Innovent Biologics’ 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 the 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.
"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,” said Professor Linong Ji, the leading principal investigator of the study, Peking University People's Hospital. “I'm encouraged by the robust weight-loss efficacy, cardiometabolic benefits and favourable 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."
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.
"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,” said Dr Lei Qian, Vice President of Clinical Development of Innovent. “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 field and help people pursue a healthy life."