CSPC PHARMA (01093) announced that its GLP-1/GIP receptor dual-targeting agonist polypeptide injection (SYH2069 injection) has received approval from the U.S. Food and Drug Administration (FDA) to commence clinical trials in the U.S. This product is poised to become China's first GLP-1/GIP receptor dual-targeting agonist to enter clinical stages. It selectively activates the cAMP pathway, significantly reducing β-arrestin recruitment, thereby minimizing receptor internalization and desensitization while enhancing efficacy and durability.

Incorporating a long half-life modification platform, the product achieves deeper and more sustained weight loss effects. Studies in diet-induced obese (DIO) mice and non-human primates demonstrated its superior weight reduction and metabolic improvement compared to existing market alternatives. Repeated-dose toxicology studies in non-human primates showed favorable tolerability, with no observed vomiting or gastrointestinal adverse reactions.

With outstanding efficacy and safety, SYH2069 holds promise as a next-generation therapy for overweight/obesity and other metabolic disorders. The approved clinical indication targets weight management in obese or overweight individuals with at least one weight-related comorbidity. Additionally, the product exhibits potential for improving glycemic control in adults with type 2 diabetes (T2DM), underscoring its high clinical development value.