Korea Pharma received the domestic bridging clinical study report (CSR) of its iron deficiency treatment, KP-01, and disclosed it on Monday.

The bridge clinical trial of KP-01 was conducted in Korea after the Ministry of Food and Drug Safety approved the investigational new drug (IND) application in the second half of 2022.

A bridge trial aims to confirm the efficacy and safety of a drug already tested and used in overseas clinical trials but needs domestic confirmation due to ethnic differences.

According to the study report, the company confirmed the pharmacokinetic properties and safety of KP-01. The single and repeated doses of KP-01 showed a significant increase in the body's iron absorption index, and the safety evaluation showed excellent safety and tolerability.

With the significant clinical trial results, Korea Pharma plans to accelerate the application for a domestic product license in the first half of this year.

"We have signed a contract with Shield Therapeutics in the U.K. to introduce KP-01 and have completed due diligence on the factory and production technology transfer," a company official said. "We expect to realize quick revenue once we obtain a marketing authorization."

If the domestic production of KP-01 is in full swing, Korea Pharma can serve as a production base that can be delivered to global markets, including the U.S. and Europe. As an iron deficiency drug approved by the U.S. FDA, sales will also be generated in overseas markets."

Korea Pharma's KP-01 is a chelating compound of trivalent iron ions that do not ionize in the gastrointestinal tract, improving gastrointestinal disorders, such as heartburn and constipation, which can occur when taking existing domestic iron deficiency anemia drugs. It showed anemia improvement in 12 weeks with low-dose iron administration and was safe for long-term administration for 64 weeks.