Innovent Biologics has received China’s National Medical Products Administration (NMPA) approval for Sycume (teprotumumab N01) for treating thyroid eye disease (TED).
Sycume is an antibody that targets the insulin-like growth factor 1 receptor (IGF-1R) signalling pathway, which is crucial for development, metabolism, and immune regulation.
It is the first IGF-1R antibody drug available in China and the second in the world, offering a new therapeutic option after 70 years.
The only IGF-1R antibody drug before Sycume’s approval was available worldwide, but not accessible in China.
Innovent clinical development senior vice president Lei Qian said: “As the first approved IGF-1R antibody and the first new TED therapy in China in 70 years, the development of SYCUME has brought together the expertise of leading ophthalmology and endocrinology specialists.
“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.
“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.”
TED is an autoimmune disorder linked to thyroid disease and is the most common orbital disease among adults, affecting those aged 40 to 60 years, with severe symptoms.
Current first-line treatment for moderate-to-severe TED involves intravenous glucocorticoid therapy, which has limitations like inadequate proptosis improvement and adverse reactions.
Sycume provides an effective, safe, and more affordable alternative for Chinese patients, with benefits in stability, cost, and patient compliance due to its liquid injection form.
The NMPA approval of Sycume is based on the Phase 3 RESTORE-1 study, in which the drug showed significant efficacy in treating TED patients.
In the study, 85.8% of patients treated with Sycume experienced a reduction in proptosis at Week 24, along with improvements in inflammation and quality of life, said Innovent.
Shanghai Jiao Tong University School of Medicine academician professor Xianqun Fan said: “Current first-line treatment for TED is glucocorticoids, though it has limitations, such as inadequate improvement in proptosis and notable side effects.
“Biologic agents targeting IGF-1R could to significantly improve proptosis and quality of life in TED patients and are expected to play an important role in its treatment.
“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. I hope that this drug will bring high-quality treatment option to TED patients as soon as possible.”
