( MENAFN - PR Newswire) SAN FRANCISCO and SUZHOU, China, May 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, today announced that the New Drug Application (NDA) for IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, has been accepted and granted priority review designation by the Center for Drug Evaluation (CDE) of the China National Drug Administration (NMPA) for the treatment of Thyroid Eye Disease (TED). IBI311 is the first anti-IGF-1R antibody with NDA submitted in China.
As a biological drug with a novel mechanism of action, IBI311 will potentially resolve an over 60-years shortage of innovative TED drugs in China by offering an effective, safe and accessible treatment option for Chinese TED patients. This NDA was accepted based on the positive results of a Phase 3 registration clinical study RESTORE-1 (CTR20223393) in subjects with TED in China. The primary endpoint of the study was successfully met in February 2024 .
Significant improvements in proptosis, disease activity, and quality of life were observed in the IBI311 group compared to placebo. The overall safety profile of IBI311 was favorable, and no new safety signals were identified. Detailed results of the RESTORE-1 study will be presented at medical c.