Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for the treatment of thyroid eye disease (TED).
The acceptance of the NDA for review comes on the heels of positive results from the Phase III RESTORE-1 study, which met its primary endpoint in February 2024. The study demonstrated that IBI311 significantly outperformed the placebo in improving eyeball protrusion, disease activity, and quality of life for subjects. The drug also exhibited an overall good safety profile, with no new safety signals identified.
IBI311’s mechanism of action involves blocking the binding of IGF-1 and IGF-2 to IGF-1R, thereby inhibiting the activation of the IGF-1R signaling pathway and the expression of downstream inflammatory factors. This inhibition reduces the adipocytosis of orbital fibroblasts (OFs) and the synthesis of hyaluronic acid and other glycosaminoglycans, which are typically increased due to OFs activation.- Flcube.com
