CSPC drug gains US FDA approval for weight management clinical trials

CSPC Pharmaceutical Group Limited announced that its GLP-1/GIP receptor dual-biased agonist polypeptide injection (SYH2069 Injection) has received approval from the U.S. Food and Drug Administration (FDA) to commence clinical trials in the United States. The product is aimed at weight management for individuals with obesity or overweight and at least one weight-related comorbidity, with potential to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).

The company expects the product to be a new-generation therapeutic agent for metabolic diseases, touting its ability to selectively activate the cAMP pathway and reduce ß-arrestin recruitment, enhancing drug efficacy and durability. Pre-clinical studies in diet-induced obesity (DIO) mice and non-human primates demonstrated superior efficacy for weight loss and metabolic improvement compared to similar marketed products.

Repeat-dose toxicology studies in non-human primates also indicated the product was well-tolerated, with no observed vomiting or gastrointestinal adverse reactions. The approval marks a significant step for the Hong Kong-based pharmaceutical company as it seeks to expand its drug pipeline internationally.