China’s National Medical Products Administration (NMPA) has approved mazdutide, the world’s first GCG/GLP-1 receptor agonist for chronic weight management. The once-weekly injectable is under development by Innovent Biologics and has a license from Eli Lilly. It is for patients who suffer from being overweight or obese.
Mazdutide Breaks into a New Class
Unlike single-target weight-loss drugs, mazdutide acts on both GLP-1 and glucagon receptors. Correspondingly, this dual mechanism suppresses appetite while increasing energy expenditure, boosting weight loss more effectively.
As a result, mazdutide represents a significant step beyond earlier GLP-1-only therapies like semaglutide.
The drug also goes by the names of IBI362 or LY3305677. It’s officially the first of its kind globally to gain approval for obesity.
Multiple Research from Clinical Trials
The approval follows robust results from the Phase 3 GLORY-1 study in China. In the 48-week trial, patients taking 6 mg of mazdutide lost 14.8% of body weight on average. Meanwhile, those on 4 mg lost 12%, compared with just 0.5% for placebo recipients.
Additionally, more than 80% of those on the 6 mg dose achieved at least 5% weight loss. In contrast, early 51% of these patients saw their weight drop by 15% or more on the 4 mg dose. Overall, these results underscore the drug’s potential for meaningful clinical impact.
Moreover, liver fat content dropped by over 80% in high-dose users, further supporting the drug’s metabolic benefits.
Mazdutide Ushers New Era for Obesity
This milestone approval marks the first time a GCG/GLP-1 dual agonist has reached the market. Until now, obesity therapies have focused on appetite control, not metabolic acceleration. Thus, mazdutide introduces a new class of treatments that may outperform current options.
Furthermore, China’s obesity burden adds urgency to this innovation. According to national data, excess body weight contributed to 11% of all noncommunicable disease deaths in 2019. Notably, this figure has doubled since 1990, intensifying the need for effective therapies.
Mazdutide Competition and Expansion
It was in 2019 when Innovent licensed mazdutide from Lilly in 2019, hence holding Chinese rights. Meanwhile, Lilly retains global development and commercialization rights.
With this approval, mazdutide enters a fast-growing market, competing with Novo Nordisk’s Wegovy and Lilly’s Zepbound. Both received approval in China in mid-2024.
Even so, mazdutide’s novel mechanism may give it a competitive edge, especially among patients with treatment-resistant obesity. Hence, Innovent plans to launch it quickly and explore approval for type 2 diabetes, using separate Phase 3 data.
Industry Response and Next Steps
Dr. Lei Qian, Senior VP of Innovent, welcomed the approval. “We hope mazdutide will provide another therapeutic option for Chinese adults [who are overweight or have] obesity improve their quality of life, and alleviate social burdens.”
Looking ahead, dual and even triple receptor agonists are likely to dominate the next wave of obesity drug development. With mazdutide, China positions itself at the forefront of this global trend.
Conclusion
Mazdutide’s approval marks a critical shift in how obesity may be treated—by combining appetite control with enhanced energy burning. As this new drug reaches patients, it may redefine therapeutic standards both in China and globally.
Photo: Freepik
