Innovent Announces Mazdutide Received Approval from China's NMPA for Glycemic Control in Adults with Type 2 Diabetes

Rhea-AI Summary

Innovent Biologics (IVBIY) has received approval from China's NMPA for mazdutide, the world's first dual GCG/GLP-1 receptor agonist for glycemic control in adults with type 2 diabetes (T2D). The approval is based on two Phase 3 clinical trials (DREAMS-1 and DREAMS-2) demonstrating superior efficacy over placebo and dulaglutide.

Key trial results showed mazdutide 6mg achieved HbA1c reductions of -2.15% and weight loss of -7.81% in DREAMS-1, while DREAMS-2 demonstrated HbA1c reductions of -1.73% and weight loss of -9.24%. The drug features an improved injection device with hidden needle design and X-cross-section technology for better patient comfort.

This approval is particularly significant for China, which has 140 million adults affected by T2D (1 in 4 global cases), addressing critical needs in long-term glucose management and complication prevention.

Positive

• First-in-class dual GCG/GLP-1 receptor agonist approved globally for T2D
• Superior efficacy vs placebo and dulaglutide in both glycemic control and weight reduction
• Innovative injection device with hidden needle and improved patient comfort features
• Addresses massive market opportunity with 140 million T2D patients in China
• Multiple metabolic benefits including cardiovascular, hepatic and renal improvements
• Strong safety profile consistent with existing GLP-1 agonists

Negative

• Will face competition from established GLP-1 agonists in the market
• Requires injection administration which may affect patient adherence

SAN FRANCISCO and SUZHOU, China, Sept. 19, 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 glycemic control in adults with type 2 diabetes (T2D). Mazdutide is the world's first dual GCG/GLP-1 receptor agonist approved for glycemic control in adults with T2D. It is expected to support disease management for the vast T2D population in China, achieving comprehensive benefits in glycemic control, weight reduction and hepato-cardio-renal metabolic indicators.

China has the highest number of T2D affected patients, facing urgent challenges in long-term glucose management and complication prevention

China leads the world in diabetes prevalence, with 140 million adults affected (1 in 4 global cases). Diabetes is a chronic condition where prolonged hyperglycemia can lead to severe complications, such as cardiovascular diseases, nephropathy, retinopathy and neuropathy. These complications not only endanger patients' lives and health but also impose a significant economic burden on families and society.

In recent years, the treatment paradigm for diabetes has progressively shifted from glycemic control alone to a comprehensive, patient-centric management strategy. This approach integrates glycemic control, weight management, cardiovascular risk factor mitigation, and prevention/treatment of hepato-cardio-renal complications.

The ADA/EASD Consensus Report on the Management of Hyperglycemia in T2D has formally recognized weight reduction as a core therapeutic target. Weight loss should be prioritized not only to improve glycemic outcomes but also to reduce the risk of weight-related complications. For some patients with T2D, achieving a 5%–15% reduction in body weight is recommended as a primary treatment goal.

Mazdutide: superior glycemic control and weight loss, with hepato-cardio-renal metabolic benefits, supporting Healthy China 2030

Building upon the established effects of GLP-1 receptor agonists, dual GCG/GLP-1 receptor agonists simultaneously improve the two core pathogenic mechanisms of diabetes - insufficient insulin secretion and insulin resistance, thus, delivering comprehensive benefits beyond glycemic control, including weight loss, and hepato-cardio-renal metabolic improvements. As a safe, effective and convenient novel therapeutic option, mazdutide addresses the critical needs of long-term glucose management and complication prevention in T2D, actively supporting the realization of the "Healthy China 2030" vision.

The approval was based on two Phase 3 clinical trials (DREAMS-1 [NCT05628311] and DREAMS-2 [NCT05606913]), which evaluated the efficacy and safety of mazdutide as monotherapy and in combination with oral antidiabetic drugs, respectively, in Chinese participants with T2D. These studies demonstrated mazdutide's superiority over placebo or dulaglutide 1.5 mg in glycemic control and weight reduction, while also showing improvements in multiple cardiometabolic, hepatic and renal parameters.

• DREAMS-1: for the efficacy estimand, at Week 24, the mean changes in HbA1c from baseline in the mazdutide 4 mg group, mazdutide 6 mg group and placebo group were -1.57%, -2.15%, and -0.14%, respectively; the proportion of participants with HbA1c <7% were 68.6%, 87.4% and 10.7%, respectively; the mean percent change in body weight from baseline were -5.61%, -7.81% and -1.26%, respectively; and the proportion of participants with HbA1c <7% and a body weight reduction≥5% were 40.6%, 64.9%, and 0%, respectively.
  
