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

CSPC PHARMA (01093) announced that the long-acting injectable peptide SYH2082, a GLP-1/GIP receptor dual biased agonist developed by the group, has been approved by the US Food and Drug Administration (FDA) for clinical trials in the United States. SYH2082 is expected to become a leading long-acting GLP-1/GIP receptor dual biased agonist in the clinical development stage, with monthly dosing. Leveraging the group's long-acting formulation technology platform, SYH2082 achieves monthly dosing, improving patient compliance and convenience of use. SYH2082 selectively activates the cAMP pathway, reduces -arrestin recruitment, thereby reducing receptor internalization and desensitization, enhancing efficacy and prolonging duration of action. In addition, SYH2082 combines half-life modification platform technology and long-acting formulation platform technology, aiming to achieve sustained weight loss within dosing intervals. In preclinical studies, SYH2082 demonstrated superior efficacy in long-term weight loss and maintenance compared to similar products on the market, supporting a monthly dosing regimen. In toxicology studies, SYH2082 showed good tolerability with no significant adverse reactions observed. The approved clinical indication for this trial is weight management in obese or overweight individuals with at least one weight-related comorbidity. Additionally, SYH2082 has the potential to improve blood sugar control in adults with type 2 diabetes (T2DM), providing additional clinical benefits. The approval of this clinical trial is an important achievement for the group's innovative long-acting product layout in the metabolic field, laying a solid foundation for the development of more innovative products in the future.