Shinshin Pharmaceutical Establishes Global Entry Barriers for Microneedle Drugs... "International Patent Application"

Transdermal drug delivery platform company Shinshin Pharmaceutical announced on the 23rd that it has completed the international patent application under the PCT (Patent Cooperation Treaty) for technology to load biopharmaceuticals onto microneedles.

The technology for which the international patent was filed this time relates to a composition for coating peptide drugs onto microneedles. By coating peptide drugs, it becomes possible to load biopharmaceuticals, which are currently administered via injections, onto microneedles. Shinshin Pharmaceutical has succeeded in improving the drug release duration of peptide components.

To enter the global microneedle pharmaceutical market, Shinshin Pharmaceutical proceeded with the PCT application following a domestic patent application in January. Microneedles are attracting attention as a next-generation transdermal formulation that can overcome the drawbacks of injectable formulations such as pain and infection risk, and improve the low bioavailability of oral formulations. Although many pharmaceutical companies worldwide are developing microneedle pharmaceuticals, there are no commercialized cases yet.

Shinshin Pharmaceutical is currently promoting domestic commercialization in accordance with the recently established guidelines for microneedle pharmaceuticals by the Ministry of Food and Drug Safety (MFDS). To rapidly obtain approval for microneedle pharmaceuticals, the company is conducting production process setup and tests to prove physicochemical equivalence. The company explained that it will also target the global market alongside domestic microneedle pharmaceutical development.

A Shinshin Pharmaceutical official said, “We are expanding TDDS (transdermal drug delivery system) technology to develop microneedle pharmaceuticals and have completed international patent applications following domestic ones to establish technological entry barriers in the global market. Through the patented technology, drugs previously administered via injectable formulations, such as obesity treatments, can be applied to microneedles, so we expect high market potential.”

He added, “Using this technology, we will accelerate the development of a soluble microneedle-based universal arthritis treatment that recently began development. Furthermore, we are pushing forward with the commercialization of the first domestic microneedle pharmaceutical, and as non-clinical trials are nearing completion, we expect to enter the full-scale approval process soon.”

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