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Innovent Provides Interpretation and Updates on Clinical Data from Mazdutide GLORY-1 Study and General Biomedicine Pipeline

2024-06-28

临床结果临床3期临床1期上市批准临床2期

SAN FRANCISCO and SUZHOU, China, June 27, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, provided interpretation and updates on clinical data from Mazdutide's GLORY-1 study and its general biomedicine pipeline at an investor conference call on June 25.

At the 2024 American Diabetes Association (ADA) Scientific Meeting, the company reported the results of its first Phase 3 clinical study (GLORY-1) on the GLP-1R/GCGR dual agonist mazdutide (Innovent R&D code: IBI362) in overweight or obese adults in China, along with the exploratory analysis results on liver fat content. During the June 25 conference call, leadership offered an in-depth interpretation of the clinical data. Innovent's Chief Financial Officer Rachel You and General Biomedicine Vice President of Clinical Development Lei Qian attended the meeting and made reports. Professor Linong Ji, MD, the principal investigator of the GLORY-1 study and Director of Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People's Hospital, also provided commentary.

GLORY-1 is tAmerican Diabetes Association (ADA)ldwide evaluating a GLP-1R/GCGR dual agonist for weight loss. The findings demonstrate significant weight rGLP-1RoGCGRobust safety, mazdutideveInnoventduction and comprehensive improvement in metabolic indicators, confirming the distinctive advantages of mazdutide as a dual agonist targeting GLP-1R and GCGR. At the same time, Innovent is actively pursuing new development pathwaInnoventuding innovative molecules that extend beyond T2D and weight management, with the aim to deliver transformative treatments in metabolic health.Peking University Diabetes Center Diabetes Peking University People's Hospital

Mazdutide is an analogue of oxyntomodulin (OXM), a natural peptide GLP-1R/GCGR dual agonistns that activates both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), to scientifically and effectively reduce weight, increase energy expenditure, burn fat and improve liver fat metabolmazdutidean also achieve comprehensiveGLP-1Rolic GCGRfits and improve phyInnoventalth. The findings from GLORY-1 underscore mazdutide's impressive weight loss effects, safety and T2Derability, and further highlight its ability to significantly reduce liver fat content and improve multiple cardiovascular metabolic risk factors. These results reaffirm the distinct advantages of new-generation of GLP-1R/GCGR dual agonists.

Mazdutide weight loss efficaoxyntomodulin (OXM)glucagon-like peptide-1 receptor (GLP-1R)mazdutide GLP-1R/GCGR dual agonists

The GLORY-1 study demonstrated mazdutide's remarkable weight loss efficacy. After 48 weeks of treatment, the mazdutide 6mg group experienced an average weight reduction of 14.3% compared to baseline. Additionally, mazdutide showed significant reductions in waist circumference, hip circumference, and neck circumference, indicating its potential in reducing body fat.

Unprecedented liver benefitsmazdutide mazdutide mazdutide

In addition to its exceptional weight management capabilities, mazdutide also demonstrated an 80.2% reduction in liver fat content in the GLORY-1 study, indicating improvements to liver health. Acting directly on the liver as a GLP-1R/GCGR dual agonist, mazdutide shows promise in treating metabolic-associated fatty liver disease (MAFLD) and metabolic-associated steatohepatitis (MASH), enhancing liver metabolic function and mitigating factors contributing to liver metabolic dysfunction.

Significant reduction in multiple cardiovascular metabolic riskmazdutidersGLP-1R/GCGR dual agonist mazdutide metabolic-associated fatty liver disease (MAFLD)metabolic-associated steatohepatitis (MASH)liver metabolic dysfunction

The data at week 48 showed that mazdutide outperformed placebo in reducing waist circumference, systolic blood pressure, triglycerides, total cholesterol, LDL-C, blood uric acid, and ALT levels compared to baseline. Furthermore, mazdutide significantly normalized blood sugar level for participants with HbA1C≥5.7%. These findings highlight mazdutide's potential to mitigate cardiovascular metabolic risk factors and improve blood sugar management.

