Innovent Annouces Multiple Clinical Study Results of Mazdutide to be Presented at the EASD 2024

SAN FRANCISCO and SUZHOU, China, Sept. 2, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that multiple clinical study results of mazdutide (GLP-1R/GCGR dual agonist) will be presented at the European Association for the Study of Diabetes® (EASD) 60th Annual Meeting in Madrid, Spain from September 9 -13, 2024. New data of mazdutide at EASD include the results from the Phase 3 study of mazdutide in Chinese adults with type 2 diabetes (DREAMS-2) in late-breaking oral presentation. Details are listed below：

Title: Mazdutide vs Dulaglutide in Patients with Type 2 Diabetes (DREAMS-2): a Randomized, Open-label, 28-week Phase 3 Trial

Abstract #：LBA 16

Presentation Form：LBA Oral Presentation

Time：September 11^th, 4:15 PM-4:30 PM (CEST)

Presenter：Prof. Lixin Guo, Peking Hospital

Title: Efficacy and Safety of Mazdutide in Chinese Participants with Overweight or Obesity (GLORY-1)

Abstract #：149

Presentation Form：Oral presentation

Time：September 12^th, 11:45 AM-12:00 PM (CEST)

Presenter：Prof. Linong Ji, Peking University People's Hospital

Title: Improvement of Liver Steatosis by Mazdutide in Chinese Participants with Overweight or Obesity—An Exploratory Analysis of GLORY-1

Abstract #：744

Presentation Form：Short Oral Presentation

Time：September 10^th, 12:30 PM (CEST)

Presenter：Prof. Leili Gao Peking University People's Hospital

Title: A Phase 2 Study of Mazdutide 9 mg in Chinese Adults with BMI≥30 kg/m²

Abstract #：733

Presentation Form：Short Oral Presentation

Time：September 12^th, 2:00 PM (CEST)

Presenter：Prof. Hongwei Jiang, the First Affiliated Hospital of Henan University of Science and Technology

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are delighted that the results of the Phase 3 study DREAMS-2 for mazdutide in T2D will be presented in the form of a late-breaking oral presentation at the EASD annual meeting. Mazdutide is the first GLP-1R/GCGR dual agonist to successfully complete a Phase 3 study for diabetes, demonstrating superior blood sugar-lowering and weight loss efficacy compared to dulaglutide. Of equal importance, a number of weight loss study data of mazdutide, including the GLORY-1 Phase 3 study, the 9 mg Phase 2 study will also be showcased at this EASD conference. The weight loss and glucose lowering efficacy and metabolic benefits of mazdutide, especially in the liver, have been consistently observed and further validated across clinical trials and patient populations."

About Mazdutide (IBI362)
Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide promotes insulin secretion, lowers blood glucose and reduces body weight similar to GLP-1 receptor agonists. Additionally, it may increase energy expenditure and improve hepatic fat metabolism by activating the glucagon receptor. Mazdutide has strong efficacy in weight loss and lowering glucose levels in clinical studies. It also offers multiple cardio-metabolic benefits, such as reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, while improving insulin sensitivity.

Mazdutide has two NDAs accepted by China's NMPA for review, including:

• For the chronic weight management in adults with obesity or overweight;
• For the glycemic control in adults with type 2 diabetes.

Currently, a total of five Phase 3 studies of mazdutide are underway, including:

• Phase 3 study conducted in Chinese adults with overweight or obesity (GLORY-1);
• Phase 3 study conducted in Chinese adults with moderate to severe obesity (GLORY-2);
• Phase 3 study in newly treated Chinese patients with type 2 diabetes (DREAMS-1);
• Phase 3 study comparing mazdutide and dulaglutide in Chinese patients with type 2 diabetes (DREAMS-2);
• Phase 3 study comparing mazdutide and semaglutide in Chinese patients with type 2 diabetes and obesity (DREAMS-3).

Among them, GLORY-1, DREAMS-1 and DREAMS-2 have reached the study endpoints and successfully completed.

About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA 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 leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company 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 is otherwise inaccurate.

source: Innovent Biologics