Innovent Biologics, Inc. („Innovent“) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China’s National Medical Products Administration (NMPA) has approved SYCUME® (teprotumumab N01, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody) for the treatment of thyroid eye disease (TED). As China’s first and the world’s second approved IGF-1R antibody drug, SYCUME® has ended a 70-year drought of no new treatment option for TED in China. This groundbreaking therapy will redefine the standard of care for TED.
TED is an organ-specific autoimmune disorder closely associated with thyroid disease. It ranks first in the incidence of orbital diseases among adults, particularly prevalent in the age group of 40 to 60 years. The estimated annual incidence of TED is 16 per 100,000 people in women and 2.9 per 100,000 people in men, with a prevalence rate of 0.1-0.3%[1]-[2]. TED can cause proptosis, orbital inflammation, diplopia and other clinical manifestations, which significantly impact a patient’s appearance, visual function, and quality of life. In severe cases, it can even lead to blindness.
At present, the first-line treatment for moderate-to-severe active TED is intravenous glucocorticoid (IVGC) therapy, although it has limitations, such as inadequate improvement in proptosis and systemic adverse reactions associated with steroid. Second-line treatments include a second course of IVGC, orbital radiotherapy, and other immunosuppressants with suboptimal outcomes. Recent Chinese and international treatment guidelines and joint consensus have recommended the use of IGF-1R-targeted biologics as a second-line treatment for TED[3]-[5]. Particularly for patients with significant proptosis or diplopia, IGF-1R-targeted biologics can be considered the first-line treatment in such cases[5].
