China's First IGF-1R Monoclonal Antibody: Innovent Announces NMPA approval of SYCUME® for the Treatment of Thyroid Eye Disease
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.
Innovent Biologics ha ricevuto l'approvazione della NMPA per SYCUME® (teprotumumab N01), il primo farmaco anticorpale IGF-1R in Cina e il secondo al mondo per il trattamento della malattia oculare tiroidea (TED). Questo traguardo segna la fine di un periodo di 70 anni senza nuovi trattamenti per la TED in Cina.
La TED, un disturbo autoimmune che colpisce la salute orbitale, ha un'incidenza annuale di 16 casi ogni 100.000 donne e 2,9 casi ogni 100.000 uomini. Lo studio di Fase 3 RESTORE-1 ha dimostrato che l'85,8% dei pazienti ha ottenuto una riduzione della proptosi ≥2 mm alla settimana 24 con il trattamento con SYCUME®.
SYCUME® offre vantaggi tra cui una formulazione iniezione liquida, stabilità migliorata e una migliore aderenza da parte dei pazienti. Questa approvazione fornisce un'opzione di trattamento più accessibile rispetto al trattamento anticorpale IGF-1R attualmente disponibile all'estero, il cui costo è di circa 3 milioni di RMB per ciclo.
Innovent Biologics ha recibido la aprobación de la NMPA para SYCUME® (teprotumumab N01), el primer fármaco anticuerpo IGF-1R en China y el segundo en el mundo para el tratamiento de la enfermedad ocular tiroidea (TED). Este avance pone fin a un período de 70 años sin nuevos tratamientos para la TED en China.
La TED, un trastorno autoinmune que afecta la salud orbital, tiene una incidencia anual de 16 por cada 100,000 mujeres y 2.9 por cada 100,000 hombres. El estudio de Fase 3 RESTORE-1 demostró que el 85.8% de los pacientes lograron una reducción de proptosis ≥2 mm a la semana 24 con el tratamiento de SYCUME®.
SYCUME® ofrece ventajas que incluyen una formulación de inyección líquida, estabilidad mejorada y una mejor adherencia por parte de los pacientes. Esta aprobación proporciona una opción de tratamiento más accesible en comparación con el tratamiento anticuerpo IGF-1R disponible en el extranjero, que cuesta aproximadamente 3 millones de RMB por ciclo.
Innovent Biologics는 SYCUME® (teprotumumab N01)에 대해 NMPA 승인을 받았으며, 이는 중국 최초이자 세계 두 번째 IGF-1R 항체 약물로 갑상선 안병증 (TED) 치료에 사용됩니다. 이 혁신은 중국에서 70년 동안 새로운 TED 치료제가 없었던 시기를 끝냅니다.
TED는 안구 건강에 영향을 미치는 자가면역 질환으로, 여성의 연간 발생률은 10만 명당 16명, 남성은 10만 명당 2.9명입니다. 3상 RESTORE-1 연구에서는 SYCUME® 치료를 받은 환자의 85.8%가 24주차에 ≥2 mm의 안구 돌출 감소를 달성했습니다.
SYCUME®는 액체 주사 형태, 개선된 안정성 및 더 나은 환자 순응도와 같은 이점을 제공합니다. 이 승인은 해외에서 제공되는 기존 IGF-1R 항체 치료에 비해 더 접근 가능한 치료 옵션을 제공합니다. 해외 치료의 비용은 약 300만 RMB입니다.
Innovent Biologics a reçu l'approbation de la NMPA pour SYCUME® (teprotumumab N01), le premier médicament anticorps IGF-1R en Chine et le deuxième au monde pour le traitement de la maladie oculaire thyroïdienne (TED). Cette avancée met fin à une période de 70 ans sans nouveaux traitements pour la TED en Chine.
La TED, un trouble auto-immun affectant la santé orbitale, a une incidence annuelle de 16 cas pour 100 000 femmes et de 2,9 cas pour 100 000 hommes. L'étude de Phase 3 RESTORE-1 a démontré que 85,8 % des patients ont obtenu une réduction de la proptose ≥2 mm à la semaine 24 avec le traitement SYCUME®.
SYCUME® offre des avantages tels qu'une formulation injectable liquide, une stabilité améliorée et une meilleure adhésion des patients. Cette approbation fournit une option de traitement plus accessible par rapport au traitement anticorps IGF-1R disponible à l'étranger, qui coûte environ 3 millions de RMB par traitement.
Innovent Biologics hat die NMPA-Zulassung für SYCUME® (teprotumumab N01) erhalten, das erste IGF-1R-Antikörpermedikament in China und das zweite weltweit zur Behandlung der Schilddrüsenaugenkrankheit (TED). Dieser Durchbruch beendet eine 70-jährige Phase ohne neue TED-Behandlungen in China.
TED, eine Autoimmunerkrankung, die die Orbitalgesundheit beeinträchtigt, hat eine jährliche Inzidenz von 16 pro 100.000 Frauen und 2,9 pro 100.000 Männern. Die Phase-3-Studie RESTORE-1 zeigte, dass 85,8 % der Patienten in der 24. Woche mit der Behandlung von SYCUME® eine Proptose-Reduktion von ≥2 mm erreichten.
SYCUME® bietet Vorteile wie eine flüssige Injektionsformulierung, verbesserte Stabilität und eine bessere Patientencompliance. Diese Genehmigung bietet eine zugänglichere Behandlungsoption im Vergleich zur bestehenden IGF-1R-Antikörperbehandlung im Ausland, die etwa 3 Millionen RMB pro Behandlung kostet.
- 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
- None.
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
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
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
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
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
About Thyroid Eye Disease (TED)
TED, an autoimmune disease involving ocular tissues, is the most common orbital disease in adults. TED affects approximately
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
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–
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.
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[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.
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FAQ
What are the clinical results of SYCUME® (IVBIY) in treating thyroid eye disease?
How does SYCUME's cost compare to existing TED treatments?
What is the market size for SYCUME® (IVBIY) in China?
What advantages does SYCUME® offer over traditional TED treatments?
