China’s First IGF-1R Monoclonal Antibody Approved, Innovent Biologics Announces

Innovent Biologics announced China’s approval of SYCUME® for thyroid eye disease (TED) earlier this week. SYCUME® is China’s first monoclonal antibody therapeutic option for TED and only the second available globally – marking the first new treatment option for TED in China in over 70 years. 

“As an ophthalmologist and the principal investigator of the RESTORE-1 study, I am delighted with the approval of the first new TED drug in China. I hope that this drug will bring high-quality treatment option to TED patients as soon as possible,” Xianqun Fan, a professor of the Chinese Academy of Engineering, Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine said in a recent press release. 

TED is an organ-specific autoimmune disease closely related to thyroid hormone imbalances. It is the most common orbital disease among people ages 40-60, with a prevalence rate of 0.1-0.3%. Common clinical manifestations include proptosis, orbital inflammation, and diplopia (double vision). Severe cases can cause optic neuropathy and eventual blindness.

The current first-line treatment for active TED is intravenous glucocorticoid (IVGC) therapy. However, it can cause significant adverse effects and notably does not lead to adequate improvement in proptosis. Other options include orbital radiotherapy and immunosuppressants, which have mixed outcomes. 

SYCUME® is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody designed to decrease inflammation and reduce disease activity. IGF-1R-targeted biologics can be considered in patients with significant proptosis or diplopia. 

China’s announcement is based on the results of the phase 3 registrational study (RESTORE-1) in TED patients, which showed SYCUME® reduced proptosis by at least 2mm in 85.8% of patients with a favorable safety profile. 

"As the first approved IGF-1R antibody and the first new TED therapy in China in 70 years, the development of SYCUME® has brought together the expertise of leading ophthalmology and endocrinology specialists,” Lei Qian, Senior Vice President of Clinical Development of Innovent said in a press release. “The approval of SYCUME® not only highlights Innovent's innovative R&D capabilities in the fields of ophthalmology and endocrinology but also reflects the high recognition of this product's clinical value by regulatory authorities.”