Efficacy, Safety, and Tolerability of a GLP-1/GCG Dual Receptor Agonist in Type 2 Diabetes With Early Dementia: A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Trial

The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 420 type 2 diabetes patients with early dementia are randomized 1:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential disease-modifying effects of mazdutide on cognitive dysfunction in type 2 diabetes.

Start Date01 Oct 2025

Sponsor / Collaborator

Shanghai First People's Hospital

[+4]

NCT07135141

/ Not yet recruitingNot ApplicableIIT

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity:A Multicenter, Randomized, Double-Blind, Placebo-Controlled Superiority Trial

The SMART study is a 96-week, multicenter, randomized, double-blind, placebo-controlled superiority clinical trial. A total of 256 severe obesity patients are randomized 1:1 to either receive the bariatric surgery plus GCG/GLP-1 dual receptor agonist group (receiving sleeve gastrectomy followed by subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the bariatric surgery plus placebo group (receiving matched procedure plus placebo injections). The primary objective is to evaluate the potential enhancing weight reduction effects of the combination therapy with bariatric surgery and mazdutide measured by the percentage change of excess weight loss.

Start Date30 Sep 2025

Sponsor / Collaborator

Beijing Friendship Hospital

ChiCTR2500109838

/ Not yet recruitingPhase 4IIT

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Superiority Trial

Start Date01 Jul 2025

Sponsor / Collaborator

Self Finance, Inc.

100 Clinical Results associated with Mazdutide

100 Translational Medicine associated with Mazdutide

100 Patents (Medical) associated with Mazdutide

Literatures (Medical) associated with Mazdutide

01 Nov 2025·DIABETES OBESITY & METABOLISM

Mazdutide reduces body weight in adults with overweight or obesity: A high‐dose Phase 1 trial

Article

Author: Ng, Shu Xuan ; Ibriga, Hilda ; Mather, Kieren J. ; Ni, Wei ; Li, Yan ; Tham, Lai San ; Gurbuz, Sirel ; Tang, Yuanyuan ; Bhattachar, Shobha N. ; Chua, Laiyi ; Thomas, Melissa K.

Abstract:

Aim:

Mazdutide, an agonist of glucagon‐like peptide‐1 and glucagon receptors, significantly reduced weight in early phase trials at doses up to 10 mg. This randomized, double‐blind, placebo‐controlled Phase 1 trial evaluated the safety and efficacy of mazdutide up to 16 mg in adults with overweight or obesity.

Materials and Methods:

Thirty‐two adults with overweight/obesity without diabetes received once‐weekly subcutaneous injections of mazdutide (n = 24) or placebo (n = 8) for 20 weeks. Two mazdutide dose escalation regimens (Cohorts 1 and 2, n = 12 each) were used to reach a 16‐mg target dose. Data were analysed using descriptive statistics and mixed model repeated measures to estimate least square means with standard error (SE).

Results:

At Week 20, mean percent change from baseline in body weight was −20.0% (SE: 1.9) for Cohort 1 and −21.0% (1.2) for Cohort 2 versus −0.1% (1.5) for placebo (p < 0.001). Weight loss of ≥15% was achieved by 66.7% of Cohort 1 and 75.0% of Cohort 2. No placebo participants achieved ≥5% weight loss. Mean percent change in waist circumference was −12.0% (SE: 1.7) in Cohort 1 and −17.0% (1.7) in Cohort 2 versus −0.8% (2.1) in placebo (p < 0.001). Improved fasting metabolic biomarker profiles and reduced appetite were associated with mazdutide treatment. No serious adverse events (AEs) were reported, and the most common AEs were mild or moderate gastrointestinal disorders.

Conclusions:

Mazdutide at 16 mg was well tolerated and associated with greater weight loss at higher doses than previously studied and improved metabolic regulation in adults with overweight or obesity.US Clinical Trials Registry: NCT05623839.

