China's First IGF-1R Monoclonal Antibody: Innovent Announces NMPA approval of SYCUME® for the Treatment of Thyroid Eye Disease

Rhea-AI Summary

Innovent Biologics has received NMPA approval for SYCUME® (teprotumumab N01), China's first and world's second IGF-1R antibody drug for treating thyroid eye disease (TED). This breakthrough ends a 70-year period without new TED treatments in China.

TED, an autoimmune disorder affecting orbital health, has an annual incidence of 16 per 100,000 in women and 2.9 per 100,000 in men. The Phase 3 RESTORE-1 study demonstrated that 85.8% of patients achieved ≥2 mm proptosis reduction at Week 24 with SYCUME® treatment.

SYCUME® offers advantages including a liquid injection formation, improved stability, and better patient compliance. This approval provides a more accessible treatment option compared to the existing IGF-1R antibody treatment available overseas, which costs approximately 3 million RMB per course.

Positive

• First IGF-1R antibody approved in China for TED treatment
• Strong efficacy with 85.8% success rate in Phase 3 trial
• Favorable safety profile demonstrated in clinical trials
• More accessible and potentially cost-effective compared to existing 3M RMB treatment
• Liquid injection formation offering better stability and compliance

Negative

• None.

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SAN FRANCISCO and SUZHOU, China, March 14, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved SYCUME^® (teprotumumab N01, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody) for the treatment of thyroid eye disease (TED). As China's first and the world's second approved IGF-1R antibody drug, SYCUME^® has ended a 70-year drought of no new treatment option for TED in China. This groundbreaking therapy will redefine the standard of care for TED.

TED is an organ-specific autoimmune disorder closely associated with thyroid disease. It ranks first in the incidence of orbital diseases among adults, particularly prevalent in the age group of 40 to 60 years. The estimated annual incidence of TED is 16 per 100,000 people in women and 2.9 per 100,000 people in men, with a prevalence rate of 0.1-0.3%^[1]-[2]. TED can cause proptosis, orbital inflammation, diplopia and other clinical manifestations, which significantly impact a patient's appearance, visual function, and quality of life. In severe cases, it can even lead to blindness.

At present, the first-line treatment for moderate-to-severe active TED is intravenous glucocorticoid (IVGC) therapy, although it has limitations, such as inadequate improvement in proptosis and systemic adverse reactions associated with steroid. Second-line treatments include a second course of IVGC, orbital radiotherapy, and other immunosuppressants with suboptimal outcomes. Recent Chinese and international treatment guidelines and joint consensus have recommended the use of IGF-1R-targeted biologics as a second-line treatment for TED^[3]-[5]. Particularly for patients with significant proptosis or diplopia, IGF-1R-targeted biologics can be considered the first-line treatment in such cases^[5].

Prior to the approval of SYCUME^®, only one IGF-1R antibody drug was approved globally and was not available in China. The cost of IGF-1R antibody oversea is extremely high, costing approximately 3 million RMB per treatment course. As China's first IGF-1R antibody, SYCUME^® offers robust  efficacy and a favorable safety profile, providing a new and accessible treatment option for TED patients, with significant clinical and societal value. Additionally, SYCUME^® adopts a liquid injection formation, which offers strengths in terms of stability, cost, manufacturing process simplicity, and patient compliance.

The approval is based on results from the Phase 3 registrational study (RESTORE-1) in TED patients, which met its primary endpoint in 2024 [link]. The study showed 85.8% of patients achieved ≥2 mm proptosis reduction at Week 24 with SYCUME^® treatment, accompanied by significant improvements in inflammation and quality of life. The overall safety profile of SYCUME^® was favorable throughout the study. RESTORE-1 results have been presented at premier conferences including World Ophthalmology Congress (WOC), Annual Meeting of Chinese Society of Endocrinology (CSE), and Congress of Chinese Ophthalmological Society (CCOS), generating substantial recognition among experts.

Professor Xianqun Fan, an academician of the Chinese Academy of Engineering, Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, stated," TED is the most common orbital disease in adults, and proptosis being its most prominent clinical manifestation. The prolonged course of TED seriously impacts a patient's visual function and appearance, often leading to heavy psychological burden. 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. "

Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated," 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. "

About Thyroid Eye Disease (TED)

TED, an autoimmune disease involving ocular tissues, is the most common orbital disease in adults. TED affects approximately 25% to 50% of Graves'disease patients, as well as individuals with other thyroid diseases and even those with normal thyroid function^[6].

The annual incidence of TED is estimated at 16 per 100,000 women and 2.9 per 100,000 men, with a prevalence of 0.1 to 0.3%^[1]-[2]. Based on disease severity, TED can be classified into mild, moderate to severe, or sight-threatening. While TED is more common in women, severe cases occur more frequently in men. The exact pathogenesis of TED is not fully understood, but multiple studies suggest that orbital fibroblasts (OFs) in muscle fibers and orbital connective tissue play a key role in orbital soft tissue hyperplasia in TED^[7].

