An announcement from CSPC PHARMA (01093) reveals that its internally developed GLP-1 receptor agonist, the long-acting semaglutide injection (SYH 9017), has received approval from the U.S. Food and Drug Administration to commence clinical trials in the United States.
The product is a once-monthly formulation of semaglutide, created using the company's proprietary long-acting delivery technology platform. It utilizes biocompatible excipients to form a gel depot upon subcutaneous injection, enabling sustained drug release.
Compared to the currently marketed weekly semaglutide injection, this new formulation is expected to extend the dosing interval to once per month, which could significantly improve patient adherence and offers clear clinical advantages.
Domestic clinical studies indicate that the product demonstrates comparable weight loss efficacy and a favorable safety profile to the marketed semaglutide injection, with a notably extended half-life that supports the development of a monthly dosing regimen.
The approved indication for the U.S. trial is for weight management in adults with overweight or obesity, as an adjunct to a reduced-calorie diet and increased physical activity.
Furthermore, the product holds potential for treating type 2 diabetes and reducing cardiovascular disease risk, representing high clinical development value.
This product is the company's first long-acting, once-monthly formulation in the GLP-1 field. The approval for U.S. clinical trials lays a solid foundation for the future development of more innovative products.
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