Mazdutide 9mg Supplementary Application Accepted for Review by China's NMPA, Potentially Offering a Novel Drug Option for Moderate-to-Severe Obese Population

SAN FRANCISCO and SUZHOU, China, Nov. 25, 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, and ophthalmologic diseases, announces that the supplementary application for the 9 mg dosage of mazdutide, an innovative glucagon (GCG)/ glucagon-like peptide-1 (GLP-1) dual receptor agonist, for the long-term weight management in adults with moderate to severe obesity has been accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). This application of mazdutide 9 mg aims to address a pressing unmet clinical need in China by offering a highly effective and safe new treatment option for adults with moderate-to-severe obesity, beyond current standard-of care metabolic and bariatrics surgery.

This application is based on the encouraging results from the Phase 3 registration clinical study GLORY-2 (NCT06164873) of mazdutide 9 mg in Chinese adults with moderate to severe obesity. The study met its primary endpoints and all key secondary endpoints. [Link]

• At Week 60, participants in the mazdutide group exhibited continuous weight loss, with no plateau observed. The mazdutide 9 mg group achieved a mean weight reduction of 18.55%, compared to 3.02% in the placebo group. 44.0% of participants in the mazdutide 9 mg group achieved a weight reduction of 20% or more, versus 2.6% in the placebo group (P<0.0001 for all comparisons).
• The key secondary endpoints also demonstrated that mazdutide 9 mg achieved a weight loss of up to 20.08% at Week 60 among participants without type 2 diabetes, with the weight loss trend not yet reaching a plateau by the end of the study. Furthermore, nearly half (48.7%) of the non-diabetic participants achieved weight loss exceeding 20% (placebo: 3.1%; P<0.0001).
• Additionally, the study observed that mazdutide 9 mg significantly reduced liver fat content, with a mean percent reduction from baseline of 71.9%, and also demonstrated significant improvements in other key cardiometabolic endpoints, including blood pressure, blood lipids, and serum uric acid, as well as significant reduction in waist circumference.
• Mazdutide 9 mg exhibited a favorable safety profile, with no new safety signals identified.
• Detailed data from the GLORY-2 study, which met all its endpoints, are planned for disclosure at future international academic conferences or in scientific publications.

Professor Linong Ji, the leading principal investigator of the study, Peking University People's Hospital, stated, "In China, individuals with severe obesity (BMI > 32.5 kg/m²) face a substantial disease burden but have very limited treatment options. According to current Chinese clinical guidelines, metabolic surgery is recommended as a first-line treatment for such patients. However, the invasiveness of the procedure and patient apprehension significantly limit its widespread clinical application. The potent weight loss efficacy demonstrated by mazdutide 9 mg in the GLORY-2 study positions it as a highly promising alternative to metabolic surgery, potentially filling a major clinical gap. Its benefits across multiple metabolic parameters highlight the unique advantages of dual GCG/GLP-1 activation. The acceptance of this application marks the potential addition of another breakthrough therapy for the management of moderate to severe obesity in China, bringing new hope for improving the health of this population."

Dr. Lei Qian, Chief R&D Officer of General Biomedicine of Innovent, stated, "Mazdutide 9 mg is currently the only GLP-1 receptor agonist that achieves over 20% weight loss in obese adults without T2D after 1 year of treatment with just a 2-step dose titration. Its development provides evidence-based medical support for effective weight management in Chinese patients with moderate-to-severe obesity, offering an alternative to metabolic surgery. We are delighted that the supplementary application for mazdutide has been accepted. Our strategic portfolio—ranging from 2mg-4mg-6mg targeting the broad overweight/obese population, to the 3 mg-6mg-9mg dosage now targeting the severely obese population—is built upon profound scientific insight and clear market needs. It is designed to provide a 'stratified,' personalized solution precisely tailored to the treatment goals and clinical needs of obese patients at different levels of disease severity. Innovent will continue to strategically build our next-generation product pipeline in the cardiovascular and metabolic (CVM) field, and help people's pursuit of a healthy life."

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.

Innovent has currently conducted or completed seven Phase 3 clinical studies of mazdutide, 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;
• 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;
• 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.

Among these, the first five Phase 3 clinical studies have all met their primary endpoints, while the remaining two Phase 3 studies are still ongoing.

In addition, several clinical studies of mazdutide are ongoing in adolescents with obesity, patients with metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF) etc.

Mazdutide has earned widespread recognition supported by robust data set. Its Phase 2 clinical trial in Chinese subjects with overweight or obesity was selected by Nature Communications as one of the 50 most important studies in translational and clinical research and highlighted as Editor's Choice. Additionally, mazdutide was listed among the "Top 10 Most Anticipated Drug Launches of 2025" by the FIERCE Pharma.

Furthermore, clinical findings on mazdutide have been featured in top-tier international journals such as The New England Journal of Medicine, Nature Communications, Diabetes Care, and eClinicalMedicine, as well as presented at leading scientific conferences including the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) annual meetings. Notably, mazdutide is the first innovative drug in China's endocrinology and metabolism field to have clinical results published in The New England Journal of Medicine, underscoring its significant clinical value.

Mazdutide has received NMPA approval for two indications:

First Indication: 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).

Second Indication: For glycemic control in adults with type 2 diabetes.

Monotherapy:

For adults with type 2 diabetes who have inadequate glycemic control despite diet and exercise interventions.

Combination Therapy:

For adults with T2D who still have poor glycemic control despite:

• Diet and exercise, plus metformin and/or sulfonylureas;
• Diet and exercise, plus metformin and/or SGLT2 inhibitors (SGLT2i).

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, Roche, Takeda, 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.

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