CSPC PHARMA's Long-Acting GLP-1/GIP Dual Agonist Receives FDA Clearance for US Clinical Trials

Stock News
Feb 16

CSPC PHARMA has announced that its long-acting injection SYH2082, a dual GLP-1/GIP receptor agonist, has received approval from the U.S. Food and Drug Administration to commence clinical trials in the United States. SYH2082 is positioned as a leading candidate in clinical development among long-acting GLP-1/GIP dual agonists, with a once-monthly dosing regimen. Leveraging the company's sustained-release formulation technology, SYH2082 enables monthly administration, improving patient compliance and convenience. The molecule selectively activates the cAMP pathway while reducing β-arrestin recruitment, which minimizes receptor internalization and desensitization, thereby enhancing efficacy and extending duration of action. Additionally, SYH2082 integrates long-half-life modification technology with a sustained-release platform, aiming to support continuous weight reduction throughout the dosing interval. In preclinical studies, SYH2082 demonstrated superior efficacy in long-term weight loss and maintenance compared to similar marketed products and supported a once-monthly dosing schedule. Toxicology studies indicated that SYH2082 was well-tolerated with no significant adverse effects observed. The approved clinical indication is weight management in individuals with obesity or overweight who have at least one weight-related comorbidity. Furthermore, SYH2082 holds potential for improving glycemic control in adults with type 2 diabetes, offering additional clinical benefits. This regulatory milestone represents a significant achievement in CSPC PHARMA's strategy to develop innovative long-acting metabolic therapies and lays a solid foundation for future development of additional novel products.

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