China Approves First IGF-1R Antibody for TED

China has approved SYCUME, the country’s first monoclonal antibody treatment for thyroid eye disease (TED), developed by Innovent Biologics. This marks a significant milestone in ophthalmology, as SYCUME is only the second TED treatment available worldwide and the first in China in over 70 years. The approval is based on positive results from the RESTORE-1 Phase 3 clinical trial, showing substantial proptosis reduction and a favorable safety profile.

China’s Landmark Approval of SYCUME for TED

Innovent Biologics announced this week that China’s National Medical Products Administration (NMPA) has approved SYCUME, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, for the treatment of thyroid eye disease (TED). This is China’s first-ever monoclonal antibody for TED and only the second therapy globally, providing a new treatment option for the first time in over 70 years.

Expert Insights on the Approval

The approval follows the successful RESTORE-1 Phase 3 registrational study, where 85.8 percent of patients achieved at least a 2mm reduction in proptosis, a key symptom of TED.

“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 a high-quality treatment option to TED patients as soon as possible,” said Professor Xianqun Fan, from Shanghai Jiao Tong University School of Medicine.

Lei Qian, Senior Vice President of Clinical Development at Innovent Biologics, highlighted the significance of this milestone, stating:
"The approval of SYCUME not only highlights Innovent's innovative R&D capabilities in ophthalmology and endocrinology but also reflects the high recognition of this product's clinical value by regulatory authorities.”

Understanding Thyroid Eye Disease (TED)

Thyroid eye disease (TED) is an autoimmune disorder associated with thyroid hormone imbalances, primarily affecting individuals between 40 and 60 years old. TED is the most common orbital disease, with a prevalence rate of 0.1-0.3 percent. Key symptoms include:

• Proptosis (bulging eyes)

• Orbital inflammation

• Diplopia (double vision)

In severe cases, TED can lead to optic neuropathy and eventual blindness.

Current TED Treatments and Challenges

The first-line treatment for TED has traditionally been intravenous glucocorticoid (IVGC) therapy, which helps reduce inflammation but has significant adverse effects and limited impact on proptosis. Additional treatments such as orbital radiotherapy and immunosuppressants show mixed results.

SYCUME's Mechanism of Action

SYCUME is an IGF-1R-targeted biologic that works by reducing inflammation and disease activity. It is particularly recommended for TED patients experiencing severe proptosis or diplopia.

RESTORE-1 Phase 3 Clinical Trial Highlights

The approval of SYCUME was based on RESTORE-1, a Phase 3 clinical trial assessing its safety and efficacy in active TED patients. The results showed:

• 85.8 percent of patients achieved a reduction of at least 2mm in proptosis

• Favorable safety profile

• Significant improvement in disease activity scores

What This Means for TED Treatment in China

The approval of SYCUME represents a major breakthrough for TED patients in China, offering an alternative to traditional treatments with targeted, biologic therapy.

With Innovent Biologics’ commitment to ophthalmology and endocrinology, SYCUME is expected to reshape TED treatment protocols in China and potentially expand to global markets in the near future.