Innovent Biologics’ Sycume: China’s First IGF-1R Monoclonal Antibody for Thyroid Eye Disease Receives NMPA Approval

Innovent Biologics’ SYCUME®: A Groundbreaking Treatment for Thyroid Eye Disease

On March 14, 2025, Innovent Biologics, Inc., a leading biopharmaceutical company based in both San Francisco and Suzhou, China, made an exciting announcement. The China National Medical Products Administration (NMPA) granted approval for SYCUME® (teprotumumab N01), a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, for the treatment of thyroid eye disease (TED).

First Approved IGF-1R Antibody Drug in China

This approval marks a significant milestone for Innovent Biologics, making SYCUME® China’s first and the world’s second approved IGF-1R antibody drug. For the past 70 years, TED patients in China have been left without new treatment options. This approval signifies the end of this drought, bringing hope to the thousands of patients suffering from this debilitating condition.

What is Thyroid Eye Disease (TED)?

Thyroid Eye Disease, also known as Graves’ ophthalmology, is an autoimmune disorder that affects the tissues surrounding the eyes. The condition can cause various symptoms, including bulging eyes, double vision, and eye pain. In severe cases, it can lead to vision loss and even blindness. Although TED is not life-threatening, it significantly affects the quality of life of those affected.

How Does SYCUME® Work?

SYCUME® works by targeting the IGF-1R receptors, which are overexpressed in TED. By blocking these receptors, the drug inhibits the production of inflammatory cytokines and reduces the activity of immune cells. This leads to a decrease in inflammation and swelling, ultimately improving the symptoms of TED.

Impact on Patients

For patients with TED, the approval of SYCUME® is a game-changer. The disease can cause significant discomfort and even lead to vision loss in severe cases. With this new treatment option, patients can look forward to improved symptoms and a better quality of life. The approval also means that patients no longer need to travel overseas for treatment, as it is now available domestically.

Global Implications

The approval of SYCUME® in China is not just a victory for the Chinese market but for the global community as well. With the second approval of an IGF-1R antibody drug, it sets a precedent for other countries to follow suit. This not only expands the reach of this life-changing treatment but also paves the way for further advancements in the field of autoimmune disorders.

Conclusion

The approval of SYCUME® by the NMPA is a significant step forward in the treatment of thyroid eye disease. Not only does it bring hope to the thousands of patients in China, but it also sets a precedent for the global community. This approval marks the end of a 70-year drought of new treatment options for TED in China and opens the door for further advancements in the field of autoimmune disorders. Innovent Biologics continues to demonstrate its commitment to developing high-quality medicines for various diseases, bringing hope and relief to those in need.

  • Innovent Biologics announces approval of SYCUME® (teprotumumab N01) for the treatment of thyroid eye disease (TED)
  • SYCUME® is China’s first and the world’s second approved IGF-1R antibody drug
  • TED is an autoimmune disorder that affects the tissues surrounding the eyes, causing symptoms such as bulging eyes, double vision, and eye pain
  • SYCUME® works by targeting IGF-1R receptors, reducing inflammation and swelling
  • Approval brings hope to thousands of patients in China and sets a precedent for other countries
  • Innovent Biologics continues to develop high-quality medicines for various diseases

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