The board of directors of Innovent Biologics, Inc. announced that the first Phase 3 clinical trial of mazdutide (R&D code: IBI-362), a glucagon-like peptide-1 receptor ("GLP-1R") and glucagon receptor ("GCGR") dual agonist, in Chinese adults with overweight or obesity ("GLORY-1") met the primary endpoints and all key secondary endpoints. The Company plans to submit the first new drug application ("NDA") of mazdutide for weight management to the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) in the near term. GLORY-1 (NCT05607680) is a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy and safety of mazdutide in Chinese adults with overweight or obesity. A total of 610 participants were randomized to receive mazdutide 4 mg, 6 mg or placebo in the 48-week double-blind treatment period. The GLORY-1 study met both primary endpoints ­ mazdutide 4 mg and 6 mg showed superiority to placebo in terms of the percentage change in body weight from baseline to week 32 and the proportion of participants with a weight loss of 5% at week 32. The weight-loss efficacy was further improved from week 32 to week 48. Furthermore, all key secondary endpoints were met, including the proportion of participants with a weight loss of 10% or 15%, as well as the changes in waist circumference, systolic blood pressure, triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), total cholesterol, serum uric acid, and alanine aminotransferase (ALT). Mazdutide demonstrates superiority to placebo in all the above weight-loss and cardiometabolic endpoints. During the double-blind treatment period, the safety profile of mazdutide was similar to those observed in previous clinical studies, and no new safety signals were observed. With economic development and lifestyle changes, the number of obese population in China has jumped to the highest in the world . As a chronic disease with a complex etiology, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, kidney diseases, joint diseases, sleep apnea in addition to cancers. Lifestyle intervention is a basic treatment option for patients with overweight or obesity. However, a considerable percentage of patients fail to achieve the desired weight loss goal through merely lifestyle intervention, highlighting the unmet clinical need for more effective and safe therapies for the Chinese obese
population. As a novel GLP-1R/GCGR dual agonist, mazdutide has accumulated clinical data on more than a thousand Chinese participants. The results of the GLORY-1 study further confirm that mazdutide has robust weight loss effect with favorable safety and tolerability, and provide high-quality clinical evidence of long-term pharmacotherapy weight management specifically for the Chinese population with overweight or obesity. The Company plans to submit mazdutide's first NDA for weight management in the near term, and will also progress the development of mazdutide for other indications on the basis of scientific evidence and unmet medical needs. The Company will continue to strategically build its innovative next-generation product pipeline in the cardiovascular and metabolic (CVM) field, and help people's pursuit of a healthy life.