11 Sep 2025·NEW ENGLAND JOURNAL OF MEDICINE

Once-Weekly Mazdutide in Obesity or Overweight

Letter

Author: Liu, Zhen-Tong ; Zhang, Yan ; Yu, Lei

01 Jul 2025·EBioMedicine

Mazdutide, a dual agonist targeting GLP-1R and GCGR, mitigates diabetes-associated cognitive dysfunction: mechanistic insights from multi-omics analysis

Article

Author: Yang, Maoxing ; Zhao, Ziyue ; Dong, Wanqing ; Zhang, Yongjiang ; Zhang, Ziyue ; Jiang, Hongwei ; Bai, Jie ; Zhang, Yingyu ; Yuan, Qibin ; Li, Hanxiao

BACKGROUND:

Cognitive impairment and dementia are highly associated with obesity and type 2 diabetes mellitus (T2DM). Recent studies have demonstrated that GLP-1 receptor agonists can improve cognitive function through brain activation in patients with T2DM, compared to other oral glucose-lowering drugs. Mazdutide, a dual agonist of the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR), has been shown to simultaneously reduce body weight, blood glucose levels, and other comorbidities associated with obesity in patients with T2DM. While its insulinotropic and glucose-lowering effects through the GLP-1 pathway are well-established, mazdutide may also enhance energy expenditure via activation of the GCGR pathway. However, its potential impact on cognitive function remains to be elucidated.

METHODS:

This study aimed to investigate the effects of mazdutide on cognitive behaviour and cerebral pathology in male db/db mice, a model of T2DM, in comparison to dulaglutide, a GLP-1 receptor agonist. All animal findings are applicable to male mice only. Behavioural tests were conducted to evaluate cognitive function, and pathological analyses were performed to assess neurodegenerative markers in the brain. Furthermore, transcriptomic, proteomic, and metabolomics analyses were employed to explore the underlying molecular mechanisms of mazdutide's effects.

FINDINGS:

Compared to dulaglutide, mazdutide significantly improved cognitive performance in db/db mice, as evidenced by comprehensive behavioural tests. Pathological assessments revealed improvements in neuronal structure and brain tissue integrity in the mazdutide-treated group. Multi-omics analyses further identified distinct molecular pathways involved in neuroprotection, energy metabolism, and synaptic plasticity, suggesting that dual GLP-1/GCGR activation contributes to enhanced cognitive resilience.

INTERPRETATION:

Our findings indicate that mazdutide, via its dual GLP-1/GCGR activation effects, exerts multifactorial improvements in cognitive function in the context of obesity and T2DM. These results suggest that mazdutide is a promising therapeutic option for mitigating cognitive deficits associated with metabolic disorders.

FUNDING:

Medical Science and Technology Research and Development Plan Major Project Jointly Constructed by the Henan Province and Ministerial Departments in China (No. SBGJ202301010).

News (Medical) associated with Mazdutide

19 Sep 2025

·www.prnewswire.com

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

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 , 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. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultLicense out/inDrug Approval

29 Aug 2025

·www.fiercepharma.com

Lilly links up with JD Health for DTC obesity, diabetes drug sales in China

Eli Lilly and JD Health said they plan to continue to grow their collaboration to offer treatments and care services to Chinese patients across more disease areas. Amid a growing push for more direct-to-consumer access to some of the world’s most popular drugs, Eli Lilly has inked a deal with China’s JD Health to sell its obesity, Type 2 diabetes and alopecia areata meds in the country through a digital health platform.The platform will aim to serve as a “one-stop” shop for chronic disease management, according to Lilly’s announcement on its WeChat channel Friday.In addition to connecting patients with both on- and offline consultations with healthcare providers, as well as any resulting prescriptions for and shipments of Lilly’s drugs, the platform will also offer follow-up services for long-term care management and disease education resources.The latter offering will target both patients and healthcare professionals: One section on the digital health app will provide educational information to increase patients’ understanding of their diagnoses and care options, while another set of tools is aimed at improving HCPs’ “professional disease management capabilities.”The team-up comes as the Chinese government has encouraged greater access to health education and long-term management tools to help prevent and treat chronic diseases, per the announcement.It's estimated there are around 148 million adults in China who have diabetes and more than 500 million who are overweight or obese, marking major opportunities for Lilly’s Mounjaro and Zepbound, respectively.The partners added that they plan to continue to grow their collaboration to offer Chinese patients DTC access to treatments and care services across more disease areas. Lilly has recently sought to expand its footprint in China. Last year, the Big Pharma appointed a new president of its business in the country, and—shortly after—CEO David Ricks took a trip to meet with China’s commerce minister, during which he reportedly expressed his commitment to increasing investment and R&D cooperation in China.In the ensuing months, both Mounjaro and Zepbound racked up Chinese approvals, and Lilly announced in October that it would pour $200 million into an expansion of its manufacturing site in Suzhou, largely to meet skyrocketing demand for the two drugs.Most recently, Lilly’s mazdutide scored a first-in-class approval in China for chronic weight management, breaking ground on a new class of competitors within the blockbuster GLP-1 space, though local biopharma Innovent Biologics holds the rights to the dual GLP-1/glucagon receptor agonist in the country.

