Innovent's SYCUME meets primary endpoint in Phase 3 trial for inactive thyroid eye disease
Innovent Biologics announced that its Phase 3 RESTORE-3 study of SYCUME (teprotumumab N01 Injection) achieved its primary endpoint in Chinese patients with inactive thyroid eye disease. The trial showed a 60.4% proptosis response rate versus 23.5% for placebo and a mean reduction of 1.88 mm in eye protrusion at week 24. The drug, the first IGF‑1R antibody approved in China, is already on the national reimbursement list.
Why it matters
The company says the results expand SYCUME’s therapeutic coverage to chronic inactive TED, which could increase its market uptake in China. Analysts note that the positive data may support higher sales forecasts for Innovent.
Key facts
- 1The RESTORE-3 trial enrolled 116 participants in an approximate 2:1 randomization to SYCUME or placebo. prnewswire.com
- 2Proptosis response rate at week 24 was 60.4% for SYCUME versus 23.5% for placebo (treatment difference 36.9 percentage points, p = 0.0003). prnewswire.com
- 3Least squares mean change in proptosis was –1.88 mm for SYCUME versus –0.88 mm for placebo (treatment difference –1.00 mm, p < 0.0001). prnewswire.com
- 4SYCUME is the first IGF‑1R antibody drug in China and the second approved worldwide. prnewswire.com
- 5SYCUME was added to China’s National Reimbursement Drug List on January 1 2026. prnewswire.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.