中国首个IGF-1R单克隆抗体：信达生物宣布SYCUME®获NMPA批准用于治疗甲状腺眼病-动脉网

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

CISION 等信源发布 2025-03-14 16:35

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可切换为仅中文







SAN FRANCISCO

旧金山

and SUZHOU,

苏州，

China

中国

，

March 14, 2025

2025年3月14日

/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 .

/PRNewswire/ -- 信达生物制药（Innovent Biologics, Inc.，简称“Innovent”）（港交所代码：01801），一家致力于开发、生产和销售用于治疗肿瘤、自身免疫、心血管和代谢疾病、眼科疾病及其他重大疾病的高质量药物的世界级生物制药公司，宣布。

China's

中国的

National Medical Products Administration (NMPA) has approved SYCUME

国家药品监督管理局（NMPA）已批准SYCUME

(teprotumumab N01, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody) for the treatment of thyroid eye disease (TED). As

（替普鲁单抗N01，一种重组抗胰岛素样生长因子1受体（IGF-1R）抗体）用于治疗甲状腺眼病（TED）。

China's

中国的

first and the world's second approved IGF-1R antibody drug, SYCUME

首个也是全球第二个获批的IGF-1R抗体药物，SYCUME

has ended a 70-year drought of no new treatment option for TED in

已经结束了TED长达70年无新治疗选择的空白期

China

中国

. This groundbreaking therapy will redefine the standard of care for TED.

这种突破性的疗法将重新定义TED的护理标准。

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%.

TED是一种与甲状腺疾病密切相关的器官特异性自身免疫性疾病。它在成人眼眶疾病中发病率居首位，尤其在40至60岁人群中较为常见。TED的年发病率估计为女性每10万人中有16例，男性每10万人中有2.9例，患病率为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.

TED可引起眼球突出、眼眶炎症、复视等临床表现，严重影响患者的外观、视觉功能和生活质量，在严重的情况下，甚至会导致失明。

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.

目前，中重度活动性TED的一线治疗方案为静脉注射糖皮质激素（IVGC）治疗，但其存在局限性，如眼球突出改善不足以及与类固醇相关的全身不良反应。二线治疗包括第二疗程的IVGC、眼眶放疗和其他免疫抑制剂，但疗效均不理想。

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.

近年来，中外国际治疗指南和联合共识都推荐将IGF-1R靶向生物制剂作为TED的二线治疗。

[3]-[5]

. Particularly for patients with significant proptosis or diplopia, IGF-1R-targeted biologics can be considered the first-line treatment in such cases

特别是对于眼球突出或复视症状明显的患者，可以考虑将IGF-1R靶向生物制剂作为此类情况的首选治疗方案。

[5]

。

Prior to the approval of SYCUME

在SYCUME获批之前

, only one IGF-1R antibody drug was approved globally and was not available in

，全球仅批准了一种IGF-1R抗体药物，并且该药物尚未上市

China

中国

. The cost of IGF-1R antibody oversea is extremely high, costing approximately 3 million RMB per treatment course. As

. IGF-1R抗体在海外的费用极高，每个治疗疗程大约需要300万人民币。作为

China's

中国的

first IGF-1R antibody, SYCUME

第一个IGF-1R抗体，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

提供了强大疗效和良好的安全性，为TED患者提供了一个新的且可及的治疗选择，具有显著的临床和社会价值。此外，SYCUME

adopts a liquid injection formation, which offers strengths in terms of stability, cost, manufacturing process simplicity, and patient compliance.

采用液体注射成型，具有稳定性、成本、制造工艺简单和患者依从性等方面的优势。

The approval is based on results from the Phase 3 registrational study (RESTORE-1) in TED patients, which met its primary endpoint in 2024

该批准基于针对TED患者的3期注册研究（RESTORE-1）的结果，该研究在2024年达到了其主要终点。

[link]

[链接]

. The study showed 85.8% of patients achieved ≥2 mm proptosis reduction at Week 24 with SYCUME

该研究表明，使用SYCUME后，85.8%的患者在第24周眼球突出度减少了≥2毫米。

treatment, accompanied by significant improvements in inflammation and quality of life. The overall safety profile of SYCUME

治疗，同时炎症和生活质量显著改善。SYCUME的整体安全性概况

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..

