Yuhan Corporation announced on May 29 that it has received approval from the Ministry of Food and Drug Safety for its clinical trial plan (IND) for the MASH treatment candidate 'YH25724'. The drug targets metabolic dysfunction-associated steatotic liver disease (MASH), which is gaining attention as a next-generation growth area following obesity treatments, with an estimated 440 million patients worldwide.
YH25724 is a dual-action biopharmaceutical candidate that simultaneously targets fibroblast growth factor 21 (FGF21) and glucagon-like peptide-1 (GLP-1). It utilizes Yuhan's protein engineering technology and Genexine's long-acting antibody fusion platform (HyFc). Preclinical studies have shown improvements in fatty liver, anti-fibrotic effects, and reductions in hepatocyte damage and inflammation.
This clinical trial marks the first phase of YH25724's domestic testing. It will be conducted on adults with a single dose and a 12-week repeated dosing regimen. The company plans to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the drug.
Kim Yeol-hong, head of R&D at Yuhan Corporation, stated, "We plan to confirm safety and tolerability across various doses and explore preliminary proof of concept. We expect to begin recruiting clinical trial participants within the year."
* This article has been translated by AI.
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