Novo Nordisk Submits Semaglutide for MASH Indicator in China

On March 3, 2026, Novo Nordisk announced that it had submitted a new marketing application for semaglutide injection in China, which is proposed for priority review.

The new indication is intended for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH) accompanied by moderate to severe hepatic fibrosis, specifically adult non-cirrhotic patients with F2–F3 stage.

Global Impact of Semaglutide

Novo Nordisk’s flagship drug semaglutide, FDA-approved in August 2025 for non-cirrhotic MASH with moderate-to-severe hepatic fibrosis (plus diet/physical activity), has filed in China. Based on partial ESSENCE trial data (weekly 2.4mg injection), it showed statistically significant hepatic fibrosis improvement and steatohepatitis resolution vs. placebo.

Clinical Trial Results

Phase 1 results of the ESSENCE trial showed the following key outcomes at Week 72:

• 36.8% of patients in the semaglutide group achieved “improvement in hepatic fibrosis with no worsening of steatohepatitis”, versus 22.4% in the placebo group.
• 62.9% of patients achieved “resolution of steatohepatitis with no worsening of hepatic fibrosis”, versus 34.3% in the placebo group.

These data confirm semaglutide’s significant efficacy in treating MASH and associated hepatic fibrosis, establishing its unique position in this field. To date, semaglutide remains the only GLP-1 therapy approved for MASH.

Sales Performance of Semaglutide

Semaglutide has delivered strong sales as Novo Nordisk’s blockbuster drug.

In 2022, total sales of semaglutide reached 228.288 billion Danish kroner (approximately USD 34.6 billion), accounting for 73.9% of the company’s total revenue.

Its three major versions performed as follows:

• Ozempic (injectable for glycemic control): 127.089 billion DKK (USD 19.267 billion), up 10% year-on-year.
• Rybelsus (oral for glycemic control): 22.093 billion DKK (USD 3.349 billion), down 2% year-on-year.
• Wegovy (for weight management, injectable and oral): 79.106 billion DKK (USD 11.992 billion), up 41% year-on-year.

Competition and Prospects in the Chinese Market

Novo Nordisk’s core compound patent for semaglutide in China is set to expire on March 20, 2026, which will intensify competition in the Chinese market.
According to Insight data, 10 domestic semaglutide products are already filed for marketing, including developers such as Chia Tai Tianqing, CSPC Pharmaceutical Group, Fosun Wanbang, Betta Pharmaceuticals, and Huisheng Biotech. Another 11 domestic semaglutide candidates are in Phase III clinical trials.Following patent expiration, these domestic products are expected to enter the market rapidly and compete fiercely for market share in the coming years.

Conclusion

As Novo Nordisk continues to expand semaglutide’s indications and promote its global adoption, the drug will further strengthen its leading position in diabetes, weight management, MASH and other therapeutic areas.

Meanwhile, the rapid progress of domestic semaglutide products, especially intense competition in China, will accelerate product innovation and reshape the market landscape in this therapeutic field.