Innovent Announces Mazdutide, First Dual GCG/GLP-1 Receptor Agonist, Received Approval from China's NMPA for Chronic Weight Management

SAN FRANCISCO and SUZHOU, China, June 27, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, for chronic weight management in Chinese adults with overweight or obesity. Mazdutide is the world's first dual GCG/GLP-1 receptor agonist approved for weight loss, offering a unique mechanism that enhances weight-loss efficacy while reducing visceral fat and delivering comprehensive metabolic benefits, named by Fierce Pharma as one of the top ten most anticipated drugs globally in 2025.

The increasing prevalence of overweight and obesity in China poses an urgent public health challenge requiring immediate intervention. In April 2025, the National Health Commission officially included "Healthy Weight Management Action" in the "Healthy China 2030" initiative. Under the updated plan, the national health authorities aim to build supportive environments for effective weight management, raise public awareness and behavior skills, and promote healthy lifestyles to curb rising rates of overweight and obesity. Aligned with these national priorities and the 2025 weight management campaign, the approval of mazdutide represents a timely and important milestone. Aiming to be an innovative leader in the cardiovascular and metabolic (CVM) disease area, Innovent is committed to accelerating the delivery of this drug to benefit a broad population in China.

Scientific and effective treatment options for weight loss are urgently needed in China

Overweight and obesity are chronic metabolic diseases characterized by excessive fat accumulation in the body. The pathogenesis of overweight and obesity includes genetic, metabolic, environmental, and behavioral factors. Obesity can significantly increase the risk of various diseases, such as cardiovascular and cerebrovascular, endocrine, specific tumors, respiratory, reproductive, and skeletal diseases, and can seriously affect quality of life^[1]. In China, over 500 million adults live with overweight (BMI ≥ 24 kg/m² and ˂ 28 kg/m²) or obesity (BMI ≥ 28 kg/m²). Nearly 90% of obese adults have comorbidities, including metabolic dysfunction-associated fatty liver disease, which affects around 50% of adults with overweight and over 80% of adults with obesity. The World Obesity Federation (WOF) estimates that obesity costs China around US$283.3 billion in GDP loss in 2020^[2]. With such heavy societal burdens, obesity and related chronic diseases have become major public health concerns in China and around the world.

In response to the escalating obesity problem, several national policies and clinical guidelines have underscored the need for structured outpatient weight management and earlier pharmacological intervention. The National Health Commission's "Notice on Effective Outpatient Settings and Management of Weight Management" encourages the development of optimized outpatient care models. Additionally, "Guidelines for the Diagnosis and Treatment of Obesity (2024 Edition)" recommended pharmacotherapy when lifestyle interventions fail to meet weight loss goals. The "Guidelines for Long-term Weight Management and Clinical Application of Drugs for Obese Patients (2024 Edition)" issued by the Chinese Society of Endocrinology further advocates for initiating drug treatment early in patients with obesity-related comorbidities.

Mazdutide is supported by robust clinical data published in multiple high-impact journals, including Nature, the Lancet sub-journals, and the New England Journal of Medicine. As the first marketed dual GCG/GLP-1 receptor agonist , mazdutide has been recommended by multiple clinical guidelines in China^{[3],[4],[5],[6]} and expert consensus on obesity management on account of its innovative mechanism and solid evidence base.

Multiple metabolic benefits of mazdutide in supporting weight management

GCG receptors are mainly expressed in the liver, and GCG receptor agonism can inhibit hepatic fat synthesis and promote hepatic lipolysis. As a dual GCG/GLP-1 receptor agonist weight loss drug, mazdutide can deliver significant weight loss efficacy and metabolic benefits such as waist circumstance and liver fat content reductions to adults with overweight or obesity.

The approval of mazdutide was mainly based on data from GLORY-1, a Phase 3 pivotal clinical study conducted in Chinese adults with overweight or obesity. The primary endpoint and all key secondary endpoints of the study were successfully achieved in 2024. Results showed that at weeks 32 and 48, the percentage of body weight reduction from baseline and the proportions of participants with a body weight reduction of ≥5%，≥10% and ≥15% in the mazdutide 4 mg group and mazdutide 6 mg group were superior to those of the placebo group.

• Based on the efficacy estimand, at week 48, the mean percentage changes in body weight relative to baseline in the mazdutide 4 mg, mazdutide 6 mg, and placebo groups were −12.0%, −14.8%, and −0.5%, respectively;
• The proportion of participants with a body weight reduction ≥ 5% relative to baseline were 73.5%, 82.8%, and 11.5%, respectively; the proportion of participants with a body weight reduction ≥ 15% relative to baseline were 37.0%, 50.6%, and 2.1%, respectively;
• The mean changes in waist circumference relative to baseline were −9.5 cm, −11.0 cm, and −1.5 cm, respectively.
• In addition, mazdutide reduced liver fat content in adults with overweight or obesity. Among participants with baseline liver fat content ≥ 10%, the mean percent change from baseline in liver fat content to week 48 were −65.85%, −80.24%, and −5.27% in the mazdutide 4 mg, 6 mg, and placebo groups, respectively.

