Innovent’s Sycume to transform thyroid eye disease treatment landscape in China and Asia: GlobalData
Sycume becomes China’s first approved IGF-1R monoclonal antibody for thyroid eye disease, offering a new treatment option after seven decades
Innovent Biologics has recently received approval for Sycume (teprotumumab biosimilar) to treat thyroid eye disease (TED) in China. It is the country’s first insulin-like growth factor 1 receptor (IGF-1R) monoclonal antibody approved for TED by the National Medical Products Administration (NMPA). It represents a significant breakthrough and has the potential to transform the standard of care for TED patients in China and Asia, says GlobalData.
Sycume is a recombinant anti-IGF-1R antibody that has demonstrated comprehensive efficacy and favorable safety results in the RESTORE-1 study.
A meta-analysis study published in 2020 in Clinical Endocrinology and another study, an update on thyroid eye disease published in 2022 in the Indian Journal of Ophthalmology, suggest that TED has a higher prevalence in Asian populations, including China, compared to some other regions.
For the past 70 years, there has been no new treatment option for TED in China. However, teprotumumab, tocilizumab, and rituximab are recommended by the Chinese Clinical Diagnosis and Treatment Guidelines for TED.
The globally approved anti-IGF-1R Tepezza (from Amgen and Horizon Therapeutics) is not available in China and is reported to have an extremely high cost (over $17,000 per course of treatment in the US). Innovent, on the other hand, has a competitive edge owing to Sycume’s liquid injection formulation, which offers strengths in terms of stability, cost, simplicity of the manufacturing process, and patient compliance.
Nadim Anwer, Pharma Analyst at GlobalData, comments, “The currenty available treatments, intravenous glucocorticoid therapy (IVGC), has limitations including inadequate improvement in proptosis (eye bulging), systemic adverse reactions with suboptimal outcomes. The approval of Sycume in China represents a significant advancement in the management of TED and offers substantial benefits to Chinese patients.”
The recent Chinese and international treatment guidelines (the European Group On Graves’ Orbitopathy) and joint consensus (Thyroid eye disease of the American Thyroid Society and the European Thyroid Society) have recommended IGF-1R-antibody as first-line and second-line treatment for TED.
According to GlobalData’s Pharma Intelligence Center, there are six assets in the late-stage (Phase III and above) of development for TED globally. While Sycume currently holds a strong position in China, it will likely face increasing competition both locally (from CSPC NBP Pharmaceuticals’ batoclimab which is in Phase III) and internationally (from companies such as Roche, Sling Therapeutics and Viridian Therapeutics with late-stage assets) from other IGF-1R inhibitors, as well as potentially from therapies with different mechanisms of action.
Moreover, Amgen’s Tepezza could also be considered as one of the competitors if Amgen decides to pursue regulatory approval in China. The future market landscape for TED treatment is expected to become more competitive with the entry of new players and innovative approaches.
Anwer concludes, “Innovent’s Sycume addresses critical unmet needs in TED treatment by providing an effective, potentially more accessible, and well-tolerated therapy that targets the underlying disease mechanism and significantly improves key clinical manifestations and patient quality of life. While the initial approval is for China, the success of Sycume could pave the way for its potential approval in other Asian countries. Notably, with the approval of Sycume, Innovent could attract strategic collaborations with foreign players.”