Well tolerated and favorable safmazdutidelemazdutide mazdutide

Mazdutide showed excellent safety and tolerability in the GLORY-1 study, establishing itself as a safe treatment choice. Most gastrointestinal symptoms observed in the treatment group, such as nausea, vomiting, and diarrhea, were mild or moderate, with no signals indicating increased cardiovascular risk. These findings underscore mazdutide's effectiveness in weight loss and improving metabolic conditions, while also highlighting its promising safety profile, positioning it as a potential best-in-class treatment option.

Mazdutideting application for mazdutide's first weight loss indication is currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). nausearovomitingdutidediarrheationed to be a safe, effective, and comprehensive solution for chronic weight management among obese and overmazdutidedividuals in China, and could aid them to improve liver fat metabolism and address obesity-related comorbidities. Moving forward, Innovent plans to explore additional indications for mazdutide, advance the research and development of next-generation GLP-1 products, and contribute to improving the quality of life for patients with chronic diseases.

Additionally, Innovent discussmazdutideoducts in the cardiovascular and metabolic (CVM) field targeting various clinical needs currently in development. SINTBILO® (PCSK9) is the first and only Chinese-develmazdutide9 monoclonal antibody approved for treating hyperlipidemia. IBI128 (a new xanthine oxidase inhibitor) represents a next-generation candidate for managing gout and hyperuricemia, with ongoing Phase 3 clinical tobesityverseas and planned Phase 1/2 studies inInnoventtarting in 2024. IBI3016 (AGT siRNA) is an inmazdutidesiRNA therapy for hypertension, with a Phase 1 clinical trial scheduled to commence in 2024. Furthermore, several early-stage projects are pchronic diseaseshe IND stage, bolstering Innovent's strategic positioning and competitive edge in CVM.

Metabolic diseInnoventnificantly affect quality of life and overall well-being. Innovent is accelerating innovation in this crucial area, dedicated to adSINTBILO unPCSK9linical needs and delivering safer, more ePCSK9 monoclonal antibodytients. Over the next fhyperlipidemiaovIBI128ans to ixanthine oxidase inhibitor xanthine oxidase metabolic products targeting diabetes, weight loss, cardiovascugoutcondihyperuricemiaer indications, aiming to establish itself as a leading research and development company in the field of IBI3016asAGTar metabolic diseases in China.hypertension Innovent

Metabolic diseasessing global unmet clinical needsInnovent Innovent diabetes cardiovascular metabolic diseases

In the field of autoimmune, Innovent has successfully launched SULINNO® (adalimumab injection), which is approved for eight indications including rheumatoid arthritis and psoriasis and is covered under the National Reimbursement Drug List. Picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, successfully met primary and key secondary endpoints in its Phase 3 clinical study (CLEAR-1) for moderate to severe plaque psoriasis in China. CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients, and Innovent is preparing for a NDA submission to the CDE of NMPA. Innovent continues to explore unmet clinical needs in autoimmune diseases globally with advancements like IBI355 (CD40L), IBI356 (OX40L), IBI3002 (IL-4Rα/TSLP) and other innovative First-in-class/Best-in-class molecules targeting indications including primary Sjögren's syndrome, systemic lupus erythematosus, atopic dermatitis, asthma, and other diseases.

In the field of ophthalmology, Innovent's new drug application for IBI311 Injection (recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, R&D) has been accepted for the treatment of thyroid eye disease (TED). This biologic with an innovative mechanism of action is poised to address a 60-year gap in domestic TED treatment, meeting significant clinical needs and offering effective, safe, and accessible treatment options for Chinese TED patients. In addition, Phase 3 clinical trials for IBI302 (VEGF/C) have commenced to address neovascular age-related maculopathy, with long-interval administration expected to achieve significant efficacy and potentially enhance management of geographic atrophy. Furthermore, IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are currently in Phase 1 clinical trials to explore their differentiated clinical value.

About Innovent Biologics:Innovent IBI311 insulin-like growth factor 1 receptor (IGF-1R) antibody insulin-like growth factor 1 receptor (IGF-1R)thyroid eye disease (TED)TED TED neovascular age-related maculopathy geographic atrophy IBI324 VEGF-A ANG-2 IBI333 VEGF-C VEGF-A

InnoveInnovent Biologicsopharmaceutical 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 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Innoventy 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 Icancert on Facebook and LinkedIn.Innovent Innovent Eli Lilly Sanofi Incyte Adimab LG Chem MD Anderson Cancer Center Cancer

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SOURCE Innovent Biologics