Yuhan Corporation is accelerating its new drug development by launching domestic clinical trials of its candidate treatment for metabolic dysfunction-associated steatohepatitis (MASH).
Yuhan announced Wednesday that it has received approval from the Ministry of Food and Drug Safety for an Investigational New Drug (IND) application to conduct a Phase 1 clinical trial in Korea of its MASH treatment candidate "YH25724." The trial marks the first domestic clinical study of YH25724 and will be conducted on adults using single-dose and 12-week repeat-dose regimens. The company plans to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) characteristics through the trial.
YH25724 is a biologic drug candidate that simultaneously acts on fibroblast growth factor 21 (FGF21) and glucagon-like peptide-1 (GLP-1). The candidate incorporates Yuhan's proprietary protein engineering technology along with Genexine's long-acting antibody fusion platform "HyFc." According to Yuhan, preclinical studies confirmed that the dual action of FGF21 and GLP-1 produced effects including improvement of steatohepatitis, anti-fibrosis, and reduction of hepatocyte damage and liver inflammation.
"Through this Phase 1 clinical trial, we plan to evaluate safety and tolerability across various dosing levels in Korean patients and explore the possibility of preliminary proof-of-concept based on pharmacodynamic indicators," said Kim Yeol-hong, President of R&D at Yuhan. "We expect to begin recruiting trial participants within this year."
YH25724 was licensed out to Boehringer Ingelheim in 2019 before its rights were returned in 2025, after which Yuhan has continued in-house development. Boehringer Ingelheim had previously confirmed safety, tolerability, and PK/PD characteristics through three Phase 1 trials. According to the official website of the European Association for the Study of the Liver (EASL) 2026, the clinical results are scheduled to be presented at the conference in Spain in May.
