预约演示

更新于：2025-07-04

Teplizumab

更新于：2025-07-04

概要

概要

基本信息

药物类型

单克隆抗体

别名

hOKT3-gamma-1-ala-ala、hOKT3-γ1-ala-ala、Teplizumab (USAN/INN)

+ [7]

靶点

CD3

作用方式

抑制剂

作用机制

CD3抑制剂(T细胞表面糖蛋白CD3复合体抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

+ [3]

非在研机构

Yale University

National Institute of Diabetes & Digestive & Kidney Diseases

权益机构

+ [2]

最高研发阶段批准上市

首次获批日期

美国 (2022-11-17),

1型糖尿病

最高研发阶段(中国)申请上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、优先药物（PRIME） (欧盟)、优先审评 (中国)

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结构/序列

Sequence Code 9717228L

来源: *****

Sequence Code 9976075H

来源: *****

关联

项与 Teplizumab 相关的临床试验

NCT06791291

/ Recruiting临床2期

Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 8 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.

This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment.
Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA.
Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 8 to 34 years.

开始日期2025-07-25

申办/合作机构

Sanofi

NCT06892002

/ RecruitingN/A

A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment.
Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.

开始日期2025-02-11

申办/合作机构

Sanofi

NCT06481904

/ RecruitingN/A

An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.
TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.
The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

开始日期2024-09-27

申办/合作机构

Sanofi

100 项与 Teplizumab 相关的临床结果

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100 项与 Teplizumab 相关的转化医学

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100 项与 Teplizumab 相关的专利（医药）

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608

项与 Teplizumab 相关的文献（医药）

2025-06-24·Current Diabetes Reports

From Prediction to Prevention: The Intricacies of Islet Autoantibodies in Type 1 Diabetes.

Review

作者: Quandt, Zoe ; Khine, Aye

PURPOSE OF REVIEW:

This review synthesizes current knowledge on islet autoantibodies (IAs) as predictive biomarkers for type 1 diabetes (T1D), focusing on their role in disease staging, autoantibody patterns, advancements in screening methodologies, and the implications of implementing population-wide screening initiatives.

RECENT FINDINGS:

Autoantibody profiling has refined T1D risk stratification, with progression rates influenced by IA characteristics including number, type, order of appearance, and affinity. While screening efforts initially targeted genetically at-risk groups, approximately 90% of new TID diagnoses occur in individuals without a family history, underscoring the need for broader population-based screening. The approval of teplizumab, a therapy shown to delay clinical T1D onset, represents a paradigm shift by providing an intervention following early identification through screening. Technological advancements have further optimized IA detection and therapeutic strategies. However, challenges such as cost-effectiveness, implementation logistics, and assay standardization remain. T1D is a chronic autoimmune disorder characterized by progressive pancreatic beta-cell destruction, leading to insulin deficiency. The natural history of T1D is typically marked by the appearance of IAs long before clinical symptoms emerge, providing a window for early detection and intervention. Identifying at-risk individuals during this asymptomatic phase can reduce disease severity at clinical onset and facilitate timely application of disease-modifying therapies like teplizumab. Emerging evidence emphasizes that IA characteristics collectively shape disease risk and progression. Advancements in screening technologies and therapies continue to support the integration of IA screening into clinical care, marking a significant step toward effective T1D prevention and management.

2025-06-01·CURRENT OPINION IN IMMUNOLOGY

Pharmacotherapeutic strategies to promote regulatory T cell function in autoimmunity

Review

作者: Campbell, Daniel J ; Wright, Robert C ; Levings, Megan K

Autoimmune diseases arise when self-antigen-specific T and B cells escape central and peripheral mechanisms of tolerance. One such mechanism is control of autoreactivity by regulatory T cells (Tregs), which have an essential role in suppressing autoimmunity. Consequently, there is significant interest in developing ways to boost or restore the function of Tregs in order to prevent or treat autoimmunity, induce tolerance, and thus reduce the reliance on broadly immunosuppressive agents. Strategies include enhancing the numbers and/or function of Tregs directly in vivo or via adoptive cell therapy. Here, we review recent advances in our understanding of how pharmacologic approaches can be applied to enhance Treg function in vivo through repurposing of established drug therapies or application of new therapies. Specifically, we discuss the potential of Treg-promoting drugs, including interleukin-2 and its derivatives, and tumor necrosis factor receptor 2 agonists, as well as Treg-preserving tyrosine kinase 2 inhibitors. We discuss how co-stimulatory blockade with CTLA-4 immunoglobulin affects tolerogenic environments and consider whether lymphodepleting therapies, such as antithymocyte globulin and teplizumab, might be needed to condition the environment for better Treg-promoting effects. We focus on the potential application of Treg-promoting drugs in type 1 diabetes and draw on evidence from transplantation. With multiple pharmacotherapeutic strategies to optimize Tregs in vivo, there is significant promise for new approaches to effectively and durably induce autoimmune disease remission.

