CSPC PHARMA (01093): GLP-1/GIP receptor biased agonist dual peptide injection approved for clinical trials in the United States.

CSPC PHARMA (01093) announced that the group's developed GLP-1/GIP receptor biased agonist dual-specificity peptide injection (SYH2069 injection) has been approved by the U.S. Food and Drug Administration (FDA) for clinical trials in the United States. This product is expected to become China's first GLP-1/GIP receptor dual-biased agonist to enter the clinical stage, selectively activating the cAMP pathway, significantly reducing -arrestin recruitment, thereby reducing receptor internalization and desensitization, and improving drug efficacy and duration of effect. Furthermore, with the combination of long half-life modification platform technology, this product can achieve a more profound and lasting weight loss effect. In studies on diet-induced obese (DIO) mice and non-human primates, this product has shown significantly better results in weight loss and metabolic improvement compared to similar products on the market. Repeat-dose toxicity studies in non-human primates have shown good tolerance to the product, with no observed vomiting or gastrointestinal adverse reactions. This product has excellent efficacy and safety, and is expected to become a new generation of therapy for obesity and other metabolic diseases. The approved clinical indications for this product are weight management in obese or overweight individuals with at least one weight-related comorbidity. Additionally, this product also has the potential to improve blood sugar control in adults with type 2 diabetes (T2DM), making it highly valuable for clinical development.