CSPC Pharmaceutical (1093) Receives U.S. FDA Nod for Monthly GLP-1/GIP Dual-Biased Injection Trial

Bulletin Express
02/16

CSPC Pharmaceutical Group Limited (the “Group”) has obtained approval from the U.S. Food and Drug Administration to conduct clinical trials for its GLP-1/GIP receptor dual-biased agonist polypeptide long-acting injection (SYH2082 Injection). The investigational therapy is designed for once-a-month dosing, aiming to enhance patient adherence and convenience. According to the announcement, SYH2082 selectively activates the cAMP pathway, reducing β-arrestin recruitment and potentially prolonging therapeutic effect.

In preclinical studies, SYH2082 demonstrated notable efficacy in achieving and maintaining weight loss while remaining well-tolerated. The clinical trial will focus on weight management for individuals with obesity or those who are overweight with at least one weight-related comorbidity. It may also provide improved glycemic control for adults with type 2 diabetes. The approval marks a significant milestone for the Group in its development of innovative long-acting metabolic treatments.

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