Semaglutide Enters MASH Treatment: China Approves Wegovy for F2–F3 Fibrosis: China NMPA | September 2026
What’s New?
China has approved semaglutide 2.4 mg (Wegovy) for adults with non-cirrhotic MASH and F2–F3 fibrosis, making it the first GLP-1 receptor agonist specifically approved for MASH in China.
Approval is supported by the phase III ESSENCE trial.
At week 72, MASH resolution without worsening fibrosis occurred in 62.9% vs 34.3% with placebo.
≥1-stage fibrosis improvement without worsening MASH occurred in 36.8% vs 22.4%.
Semaglutide simultaneously addresses several major metabolic drivers of MASH, including obesity and type 2 diabetes, with established cardiovascular benefits in relevant populations.
The MASH indication is specifically for non-cirrhotic F2–F3 disease.
Why Does It Matter?
MASH treatment is expanding beyond liver-directed antifibrotic therapy toward drugs capable of addressing liver disease and cardiometabolic risk together.
GastroAGI Takeaway
This is an important shift toward integrated metabolic–liver therapy. Semaglutide now has randomized phase III evidence and regulatory recognition for MASH with F2–F3 fibrosis in China. However, this indication should not be extrapolated to cirrhosis, and regulatory approval and reimbursement remain country-specific.