CSPC Submits NDA for GLP-1 Analogue for Weight Management

CSPC Pharma has filed a new drug application (NDA) with China's National Medical Products Administration (NMPA) for GLP-1 analogue efmedaglutide alfa as a weekly subcutaneous injection for long-term weight management in overweight or obese adults. The recombinant human GLP-1 Fc fusion protein demonstrated significant weight reduction alongside improvements in waist circumference, blood glucose, blood pressure and lipid profiles in Phase III trial versus placebo. The candidate showed favourable gastrointestinal tolerability with lower adverse event-related treatment discontinuation rates and simplified four-week dose escalation protocol compared to existing GLP-1 receptor agonists.

Efmedaglutide alfa represents a novel biological drug with effects including appetite suppression and glucose-dependent glycaemic control. CSPC concurrently submitted an abbreviated NDA for a semaglutide copycat in August 2025, positioning the company as a key player in China's rapidly expanding metabolic disease market. The weight-management indication addresses a substantial unmet need in the obesity treatment landscape where pharmacotherapy options remain limited despite high prevalence rates exceeding 50% in adult populations.

PharmCube's NextBiopharm® database lists over 80 GLP-1R-targeting peptide projects from nearly 70 developers in China alone. Click here to request a free trial for NextBiopharm®.

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