Innovent announces approval of mazdutide injection in Macao, introducing a novel therapeutic option to patients with obesity and overweight
On December 15, 2025, Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that mazdutide (glucagon [GCG]/glucagon-like peptide-1 [GLP-1] dual receptor agonist) has been approved for marketing by the Pharmaceutical Administration Bureau (ISAF) of the Macao Special Administrative Region of China. The therapy is indicated for long-term weight management in adults with obesity or overweight. Several of Innovent's innovative products have already been approved for marketing in various countries and regions including Indonesia, Hong Kong China, Macao China, and Taiwan China.
Mazdutide is the world's first GCG/GLP-1 dual receptor agonist for weight management. Its unique dual agonist mechanism not only activates the GLP-1 receptor to suppress appetite and reduce calorie intake, but also activates the GCG receptor, which has been associated with increased energy expenditure and reductions in visceral fat, thereby supporting the weight loss effect of mazdutide. Clinical studies have shown that mazdutide achieves robust weight reduction, reduces liver fat content by more than 80%, decreases waist circumference by up to 11cm, and reduces neck circumference by up to 3cm. It also improves cardiovascular and metabolic indicators such as blood glucose, blood pressure, blood lipids, blood uric acid and transaminase levels, bringing comprehensive benefits. It has been rated as one of the Top 10 Most Anticipated Drugs Globally in 2025 (FIERCE Pharma 2025), and its research findings were published in the New England Journal of Medicine, accompanied by a dedicated expert commentary.
In October this year, mazdutide achieved the primary endpoint in the Phase 3 clinical trial DREAMS-3 (ClinicalTrials.gov Identifier: NCT06184568). The study results showed that in Chinese patients with type 2 diabetes (T2D) combined with obesity, mazdutide demonstrated significantly superior comprehensive efficacy in glycemic control and weight management compared with semaglutide. It also showed better improvement in multiple cardiometabolic risk factors such as fasting blood glucose, waist circumference, systolic blood pressure, and triglycerides.
Notably, the approved mazdutide injection is designed with patient convenience and safety in mind. It features a hidden needle design, a single-use format to prevent cross-contamination, and a specially engineered X-shaped needle cross-section shown in comparative studies to reduce pain and improve ease of skin penetration, contributing to a more comfortable injection experience. These design details not only enhance convenience but also support long-term treatment adherence, adding practical advantages for clinical adoption.
As a leading biopharmaceutical company in China, Innovent Biologics has built a robust product pipeline of more than 30 new drug candidates, spanning major therapeutic areas, including oncology, autoimmune diseases, cardiovascular and metabolic diseases, and ophthalmology. The approval of mazdutide in Macao not only provides a breakthrough weight management option for patients with obesity but also contributes to advancing public health and fostering medical innovation in the region. Innovent remains committed to its mission of "empowering patients worldwide with affordable, high-quality biopharmaceuticals" and will continue to drive more innovative therapies to broader markets, benefiting more patients.