Chinese clinics treating thyroid eye disease just got a new tool. Sycume, Innovent Biologics’ IGF-1R antibody, outperformed placebo in the phase 3 RESTORE-3 trial, setting a new standard for inactive TED care. The double-blind study enrolled 116 patients. At 24 weeks, 60.4% of those on Sycume saw a proptosis response, compared to 23.5% for placebo. That’s a 36.9-point gap, with a P value of 0.0003. Independent industry sources confirmed the result, putting Sycume’s efficacy in sharp relief for this group.
For people living with chronic, inactive TED, the numbers mean more than a statistical win. Many have faced years of visible eye bulging and few real options. Sycume, a recombinant anti-IGF-1R monoclonal antibody, now stands as the first targeted TED therapy approved and reimbursed in China. The NMPA signed off in March 2025, and the drug hit the National Reimbursement Drug List at the start of 2026. Still, being on the NRDL doesn’t guarantee every patient can get it. Local insurance, hospital purchasing, and supply chains all shape real-world access.
Sycume is the first IGF-1R antibody approved for thyroid eye disease in China and only the second such therapy worldwide.
Mechanism and clinical evidence
Sycume blocks IGF-1R signaling, which cuts inflammatory factors and stops orbital fibroblasts from turning into fat or muscle cells—two main drivers of TED. RESTORE-3 enrolled patients with bilateral Clinical Activity Score ≤2, meaning inactive disease, and an average disease duration of 4.3 years. Baseline mean study-eye proptosis measured 22.16 mm. The key secondary endpoint, least squares mean change in study-eye proptosis at week 24, favored Sycume by -1.00 mm (-1.88 mm vs -0.88 mm; P < 0.0001), as reported in the RTTNews clinical report. Non-study eye response rates also improved, with 46.0% for Sycume and 19.8% for placebo (P = 0.0071).
Safety tracked with expectations. Most adverse events were mild or moderate, and no new safety issues appeared. Follow-up continues, with full data due at upcoming conferences or in peer-reviewed journals. RESTORE-3’s positive results now extend Sycume’s evidence base from active to inactive TED, according to Clinical Trial Vanguard’s analysis.
Therapeutic and regulatory context
Sycume’s approval changed the TED treatment landscape in China. It’s the country’s first IGF-1R antibody and only the second such drug worldwide after Tepezza. Fast-track inclusion in the NRDL boosts patient access, a move Innovent’s general biomedicine R&D chief Lei Qian, MD, PhD, says is already helping many TED patients. Lead investigator Zhongyan Shan, MD, PhD, called the trial “validation of IGF-1R targeting in long-duration inactive TED” and said it gives tens of thousands of chronic TED patients and their doctors a new non-surgical option.
China’s clinical research scene keeps producing high-impact data in rare and tough diseases. The momentum echoes recent studies like the IASO Bio trial for plasma cell neoplasms.
While Sycume’s inclusion in the National Reimbursement Drug List marks a major step for patient access, actual coverage can vary by region and hospital, depending on local insurance policies, procurement processes, and drug availability.
Editorial perspective
Sycume’s phase 3 data shows targeted biologics can deliver for chronic, inactive TED—a group left behind by surgery and immunosuppression. The strong proptosis reduction, manageable safety, and quick reimbursement mark a shift for TED care in China. As follow-up data rolls in, the field will watch for lasting real-world gains. Innovent’s results now set the pace for future players in Chinese ophthalmology and autoimmune drug development.
