Innovent Biologics Launches First-in-Class IGF-1R Monoclonal Antibody for Thyroid Eye Disease
Innovent Biologics has introduced SYCUME® (teprotumumab N01) as a groundbreaking IGF-1R-targeting antibody for thyroid eye disease (TED), marking China’s first and the world’s second approved therapy of its kind.
TED primarily affects patients with Graves' disease but can also occur in those with other thyroid disorders or even in individuals with normal thyroid function. The disease is classified as mild, moderate-to-severe, or sight-threatening.
Symptoms include proptosis, orbital inflammation, and diplopia, which can severely impact vision and quality of life. In severe cases, TED may lead to blindness.
SYCUME® (teprotumumab N01) is a recombinant monoclonal antibody that blocks IGF-1R signalling, which plays a key role in TED pathogenesis. By inhibiting IGF-1R, the drug reduces inflammation and tissue expansion caused by orbital fibroblasts, alleviating symptoms such as proptosis, diplopia, and orbital congestion.
SYCUME® presents a cost-effective alternative with strong efficacy and a favourable safety profile. Its liquid injection formulation enhances manufacturing efficiency, stability, cost management, and patient compliance.
The approval is based on findings from the Phase 3 RESTORE-1 trial, which demonstrated that 85.8% of patients treated with SYCUME® achieved a reduction in proptosis of at least 2 mm at 24 weeks.
