[Featured Stock] Shinshin Pharmaceutical, Solving Insomnia Worries with a Patch... World's First Treatment Project Completed

Shinshin Pharmaceutical is showing strong performance. The news that it has completed a government-funded project to develop a sleep-inducing patch containing melatonin and is preparing to submit an Investigational New Drug (IND) application for Phase 1 clinical trials appears to be influencing its stock price.

At 10:43 AM on the 1st, Shinshin Pharmaceutical was trading at 5,530 KRW, up 23.3% from the previous day.

Shinshin Pharmaceutical aims to obtain approval for SS-262 within this year and complete Phase 1 clinical trials next year. In 2021, Shinshin Pharmaceutical was selected for a bio-medical technology commercialization government project by the Seoul Business Agency and is developing SS-262 for insomnia as the indication. The project’s main goal is to complete preclinical trials of SS-262 and submit the Phase 1 clinical trial application by August 31.

Through the government project, Shinshin Pharmaceutical has nearly completed the preclinical procedures for SS-262 development and is designing the Phase 1 clinical trial protocol. If Phase 1 is approved, the drug’s safety will be evaluated in a small number of healthy adults.

Based on its research and development capabilities in the transdermal drug delivery system (TDDS) field, Shinshin Pharmaceutical has reduced the drug delay time and increased absorption for SS-262. They expect that the TDDS technology will solve the drug crystallization and stability issues found in existing melatonin-based treatments.

Shinshin Pharmaceutical holds two registered patents related to the development of SS-262. The patented technologies are “transdermal absorption formulation containing melatonin” and “transdermal absorption formulation for treating sleep disorders.”

A Shinshin Pharmaceutical representative stated, "If SS-262 is commercialized, it will become the world’s first patch-type prescription drug for treating insomnia," and added, "New drugs based on the transdermal drug delivery platform are expected to create synergy effects in research and development of other pipelines through the technologies secured during the development process."

He continued, "Shinshin Pharmaceutical is currently exporting melatonin-based patch products to the North American market," and added, "Additional exports will be possible upon the development of SS-262." Furthermore, he noted, "The U.S. insomnia treatment market had already surpassed 1 trillion KRW in 2019, making it a highly notable market."

Shinshin Pharmaceutical is a pioneer in the transdermal drug delivery system (TDDS) field, having developed and commercialized the first topical patch in Korea. The company is currently designing the Phase 3 clinical trial protocol for ‘UIP-620,’ indicated for overactive bladder, and expects to receive IND approval by the end of the year. Shinshin Pharmaceutical recorded sales of 92 billion KRW last year, a 24.2% increase compared to the previous year. Operating profit turned positive at 5.4 billion KRW. The company is also expected to achieve its sales target of 100 billion KRW this year.

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