India Pharma Outlook Team | Thursday, 10 September 2026
Novo Nordisk gains a clear edge in the global race to treat MASH after China clears Wegovy as the first GLP-1 receptor agonist for this progressive liver disease.
Novo Nordisk announced on September 10 that Chinese regulators authorized the medicine for metabolic dysfunction-associated steatohepatitis.
The company says the decision extends Wegovy’s proven benefits from weight management and cardiovascular health into liver health.
The move follows the drug’s earlier accelerated approval in the United States and strengthens Novo’s position as the first company to secure this indication in a major market with a large population at risk of obesity-related liver disease.
MASH is a progressive form of fatty liver disease linked to metabolic dysfunction. Until recently, treatment options remained extremely limited. Wegovy, already widely used for weight loss, now carries formal approval for the liver indication in both the US and China, giving Novo an early regulatory lead.
Novo frames the China approval as a logical extension of existing data rather than an entirely new scientific finding. The US Food and Drug Administration granted accelerated approval in August 2025 on the basis of Part 1 of the Phase 3 ESSENCE trial.
In that study, Wegovy improved liver fibrosis without worsening steatohepatitis in 37 percent of patients compared with 22 percent on placebo. It also resolved steatohepatitis without worsening fibrosis in 33 percent of patients versus 16 percent on placebo after 72 weeks.
Chinese authorities have now accepted this evidence base and authorized the same molecule as the first GLP-1 therapy for MASH in the country.
Also Read: 10 GLP-1 Drugs Revolutionizing Diabetes & Obesity Treatment
The China MASH approval lands in a market already defined by intense rivalry between Novo Nordisk and Eli Lilly. In India, Lilly’s Mounjaro (tirzepatide) recorded Rs 1,256 crore in sales over the 12 months ending August 2026 and became the country’s top-selling pharmaceutical brand.
Tirzepatide now commands roughly three-quarters of the injectable GLP-1 market by value and 62 percent of the overall GLP-1 segment. India’s total GLP-1 market has expanded almost 15-fold since August 2022 to reach Rs 2,333 crore, showing how quickly patient demand is shifting toward weekly injectables.
Lilly has committed an additional USD 4.5 billion to expand its Indiana sites, while Novo is increasing capacity at its Athlone facility in Ireland, especially for oral GLP-1 products. At the same time, US employers are reassessing coverage: about 14 percent have already dropped or plan to drop GLP-1 weight-loss coverage in 2027, and overall employer coverage has fallen from 72 percent in 2025 to 60 percent in 2026.
These dynamics create a dual challenge for Novo. The company must defend its multi-indication franchise, including the new China MASH label, while competing against Lilly’s rapid commercial momentum, expanding manufacturing footprint, and push into oral formulations.
The broader GLP-1 market is growing fast, yet cost concerns and incomplete patient response rates remain real constraints that both firms must navigate as they seek to convert regulatory wins into sustained market leadership.
Leading Indian pharmaceutical companies, including Sun Pharma, Dr. Reddy’s Laboratories, Zydus Lifesciences and Torrent Pharma, have already moved from planning to active commercialization of semaglutide.
After securing approvals from the Central Drugs Standard Control Organization, they launched lower-cost generic versions in multi-dosage vials, pre-filled injection pens and oral tablets following the expiry of Novo Nordisk’s patent in India on March 20, 2026.
A widening global approval footprint for Wegovy in MASH, including the latest China clearance, now raises the commercial stakes around the molecule still further. Stronger evidence and additional geographic labels make the originator product more entrenched.
This could influence how these Indian firms time further regulatory submissions, scale manufacturing and position their products for both weight-management and potential future liver indications. The development also keeps pressure on Indian regulators to clarify pathways for innovative and biosimilar versions of GLP-1 therapies that address metabolic complications beyond obesity alone.
For patients, the approval expands access to a therapy that can address both excess weight and progressive liver damage. For the industry, it marks another step in the contest to define the standard of care for MASH.
