Innovent Announces the NDA of Mazdutide for Type 2 Diabetes has been Accepted by the NMPA of China

Rhea-AI Summary

Innovent Biologics (HKEX: 01801) announces the acceptance of a New Drug Application (NDA) for mazdutide, a GLP-1R and GCGR dual agonist, by China's NMPA for the treatment of type 2 diabetes (T2D). This marks mazdutide as the first GLP-1R/GCGR dual agonist to succeed in Phase 3 trials for T2D. The NDA is based on two Phase 3 studies (DREAMS-1 and DREAMS-2) demonstrating superior efficacy to placebo or dulaglutide in glycemic control, weight reduction, and cardiovascular and renal improvements. Mazdutide showed a safety profile similar to other GLP-1R agonists with no new concerns. If approved, it could offer a novel treatment option for China's diabetic population, providing comprehensive metabolic benefits.

Positive

• First GLP-1R/GCGR dual agonist to succeed in Phase 3 trials for type 2 diabetes
• NDA accepted by China's NMPA for type 2 diabetes treatment
• Demonstrated superior efficacy in glycemic control and weight reduction compared to placebo and dulaglutide
• Showed improvements in cardiovascular and renal indicators
• Safety profile similar to other GLP-1R agonists with no new concerns

Negative

• None.

SAN FRANCISCO, U.S. and SUZHOU, China, Aug. 1, 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 the second New Drug Application (NDA) of mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of adults with type 2 diabetes (T2D). As the first GLP-1R/GCGR dual agonist to achieve success in Phase 3 trials for T2D, mazdutide, once approved, is expected to provide a novel treatment option for the vast population of diabetic patients in China, with comprehensive benefits in glycemic control, weight reduction and multiple metabolic benefits.

The NDA is mainly based on the results of two Phase 3 clinical studies, which respectively evaluate the efficacy and safety of mazdutide as monotherapy (DREAMS-1, NCT05628311) and in combination with oral antidiabetic drugs (OADs) (DREAMS-2, NCT05606913) in Chinese patients with T2D. These studies demonstrate that mazdutide is superior to placebo or dulaglutide 1.5 mg in glycemic control, weight reduction, and improvements on multiple cardiovascular and renal indicators. In both studies, the safety profile of mazdutide is similar to previous clinical studies and those of other GLP-1R agonists, with no new safety concerns. Detailed data will be published at academic conferences or in peer-reviewed journals.

Dr Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are glad that, following the acceptance of the first NDA for weight management, NDA of mazdutide for the treatment of T2D has also been accepted, with the support from regulatory authorities, investigators, and contributions from trial participants. As both a monotherapy and in combination with OADs, mazdutide demonstrates robust glucose-lowering and weight loss effects, together with multiple cardiovascular and renal benefits, as well as good safety and tolerability profiles. The results support the use of mazdutide as the first GLP-1R/GCGR dual agonist for the treatment of T2D. We will actively cooperate with the NMPA and look forward to providing better treatment option for T2D patients in China, helping them achieve glycemic control, weight reduction, and cardio-renal benefits."

About Diabetes

According to the International Diabetes Federation's 2021 global overview of diabetes, China has the highest number of diabetes patients worldwide, with an estimation of 140 million in 2021 and over 174 million by 2045^[1]. Poor glycemic control can lead to irreversible microvascular and macrovascular complications, such as decreased visual acuity, blindness, renal dysfunction, peripheral neuropathy, myocardial infarction, stroke and amputation^[2]. The high prevalence of diabetes, along with its serious complications, poses a significant threat to human health. At present, there are many therapeutic regimens for diabetes. In addition to effectively controlling blood glucose, the development of new hypoglycemic drugs has begun to include the additional benefits of weight loss, cardiovascular risk reduction and kidney protection for patients with diabetes^[3].

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.

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 10 products in the market, 4 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.

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 new drug application for mazdutide by Innovent Biologics (IVBIY) for?

Innovent Biologics' New Drug Application (NDA) for mazdutide is for the treatment of adults with type 2 diabetes in China.

What type of drug is mazdutide developed by Innovent Biologics (IVBIY)?

Mazdutide is a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist developed by Innovent Biologics.

What were the key findings from the Phase 3 trials of mazdutide by Innovent Biologics (IVBIY)?

The Phase 3 trials (DREAMS-1 and DREAMS-2) showed that mazdutide was superior to placebo or dulaglutide 1.5 mg in glycemic control, weight reduction, and improvements on multiple cardiovascular and renal indicators.

When was the NDA for mazdutide accepted by China's NMPA for Innovent Biologics (IVBIY)?

The NDA for mazdutide was accepted by China's National Medical Products Administration (NMPA) on August 1, 2024, as announced in the press release.