China-based Innovent Biologics Inc. (HKG: 1801) announced that its New Drug Application (NDA) for Sycume (teprotumumab), a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has been approved by China’s National Medical Products Administration (NMPA). This approval marks Sycume as China’s first and the world’s second approved IGF-1R antibody drug, designated for the treatment of thyroid eye disease (TED).
Significance of Approval
The NMPA’s approval of Sycume represents a significant milestone in the treatment of TED in China. Prior to this approval, only one IGF-1R antibody drug had been approved globally, and it was not available in China. This development broadens treatment options for patients suffering from this debilitating condition.
Understanding Thyroid Eye Disease
TED is an organ-specific autoimmune disorder closely associated with thyroid disease. It is the most common orbital disease among adults, particularly prevalent in individuals aged 40 to 60 years. The annual incidence is estimated at 16 per 100,000 women and 2.9 per 100,000 men, with a prevalence rate of 0.1-0.3%. TED can cause proptosis, orbital inflammation, diplopia, and other clinical manifestations, significantly impacting a patient’s appearance, visual function, and quality of life. In severe cases, it can lead to blindness.-Fineline Info & Tech
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