在整个研究过程中表现良好。RESTORE-1 的结果已在包括世界眼科大会 (WOC)、中华内分泌学会年会 (CSE) 和中华眼科学会大会 (CCOS) 在内的顶级会议上发表，获得了专家们的广泛认可。

Professor

教授

Xianqun Fan

范先群

, an academician of the Chinese Academy of Engineering, Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine,

，中国工程院院士，上海交通大学医学院附属第九人民医院眼科

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.

TED是成年人最常见的眼眶疾病，眼球突出是其最显著的临床表现。该病病程冗长，严重影响患者的视觉功能和外观，常造成沉重的心理负担。目前TED的一线治疗为糖皮质激素，但其存在改善突眼效果不佳、副作用明显等不足。

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 .

针对IGF-1R的生物制剂可以显著改善TED患者的突眼症状并提高其生活质量，预计将在其治疗中发挥重要作用。作为RESTORE-1研究的眼科医生和主要研究者，我对第一种新型TED药物的批准感到非常高兴。

China

中国

. I hope that this drug will bring high-quality treatment option to TED patients as soon as possible. '

“我希望这种药物能尽快为TED患者带来新的高质量治疗选择。”

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

雷谦博士，信达生物临床开发高级副总裁，

stated,' As the first approved IGF-1R antibody and the first new TED therapy in

声明：“作为第一个获批的IGF-1R抗体，也是第一个新的TED疗法，

China

中国

in 70 years, the development of SYCUME

70年来，SYCUME的发展

has brought together the expertise of leading ophthalmology and endocrinology specialists. The approval of SYCUME

汇集了领先的眼科和内分泌学专家的专业知识。SYCUME 的批准

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.

不仅凸显了信达生物在眼科和内分泌科领域的创新研发实力，也反映了监管部门对该产品临床价值的高度认可，同时标志着信达生物在治疗TED等重大疾病领域又迈出了一个重要的里程碑。信达生物将继续致力于推进创新疗法，践行服务全球更多患者的承诺。

。

About Thyroid Eye Disease (TED)

关于甲状腺眼病 (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

TED是一种涉及眼部组织的自身免疫性疾病，是成人中最常见的眼眶疾病。TED影响了大约25%至50%的格雷夫斯病患者，同时也包括其他甲状腺疾病的患者，甚至甲状腺功能正常的个体。

[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%

每年每 10 万名女性中约有 16 人、每 10 万名男性中约有 2.9 人罹患甲状腺眼病，患病率为 0.1% 至 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.

根据疾病严重程度，TED可分为轻度、中度至重度或威胁视力的类型。虽然TED在女性中更常见，但严重病例在男性中更频繁发生。TED的确切发病机制尚未完全了解，但多项研究表明，肌肉纤维和眼眶结缔组织中的眶成纤维细胞（OFs）在TED的眼眶软组织增生中起关键作用。

[7]

。

The natural progression of TED is divided into active and inactive stages

TED的自然进程分为活动期和非活动期。

[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.

常见症状包括眼干、异物感、畏光、流泪、复视和眼球后压力感。典型体征包括上眼睑退缩、眼球突出、眶周软组织充血和水肿以及眼球运动障碍。虽然甲状腺相关眼病（TED）通常为轻度至中度或重度，但约3-5%的患者会发展为威胁视力的TED，可能导致威胁视力的角膜溃疡或压迫性视神经病变。

[9]

. In addition to affecting appearance and visual function, TED significantly impacts patients' social functioning and quality of life.

除了影响外观和视觉功能外，TED还显著影响患者的社会功能和生活质量。

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.

目前，中重度活动性TED的一线治疗为静脉注射糖皮质激素（IVGC）治疗，但其有局限性，如眼球突出改善不足以及与类固醇相关的全身不良反应。二线治疗包括第二疗程的IVGC、眼眶放疗和其他免疫抑制剂，但这些疗法的效果均不理想。

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.

