Yuhan Corporation Receives Approval for Phase 1 Clinical Trial of MASH Therapy 'YH25724' in Korea

Patient Recruitment Planned Within the Year

Yuhan Corporation is set to begin a Phase 1 clinical trial in Korea for its investigational therapy for metabolic dysfunction-associated steatohepatitis (MASH), 'YH25724'. The company is resuming the development of this pipeline in-house after it was returned following an out-licensing deal in 2019.

Yuhan Corporation 100th Anniversary Emblem. Yuhan Corporation

On May 29, Yuhan Corporation announced that it had received approval from the Ministry of Food and Drug Safety for the Phase 1 investigational new drug (IND) application of 'YH25724' for the treatment of MASH.

YH25724 is a dual-acting biological drug candidate targeting both fibroblast growth factor 21 (FGF21) and glucagon-like peptide-1 (GLP-1). The drug incorporates Yuhan Corporation’s protein engineering technology and Genexine’s long-acting antibody fusion platform, known as 'HyFc'.

Preclinical studies have demonstrated improvements in steatohepatitis, anti-fibrotic effects, as well as reductions in hepatocellular injury and liver inflammation. MASH is a stage of fatty liver disease characterized by inflammation and liver cell damage, presenting a high risk of fibrosis.

This Phase 1 clinical trial will be the first in humans conducted in Korea, and will include both a single-dose and a 12-week multiple-dose part in adult participants. Yuhan Corporation plans to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) characteristics.

Yeol Hong Kim, Head of R&D at Yuhan Corporation, stated, "We plan to assess safety and tolerability across various doses and to explore the potential for preliminary proof of concept based on pharmacodynamic indicators," adding, "We aim to begin recruiting clinical trial participants within the year."

YH25724 is a pipeline that was out-licensed to the German pharmaceutical company Boehringer Ingelheim in 2019. The rights were returned in 2025, and Yuhan Corporation is now pursuing independent development. Boehringer Ingelheim previously conducted three Phase 1 clinical trials to assess safety and PK/PD characteristics.

According to the official website of the European Association for the Study of the Liver (EASL) 2026, the results of Boehringer Ingelheim’s Phase 1 clinical trials for YH25724 are scheduled to be presented at the annual scientific conference being held in Spain this month.

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