Executive Change

27 Aug 2025

·www.prnewswire.com

Innovent Announces 2025 Interim Results and Business Updates

Robust revenue growth and substantial profit improvement Continued exceptional executions under a clear roadmap of dual-driven growth and global innovation SAN FRANCISCO and SUZHOU, China, Aug. 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 cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2025 interim results and major business updates. Continue Reading Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We delivered an outstanding performance in the first half of 2025, driven by the comprehensive acceleration of our dual-engine growth model and global innovation strategy. Supported by our oncology leadership and successful commercial launch across our general biomedicine portfolio, we have expanded our product portfolio to 16 drugs and achieved a notable improvement in revenue and profitability, maintaining strong business momentum. On the innovation front, several core pipeline candidates with global potential achieved key proof-of-concept data, and are entering global registration trials. This demonstrates the depth of Innovent's innovation capabilities and lays a solid foundation for globalization. We firmly believe that a clear strategic vision combined with excellent execution will continue to drive Innovent's growth. Looking ahead, we will further consolidate our leadership in oncology, continue exploring and implementing diversified commercialization strategies across our general biomedicine product portfolio, and accelerate the global development of our next-generation innovative pipeline. Anchored by our strategic goals of achieving RMB 20 billion in product revenue by 2027 and advancing five pipeline programs into global Phase 3 trials by 2030, Innovent will continue striving to become a world-class biopharmaceutical company." Dual-driven revenue growth with execution excellence Robust revenue growth and substantial profit improvement[1] Total revenue: RMB 5.95 billion, up 50.6% year-on-year Product revenue: RMB 5.23 billion, up 37.3% year-on-year Net profit: RMB 1.21 billion; EBITDA: RMB 1.41 billion Gross margin: 86.8%, up 2.7 percentage points year-on-year Selling and administrative expenses ratio: 44.2%, down 7.9 percentage points year-on-year R&D investment: RMB 903 million Cash on hand: approximately USD 2 billion[2] Dual-engine growth supported by comprehensive and diversified product portfolio Expansion of oncology product portfolio with three new launches Dovbleron® (taletrectinib) : Potentially best-in-class ROS1 inhibitor Limertinib : Third-generation EGFR TKI Jaypirca®(pirtobrutinib) : First non-covalent BTK inhibitor Strengthening general biomedicine portfolio with innovative pipeline SINTBILO® (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL, received approval by Macau ISAF in May 2025 SYCUME ® ( teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease (TED) in China Mazdutide (GCG/GLP-1) : Globally first and only GCG/GLP-1 dual receptor agonist for weight management, with another NDA for glycemic control of T2D adults under NMPA review Innovative commercial strategy with multi-channel coverage Actively responding to the national "Year of Weight Management": Participating in the development of the weight-loss industry ecosystem, promoting the concept of scientific weight management, and advancing obesity prevention and chronic disease management Deepening hospital presence and academic influence: Strengthening academic coverage in public hospitals, with the GLORY-1 study published in The New England Journal of Medicine, significantly enhancing academic influence Innovative multi-channel coverage: Leveraging a comprehensive sales team of over 1,000 people, integrating public hospitals, retail pharmacies, online medical platforms, and private clinic networks to facilitate convenient access to medications for chronic disease patients Emphasizing disease education and patient management: Integrating digital tools and professional activities to establish a patient-centric disease management system, enhancing chronic disease education and patient adherence Enhancing brand strength through the establishment of a lifecycle management system TYVYT ® : NDAs for renal and colorectal cancer are under regulatory review; Phase 3 study of neoadjuvant treatment in lung cancer