2025-06-01·DIABETES RESEARCH AND CLINICAL PRACTICE

Paediatric screening in Italy as a gateway to secondary prevention in type 1 diabetes

Review

作者: Messina, M V ; Pozzilli, P ; Zampetti, S

This article explores Italy's pioneering national paediatric screening initiative for type 1 diabetes (T1D), the first of its kind to be mandated by the Italian law for the general population aged 1-17 years. This initiative is designed to facilitate early detection and secondary prevention of T1D and coeliac disease (CD), aiming to identify children in presymptomatic stages of T1D, regardless of family history. Emphasis is placed on autoantibody screening for T1D and CD to refine risk prediction and enhance secondary prevention efforts. Furthermore, the anti-CD3 + T cell monoclonal antibody teplizumab, which may be considered at present for compassionate use only, represents a step forward in delaying T1D onset in stage 2 patients. Italy's comprehensive screening law, passed in 2023, allows for early detection of T1D minimising the risk of consequences such as DKA at diagnosis. The screening will also advance our understanding of T1D disease pathogenesis and progression. These insights advocate for tailored prevention strategies, thus improving the design of clinical trials.

298

项与 Teplizumab 相关的新闻（医药）

2025-06-17

·研发客

100亿欧元在手，赛诺菲要怎么花？

