Innovent's NDA for Mazdutide in Type 2 Diabetes Accepted by China's NMPA
SAN FRANCISCO, U.S. and SUZHOU, China, Aug. 1, 2024 — Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a globally recognized biopharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted its second New Drug Application (NDA) for mazdutide. This GLP-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist is targeted for the treatment of adults with type 2 diabetes (T2D). Mazdutide is set to become the first GLP-1R/GCGR dual agonist in China to reach Phase 3 success for T2D, promising advancements in glycemic control, weight reduction, and various metabolic benefits for diabetic patients.
The NDA submission is supported by data from two Phase 3 clinical trials. These trials evaluated mazdutide both as a standalone treatment (DREAMS-1, NCT05628311) and in combination with oral antidiabetic drugs (OADs) (DREAMS-2, NCT05606913) in Chinese patients with T2D. Findings from these studies showed that mazdutide outperformed placebo and dulaglutide 1.5 mg in improving glycemic control, reducing weight, and enhancing multiple cardiovascular and renal indicators. The safety profile of mazdutide was consistent with previous studies and other GLP-1R agonists, revealing no new safety issues. The detailed results are set to be published in academic venues.
Dr. Lei Qian, Vice President of Clinical Development at Innovent, remarked, "We are thrilled that alongside the NDA for weight management, the application for treating T2D with mazdutide has also been accepted. Supported by regulatory bodies and the hard work of our investigators and trial participants, mazdutide has shown significant benefits in glucose management, weight loss, and cardiovascular and renal health. We are eager to collaborate with the NMPA to bring this innovative treatment to the market for T2D patients in China."
The backdrop of this development is the alarming diabetes statistics in China. According to the International Diabetes Federation, China had the highest number of diabetes patients globally in 2021, with numbers projected to swell from 140 million to over 174 million by 2045. Poor glycemic control can have severe consequences, leading to complications like vision loss, renal dysfunction, neuropathy, heart attacks, strokes, and amputations. Given the high prevalence of diabetes and its serious complications, there is a pressing need for effective treatments. Current therapeutic approaches aim to not only control blood glucose but also offer benefits like weight loss, cardiovascular risk reduction, and kidney protection.
Mazdutide (IBI362), developed under an exclusive agreement with Eli Lilly and Company, is a GLP-1R/GCGR dual agonist classified as a mammalian oxyntomodulin (OXM) analogue. It functions by promoting insulin secretion, reducing blood glucose levels, and aiding weight loss, similar to GLP-1 receptor agonists. Additionally, it can enhance energy expenditure and improve liver fat metabolism by activating the glucagon receptor. Clinical studies have demonstrated mazdutide’s strong efficacy in both weight loss and glucose reduction, along with multiple cardio-metabolic benefits including the reduction of waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, all while improving insulin sensitivity.
Currently, five Phase 3 trials of mazdutide are ongoing. They include studies on weight management and glycemic control in various patient groups in China:
1. GLORY-1 for overweight or obesity,
2. GLORY-2 for moderate to severe obesity,
3. DREAMS-1 for newly treated T2D patients,
4. DREAMS-2 comparing mazdutide with dulaglutide in T2D patients,
5. DREAMS-3 comparing mazdutide with semaglutide in T2D patients with obesity.
Innovent, founded in 2011, aims to provide accessible high-quality biologics. The company has developed treatments for diseases like cancer, cardiovascular and metabolic disorders, autoimmune diseases, and eye conditions. With ten products already in the market and multiple others in various stages of clinical trials, Innovent collaborates with global healthcare leaders to advance the biopharmaceutical industry and ensure the wide availability of innovative medicines.
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