is underway SYCUME ® ( teprotumumab N01 injection): new Phase 3 studies in plan for inactive TED and head-to-head comparison with steroid therapy in TED Mazdutide (GCG/GLP-1): second NDA for glycemic control of T2D adults is under regulatory review, alongside with two new Phase 3 studies for obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). Additional PoC studies are ongoing for adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), etc. Picankibart (IL-23p19): a potent and long-acting IL-23p19 for moderate-to-severe plaque psoriasis pending NMPA approval; Phase 3 studies are ongoing for treatment withdrawal maintenance and psoriasis with prior inadequate response to IL-17 biologics Emerging value from globalization strategy, prioritizing novel pipeline's global R&D Flagship pipeline showcased at top-tier conferences, entering global registration studies IBI363 (PD-1/IL-2 α -bias ): Unleashing potential as a next-generation IO therapy with global first-in-class design Three oral presentations at ASCO highlighted breakthrough PoC data across difficult-to-treat tumors such as IO resistant cold tumors and low PD-L1 expression, demonstrating the unique advantages of dual immune activation and long-term survival benefits Three pivotal studies are underway or in plan: the first global Phase 3 study is initiating in China and the U.S. to address unmet needs in IO-resistant squamous NSCLC; the first pivotal Phase 2 study in melanoma was initiated, challenging Keytruda in first-line setting; and the first Phase 3 study in late-line colorectal cancer is about to initiate Continuous exploration in first-line settings and more cancer types, including first-line lung cancer, first-line colorectal cancer, neoadjuvant lung cancer, EGFR-mutated lung cancer, platinum-resistant ovarian cancer, and more BI343 (CLDN18.2 ADC): two registration trials in GC and PDAC; globally the first ADC to enter a Phase 3 trial in PDAC First MRCT Phase 3 study of GC has been initiated in China and Japan First Phase 3 study of PDAC has been initiated Global MRCT of PDAC is in plan NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted Over 10 next-generation programs advancing into global development Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), IBI3003 (GPRC5D/BCMA/CD3), IBI3005 (EGFR/HER3 ADC), IBI3014 (PD-L1/TROP2 ADC), IBI3020 (CEACAM5 dual-payload ADC), etc CVM: IBI3016 (AGT siRNA), IBI3032 (oral GLP-1), etc A uto immune: IBI356 (OX40L), IBI3002 (TSLP/ IL-4Rα), etc Hybrid models to accelerate innovation IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide Enhance global presence with broader market access Six products (TYVYT®, BYVASDA®, Pemazyre®, Dupert®, SINTBILO®, SYCUME®) have been launched in markets including Hong Kong, Macau, Taiwan, and Southeast Asia More launches planned Brazil, Mexico, Columbia, India, etc Research innovation showcased at medical conferences Oncology pipeline: AACR, ASCO, Nature Medicine General biomedicine pipeline: ADA, NEJM Facilities and manufacturing capacity adhering to high-quality standards 7,500 employees globally Global R&D centers located in the San Francisco Bay Area, Shanghai, and Suzhou To date, Innovent has a total of 140,000L of operational capacity, accounting for 20% of China's total biopharmaceutical production capacity First manufacturing site: 60,000L antibody and ADC production capacity in operation, ensuring high-quality supply Second manufacturing site: first phase of 80,000L antibody production capacity in operation, for global supply and CDMO operations Committed to responsible business practices and enhancing ESG management practices Over 3,000 new oncology patients begin treatment with Innovent-developed therapeutics each day, and to date, more than 5 million patients have benefited from Innovent's innovative drugs Innovent has been graded 'AAA' rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise" Provided over 2,200 job opportunities for recent graduates To date, Innovent Biologics has contributed more than RMB 6 billion in taxes and fees 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 III 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 , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. 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. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalBreakthrough TherapyPhase 3Phase 2Fast Track

