CSPC Pharma has received U.S. Food and Drug Administration approval to initiate clinical trials for SYH9017, a long-acting semaglutide injection formulated for once-monthly dosing.
The investigational GLP-1 receptor agonist, developed independently on the company’s proprietary long-acting delivery platform, forms a subcutaneous gel depot that extends drug release beyond the once-weekly regimen of existing semaglutide products. Domestic studies cited in the announcement indicate weight-loss efficacy comparable to marketed formulations, a favorable safety profile, and a significantly prolonged half-life—factors expected to enhance patient adherence.
The U.S. trial will evaluate SYH9017 for weight management in overweight or obese adults in conjunction with reduced-calorie diet and increased physical activity. CSPC Pharma also highlights potential broader indications, including type 2 diabetes treatment and cardiovascular risk reduction.
Management notes that SYH9017 is the group’s first once-monthly GLP-1 candidate, and the FDA clearance establishes a foundation for advancing additional long-acting innovations within its pipeline.
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