// •接连完成几笔有针对性的收购和BD交易来延续Dupixent的辉煌战绩；•在MNC们纷纷砍掉罕见病管线的当口，逆流而上收购罕见病公司、补充自免罕见病产品；•对原有旧管线进行整理之后，今年又两度出手CNS领域。在宣布95亿美元收购Blueprint消息的同时，赛诺菲CEO Paul Hudson表示，公司仍然保留相当大的进一步收购能力。这句话并非空穴来风。同一天，赛诺菲与Nurix就一款STAT6降解剂达成授权交易，包括1500万美元的独家许可权费用和最高4.65亿美元的开发、商业化等里程碑付款。今年，赛诺菲频繁出手，表面来看，原因非常简单。一个月前，公司将消费者健康业务欧彼乐正式归于D&R麾下，作为其“瘦身”计划的一部分，50%欧彼乐的控股权换到了100亿欧元的净现金收益，也让它在近期的收购和BD交易中表现得更加慷慨。然而，有别于辉瑞的挥金如土、礼来的以守为攻，赛诺菲的“买买买”更接近一种庖丁解牛的姿势，这家曾经靠并购扩张起来的法国公司，精确地知道自己要什么。当然，这不代表它的每一次出手都是正确的。那么，接下来的钱，它会怎么花？延续Dupixent的战绩目前，赛诺菲拥有多条自免核心管线，包括白介素因子、TSLP、TL1A等靶点。其中，OX40单抗amlitelimab一直被视为Dupixent的接班者。不过，针对哮喘的临床研究结果差强人意。据赛诺菲最近公布的TIDE-Asthma Ⅱ期研究的初步结果显示，在中重度哮喘患者中，amlitelimab在缓解病情加重、改善肺功能和减轻症状方面取得了具有临床意义的效果，但是最高剂量组在第48周的年化严重哮喘急性发作率（AAER）未达到预期目标。尽管amlitelimab在治疗特应性皮炎方面已经取得了一些积极成果，但速度上或将落后于安进的rocatinlimab。rocatinlimab是全球首个完成Ⅲ期临床的OX40单抗。还有另一款OX40单抗为创响生物所有。去年，IMG-007在特应性皮炎和斑秃的Ⅱa期临床均取得积极的结果，展现出BIC潜力。同年，创响生物在纳斯达克完成了反向收购。拓展阅读猛虎嗅蔷薇：岸迈创响等多桩交易背后的资本推手为了巩固江湖地位，赛诺菲这两年接连完成了几笔有针对性的收购和BD交易。首先瞄准的是蛋白降解药物。2019年，赛诺菲与Nurix达成合作，支付5500万美元首付款，利用Nurix专有的DEL-AI药物发现平台开发特定的靶向蛋白降解药物。第二年，赛诺菲又为该合作追加2200万美元。今年4月，赛诺菲支付1500万美元，得到Nurix一款之前无法成药的自身免疫性疾病转录因子降解剂的独家授权。这两家公司最近一笔合作，即本文开头提到的本月初达成的STAT6降解剂授权交易。站在TCE的风口上，赛诺菲以6亿美元首付款拿到了Dren Bio旗下一款髓系细胞衔接器双抗DR-0201。这是一款潜在首创靶向CD20双抗，在临床前和早期临床研究中显示出强大的B细胞耗竭作用。深层B细胞耗竭能重置适应性免疫系统，有望在难治性B细胞介导的自身免疫性疾病如狼疮等发挥潜力。目前，DR-0201正在开展干燥综合征、多发性肌炎等适应症Ⅰ期临床试验。去年，赛诺菲又以1.25亿美元的首付款押注TL1A（肿瘤坏死因子样配体1A）赛道，与专注AI驱动药物开发的Earendil Labs达成合作，拿到Integrin α4β7/TL1A双抗HXN-1002与TL1A/IL-23双抗HXN-1003的全球独家权益。此外，赛诺菲在白介素赛道上继续发力，与Synthekine达成合作，开发用于治疗炎症性疾病的IL-10受体激动剂并将其商业化。另以7亿美元收购Belharra Therapeutics，利用其非共价化学蛋白质组学平台筛选及验证赛诺菲免疫学相关的药物靶点。实际上，CEO Paul Hudson上任之后的一系列重组计划，也在为Dupixent之后的接棒者做准备。今年一季度，Dupixent卖出了34.8亿欧元，实现20.3%的同比增长，占2025Q1总收入的1/3。尽管在适应症上还有不小的拓展空间，但是，要成为真正意义上的免疫巨头，只有一款产品是远远不够的。至少，艾伯维和强生在免疫领域的基本功同样扎实。