Mazdutide pre-filled multi-dose pen approved by NMPA, bringing new options for long-term treatment of patients with type 2 diabetes
2026-05-08 · Innovent Biologics (Suzhou) Co. Ltd. · original innoventbio.com ↗
San Francisco, U.S. and SUZHOU, China, April XX, 2026 - Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncological, cardiovascular and metabolic, autoimmune, ophthalmological and other major diseases, announces that a prefilled, multi-dose pen for mazdutide injection, the world's first GCG/GLP-1 dual-receptor agonist, has been approved by the National Medical Products Administration (NMPA), providing more flexible long-term treatment options for Chinese clinicians and diabetes patients in disease management. Pre-filled multi-dose pen: one pen covers the full dosing requirements, improving long-term treatment adherence The approved pre-filled multi-dose injection pen (2 ml:24 mg) for mazdutide enables precise titration to the target full doses of 2 mg/4 mg/6 mg using a single pen, which can be flexibly adjusted in response to patients' blood glucose control and combined medication regimens, which supporting individualized needs across the full treatment period, including initiation, dose titration, and long-term maintenance. It can be stored at 2-8°C for up to 12 weeks after first use, offering Mazdutide: A worldwide first-in-class dual-target therapy with simultaneous treatment of glucose and liver function to advance a new paradigm in controlling glucose Mazdutide is the world's first and only approved GCG/GLP-1 dual receptor agonist. In addition to GLP-1 receptor agonist activity, it activates the GCG receptor, targeting two core pathogenic mechanisms of type 2 diabetes: insufficient insulin secretion and insulin resistance. It thereby helps patients achieve improved glycemic control. At the same time, mazdutide provides multiple benefits, including weight reduction, and improvements of hypertension, dyslipidemia, hyperuricemia and liver enzymes in patients with type 2 diabetes. The results of two Phase 3 clinical studies (DREAMS-1 and DREAMS-2) of mazdutide in Chinese patients with type 2 diabetes were published in December 2025 in Nature, a leading international academic journal. Nature has simultaneously published two Phase 3 clinical studies back-to-back in the field of metabolic and endocrine diseases since its inception. The studies showed robust glycemic efficacy, with 24-week treatment at 6 mg leading to a reduction in HbA1c of up to 2.15%, which was superior to that of placebo or dulaglutide. In addition, mazdutide showed comprehensive benefits across multiple cardiometabolic parameters, including fasting blood glucose, 7-point self-monitored glucose, waist circumference, blood pressure, blood lipids, and liver enzymes, further validating the therapeutic advantages of the dual GCG/GLP-1 receptor activation. Innovent: Advancing metabolic innovation to support Healthy China Initiative According to the 2025 global diabetes report published by the International Diabetes Federation, China ranks first globally in the number of people with diabetes, with an estimated 148 million people in 2024, projected to reach 168 million by 20501. Notably, more than 60% of Chinese patients with type 2 diabetes also have fatty liver disease2. This proportion is significantly higher than the global average and is continuing to rise annually. As a typical chronic disease, more than 90% of patients with diabetes require lifelong medication management. Clinical data show that every 10% increase in compliance can reduce complication risk by 23% and lower healthcare costs by 15–20%3-4. As a leading Chinese company in the field of cardiovascular and metabolic diseases, Innovent is building an innovative product pipeline centered on mazdutide for indications including diabetes, obesity, overweight, metabolic-associated fatty liver disease, and cardiovascular conditions. The approval of the new prefilled multi-dose pen further expands treatment options and is expected to better meet the needs of patients with type 2 diabetes by addressing comorbidities and long-term disease management. For more information about the new pen, including launch timing and access details, please refer to subsequent official announcement from Innovent Biologics, or consult a licensed healthcare professional in accordance with medical guidance. About Mazdutide Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists, such as promoting insulin secretion, lowering blood glucose and reducing body weight. