Innovent Biologics, Inc. announced that the Centre for Drug Evaluation (?CDE?) of the National Medical Products Administration of China (?NMPA?) has accepted the New Drug Application (?NDA?) for IBI311, a recombinant anti-insulin-like growth factor 1 receptor (?IGF-1R?) antibody, for the treatment of thyroid eye disease (?TED?). 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 of subjects were observed in the IBI311 group compared to placebo group. The overall safety profile of IBI311 was favorable, and no new safety signals were identified during the treatment. Detailed results of the RESTORE-1 study will be presented at medical conferences and journals in 2024.

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, with the estimated prevalence of 0.1% to 0.3%. Currently, the use of IGF-1R-targeted antibody has been recommended in multiple clinical treatment guidelines worldwide; particularly, IGF-1R-targeted antibody is recommended as first-line therapy for patients with clinically significant proptosis.

In China, no new drugs were approved for a long period, and there is an urgent need for effective, safe and accessible treatment options for TED. IBI311 is the first anti-IGF-1R antibody with NDA submitted in China. IBI311 has demonstrated favorable safety and comprehensive efficacy benefits in the RESTORE-1 registrational study.

The Company will work closely with the regulatory authorities, hoping to provide an effective, safe and accessible treatment option for Chinese TED patients.