The natural progression of TED is divided into active and inactive stages^[8]. Common symptoms include dry eye, foreign body sensation, photophobia, lacrimation, diplopia, and pressure behind the eyes. Typical signs include upper eyelid retraction, proptosis, periorbital soft tissue congestion and edema, and ocular motility disorders. While TED is usually mild to moderate-to-severe, about 3–5% of patients develop sight-threatening TED, which can result in vision-threatening corneal ulcers or compressive optic neuropathy^[9]. In addition to affecting appearance and visual function, TED significantly impacts patients' social functioning and quality of life.

At present, the first-line treatment for moderate-to-severe active TED is intravenous glucocorticoid (IVGC) therapy, though it has limitations, such as inadequate improvement in proptosis and systemic adverse reactions associated with steroid. Second-line treatments include a second course of IVGC, orbital radiotherapy, and other immunosuppressants with suboptimal outcome. Recent Chinese and international treatment guidelines and joint consensus have recommended the use of IGF-1R-targeted biologics as a second-line treatment for TED^[3]-[5]. Particularly for patients with significant proptosis or diplopia, IGF-1R-targeted biologics can be considered the first-line treatment in such cases^[5].

About SYCUME^®

SYCUME^® (teprotumumab N01) is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody developed by Innovent for the treatment of TED. IGF-1R is a transmembrane tyrosine kinase receptor involved in development, metabolism, and immune regulation, and is overexpressed in OFs, B cells, and T cells of TED patients^[10]. SYCUME^®  blocks the activation of IGF-1R signaling pathway mediated by IGF-1 and related ligands or agonistic antibodies, reducing the expression of downstream inflammatory factors. This inhibition decreases the synthesis of hyaluronic acid and other glycosaminoglycans caused by OFs activation, thereby alleviating inflammation. It also prevents OFs differentiation into adipocytes or myofibroblasts, consequently reducing disease activity and improving clinical manifestations such as proptosis, diplopia, orbital congestion and edema.

In March 2025, SYCUME^® was approved by the NMPA for the treatment of TED.

About Innovent Biologics

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 16 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.

For more information, please visit the company's website at www.innoventbio.com or the company's leading account at www.linkedin.com/company/innovent-biologics/.

Statement:

Innovent does not recommend the use of any unapproved drug (s)/indication (s).

Disclaimer: Innovent does not recommend any off-label usage. 

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

REFERENCES

[1].     Bartley G. The epidemiological characteristics and clinical course of ophthalmology associated with autoimmune thyroid disease in Olmsted Country, Minnesota. Trans Am Ophthalmol Soc 1994;92:477-588.
[2].     Hiromatsu Y, Eguchi H, Tani J, Kasaoka M, Teshima Y. Graves' ophthalmopathy: epidemiology and natural history. Intern Med. 2014;53(5):353-60.
[3].     Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67.
[4].     中华医学会眼科学分会眼整形眼眶病学组, 中华医学会内分泌学分会甲状腺学组. 中国甲状腺相关眼病诊断和治疗指南 （2022年）.中华眼科杂志. 2022;58(9).
[5].     Burch HB, et al. Management of thyroid eye disease: a Consensus Statement by the American Thyroid Association and the European Thyroid Association. Eur Thyroid J. 2022;11(6):e220189.
[6].     Li Z, Cestari D M, Fortin E. Thyroid eye disease: what is new to know? Curr Opin Ophthalmol. 2018;29(6):528-534.
[7].     Ali F, Chorsiya A, Anjum V, Ali A. Teprotumumab (TEPEZZA): from the discovery and development of medicines to USFDA approval for active thyroid eye disease (TED) treatment. Int Ophthalmol. 2021;41(4):1549-1561.
[8].     Dolman P J. Evaluating Graves' orbitopathy. Best Pract Res Clin Endocrinol Metab.2012;26(3):229-248.
[9].     Bahn R S. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738.
[10].  Douglas RS, Naik V, Hwang CJ, et al. B cells from patients with Graves' disease aberrantly express the IGF-1 receptor: implications for disease pathogenesis. J Immunol 2008;181:5768-5774.

FAQ

What are the clinical results of SYCUME® (IVBIY) in treating thyroid eye disease?

In the Phase 3 RESTORE-1 study, 85.8% of patients achieved ≥2 mm proptosis reduction at Week 24 with significant improvements in inflammation and quality of life.

How does SYCUME's cost compare to existing TED treatments?

SYCUME® is expected to be more affordable than the overseas IGF-1R antibody treatment, which costs about 3 million RMB per course.

What is the market size for SYCUME® (IVBIY) in China?

TED affects 16 per 100,000 women and 2.9 per 100,000 men annually, with a prevalence rate of 0.1-0.3% in the population.

What advantages does SYCUME® offer over traditional TED treatments?

SYCUME® features a liquid injection formation, better stability, simpler manufacturing, and improved patient compliance compared to standard glucocorticoid therapy.