Dupixent的核心专利将在2031年到期，赛诺菲需要更多种子选手。罕见病的路好走吗？2011年斥资200亿美元收购了健赞之后，赛诺菲就有了罕见病的基因。而在MNC们纷纷砍掉罕见病管线的当口，以95亿美元收购Blueprint的决策更有些逆流而上的味道。这笔交易可能成为今年欧洲制药企业最大金额收购案。从Blueprint手中，赛诺菲获得已上市产品Ayvakit，用于治疗系统性肥大细胞增多症（一种罕见免疫性疾病），以及下一代高选择性KIT D816V 抑制剂elenestinib。此外还有一款野生型KIT 抑制剂BLU-808，针对慢性荨麻疹/过敏性鼻炎等自免适应症。赛诺菲的几款已上市罕见病产品中，用于治疗血友病A的Altuviiio表现不俗，2025Q1实现2.51亿欧元的销售额，同比增长100%。CEO Paul Hudson认为，随着产品的继续放量，Altuviiio将有可能成为全年的下一个重磅炸弹。今年，另一款血友病药物Qfitlia获FDA批准，成为首个获批用于预防或减少成人和12岁以上儿童血友病患者出血频率的疗法，并且该疗法已在中国提交上市申请。此外，BTK抑制剂rilzabrutinib上市在即，用于治疗持续性或慢性免疫性血小板减少症（ITP）。这款产品是2020年赛诺菲以37亿美元收购Principia Biopharma而获得。去年，赛诺菲又以22亿美元收购Inhibrx，获得了一款罕见病在研产品INBRX-101，用于治疗α-1抗胰蛋白酶缺乏症（AATD），现已进入临床Ⅱ期。此番收购Blueprint的举动可以看出，赛诺菲在罕见病领域的布局将继续围绕自免适应症。再次进攻CNS2022年开始，赛诺菲着手调整神经系统领域的产品和管线，将治疗中枢神经系统疾病、疼痛和血管疾病的15款产品组合卖给了Neuraxpharma，又将精神治疗、抗焦虑、抗癫痫和抗精神病的11种药物出售给Pharmanovia。不过，这并不表示赛诺菲从CNS领域离场。相反，今年5月，赛诺菲花4.7亿美元收购了纳斯达克上市公司Vigil Neuroscience，旨在进攻阿尔茨海默病。旗下一款口服小分子TREM2激动剂VG-3927，已完成了该适应症的Ⅰ期临床试验，并取得积极结果。预计在今年三季度开展Ⅱ期临床。上周，Vigil另一款TREM2激动剂iluzanebart启动Ⅱ期临床，治疗成人脑白质病伴轴索球样变和色素胶质细胞（ALSP）。此外，今年早些时候，赛诺菲与Alloy达成合作，利用其AntiClastic反义平台开发CNS基因药物，并意图实现跨越血脑屏障。下一笔钱，花在哪里？看似低调的赛诺菲一直在并购交易的路上，搭建自免领域“护城河”应当是其最重要的目标。那么，未来这家公司可能在哪些领域投资呢？从近两年的几笔投资来看，疫苗领域没有涉及。2025Q1，赛诺菲疫苗领域销售额为13.26亿欧元，同比增长11.4%。RSV疫苗Beyfortus是主要功臣。目前，赛诺菲有几款mRNA疫苗在研产品，包括流感、痤疮、衣原体感染等。而CNS素来是最容易摔跟头的领域，想要拔得头筹恐怕还需要投入更多的机会成本。那么，曾经在糖尿病治疗创下辉煌的赛诺菲，会不会重新杀回代谢领域？2023年，赛诺菲以29亿美元收购了Provention Bio，其核心资产Tzield（用于治疗延迟1型糖尿病的发作）。这笔收购似乎并没有带来太好的回报，Tzield在2025Q1卖出1100万欧元，同比增长10%，表现不理想。如果要在短时间内重回巅峰，恐怕还要依靠新的交易来实现。编辑 | 姚嘉yao.jia@PharmaDJ.com总第2473期访问研发客网站，深度报道和每日新闻抢鲜看www.PharmaDJ.com

