Innovent Biologics announces approval of SYCUME in China for thyroid eye disease

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Innovent Biologics announced the approval of SYCUME, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, for the treatment of thyroid eye disease (TED). The treatment was approved by China’s National Medical Products Administration (NMPA) and is the nation’s first and the world’s second approved IGF-1R antibody drug.

After 70 years, SYCUME is the newest treatment option for TED in China. Before its approval, there was only one IGF-1R antibody drug approved globally, and it was not available in China. Now, SYCUME allows for high efficacy and a satisfactory safety profile, providing a new and accessible treatment option for patients.

“The approval of SYCUME not only highlights Innovent's innovative R&D capabilities in the fields of ophthalmology and endocrinology but also reflects the high recognition of this product's clinical value by regulatory authorities,” Lei Qian, senior vice president of clinical development of Innocent, said. “It also marks another milestone of Innovent in the treatment of major diseases such as TED. Innovent will continue to focus on advancing innovation therapies to fulfill its commitment of serving more patients worldwide.”

SYCUME uses a liquid injection formation, offering many benefits in terms of stability, cost, manufacturing process simplicity, and patient compliance.

The approval of the new treatment is a result of the Phase 3 registrational study (RESTORE-1) in TED patients, which ended in 2024. In the study, 85.5% of patients achieved a lower proptosis reduction at Week 24 with SYCUME, which resulted in significant improvements in inflammation and quality of life.

“As an ophthalmologist and the principal investigator of the RESTORE-1 study, I am delighted with the approval of the first new TED drug in China,” Xianqun Fan, professor and an academician of the Chinese Academy of Engineering, said. “I hope that this drug will bring high-quality treatment option to TED patients as soon as possible.”

Reference:

1. China’s First IGF-1R Monoclonal Antibody: Innovent Announces NMPA approval of SYCUME for the Treatment of Thyroid Eye Disease. Innovent Biologics. Accessed March 17, 2025. https://www.ksnt.com/business/press-releases/cision/20250314CN41219/chinas-first-igf-1r-monoclonal-antibody-innovent-announces-nmpa-approval-of-sycume-for-the-treatment-of-thyroid-eye-disease/