  
• DREAMS-2: for the efficacy estimand, at Week 28, the mean changes in HbA1c from baseline in the mazdutide 4 mg group, mazdutide 6 mg group and dulaglutide 1.5 mg group were -1.69%, -1.73% and -1.38%, respectively; the proportion of participants with HbA1c <7% were 71.2%, 74.2% and 62.1%, respectively; the mean percent change in body weight from baseline were -7.31%, -9.24% and -2.86%, respectively; and the proportion of participants with HbA1c <7% and a body weight reduction≥5% were 50.1%, 64.3%, and 19.4%, respectively.

Mazdutide exhibited a safety profile consistent with previous clinical studies and other GLP-1R agonists, with no new safety signals identified.

DREAMS-1 results were orally presented (Abstract #: 306-OR) at the 85th Scientific Sessions of the ADA; DREAMS-2 results were presented as a late-breaking oral presentation (Abstract #: LBA 16) at the 60th Annual Meeting of the EASD. Based on the innovative mechanism and robust evidence of mazdutide, it has been recommended in expert consensus in China..

It is worth noting that the mazdutide injection device demonstrates significant improvements in both convenience and safety compared to existing injection devices of the same type. The device features a hidden needle, ensuring the needle remains out of sight throughout the process, effectively reducing patient anxiety associated with injections. Additionally, it is a single-use device, designed for immediate disposal after use, which significantly lowers the risk of drug contamination caused by reuse or improper handling. Furthermore, the injection device incorporates innovative X-cross-section technology, delivering a smoother and painless injection experience, thereby enhancing patient comfort and treatment adherence.

Professor Dalong Zhu, the Principal Investigator of DREAMS-1 study, Nanjing University Affiliated Drum Tower Hospital, said: "China has a high prevalence of T2D globally, with over 140 million adult patients. A significant proportion of these individuals also suffer from overweight or obesity, cardiovascular diseases, and/or kidney diseases, making prevention and treatment particularly challenging. Mazdutide, as a dual GCG/GLP-1 receptor agonist, demonstrated superior efficacy in glycemic control and weight reduction compared to placebo in the DREAMS-1 study in Chinese patients with T2D inadequately managed by diet and exercise alone. It also showed a favorable safety profile. Additionally, mazdutide offered improvements such as reduced waist circumference, blood pressure and lipid levels. I am pleased to see mazdutide's pivotal clinical study results in T2D patients have gained approval from national regulatory authorities, culminating in its market authorization, which could offer a new treatment option for T2D patients in China."

Professor Jiajun Zhao, the Principal Investigator of DREAMS-1 study, Shandong Provincial Hospital, said: "In recent years, the treatment for diabetes has gradually shifted from mere glycemic control to a 'patient-centered' approach, integrating glycemic control, weight management, cardiovascular risk factor management, and addressing cardiorenal comorbidities and complications. GLP-1 receptor agonists not only excel in glycemic control but also effectively reduce weight, making them a hotspot and frontier in metabolic disease drug development. The Phase 3 study of mazdutide in participants with T2D has once again confirmed its outstanding efficacy in glycemic control and weight reduction, along with multiple metabolic benefits and a favorable safety profile. I am delighted to see the approval of mazdutide for the indication of glycemic control in adults with T2D, and I hope it will bring significant benefits to patients with T2D in China."

Professor Lixin Guo, the principal investigator of the DREAMS-2 study, Beijing Hospital, said: "China has a high prevalence of T2D, yet the overall glycemic control rate among patients remains suboptimal. Many patients also accompany multiple cardiovascular risk factors such as obesity, hyperlipidemia, coronary heart disease, fatty liver disease, and renal diseases, which not only increase disease burden but also complicate treatment. There is an urgent clinical need for innovative therapies that demonstrate proven efficacy, favorable safety, convenient administration, and multiple cardiovascular benefits. The Phase 3 clinical study results of mazdutide in Chinese participants with T2D demonstrated not only significant glucose-lowering efficacy but also showed potential superiority over the dulaglutide in weight reduction. The approval of mazdutide for glycemic control in adults with T2D will provide more treatment options to Chinese T2D patients."