100 Deals associated with Mazdutide

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	China	Innovent Biologics (Suzhou) Co. Ltd.	16 Sep 2025
Obesity	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Jun 2025
Overweight	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Jun 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Apnea, Obstructive	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	13 May 2025
Metabolic dysfunction-associated steatotic liver disease	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Apr 2025
Early-onset type II diabetes	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	29 Feb 2024
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	20 Jun 2025
Heart failure with mid range ejection fraction	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Apr 2025
Heart failure with normal ejection fraction	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Apr 2025
Heart failure with reduced ejection fraction	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Apr 2025
Renal Insufficiency	Phase 1	China	Innovent Biologics (HK) Ltd.	05 May 2023
Hyperuricemia	Preclinical	China	Innovent Biologics (Suzhou) Co. Ltd.	12 Jul 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05623839 (Pubmed \| Diabetes Obes Metab)	Phase 1	Overweight \| Obesity	32	Mazdutide (Cohort 1)	foqskkqdjd(oulpxgkltt) = the most common AEs were mild or moderate gastrointestinal disorders. ziwdrumgvi (hwvcnotrcr )	Positive	20 Aug 2025
				Mazdutide (Cohort 2)
NCT05607680 (GLORY-1, Pubmed) Manual	Phase 3	Overweight \| Obesity	610	mazdutide 4mg	ymlunvndoa(mxpxbeoxcs) = xelsyemhwk aetlkxkaji (kghvvyykgi, -11.15 to -9.04) View more	Positive	24 May 2025
				mazdutide 6mg	ymlunvndoa(mxpxbeoxcs) = hrcnxjotfn aetlkxkaji (kghvvyykgi, -13.64 to -11.45) View more
NCT05607680 (GLORY-1, NEWS) Manual	Phase 3	Overweight \| Obesity	610	Mazdutide	ollwozjfhl(ylvanprsew) = affgusuyxi mzuxmmnjee (kvdgimewxv ) View more	Positive	13 Sep 2024
				Mazdutide (4 mg)	ppjhlafadn(zagfgiezzo) = nkfokshsyx innxcbtrjh (gilyuvcrrp ) View more
NCT05606913 (DREAMS-2, EASD2024) Manual	Phase 3	Diabetes Mellitus, Type 2	731	mazdutide 4mg	gvsejwypul(crykthinzm) = owmfqcbwfm kkwxizekvl (fkmlkpueet ) View more	Positive	11 Sep 2024
				mazdutide 6mg	gvsejwypul(crykthinzm) = cqienrfiti kkwxizekvl (fkmlkpueet ) View more
NCT05623839 (EASD2024) Manual	Phase 1	Overweight \| Obesity	32	Mazdutide (cohort 1)	oiiluvoyfz(gysvythwkk) = wlmexngdcz btmataouxh (wnomiylzqi ) View more	Positive	09 Sep 2024
				Mazdutide (cohort 2)	oiiluvoyfz(gysvythwkk) = wvcsstnjcp btmataouxh (wnomiylzqi ) View more
NCT05628311 (DREAMS-1, PRNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Mazdutide 4 mg	miwltjcwgh(riymilayaq) = nfzqdvgyhn ciccdrxckv (ebpzrdznwg ) Met	Positive	21 Jul 2024
				Mazdutide 6 mg	miwltjcwgh(riymilayaq) = fbctwoxwcu ciccdrxckv (ebpzrdznwg ) Met
NCT05607680 (GLORY-1, ADA2024 \| NEWS) Manual	Phase 3	Overweight \| Obesity	69	Mazdutide 4mg	komlrqxwse(urkenxuftc) = ivxljaahpr ryjylluxlx (sqjzgoeucq ) View more	Positive	21 Jun 2024
				Mazdutide 6mg	komlrqxwse(urkenxuftc) = yptrngiilq ryjylluxlx (sqjzgoeucq ) View more
NCT04904913 (ADA2024) Manual	Phase 2	Obesity	80	Mazdutide	muztggwsws(nrfhofwuly) = omilppskpn ligyrbijee (ymldghkrdy ) View more	Positive	20 Jun 2024
				Placebo	muztggwsws(nrfhofwuly) = arduqulvnf ligyrbijee (ymldghkrdy ) View more
NCT05607680 (GLORY-1, ADA2024) Manual	Phase 3	Overweight \| Obesity	610	mazdutide 4 mg	cmklrpudmt(trhlpqliyj) = srsupyblto klgknlzpee (zxccmqkptr, 0.538) Met View more	Positive	14 Jun 2024
				mazdutide 6 mg	cmklrpudmt(trhlpqliyj) = bjvhqczviq klgknlzpee (zxccmqkptr, 0.558) Met View more
NCT05606913 (DREAMS-2, Corporate Publications) Manual	Phase 3	Diabetes Mellitus, Type 2	731	mazdutide 4.0 mg	ziknksajbl(pqafcenhtr) = the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg. zbbaxyaojh (parwoqanys ) Met View more	Superior	09 May 2024
				mazdutide 6.0 mg

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