Yuhan said on the 29th that it received approval from the Ministery of Food and Drug Safety for an investigational new drug (IND) application for a phase 1 clinical trial in Korea of YH25724, a candidate treatment for metabolic dysfunction-associated steatohepatitis (MASH).
YH25724 is a novel biologic candidate that acts simultaneously on the fibroblast growth factor 21 (FGF21) and glucagon-like peptide-1 (GLP-1) receptors, and incorporates Yuhan's proprietary protein engineering technology and Genexine's long-acting antibody fusion platform "HyFc."
After being out-licensed in 2019 to C. H. Boehringer Sohn AG & Co. KG and returned in 2025, Yuhan has been developing it in-house.
In prior preclinical studies, dual action of FGF21 and GLP-1 was shown to improve steatohepatitis, produce antifibrotic effects, and reduce hepatocyte injury and liver inflammation.
The approved phase 1 trial is the first clinical study of YH25724 in Korea and consists of a single-dose part and a 12-week multiple-dose part in adults. The company plans to evaluate safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles in this study.
Kim Yeolhong, Yuhan's head of research and development (R&D), said, "Through this phase 1, we plan to assess safety and tolerability across various dose levels in Koreans and explore the potential for preliminary proof of concept based on pharmacodynamic endpoints," adding, "We plan to begin recruiting participants within the year."