近年来，中外国际治疗指南和联合共识都推荐将IGF-1R靶向生物制剂作为TED的二线治疗。

[3]-[5]

. Particularly for patients with significant proptosis or diplopia, IGF-1R-targeted biologics can be considered the first-line treatment in such cases

特别是对于眼球突出或复视症状明显的患者，可以考虑将IGF-1R靶向生物制剂作为此类情况的首选治疗方案。

[5]

。

About SYCUME

关于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.

(teprotumumab N01) 是信达生物开发的一种用于治疗甲状腺眼病 (TED) 的重组抗胰岛素样生长因子 1 受体 (IGF-1R) 抗体。IGF-1R 是一种跨膜酪氨酸激酶受体，参与发育、代谢和免疫调节，在 TED 患者的眶成纤维细胞 (OFs)、B 细胞和 T 细胞中过度表达。

[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.

阻断IGF-1及相应配体或激动剂抗体介导的IGF-1R信号通路的激活，减少下游炎性因子的表达。这种抑制作用降低了OFs活化引起的透明质酸及其他糖胺聚糖的合成，从而减轻炎症。

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..

它还阻止OFs分化为脂肪细胞或肌成纤维细胞，从而降低疾病活动性，改善眼球突出、复视、眼眶充血和水肿等临床表现。

在

March 2025

2025年3月

, SYCUME

，SYCUME

was approved by the NMPA for the treatment of TED.

获得NMPA批准用于治疗TED。

About Innovent Biologics

关于信达生物

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.

信达生物是一家领先的生物制药公司，成立于2011年，其使命是为全球患者提供负担得起的高质量生物制药。公司致力于发现、开发、生产和商业化针对一些最难治疾病的创新药物。其开创性疗法用于治疗癌症、心血管和代谢疾病、自身免疫性疾病以及眼科疾病。

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..

信达生物已上市15款产品，有3个新药申请处于监管审评中，3项资产处于III期或关键性临床试验中，还有16个分子处于早期临床阶段。信达生物与超过30家全球医疗保健公司合作，包括礼来、赛诺菲、Incyte、Adimab、LG化学和MD安德森癌症中心。

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.

信达秉持“始于信，达于行”的理念，践行最高行业标准，与各方紧密合作，推动生物医药产业发展，使一流的生物药物惠及大众。

For more information, please visit the company's website at

有关更多信息，请访问公司网站

www.innoventbio.com

or the company's leading account at

或公司的主要账户在

www.linkedin.com/company/innovent-biologics/

www.linkedin.com/company/信达生物制药/

。

Statement:

声明：

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

信达不建议使用任何未经批准的药物/适应症。

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

免责声明：信达不建议任何非标签用途。

Forward-looking statement

前瞻性声明

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.

本新闻稿可能包含某些前瞻性陈述，这些陈述因其性质而受到重大风险和不确定性的影响。与信达相关的“预期”、“相信”、“估计”、“预计”、“意图”等词语及类似表达旨在识别其中某些前瞻性陈述。

Innovent does not intend to update these forward-looking statements regularly..

信达生物并不打算定期更新这些前瞻性声明。

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.

这些前瞻性声明是基于信达生物管理层在作出这些声明时对未来事件的现有信念、假设、期望、估计、预测和理解。这些声明并非对未来发展的保证，且受风险、不确定性及其他因素影响，其中部分因素超出信达生物的控制范围并且难以预测。

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..

因此，由于我们业务、信达的竞争环境以及政治、经济、法律和社会状况的未来变化或发展，实际结果可能与前瞻性陈述中包含的信息有重大差异。

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.

信达、信达的董事及员工（a）不承担纠正或更新本网站中包含的前瞻性陈述的义务；且（b）在任何前瞻性陈述未能实现或被证实不正确的情况下不承担责任。

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[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.

[10]. Douglas RS, Naik V, Hwang CJ, 等。Graves病患者的B细胞异常表达IGF-1受体：对疾病发病机制的启示。《免疫学杂志》2008;181:5768-5774。

SOURCE Innovent Biologics

来源：信达生物

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