The results of GLORY-1 study have been presented at the American Diabetes Association (ADA) Annual Meeting and published in the New England Journal of Medicine, which have received widespread attention from industry experts and scholars.

Mazdutide addresses a critical unmet need in China by offering effective treatment for weight reduction while also improving cardiometabolic indicators in adults with overweight or obesity. Its use may help reduce the long-term societal and economic burdens associated with obesity-related diseases.

Professor Linong Ji, the Leading Principal Investigator of GLORY-1, Peking University People's Hospital, stated, "Obesity is a chronic disease that demands a coordinated societal response. With China facing a high prevalence of overweight and obesity, the associated cardiometabolic disease burdens continue to rise. There is an urgent need for weight-loss therapies that are both effective and safe, with proven cardiovascular and metabolic benefits. As the principal investigator of this novel dual GCG/GLP-1 receptor agonist with a unique mechanism of action, I'm proud to see our clinical results recognized by China's national regulatory authority and anticipate its subsequent approval for market launch. My fellow researchers and I hope mazdutide will become a valuable therapeutic option for Chinese adults with overweight or obesity."

Dr. Lei Qian from Innovent Biologics, stated, "Mazdutide represents the next-generation dual GCG/GLP-1 receptor agonist. Its clinical development has been made possible by pooling the collective expertise of leading endocrinology experts across China, and its successful approval reflects the NMPA's high recognition of its clinical value and safety. This milestone marks another breakthrough for Innovent in the cardiovascular and metabolic fields. We hope mazdutide will provide another therapeutic option for Chinese adults with overweight or obesity, improve their quality of life, and alleviate societal burdens. Centered on patient needs and innovation, Innovent has established and will continue to expand its rich CVM pipeline with mazdutide as a cornerstone product, aiming to continuously address the public's growing demand for health and quality of life and to serve more patients."

About Obesity/Overweight

Obesity is a chronic metabolic disease with complex causes, and it serves as a major risk factor for a range of diseases including diabetes, fatty liver disease, cardiovascular and cerebrovascular diseases, kidney disease, joint disorders, sleep-disordered breathing, and cancer. China has the world's largest population of individuals with overweight or obesity, a trend that is likely to rise^[7]. Obesity is associated with multiple comorbidities and is a major contributor to reduced life expectancy and quality of life. In 2019, overweight and obesity accounted for 11.1% of deaths from chronic non-communicable diseases in China, nearly doubling from 5.7% in 1990^[8].

Despite the chronic nature of obesity and its need for long-term management, treatment options remain limited. While lifestyle interventions remain the cornerstone of treatment, many patients struggle to achieve or maintain meaningful weight reduction. This underscores the urgent need for safe, effective, and sustainable pharmacological interventions.

About Mazdutide

Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide, a dual GCG /GLP-1 receptor agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, liver fat content and improved insulin sensitivity.

Mazdutide is approved by NMPA for chronic weight management in adults with overweight or obesity*; and mazdutide currently has another NDA accepted for review by NMPA, for glycemia control in adults with type 2 diabetes.

Mazdutide has currently conducted seven Phase 3 clinical studies, including:

• GLORY-1: A Phase 3 clinical study conducted in Chinese adults with overweight of obesity;
• GLORY-2: A Phase 3 clinical study conducted in Chinese adults with moderately to severely obesity;
• GLORY-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with overweight of obesity accompanied metabolic-associated fatty liver disease (MAFLD);
• GLORY-OSA: A Phase 3 trial in Chinese participants with obstructive sleep apnea (OSA) and obesity;
• DREAMS-1: A Phase 3 clinical study conducted in Chinese adults with untreated type 2 diabetes;
• DREAMS-2: A Phase 3 clinical study comparing mazdutide versus dulaglutide in Chinese adults with type 2 diabetes who have poor glycemia control with oral medication;
• DREAMS-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with type 2 diabetes and obesity;

Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints and the other four studies are currently ongoing.

In addition, several new clinical studies of mazdutide are initiated or planned, including:

• A Phase 3 trial in adolescents with obesity;
• New studies in patients with metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF).

*Mazdutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial Body Mass Index (BMI) of:

• BMI ≥ 28 kg/m² (obesity); or
• BMI ≥ 24 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, or obstructive sleep apnea syndrome and etc.).

About Innovent Biologics

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

REFERENCES

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