Mazdutide Injection Approved as China’s First Dual-Action Metabolic Agonist Targeting GLP-1 and GCG

The National Medical Products Administration (NMPA) has officially approved the marketing application for Mazdutide Injection (brand name: Xin Er Mei). The drug is a Class 1 innovative therapy developed by Innovent Biologics (Suzhou) Co., Ltd.

💉 Mazdutide injection is a next-generation metabolic modulator designed for long-term weight management in adults.

Its approval marks a major milestone in China’s progress in obesity and metabolic disease treatment.

✨ This new therapy offers patients a more effective and scientifically advanced option for managing overweight and obesity.

Mazdutide Injection—Long-Term Weight Management for Adults with Overweight or Obesity

Mazdutide Injection is approved for long-term weight management in combination with dietary control and increased physical activity.

It is indicated for:

• Adults with BMI ≥ 28 kg/m² (obesity)
• Adults with BMI ≥ 24 kg/m² (overweight) and at least one weight-related comorbidity

(including hyperglycemia, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea, etc.)

👱 With the continued rise in obesity prevalence and related comorbidities in China, the launch of Mazdutide is expected to meet the increasing clinical demand for safer, more effective, and sustainable weight-management therapies.

Key Features: Dual-Target Mechanism Unlocks Stronger Metabolic Benefits

Mazdutide injection is a GLP-1/GCG dual receptor agonist jointly developed by Innovent Biologics and Eli Lilly.

As an analogue of oxyntomodulin (OXM), Xinermei activates two critical metabolic pathways, giving it a unique advantage in weight control and systemic metabolic improvement.

Mechanism of Action

• GLP-1 receptor activation
  Enhances insulin secretion, suppresses appetite, slows gastric emptying, and reduces energy intake.
• GCG receptor activation
  Increases energy expenditure and enhances lipid metabolism, amplifying weight-loss efficacy and improving hepatic fat metabolism.

Advantages Over Traditional GLP-1RA Therapies

Compared with single-target GLP-1 receptor agonists, Mazdutide demonstrates:

• Dual synergistic action through simultaneous GLP-1 and GCG receptor activation
• Potential for greater weight-loss efficacy
• Broader metabolic improvements, including better glycemic control, lipid profile optimization, and reduction in liver fat
• Convenient dosing regimen, improving treatment adherence

🌐 As global obesity and metabolic disease research moves toward multi-target incretin therapies, the approval of Mazdutide signals China’s entry into the world’s leading tier of metabolic drug innovation.

Robust Clinical Evidence

The approval of Mazdutide is supported by a solid body of clinical evidence.

👉 Four Phase III registration studies are currently underway in China, targeting overweight/obese populations (GLORY-1, GLORY-2) and adults with type 2 diabetes (DREAMS-1, DREAMS-2).

In January, Innovent Biologics announced that the first Phase III trial in overweight or obese adults—GLORY-1—successfully met all primary and key secondary endpoints.

GLORY-1 Study Overview

• Multicenter, randomized, double-blind, placebo-controlled Phase III trial
• 610 participants randomized to Mazdutide 4 mg, 6 mg, or placebo
• 48-week evaluation period

Key Findings

• Significant reduction in body weight at Week 32, with further improvement by Week 48
• Higher proportions of participants achieving ≥5%, ≥10%, and ≥15% weight loss vs. placebo
• Meaningful improvements in:
  • Waist circumference
  • Systolic blood pressure
  • Triglycerides and LDL-C
  • Total cholesterol
  • Uric acid
  • Liver enzymes

Safety

✅ Mazdutide demonstrated favorable tolerability, with no new safety signals identified throughout the study period.

Clinical Development Progress: Expanding into Multiple Metabolic Disease Areas

In addition to obesity management, Mazdutide injection is being actively explored for broader therapeutic applications.

Ongoing or Planned Research Areas

• Long-term weight management studies, including real-world evidence in Chinese populations
• Treatment of type 2 diabetes (T2DM)
• Non-alcoholic fatty liver disease (NAFLD/NASH)
• Cardiometabolic outcomes trials (CVOT)
• Studies on obesity-related complications (e.g., OSA, dyslipidemia)

With accumulating clinical evidence, Mazdutide is positioned to become one of the most promising “full-spectrum metabolic management” therapies in China, with potential expansion into global markets.

Conclusion

The official approval of Mazdutide Injection represents a significant milestone in China’s treatment landscape for obesity and metabolic diseases.

🔬 As a next-generation multi-target metabolic therapy, Mazdutide not only shows strong potential in weight management but also opens new possibilities for treating chronic metabolic conditions associated with obesity.

As clinical research continues to advance, Mazdutide is expected to demonstrate broader clinical value across obesity, diabetes, fatty liver disease, and multiple metabolic disorders.

🙂 As an industry platform committed to tracking metabolic disease research trends, DengYue Medicine will continue to follow the clinical progress and latest findings of Mazdutide and other innovative therapies, providing professional and timely insights for the industry and the public.