SEOUL — The pharmaceutical industry is witnessing an unprecedented wave of innovation in treating metabolic dysfunction-associated steatohepatitis (MASH), a notoriously difficult-to-treat liver disease. Following the commercial breakthrough of the world’s first approved MASH therapy, subsequent treatments developed by global and South Korean drugmakers are making major strides in mid-stage clinical trials.

A Blockbuster Market is Born

MASH, characterized by excessive fat accumulation in the liver leading to chronic inflammation, cell damage, and potentially fatal liver fibrosis or cirrhosis, has long posed a significant challenge for medical researchers.

The market dynamics shifted dramatically when Madrigal Pharmaceuticals launched Rezdiffra (resmetirom) in the United States. Acting as a liver-directed thyroid hormone receptor-beta (THR-β) agonist, the once-daily oral medication has proven its commercial viability. Market figures show Rezdiffra crossing the $1 billion threshold within the first three quarters, solidifying its status as a blockbuster drug roughly two years after its debut.

Meanwhile, Novo Nordisk’s blockbuster weight-loss therapy Wegovy (semaglutide) also secured a MASH indication in the U.S., using a systemic metabolic approach via GLP-1 receptor agonism. While both treatments received accelerated approval based on liver biopsy results showing inflammation resolution and fibrosis improvement, long-term confirmatory trials assessing clinical outcomes such as preventing cirrhosis or liver failure remain ongoing.

Korean Biotech Innovation Gains Global Spotlight

With the first wave of treatments paving the way, late-stage contenders have shared compelling clinical data at the American Association for the Study of Liver Diseases (AASLD) annual meeting. Korean pharmaceutical achievements have drawn notable attention from international investors.

Hanmi Pharmaceutical & MSD: Epinopegdutatide (MK-6024), a dual GLP-1 and glucagon (GCG) receptor dual-agonist licensed out to Merck (MSD) in 2020, met its primary endpoints in a 52-week Phase 2b clinical trial involving 381 patients with MASH and moderate-to-severe fibrosis (F2-F3). Patients receiving the 7mg dose demonstrated statistically significant improvements, with 63% achieving MASH resolution without worsening fibrosis (compared to 13% in the placebo group) and 52% showing at least a one-stage fibrosis improvement. Market analysts highlighted its competitive edge over existing therapies like semaglutide.
DandD Pharmatech: The company’s proprietary asset, Zaboprogdutatide (DD01), demonstrated comparable efficacy in a 48-week biopsy analysis. Among compliant participants, 50% achieved fibrosis improvement without worsening MASH, while 62.5% achieved MASH resolution without worsening fibrosis. The promising data earned DD01 a late-breaking abstract (LBA) oral presentation spot at the AASLD meeting for the second consecutive year, fueling expectations for potential global out-licensing deals.

The Road Ahead: Long-Term Efficacy and Differentiation

As an increasing number of pipeline candidates demonstrate success in tissue-level recovery, the competitive focus is shifting toward long-term therapeutic benefits. Proving the ability to halt disease progression into advanced conditions like cirrhosis or liver failure—and exploring potential combination therapies—will ultimately dictate the commercial success of emerging developers.

Other Korean pharmaceutical companies are also actively advancing their pipelines. Yuhan Corporation has resumed the clinical development of its MASH candidate YH25724 following its return from Boehringer Ingelheim, targeting domestic Phase 1 patient recruitment this year. Concurrently, OliX Pharmaceuticals has concluded repeat-dose Phase 1 trials in Australia for OLX702A, a candidate out-licensed to Eli Lilly, with subsequent Phase 2 developments anticipated under Lilly's purview.

As the trillion-won MASH market continues to expand, the industry's next frontier lies in demonstrating superior clinical safety, robust long-term outcomes, and differentiation in an increasingly crowded global landscape.

[ⓒ Global Economic Times. 무단전재-재배포 금지]