The world's first dual-target weight-loss drug (Simulijie® Masidutide Injection) has been approved for marketing by the NMPA. Continued attention to opportunities in the GLP-1 sector.
Publish Time:
2025-07-07
On June 27, 2025, Innovent Biologics announced that its drug, Simulij® (Marsetide injection), has been approved by the NMPA for long-term weight management in obese or overweight adults.
Simulij® (Marsetide injection) is a glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist jointly developed by Innovent Biologics and Eli Lilly and Company. By simultaneously acting on both GLP-1R and GCGR targets, it provides multiple metabolic benefits, including weight loss, blood sugar reduction, reduced waist circumference, improved blood lipid levels, blood pressure, uric acid, liver enzymes and liver fat content, and improved insulin sensitivity.
This approval is primarily based on the results of the Phase III registration clinical study (GLORY-1). The study showed that at week 48, the mean percentage change from baseline in body weight for the Simulij® 4mg, 6mg, and placebo groups were -12.0%, -14.8%, and -0.5%, respectively; the mean change from baseline in waist circumference was -9.5cm, -11.0cm, and -1.5cm, respectively. In addition, Simulij® significantly reduced liver fat content in overweight or obese subjects. In subjects with baseline liver fat content ≥10%, at week 48, the mean percentage change from baseline in total liver average fat content for the Marsetide 4mg, 6mg, and placebo groups were -65.85%, -80.24%, and -5.27%, respectively.
The second NDA for Marsetide is currently under review by the NMPA for the treatment of blood glucose control in adults with type 2 diabetes.
Congen pharma focuses on the research and development and production of peptides and small molecule drugs, committed to providing customers with high-quality peptide products and solutions, and striving to make sustainable and affordable peptides benefit human beauty and health.
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