Innovent Biologics, Inc., 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. 

TED is an autoimmune disease that causes progressive inflammation and damage to tissues around the eyes. The annual incidence of TED is estimated to be 16/100,000 in women and 2.9/100,000 in men ^[1], with the estimated prevalence of 0.1-0.3%^[2].The use of IGF-1R-targeted antibody ahas been recommended in multiple clinical treatment guidelines worldwide^{[3, 4, 5]}; particularly, IGF-1R-targeted antibody is recommended as first-line therapy for patients with clinically significant proptosis. In China, there exists an urgent need for effective, safe and accessible treatment options.

Professor Xianqun Fan, an academician of the Chinese Academy of Engineering and the leading principal investigator of the study, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, stated, "TED is one of the most common orbital diseases in adults, with proptosis as the most apparent clinical manifestation. The course of TED is protracted, which seriously impairs patients' visual function and appearance, and usually brings a heavy psychological burden to patients. In China, physicians are hampered with limited choice of treatment. IBI311 has shown encouraging efficacy with respect to proptosis and orbital soft tissue inflammation with good safety in clinical studies. As the principal investigator of the RESTORE-1 study, I am proud of the NDA submission based on IBI311's promising efficacy and safety demonstrated in the pivotal study and would like to thank the effort of all investigators from participating sites. We look forward to the approval of IBI311, which will be a great advance in the management of TED and benefit more Chinese patients."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are honored to receive the regulatory acceptance of NDA for IBI311 with the support and dedication of participants, investigators and regulatory authorities. IBI311 has demonstrated favorable safety and comprehensive efficacy benefits in the RESTORE-1 study, including relief of proptosis, control of disease activity, and improvement in quality of life. We will actively communicate with the regulatory authorities during the NDA review and hope to provide an effective, safe and more accessible treatment option for Chinese TED patients as soon as possible. Innovent is strategically establishing its innovative commercial and late-stage portfolio in the fields of ophthalmology, autoimmunity, cardiovascular and metabolic (CVM) , aiming to help more people pursue a healthy life."