并购临床2期临床结果临床3期

2025-05-22

·PRNewswire

Laureate Announced for Hamm International Prize for Diabetes Research

Honoree has made outstanding contributions toward understanding the pathogenesis and prevention of Type 1 diabetes OKLAHOMA CITY, May 22, 2025 /PRNewswire/ -- The prestigious Harold Hamm International Prize for Biomedical Research in Diabetes, an honor bestowed by OU Health Harold Hamm Diabetes Center at the University of Oklahoma Health Sciences, will be awarded this fall to Professor Dr. Anette-Gabriele Ziegler, Director of the Institute of Diabetes Research, Helmholtz Munich, German Research Center for Environmental Health. She is also Chair in Diabetes and Gestational Diabetes at Technische Universität München, School of Medicine. She is being honored for her research to understand the pathogenesis of Type 1 diabetes and efforts toward its prediction, early diagnosis and prevention. Continue Reading Professor Dr. Anette-Gabriele Ziegler, director of the Institute of Diabetes Research at the Helmholtz Munich, German Research Center for Environmental Health, has been selected as the 2025 recipient of the prestigious OU Health Herald Hamm Diabetes Center's Harold Hamm International Prize for Biomedical Research in Diabetes. The Hamm Prize recognizes and encourages lasting advances in research related to Type 1 or Type 2 diabetes. It is awarded to an individual who has either demonstrated lifelong contributions to the field or realized a singular advance, especially one that promotes curative potential. The honor includes a $250,000 award, the largest of its kind in the world. It was established to recognize and promote lasting achievements in diabetes research focused on progress toward a cure. "The award is an incredible motivation to look ahead and continue on the path toward understanding the pathogenesis of Type 1 diabetes and developing preventive therapies – with the ultimate goal of finding a cure," Ziegler said. The prize, established in 2012, is named for Harold Hamm, chairman and chief executive officer of Oklahoma-based Continental Resources Inc., who provided an endowment to fund the prize in perpetuity. The Hamm Prize laureate is selected by a rotating jury of national and international leaders in the diabetes research community and is awarded every two years. "This prize honors work that changes the course of science – and Dr. Ziegler's research does exactly that. Her leadership in uncovering how Type 1 diabetes begins and how we might stop it before it starts is the kind of bold, life-changing progress this prize was meant to recognize. Her work fuels our hope – and brings us all one step closer to the cure," Hamm said. Ziegler's research has been at the forefront of translating important research questions into longitudinal studies, including more than 20 clinical trials, as well as implementing findings into public health. Her achievements include: Launched BabyDiab, the first birth cohort to study when and how Type 1 diabetes begins. Launched Fr1da, a public screening program to detect early signs of Type 1 diabetes, now a model for similar global efforts. Initiated and serves as speaker of GPPAD (Global Platform for the Prevention of Autoimmune Diabetes), a European platform to translate knowledge about disease pathogenesis into trials seeking to prevent Type 1 diabetes. More than 2,000 infants have been enrolled in GPPAD's clinical trials and screened for genetic risk of Type 1 diabetes. Conducted research that led to a landmark clinical trial resulting in Food and Drug Administration approval for teplizumab, the first immunotherapy drug shown to delay the onset of Type 1 diabetes in at-risk individuals. In addition, Ziegler has made the following research discoveries: Autoimmunity to insulin is a key starting point for Type 1 diabetes in children, and Type 1 diabetes susceptibility genes predispose for autoimmunity. Islet autoimmunity (when the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas) starts early in life, with a peak incidence around age 1 to 2. Children with two or more islet autoantibodies almost always develop diabetes. Respiratory viral infections in early life, including COVID-19, raise the risk of islet autoimmunity in genetically at-risk children. Early changes in blood sugar and immune activity appear to precede the onset of autoimmunity to insulin. A physician who conducts research, Ziegler said caring for patients has informed her career as a scientist. "My mentor always used to say, 'A researcher is the best doctor,'" she said. "I'm not sure if the reverse is true, but my daily work with people living with diabetes and my experience as a physician have certainly shaped my research. They have especially influenced my strong focus on translational research, clinical trials, and investigating the origins of the disease in humans." Ziegler will receive the Hamm Prize during a gala in October. Jed Friedman, Ph.D., director of Harold Hamm Diabetes Center, said Ziegler's distinguished research career has significantly advanced the aim of preventing Type 1 diabetes. "Professor Dr. Ziegler's visionary leadership and unwavering commitment have not only advanced scientific understanding but also paved the way for novel interventions that improve patient outcomes by delaying the onset of Type 1 diabetes," Friedman said. "Her work exemplifies the integration of rigorous research with compassionate clinical application, embodying the highest ideals of medical science. We are privileged to honor [her] for her unparalleled contributions to diabetes research and her enduring impact on public health." About the project For more information about the Harold Hamm International Prize for Biomedical Research in Diabetes, visit the prize website here. About the University of Oklahoma Founded in 1890, the University of Oklahoma is a public research university with campuses in Norman, Oklahoma City and Tulsa. As the state's flagship university, OU serves the educational, cultural, economic and health care needs of the state, region and nation. In Oklahoma City, OU Health Sciences is one of the nation's few academic health centers with seven health profession colleges located on the same campus. OU Health Sciences serves approximately 4,000 students in more than 70 undergraduate and graduate degree programs spanning Oklahoma City and Tulsa and is the leading research institution in Oklahoma. For more information about OU Health Sciences, visit . SOURCE University of Oklahoma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究免疫疗法

