuticals domestically, we plan to supply microneedle pharmaceuticals to global markets such as Japan.”