Innovent Biologics Inc (HKEX:01801), a China-based biopharmaceutical company that develops, manufactures and commercialises medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced on Monday that the US Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to initiate a Phase 1 clinical trial of IBI3032, the company's novel oral GLP-1R agonist.

Discovered and developed by Innovent Biologics, IBI3032 is an orally administered small-molecule GLP-1 receptor agonist with bias for cAMP signalling pathway. Preclinical data demonstrate its superior pharmacokinetic (PK) and physicochemical properties compared to peer compounds. In animal models, IBI3032 achieved 5 to 10 times higher oral exposure at equivalent doses, with improved efficacy and good tolerability in both GLP-1R KI DIO mice and obese monkey models, achieving comparable therapeutic effects at lower doses.

The Phase 1 clinical trials of IBI3032 are planned to be conducted concurrently in China and the United States. Dosing in healthy volunteers and overweight or obese participants is expected to begin in the second half of 2025.