China-based Innovent Biologics (HKEX: 01801) reported positive results from the Phase III RESTORE-3 trial of Sycume (IBI311, teprotumumab N01), an anti-IGF-1R antibody, in patients with inactive thyroid eye disease (TED). The trial met its primary endpoint, with 60.4% of treated patients achieving a clinically meaningful reduction in eye protrusion (proptosis) at Week 24, compared with 23.5% receiving placebo (p=0.0003).
The China-based, randomized, double-blind study enrolled 116 patients and also met its key secondary endpoint, with a mean reduction in proptosis of 1.88 mm for Sycume versus 0.88 mm for placebo (p<0.0001). Most treatment-emergent adverse events were mild to moderate, with no new safety signals identified. Detailed safety data were not disclosed, and follow-up remains ongoing.
Sycume has the same amino acid sequence as Amgen's Tepezza (teprotumumab) - approved in the US for TED in January 2020 - but uses a different formulation developed by Innovent for the Chinese market. The product was approved by China's NMPA in March 2025 following a separate clinical development program.