Wegovy Becomes First GLP-1 Receptor Agonist Approved in China for MASH With Moderate-to-Severe Fibrosis
核心洞察
China's National Medical Products Administration (搜索) approved Novo Nordisk's Wegovy for non-cirrhotic adults with MASH and moderate-to-severe liver fibrosis (搜索), the first GLP-1 receptor (搜索) agonist cleared for this indication in China.
The approval expands Wegovy's indications beyond weight management and cardiovascular health into liver disease, where treatment options have long been limited to lifestyle changes.
Novo Nordisk's four core semaglutide products generated about USD 17.5 billion in combined first-half sales, and the new MASH indication could further boost commercial performance.
China's National Medical Products Administration (搜索) (NMPA) has approved Novo Nordisk's Wegovy for the treatment of non-cirrhotic adults with metabolic dysfunction-associated steatohepatitis (搜索) (MASH) accompanied by moderate to severe liver fibrosis (搜索), the Copenhagen-based company announced on Sept. 10. The decision makes Wegovy the first glucagon-like peptide-1 (GLP-1) receptor agonist approved in China to treat MASH, an inflammatory form of fatty liver disease (搜索), and extends the drug's indications from weight management and cardiovascular health into liver disease.
A First-in-Class Regulatory Milestone in China
The approval positions semaglutide, the active ingredient in Wegovy, as the first GLP-1 receptor (搜索) agonist cleared for a MASH indication in the Chinese market. GLP-1 receptor agonists were initially developed to treat diabetes but have evolved into a widely used class of weight loss drugs globally. Among the best-known agents in this class are Novo Nordisk's semaglutide, sold as Ozempic and Wegovy, and Eli Lilly's tirzepatide, marketed as Mounjaro and Zepbound.
Addressing a High-Burden Liver Disease
MASH involves fat buildup and inflammation in the liver and is increasingly common in China. According to Novo Nordisk, approximately one-third of Chinese adults have fatty liver disease (搜索), and prevalence reaches 82 percent among those who are overweight or obese. Drug treatment options for fatty liver disease have long been limited in clinical practice, with lifestyle changes remaining the main treatment approach, said Jia Jidong, director of the Liver Research Center at Beijing Friendship Hospital, Capital Medical University. The Wegovy approval provides patients with a new treatment option, he said.
Commercial Stakes and Competitive Landscape
The new indication could further boost the commercial performance of Novo Nordisk's blockbuster product. Novo Nordisk markets four core semaglutide products globally: the injectable diabetes drug Ozempic, the oral diabetes medicine Rybelsus, and injectable and oral versions of Wegovy. The four products generated about USD 17.5 billion in combined sales in the first half of this year, according to the company's financial report.
In China, Novo Nordisk faces competition not only from Eli Lilly but also from domestic drugmakers including Innovent Biologics (搜索) and Hengrui Pharmaceuticals (搜索), which have joined the race for the GLP-1 receptor (搜索) agonist market. Novo Nordisk is therefore actively seeking approval for additional semaglutide products and indications. On Aug. 27, the company announced that its application to the NMPA to market oral Wegovy in China for long-term weight management had entered the review process.