CSPC Group (01093): GLP-1/GIP receptor bidirectional agonist polypeptide injection approved for clinical trials in the US

Zhitong Finance App News, Shiyao Group (01093) announced that the GLP-1/GIP receptor bidirectional agonist peptide injection (SYH2069 injection) (this product) developed by the Group has been approved by the US Food and Drug Administration (FDA) and can conduct clinical trials in the US.

This product is expected to be the first GLP-1/GIP receptor bidirectional agonist to enter the clinical stage in China. It can selectively activate the cAMP pathway and significantly reduce beta-arrestin recruitment, thereby reducing receptor endothelism and desensitization, and improving efficacy and durability of effects. At the same time, combined with long half-life modification platform technology, the product can achieve deeper and longer lasting weight loss effects. In studies on diet-induced obesity (DIO) mice and non-human primates, the effects of this product in weight loss and metabolic improvement were significantly superior to similar marketed products. Repeated dose toxicology studies in non-human primates showed that the product was well tolerated, and no vomiting or gastrointestinal adverse effects were observed. The product has excellent efficacy and good safety, and is expected to become a next-generation treatment for overweight/obesity and other metabolic diseases.

The approved clinical indication is weight management for people who are obese or overweight with at least one weight-related complication. In addition, the product also has the potential to improve blood sugar control in adult type 2 diabetes (T2DM) patients, and has high clinical development value.