Innovent's Mazdutide, First Dual GCG/GLP-1 Agonist, Approved by China's NMPA for Weight Management

Innovent Biologics, Inc., a leading biopharmaceutical company, recently announced that China's National Medical Products Administration (NMPA) has given the green light to mazdutide, a novel dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, for managing weight in adults who are overweight or obese in China. This approval makes mazdutide the first drug of its kind globally to tackle weight loss, making use of a unique mechanism that boosts weight-loss effectiveness while reducing belly fat and providing other metabolic advantages. This drug was highlighted by Fierce Pharma as one of the most eagerly awaited drugs worldwide in 2025.

The rising rates of overweight and obesity in China pose a significant public health concern, prompting the National Health Commission in April 2025 to incorporate "Healthy Weight Management Action" into the "Healthy China 2030" initiative. This program aims to create supportive environments for effective weight control, increase public awareness, and encourage healthy lifestyles to counter the increasing obesity rates. With its approval, mazdutide aligns with these national health priorities and represents a significant milestone in the fight against obesity. Innovent is committed to making this drug accessible to a wide population in China.

Overweight and obesity are chronic conditions marked by excessive fat buildup, influenced by genetic, metabolic, environmental, and behavioral factors. Obesity elevates the risk for various diseases, including cardiovascular, cerebrovascular, endocrine disorders, and certain cancers, significantly impacting quality of life. More than 500 million adults in China are classified as overweight or obese, with nearly 90% of obese adults having related health conditions. The World Obesity Federation estimated obesity cost China about $283.3 billion in GDP losses in 2020. Given these societal burdens, obesity and related chronic diseases are pressing public health issues in China and globally.

Addressing the obesity crisis, national policies and clinical guidelines have emphasized the importance of structured outpatient weight management and early pharmacological intervention. The National Health Commission's "Notice on Effective Outpatient Settings and Management of Weight Management" supports developing optimized outpatient care models. Additionally, "Guidelines for the Diagnosis and Treatment of Obesity (2024 Edition)" recommend medications when lifestyle changes fail to meet weight loss goals. The "Guidelines for Long-term Weight Management and Clinical Application of Drugs for Obese Patients (2024 Edition)" advocates for early drug treatment in patients with obesity-related comorbidities.

Mazdutide’s approval is backed by strong clinical data from multiple high-impact journals. As the first marketed dual GCG/GLP-1 receptor agonist, mazdutide is recommended by various Chinese clinical guidelines due to its innovative mechanism and solid evidence base.

Mazdutide provides several metabolic benefits, particularly in weight management. It works through GCG receptors, primarily found in the liver, to inhibit fat synthesis and promote fat breakdown. The drug has shown substantial efficacy in reducing weight and liver fat content in overweight or obese adults.

The approval was largely based on data from the GLORY-1 study, a Phase 3 clinical trial in Chinese adults with excess weight or obesity. The study met all its primary and secondary endpoints in 2024, demonstrating superior weight reduction in participants compared to a placebo group. At 48 weeks, participants taking mazdutide showed significant reductions in body weight, waist circumference, and liver fat content.

Mazdutide addresses a critical unmet need in China, providing effective weight loss treatment while improving cardiometabolic health in overweight or obese adults. It holds potential to lessen the societal and economic burdens of obesity-related diseases.

Professor Linong Ji, the lead investigator of GLORY-1, emphasized the urgent need for effective and safe weight-loss therapies in China, given the high prevalence of obesity and related diseases. Dr. Lei Qian from Innovent Biologics highlighted mazdutide as a next-generation therapy developed with the expertise of leading endocrinology experts, reflecting its clinical value and safety.

Innovent Biologics, founded in 2011, is a prominent biopharmaceutical company committed to providing affordable, high-quality therapies for intractable diseases. The company has launched 16 products and maintains a robust pipeline of drugs in various stages of clinical development.