CSPC PHARMA (01093): GLP-1/GIP Receptor Dual-Biased Agonist Polypeptide Injection (SYH2069 Injection) Receives Clinical Trial Approval in China

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2025/12/29

CSPC PHARMA (01093) announced that the GLP-1/GIP receptor dual-biased agonist polypeptide injection (SYH2069 Injection) developed by the group has been approved by the National Medical Products Administration (NMPA) of China to commence clinical trials in the country. Previously, this product had also received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. The product is expected to become China's first GLP-1/GIP receptor dual-biased agonist to enter the clinical stage; it selectively activates the cAMP pathway, significantly reduces β-arrestin recruitment, thereby minimizing receptor internalization and desensitization, which enhances drug efficacy and prolongs its duration of action. Furthermore, utilizing a long half-life modification platform technology, this product can achieve more profound and sustained weight loss effects. In studies involving diet-induced obese (DIO) mice and non-human primates, the product demonstrated significantly superior effects in weight reduction and metabolic improvement compared to similar marketed products. Repeated-dose toxicology studies in non-human primates indicated that the product is well-tolerated, with no observations of vomiting or gastrointestinal adverse reactions. With its excellent efficacy and favorable safety profile, the product holds promise as a next-generation therapy for overweight/obesity and other metabolic diseases. The clinical indication approved this time is for weight management in individuals with obesity or overweight accompanied by at least one weight-related comorbidity. Additionally, the product also possesses the potential to improve glycemic control in adults with type 2 diabetes (T2DM), indicating significant clinical development value.

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