Korean Pharma Applies to MFDS for Clinical Trial Plan of Iron Deficiency Treatment 'KP-01'

[Asia Economy Reporter Lee Gwan-joo] Korea Pharma announced on the 12th that it has submitted an Investigational New Drug (IND) application for the iron deficiency treatment 'KP-01' to the Ministry of Food and Drug Safety.

KP-01 is a trivalent iron ion chelate compound that does not ionize in the gastrointestinal tract, improving gastrointestinal side effects such as heartburn and constipation that may occur with existing domestic iron deficiency anemia treatments. It has received approval from the U.S. Food and Drug Administration (FDA) to be prescribed for iron deficiency regardless of anemia status. It shows significant anemia improvement effects within 12 weeks with low-dose iron administration and has secured safety even with long-term administration over 64 weeks.

Korea Pharma signed a licensing agreement for KP-01 with Shield Therapeutics in the UK last August, conducted a factory inspection in November, and then negotiated technology transfer for production. Korea Pharma plans to apply for product approval after completing bridging clinical trials. Bridging clinical trials are studies conducted on Koreans to verify efficacy and safety differences due to racial factors for drugs already tested and used overseas.

A Korea Pharma official stated, "This IND application is part of the process for KP-01's product approval," adding, "This treatment will not only drive domestic sales growth but also, through high-quality production technology, become a production base for KP-01 sold in the U.S., Europe, and other markets."

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