Innovent's First New Drug Application of Mazdutide for Chronic Weight Management has been Accepted by the NMPA of China

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Innovent Biologics, Inc. announces the acceptance of the New Drug Application (NDA) for mazdutide, a GLP-1R/GCGR dual agonist, by the National Medical Products Administration (NMPA) of China for chronic weight management in adults with obesity or overweight. The Phase 3 clinical trial of mazdutide in Chinese adults with overweight or obesity met primary and secondary endpoints, showing superiority over placebo in terms of body weight reduction and cardiometabolic endpoints. The safety profile was similar to previous clinical studies, with no new safety signals observed. The leading principal investigator of the study, Professor Linong Ji, emphasized the potential benefits of mazdutide in reducing chronic disease risks, and Dr. Lei Qian, Vice President of Clinical Development of Innovent, highlighted the potential of mazdutide as a next-generation GLP-1-based anti-obesity drug with robust weight-loss efficacy and cardiometabolic benefits.

ROCKVILLE, Md. and SUZHOU, China, Feb. 7, 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 New Drug Application (NDA) for mazdutide (Innovent R&D code: IBI362), 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 the National Medical Products Administration (NMPA) of China, for chronic weight management in adults with obesity or overweight.

Mazdutide is the first GLP-1R/GCGR dual agonist to successfully complete Phase 3 trials in support of a NDA submission. As a new generation of weight-loss drugs activating both GLP-1 and glucagon receptors, mazdutide could bring an efficacious, safe and easy-to-use treatment option to the vast and ever-growing population with overweight or obesity in China.

In January 2024, the Phase 3 GLORY-1 (NCT05607680) clinical trial of mazdutide in Chinese adults with overweight or obesity met the primary endpoints and all key secondary endpoints. Mazdutide 4 mg and 6 mg showed superiority over placebo in terms of body weight reduction and multiple weight-related and cardiometabolic endpoints. The safety profile was similar to that observed in previous clinical studies of mazdutide, with no new safety signals observed. Innovent will release detailed results from the GLORY-1 study in medical conferences or journals later in 2024.

Professor Linong Ji, the leading principal investigator of the study, Peking University People's Hospital, stated, "With early prevention and timely intervention of overweight and obesity, the risks for numerous chronic diseases such as cardiovascular and cerebrovascular diseases, type 2 diabetes, hypertension, and fatty liver could be effectively reduced, which would improve quality of life and alleviate disease burdens. However, weight loss and management through lifestyle intervention alone is usually difficult to achieve or maintain for many people living with obesity or overweight. Safe and efficacious weight management pharmacotherapies could significantly reduce body weight and improve weight-related cardiometabolic risk factors and health-related outcomes. I'm encouraged by the robust weight-loss efficacy, cardiometabolic benefits and favorable safety of mazdutide. Together with the other investigators in the study, I'm proud of its NDA submission as an innovative anti-obesity pharmacotherapy in China. We are hopeful for the approval of mazdutide, which will benefit hundreds of millions of Chinese people with obesity or overweight."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "With regulatory acceptance of the first NDA, mazdutide continues to pioneer the clinical development of GLP-1R/GCGR dual agonists. As a next-generation GLP-1-based anti-obesity drug, mazdutide has demonstrated robust weight-loss efficacy and cardiometabolic benefits in several clinical trials with more than one thousand subjects enrolled. We will communicate closely with the NMPA and expect to provide a safe and effective weight management medication for Chinese people with overweight or obesity soon. We are also developing mazdutide for other indications based on scientific evidence and unmet medical needs. Innovent will continue strategically building our next-generation product pipeline in the cardiovascular and metabolic (CVM) field and help people pursue a healthy life."

About Obesity

As a chronic disease with complex underlying causes, obesity is one of the leading risk factors for type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, kidney diseases, joint diseases, sleep apnea and cancers. With economic development and related lifestyle changes, the number of people with overweight and obesity in China has jumped to the highest in the world^[1]. The incidence and mortality of cardiovascular disease, type 2 diabetes and certain tumors are also higher in the population with severe obesity. Deaths caused by overweight and obesity in China accounted for 11.1% of deaths related to chronic non-communicable diseases in 2019, a significant increase from 5.7% in 1990^[2]. Overweight and obesity have become serious health problems. Lifestyle intervention is a basic treatment option for people with overweight or obesity. However, a considerable percentage of people fail to achieve desired weight loss goals based on lifestyle intervention only and may require pharmacological intervention. Traditional pharmacological therapies in China have limited efficacy and multiple safety issues, highlighting the unmet clinical need for more effective and safe therapies for people with obesity in China.

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, with the effects of GLP-1 receptor agonists to promote 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 robust weight loss and glucose-lowering effects in clinical studies as well as improvements in multiple cardio-metabolic indicators including reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, liver fat content and improved insulin sensitivity. Currently, five Phase 3 studies of mazdutide in Chinese adults with overweight or obesity (GLORY-1 and GLORY-2) and type 2 diabetic (DREAMS-1, DREAMS-2 and DREAMS-3) subjects are underway, where GLORY-1 study has met the primary and all key secondary endpoints.

In February 2024, the first NDA of mazdutide was accepted by the CDE of the NMPA of China for chronic weight management in adults with obesity or overweight.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. Headquartered in China, the company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 20 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.

Note:

TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer: Innovent does not recommend any off-label usage.

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.

[1] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92.

[2] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. http://ghdx.healthdata.org/gbd-resultstool (accessed Jan 10, 2021).

 

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SOURCE Innovent Biologics

FAQ

What is the NDA for mazdutide by Innovent Biologics, Inc.?

The NDA for mazdutide is for chronic weight management in adults with obesity or overweight, accepted by the National Medical Products Administration (NMPA) of China.

What are the primary and secondary endpoints met in the Phase 3 clinical trial of mazdutide?

In the Phase 3 clinical trial, mazdutide showed superiority over placebo in terms of body weight reduction and cardiometabolic endpoints.

Who is the leading principal investigator of the mazdutide study?

Professor Linong Ji, from Peking University People's Hospital, is the leading principal investigator of the mazdutide study.

What are the potential benefits of mazdutide highlighted by Professor Linong Ji?

Professor Linong Ji emphasized the potential benefits of mazdutide in reducing chronic disease risks associated with overweight and obesity.

What is the role of Dr. Lei Qian in the development of mazdutide?

Dr. Lei Qian is the Vice President of Clinical Development of Innovent, and he highlighted the potential of mazdutide as a next-generation GLP-1-based anti-obesity drug with robust weight-loss efficacy and cardiometabolic benefits.