2025-05-21

·药事纵横

千亿蓝海的进击之路——自身免疫药物创新版图

自身免疫性疾病是一类因免疫系统异常攻击自身组织而引发的慢性炎症性疾病，涵盖类风湿关节炎、系统性红斑狼疮、银屑病、克罗恩病、多发性硬化症等上百种疾病。全球约7.6%-9.4%的人口受其困扰，患者需终身用药以控制病情，部分重症甚至威胁生命。随着医学研究的高歌猛进，药物开发领域正掀起一场从传统小分子药向靶向生物制剂、细胞疗法等创新方向变革的浪潮，市场版图也随之不断拓展。全球市场规模已从2018年的1099亿美元攀升至2025年预期的1522亿美元，中国市场更是以高达24.1%的复合年增长率蓬勃发展。从广谱抑制到精准靶向传统广谱免疫抑制剂的局限：在自身免疫性疾病治疗的早期阶段，广谱免疫抑制剂如甲氨蝶呤、环孢素等小分子药物扮演了重要角色。它们通过阻断DNA合成或T细胞活化通路来抑制炎症反应，但这类药物在抑制致病免疫细胞的同时，也对正常细胞造成严重伤害，引发感染、肝肾功能损伤等一系列风险，极大限制了其临床应用效果和安全性。生物制剂靶向治疗时代的开启：2000年后，生物制剂的出现为自身免疫性疾病治疗带来了曙光，其中以肿瘤坏死因子-α(TNF-α)抑制剂为代表。艾伯维的修美乐（阿达木单抗）作为这一领域的明星产品，能精准中和TNF-α，有效缓解类风湿关节炎和银屑病症状，在全球市场取得了巨大成功。即便如此，它也并非完美无缺，部分患者对其无效，且长期使用可能增加结核复发风险，这促使科研人员继续向更上游的炎症通路探索。聚焦白介素家族的精准打击：白介素（IL）家族在自身免疫性疾病中扮演着关键角色，如IL-17和IL-23是银屑病、强直性脊柱炎等疾病的核心介质。康方生物的古莫奇单抗（IL-17抑制剂）在3期临床试验中大放异彩，治疗中重度斑块型银屑病患者52周后，PASI75应答率接近100%，PASI100应答率超70%，疗效远超传统疗法。信达生物的匹康奇拜单抗（IL-23p19抗体）不仅在3期试验中16周PASI90应答率达80%，还通过延长给药间隔至12周，极大提升了患者治疗依从性。礼来的米吉珠单抗（IL-23p19抑制剂）在克罗恩病全球3期试验中表现出色，使患者临床缓解率较安慰剂组提高近30%，成功获FDA批准用于溃疡性结肠炎和克罗恩病治疗，为这类患者带来了新的希望。小分子靶向药的崛起：小分子靶向药凭借可口服的优势，在自身免疫性疾病治疗领域备受关注。恒瑞医药的艾玛昔替尼（JAK1抑制剂）通过高选择性减少血栓风险，在特应性皮炎3期试验中，患者湿疹面积和严重程度指数（EASI）改善率达75%，填补了小分子靶向药在这一疾病领域的空白。赛诺菲的替利珠单抗CD（3单抗）更是通过保护胰岛β细胞延缓1型糖尿病进展，3期试验显示高危人群糖尿病发病风险降低50%，成为首个病因干预疗法，并入选《时代》周刊2023年度最佳发明，为自身免疫性疾病治疗的精准化注入了新的活力。细胞疗法的跨界突破CAR-T疗法的创新应用：CAR-T疗法在血液肿瘤领域取得辉煌成就后，科研人员开始探索其在自身免疫病中的应用。在类风湿关节炎小鼠模型实验中，CAR-T技术成功清除致病性B细胞，且创新性地通过光控断裂基团实现CAR-T活性的即时终止，有效避免了细胞因子风暴这一严重风险。体外实验进一步验证了其有效性，针对类风湿关节炎患者B细胞的清除率高达90%，为CAR-T疗法在自身免疫病领域的临床转化奠定了坚实基础。补体抑制剂与FcRn抗体的新突破：优时比的泽勒普肽（C5补体抑制剂）和巴托利单抗（FcRn抗体）为重症肌无力治疗开辟了新路径。泽勒普肽的3期试验显示，患者日常活动评分（MG-ADL）改善率达65%，皮下注射的给药方式相较于传统静脉给药更加便捷，显著提升了患者治疗体验。巴托利单抗则通过加速致病抗体降解，在重症肌无力3期扩展研究中，使患者肌力评分（QMG）改善超过40%，且长期安全性良好，为重症肌无力患者带来了新的治疗选择。RNA改造细胞疗法的崭露头角：RNA改造细胞疗法作为一种新兴技术，在自身免疫病领域崭露头角。CartesianTherapeutics的Descartes-25通过递送双特异性抗体和IL-12，在骨髓瘤临床前模型中展现出协同抗肿瘤活性，其正在进行的1/2a期试验正探索其在多发性骨髓瘤中的潜力，为未来细胞疗法在自身免疫病治疗中的跨界应用提供了全新思路，也为患者带来了更多希望。市场扩容与国产创新药的崛起全球自身免疫药物市场呈现“双轨并行”格局：成熟靶点如TNF-α、IL-17等仍占据主要份额，而新兴靶点如TSLP、TL1A等加速布局。修美乐虽因专利到期销售额下滑，但赛诺菲的度普利尤单抗（IL-4Rα抗体）凭借适应证扩展成为新晋“销冠”，2024年销售额达141.8亿美元。中国市场中，化学药仍占主导（80%），但生物制剂增速迅猛，预计2030年占比将升至69.1%。国产药企通过差异化策略突围：康诺亚的司普奇拜单抗（IL-4Rα抗体）凭借价格优势和快速审批，三年内获批特应性皮炎、鼻息肉等多个适应证，并通过“NewCo模式”授权海外开发，加速国际化进程。