Innovent secures NMPA approval for SYCUME, China’s first IGF-1R antibody for thyroid eye disease

Innovent Biologics has received approval from China’s National Medical Products Administration (NMPA) for SYCUME (teprotumumab N01), marking a major milestone in the treatment of thyroid eye disease (TED). As China’s first IGF-1R monoclonal antibody and only the second such drug approved worldwide, SYCUME introduces a long-awaited alternative for patients facing limited treatment options. Until now, TED therapies in China have remained largely unchanged for decades, leaving many to rely on intravenous glucocorticoids (IVGC) despite their well-documented limitations.

The arrival of SYCUME in China is expected to reshape the treatment landscape for TED, a disease that significantly affects eye health, vision, and facial appearance. With its approval, Innovent Biologics strengthens its presence in ophthalmology and autoimmune disease treatment, positioning itself as a key player in the country’s rapidly growing biopharmaceutical market.

Why Is Thyroid Eye Disease a Major Concern?

Thyroid eye disease is an autoimmune disorder that causes inflammation and swelling in the tissues surrounding the eyes. It is strongly linked to Graves’ disease, though it can also occur in individuals without thyroid dysfunction. The condition primarily affects adults between 40 and 60 years old, with an annual incidence rate of 16 per 100,000 women and 2.9 per 100,000 men.

TED symptoms range from dry eyes, light sensitivity, and swelling to more severe manifestations such as proptosis (eye bulging), double vision, and even vision loss. In advanced cases, optic nerve compression can lead to irreversible blindness, making effective treatment crucial.

Until now, TED treatment in China has been largely reliant on IVGC therapy, which can reduce inflammation but often fails to improve proptosis and carries significant systemic side effects. Other interventions, including orbital radiotherapy and additional immunosuppressants, have shown limited efficacy. Given these shortcomings, targeting the IGF-1R pathway has emerged as a promising approach to managing TED.

How Does SYCUME Work in Treating TED?

SYCUME is a recombinant monoclonal antibody that specifically targets the insulin-like growth factor 1 receptor (IGF-1R), a protein involved in cell growth, immune signaling, and inflammation. In TED, overactive IGF-1R signaling contributes to excessive fibroblast activation, leading to tissue swelling, inflammation, and protruding eyes. By blocking this pathway, SYCUME reduces orbital inflammation, prevents soft tissue expansion, and improves eye positioning and function.

Clinical trials for SYCUME demonstrated significant therapeutic benefits. In the Phase 3 RESTORE-1 study, conducted in 2024, 85.8% of TED patients who received SYCUME achieved at least a 2 mm reduction in proptosis by Week 24. The study also highlighted notable improvements in quality of life, reduced inflammation, and fewer reported side effects compared to existing treatments. SYCUME’s approval now positions it as a major breakthrough in TED management, addressing critical gaps in patient care.

What Makes SYCUME a Game-Changer for Chinese Patients?

Before SYCUME’s approval, China lacked an IGF-1R-targeted treatment for TED, forcing patients to either endure less effective therapies or seek treatment abroad at prohibitive costs. The only other approved IGF-1R antibody for TED, developed internationally, was unavailable in China and carried an estimated treatment cost of 3 million RMB per course.

With SYCUME’s introduction, TED patients in China now have a domestically available, clinically validated option that is expected to be more accessible in terms of pricing and availability. Furthermore, the drug’s liquid injection formulation enhances stability, reduces production costs, and simplifies administration, improving patient adherence.

What Are Experts Saying About SYCUME’s Approval?

The approval of SYCUME has generated strong reactions from medical experts and industry leaders, who view it as a long-awaited innovation in ophthalmology and endocrinology. Professor Xianqun Fan, an expert in ophthalmology at Shanghai Ninth People’s Hospital, noted that TED’s impact on both vision and appearance can place a heavy psychological burden on patients. He emphasized that while glucocorticoids remain a first-line treatment, their side effects and limitations necessitate better alternatives like IGF-1R biologics.

Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent Biologics, stated that SYCUME’s approval underscores China’s commitment to advancing biopharmaceutical research. He highlighted that the drug’s success reflects Innovent’s expanding capabilities in autoimmune disease therapeutics, reinforcing the company’s role in developing cutting-edge biologics for major diseases.

How Does SYCUME Fit Into the Global Biopharma Landscape?

SYCUME’s approval aligns with a global trend toward biologic-based therapies for autoimmune diseases. IGF-1R inhibitors have gained increasing recognition as effective targeted treatments, particularly in ophthalmology. As more countries explore regulatory pathways for TED biologics, China’s move to approve SYCUME signals a growing acceptance of IGF-1R targeting as a mainstream approach.

For Innovent Biologics, this approval strengthens its position in China’s biopharmaceutical industry, potentially driving strong market performance. With a pipeline of novel biologics targeting oncology, autoimmune diseases, and metabolic disorders, the company is strategically expanding its portfolio to address unmet medical needs. Investors are likely to watch how SYCUME’s market adoption unfolds in the coming months, as its pricing, distribution, and real-world efficacy shape its long-term commercial success.

What Comes Next for TED Treatment in China?

The introduction of SYCUME represents a critical shift in TED management, but its impact will depend on clinical adoption, physician training, and long-term patient outcomes. As more ophthalmologists and endocrinologists integrate IGF-1R inhibitors into treatment protocols, real-world data will further validate its efficacy and safety.

Additionally, SYCUME’s approval could pave the way for expanded research into combination therapies and new treatment pathways for TED and other immune-related eye disorders. Its availability in China may also set the stage for broader accessibility across other Asian markets, where TED prevalence is similarly significant.

With China’s first IGF-1R biologic now approved, TED patients finally have access to a targeted therapy capable of addressing both inflammation and proptosis effectively. The drug’s launch is expected to reshape treatment standards, offering new hope to those who have struggled with limited and often inadequate treatment options for decades.