Professor Wenying Yang, the principal investigator of the DREAMS-2 study, China–Japan Friendship Hospital, said: "In recent years, GLP-1 receptor agonists have emerged as superior therapeutic options for T2D patients by delivering comprehensive benefits in glycemic control, weight management, and cardiovascular/renal outcomes. As the first approved dual GCG/GLP-1 receptor agonist, Mazdutide demonstrated better efficacy than dulaglutide in both glucose-lowering and weight reduction during Phase 3 study in participants with T2D, while also showing multiple metabolic advantages and favorable safety profiles. These robust clinical results support its application as a next-generation GLP-1-based therapy for Chinese patients with T2D. I am delighted that Mazdutide has entered clinical practice, offering a novel treatment alternative for eligible T2D patients and contributing to improved clinical outcomes in diabetes management."

Dr. Lei Qian, Chief R&D Officer of General Biomedicine from Innovent Biologics, stated, "Mazdutide represents the next-generation dual GCG/GLP-1 receptor agonist. Multiple clinical studies of mazdutide conducted in Chinese adults with T2D have demonstrated mazdutide's exceptional dual advantages in both glycemic control and weight reduction across two major patient populations—those receiving monotherapy and those failing on multiple oral antidiabetic drugs. The treatment has shown multiple metabolic benefits for cardiovascular, hepatic and renal systems while maintaining an excellent safety profile. The successful approval of mazdutide reflects the national drug regulatory authority's strong endorsement of its clinical value and safety profile, while fully validating Innovent Biologics' innovative R&D capabilities in metabolic therapeutics. We hope mazdutide will provide superior treatment options for Chinese patients with T2D and help alleviate the disease burden on our society."

About Diabetes

According to the 2021 global diabetes overview by the International Diabetes Federation, China leads the world in the number of patients with diabetes, with an estimated 140 million cases in 2021 and projected to reach 174 million by 2045^[1]. Poor glycemic control can lead to irreversible microvascular and macrovascular complications, including reduced visual acuity, blindness, renal dysfunction, peripheral neuropathy, myocardial infarction, stroke and amputation^[2]. The high prevalence of diabetes and its serious complications pose a significant threat to human health. Currently, various therapeutic approaches are available for diabetes management. In addition to controlling blood glucose, new hypoglycemic drugs are being developed to offer additional benefits such as weight loss, cardiovascular risk reduction and kidney protection^[3].

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 has 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 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 and etc.);

Second Indication (Newly Approved): 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, or 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, 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 (s)/indication (s).

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

[1].     Sun H, Saeedi P, Karuranga S, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projects for 2045 [published correction appeals in Diabetes Res Clin Pract. 2023 Oct; 204: 110945]. Diabetes Res Clin Pract. 2022; 183: 109119. doi: 10.1016/j.diabres.2021. 109119

[2].     Gregg EW, Sattar N, Ali MK. The changing face of diabetes complications. Lancet Diabetes Endocrinol. Published online 2016. doi: 10.1016/S2213-8587 (16) 30010-9

[3].     Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes-state-of-the-art. Mol Metab. Published online 2020. doi: 10.1016/j.molmet.2020. 101102

 

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SOURCE Innovent Biologics

FAQ

What is the significance of Innovent's (IVBIY) mazdutide approval in China?

Mazdutide is the world's first dual GCG/GLP-1 receptor agonist approved for type 2 diabetes, offering superior glycemic control and weight loss benefits in China's market of 140 million T2D patients.

How effective is mazdutide in treating type 2 diabetes compared to existing treatments?

In Phase 3 trials, mazdutide 6mg showed superior efficacy with HbA1c reductions of -2.15% and weight loss of -7.81% vs placebo, and outperformed dulaglutide with -1.73% HbA1c reduction and -9.24% weight loss.

What are the key features of Innovent's mazdutide injection device?

The device features a hidden needle design, single-use disposal system, and X-cross-section technology for smoother, painless injections, improving patient comfort and treatment adherence.

What clinical trials supported mazdutide's approval in China?

Two Phase 3 trials - DREAMS-1 (NCT05628311) evaluating mazdutide as monotherapy and DREAMS-2 (NCT05606913) testing it in combination with oral antidiabetic drugs - demonstrated superior efficacy and safety.

How does mazdutide's dual mechanism of action work in type 2 diabetes?

Mazdutide acts as both a glucagon (GCG) and glucagon-like peptide-1 (GLP-1) receptor agonist, improving insulin secretion and insulin resistance while providing additional benefits in weight loss and metabolic health.