SignalFDA/Bio
Innovent Announces Phase 3 RESTORE-3 Study of SYCUME® (Teprotumumab N01 Injection) Met Primary Endpoint in Inactive Thyroid Eye Disease
Phase 3 met primary endpoint in thyroid eye disease, a key clinical catalyst.
Context
What happened: Innovent said its Phase 3 RESTORE-3 study of SYCUME (Teprotumumab N01 Injection, IBI311) met its primary endpoint at Week 24 in Chinese participants with inactive thyroid eye disease.
Key numbers: 116 participants randomized about 2:1 to IBI311 or placebo.
Why it matters: The company said the results mark a milestone for SYCUME in full-course TED management, with patients with inactive TED making up roughly two-thirds of the overall TED population. SYCUME was included in China's National Reimbursement Drug List on January 1, 2026.
Market: -1.2% by next close ($91.65 on Oct 12), +13.5% YTD
What changed
Innovent said its Phase 3 RESTORE-3 study of SYCUME (Teprotumumab N01 Injection, IBI311) met its primary endpoint at Week 24 in Chinese participants with inactive thyroid eye disease.
Why it matters
The company said the results mark a milestone for SYCUME in full-course TED management, with patients with inactive TED making up roughly two-thirds of the overall TED population. SYCUME was included in China's National Reimbursement Drug List on January 1, 2026.
Market: -1.2% by next close ($91.65 on Oct 12), +13.5% YTD