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity. Mazdutide has been conducted in or completed a total of nine Phase 3 clinical studies, including: GLORY-1: A Phase 3 trial (Mazdutide 4 mg and 6 mg) in Chinese participants with overweight or obesity. GLORY-2: A Phase 3 trial (Mazdutide 9 mg) in Chinese participants with moderate-to-severe obesity. DREAMS-1: A Phase 3 trial in treatment-naïve Chinese participants with T2D. DREAMS-2: A Phase 3 trial comparing Mazdutide and dulaglutide in Chinese T2D participants with inadequate glycemic control on oral antidiabetic drugs. DREAMS-3: A Phase 3 trial comparing Mazdutide and semaglutide in Chinese participants with T2D and obesity. GLORY-3: A Phase 3 trial comparing Mazdutide and semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD). GLORY-OSA: A Phase 3 trial in Chinese participants with OSA and obesity. GLORY-YOUNG: A Phase 3 trial in Chinese adolescents with obesity. GLORY-H: A Phase 3 trial in Chinese participants with obesity and hypertension. Among these, the first five Phase 3 studies have met primary endpoints, and the latter four Phase 3 trials remain ongoing. In addition, several clinical studies of mazdutide are ongoing, including studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF) and a head-to-head comparation of high-dose mazdutide versus tirzepatide for the treatment of moderate-to-severe obesity. *Mazdutide has received NMPA approval for two indications: Long-term weight control in adult patients As an adjunct to dietary control and increased physical activity in adults with initial BMI: ≥28 kg/m² (obesity), or ≥24 kg/m² (overweight) plus ≥1 weight-related comorbidity (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome). Glycemic control in adults with T2D: Monotherapy: Adults with inadequately controlled T2D after diet/exercise intervention alone. Combination Therapy: Adults with inadequately controlled T2D who have insufficient glycemic control despite diet and exercise plus background therapy with metformin and/or sulfonylureas, or metformin and/or sodium-glucose cotransporter 2 inhibitors (SGLT2i) . Mazdutide has garnered significant academic and industry recognition for its robust clinical data. Clinical results have been presented in globally renowned journals including Nature, NEJM, Nature Communications, Diabetes Care, and eClinicalMedicine. Mazdutide is the first China-developed innovative drug with two clinical studies simultaneously published in Nature and the only GLP-1-based therapy ever to achieve top-tier publications in both Nature and NEJM. It has now been included in multiple Chinese expert consensus guidelines for obesity and type 2 diabetes management. Previously, mazdutide was named one of FIERCE Pharma's "Top 10 Most Anticipated Innovative Drugs of 2025", and its Phase 2 clinical trial in Chinese overweight/obese participants was selected by Nature Communications as one of the "50 Most Significant Translational Medicine Studies" and featured as an Editor's Highlight. 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 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 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. Statement: Innovent does not recommend the use of any unapproved drug/indication. Forward-Looking Statements 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. Reference: Zhu D., Zhao J., Cai H., et al. Mazdutide versus placebo in Chinese adults with type 2 diabetes. Nature (2025). doi: 10.1038/s41586-025-10026-w Guo L., Zhang B., Xue X., et al. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature (2025). doi: 10.1038/s41586-025-10031-z IDF Diabetes Atlas, 11th Edition [M]. Brussels: International Diabetes Federation, 2025. Expert Consensus on Multidisciplinary Management of Type 2 Diabetes Mellitus Complicated with Metabolic-Associated Fatty Liver Disease (2026 Edition). Chinese Medical Journal, 2026, 106(4): 305-320. Bonaca M P, Maroo A, Hauser M, et al. Association Between Adherence to Pharmacotherapy and Outcomes in Type 2 Diabetes: A Meta-analysis [J]. Diabetes Care, 2017, 40(11): 1588-1596. Cramer A. Medication Adherence and Its Effect on Costs and Outcomes: A Systematic Review and Meta-analysis [J]. Journal of Managed Care & Specialty Pharmacy, 2011, 17(4): 291-300.
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