Innovent Biologics, Inc. announce that the primary endpoint has been achieved in the Phase 3 registrational clinical study ("RESTORE-1") of IBI311, a recombinant anti-insulin-like growth factor 1 receptor ("IGF-1R") antibody, in Chinese subjects with Thyroid Eye Disease ("TED "). The Company plans to submit a New Drug Application ("NDA") of IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA). RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical study to evaluate the efficacy and safety of IBI311 in subjects with TED.

The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye (the percentage of subjects with a reduction in proptosis of 2 mm from baseline in the study eye without deterioration 2 mm increase of proptosis in the fellow eye) was significantly higher in subjects treated with IBI311 than in subjects treated with placebo: 85.8% vs. 3.8%, with a difference of 81.9% (95% CI: 69.8% to 93.9%, P < 0.0001). In addition, the key secondary endpoints of the study, such as overall response rate (the percentage of subjects with a reduction in proptosis of 2 mm from baseline and improvement in clinical activity score 2 in the study eye), percentage of subjects with a clinical activity score (CAS) of 0 or 1, and mean change in proptosis from baseline in the study eye, were successfully met: IBI311 significantly improved all the above parameters as compared to the placebo.

The overall safety profile of IBI311 was favorable throughout the study with no serious adverse events occurred. The efficacy and safety profiles in the Phase 3 part of the RESTORE-1 study were consistent with its Phase 2 results. Detailed results from the study will be released in medical conferences or journals in the future.

As an organ-specific autoimmune disease closely related to thyroid disease, TED is one of the most common orbital diseases in adults, and seriously affects the visual function and appearance of patients. The annual incidence of TED is estimated to be 16/100,000 in women and 2.9/100,000 in meni, and the estimated prevalence of clinically relevant TED ranges from 0.1% to 0.3%ii. At present, there is no targeted drug approved for the treatment of TED in China, while the treatment costs of overseas targeted drugs are beyond many patients' reach, and hence, there are huge unmet medical needs.