Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. 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.

IBI3032 is an orally administered small-molecule GLP-1 receptor agonist with bias for cAMP signaling pathway, discovered and developed by Innovent Biologics with proprietary rights. 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 U.S. Dosing in healthy volunteers and overweight or obese participants is expected to begin in the second half of 2025. Innovent is building up its CVM pipeline with mazdutide as the cornerstone, and the initiation of the IBI3032 clinical study marks a significant step in the evolution of its CVM pipeline portfolio with global potential.

Dr. Lei Qian, Chief R&D Officer for General Biomedicines Pipeline at Innovent Biologics, said, "GLP-1 has emerged as a blockbuster target over the past decade. Its oral form, with its convenience, flexibility, and unique advantage in combination treatment strategies, holds promise as a differentiated complement to GLP-1R-targeting biologicals. Beyond traditional applications in diabetes and weight management, oral GLP-1 possess potential in treating related diseases such as hypertension and OSA (obstructive sleep apnea). IBI3032 has demonstrated its promising efficacy profiles in animal models, where IBI3032 exhibited a longer elimination half-life and higher drug exposure levels than its competitors at the same dose. We are excited to advance this candidate into clinical development. This IND approval reflects Innovent's strong R&D capabilities and, most importantly, our commitment to global innovation. We hope that in the near future, IBI3032 can offer more effective and convenient treatment options to benefit patients around the world. "