Shinshin Pharmaceutical Nears Commercialization of First Improved Drug Based on Transdermal Drug Delivery Platform... "Entering Phase 3 Clinical Trials"

The development of Shinsin Pharmaceutical's first improved new drug, a transdermal drug delivery platform company, is accelerating. On the 28th, Shinsin Pharmaceutical announced that it is designing the domestic Phase 3 clinical trial protocol for ‘UIP-620,’ indicated for overactive bladder, and expects to receive IND (Investigational New Drug) approval by the end of the year.

Shinsin Pharmaceutical is selecting hospitals to conduct the domestic Phase 3 clinical trial of UIP-620 and is preparing patient recruitment procedures. The domestic Phase 3 trial of UIP-620 will be conducted at about 10 hospitals with a total of 500 patients. After completing the clinical trial preparation process, Shinsin Pharmaceutical plans to apply for IND around October and aims to enter clinical trials within the year.

UIP-620 is the fastest developing pipeline among Shinsin Pharmaceutical’s improved new drugs under development. If the Phase 3 clinical trial is successfully completed, it will become Shinsin Pharmaceutical’s first improved new drug and the first domestic transdermal treatment for overactive bladder. Furthermore, upon approval of UIP-620, the company will secure transdermal absorption technology, which can be applied to pipelines such as ‘SS-262’ and ‘TSM-001,’ indicated for insomnia and benign prostatic hyperplasia, accelerating pipeline development, the company explained.

Shinsin Pharmaceutical has long been a leader in the transdermal drug delivery system (TDDS) field, having developed and commercialized the first domestic topical agent. During the development of UIP-620, Shinsin Pharmaceutical increased the transdermal permeability and drug stability by using a permeation enhancer specialized for basic drugs, based on its proprietary TDDS technology, enhancing the fluidity of the drug within the matrix.

UIP-620, which applies Shinsin Pharmaceutical’s TDDS technology, demonstrated in the previous Phase 1 clinical trial that it has fewer toxicological concerns compared to a control drug with the same ingredient and that its efficacy can be rapidly manifested. Based on the excellent Phase 1 results, the Ministry of Food and Drug Safety exempted it from Phase 2 clinical trials, and it is now preparing for Phase 3.

A Shinsin Pharmaceutical official stated, “UIP-620 is the improved new drug closest to commercialization among our pipelines,” adding, “If the development of UIP-620 succeeds, it is expected to accelerate the development of other improved new drugs and secure additional pipelines.”

He continued, “UIP-620 maximizes drug delivery effectiveness and sustainability by utilizing TDDS technology secured through long-term research and development, and it is designed for long-term adhesion,” emphasizing, “We will continue to develop improved new drugs that apply transdermal formulations in the treatment of aging-related diseases to improve side effects and maximize patient convenience.”

Shinsin Pharmaceutical recorded sales of 92 billion KRW last year, a 24.2% increase compared to the previous year, and turned to a profit with an operating income of 5.4 billion KRW. This year, it is expected to easily achieve its sales target of 100 billion KRW. Based on steadily increasing performance in the over-the-counter drug sector, Shinsin Pharmaceutical plans to accelerate the development of new prescription drugs and leap forward as a new drug development company based on the TDDS platform.

Meanwhile, according to the pharmaceutical market research firm Ubist, the domestic overactive bladder treatment market reached 128 billion KRW as of 2021, and with the aging trend, the domestic production of adult diapers recorded 97.2 billion KRW last year, indicating continuous expansion of the related market.

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