三生国健的SSGJ-608（IL-17A单抗）在银屑病3期试验中PASI75应答率达85%，预计2025年获批后将成为国产IL-17赛道的重要竞争者。政策支持亦推动行业升级。2024年国家医保目录新增多款生物制剂，如信达生物的匹康奇拜单抗和恒瑞的艾玛昔替尼，患者年治疗费用从10万元以上降至3万-5万元，显著提升可及性。此外，本土药企通过License-out模式拓展全球市场，例如和铂医药将巴托利单抗大中华区权益授权石药集团，交易金额超10亿元，加速商业化布局。挑战与未来尽管创新疗法层出不穷，行业仍面临多重挑战。首先，诊断标准化不足制约精准治疗。约40%的自身免疫病患者经历误诊，部分检测技术如基因测序成本高昂，低收入地区可及性差。其次，生物制剂的高价限制普及，中国仅20%的自身免疫生物药进入医保，患者年治疗费用常超10万元。此外，细胞疗法的复杂制备工艺和长期安全性仍需验证。根据上述分析，未来趋势或将聚焦以下方向：一是个体化诊疗：结合AI和生物标志物开发预测模型，例如利用机器学习分析抗体谱指导CAR-T连接臂设计；二是长效化与便利性：罗氏的奥瑞利珠单抗（CD20单抗）每年仅需输注两次，信达生物药物将给药间隔延长至12周，患者依从性显著提升；三是多靶点协同：TL1A、OX40等新靶点可调节多重免疫通路，礼来的米吉珠单抗（IL-23p19抑制剂）在克罗恩病中展现对难治性患者的更高响应率；四是可支付性创新：通过本土化生产、医保谈判和新型支付模式（如按疗效付费）降低患者负担加速审评并降低成本。自身免疫疾病的治疗正经历一场深刻变革，从传统的“一刀切”模式逐步走向精准化、长效化。靶向生物制剂与细胞疗法的有机结合，不仅重塑了临床治疗实践，更推动了千亿级市场的重构。国产药企凭借快速跟进与自主创新，逐步打破跨国药企的垄断地位，在全球市场中崭露头角。随着诊断技术的不断进步、支付体系的持续完善以及跨学科合作的日益深化，未来十年有望见证更多能够从根本上治愈自身免疫疾病的“治本”疗法的诞生，最终实现从缓解症状到免疫重建的伟大跨越，为全球自身免疫疾病患者带来曙光。参考文献：[1]A M M ,F N F ,H B A , et al.Smart Multivariate Spectrophotometric Determination of Two Co-Administered Autoimmune Drugs; Sulfasalazine and Pentoxifylline; in Bulk and Spiked Human Plasma.[J].Journal of AOAC International,2023,[2]University of Southampton; A 'switch' that turns autoimmunity drugs into powerful anti-cancer treatments[J].NewsRx Health & Science,2020,[3]Jarvis M L .Lilly inks deal for autoimmune drug[J].Chemical & Engineering News,2019,19.[4]A J I ,Carmelo C ,M D S , et al.Brief Report: Drugs Implicated in Systemic Autoimmunity Modulate Neutrophil Extracellular Trap Formation.[J].Arthritis & rheumatology (Hoboken, N.J.),2018,70(3):468-474.药事纵横投稿须知：稿费已上调，欢迎投稿

临床3期免疫疗法临床结果细胞疗法临床成功

100 项与 Teplizumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09013	Teplizumab	-	DB06606

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
1型糖尿病	美国	Provention Bio, Inc.	2022-11-17

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
葡萄糖耐受不良	临床2期	美国	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
葡萄糖耐受不良	临床2期	加拿大	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
葡萄糖耐受不良	临床2期	德国	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
慢性大斑块银屑病	临床2期	美国	MacroGenics, Inc.	2009-12-01
慢性大斑块银屑病	临床2期	美国	Eli Lilly & Co.	2009-12-01
2型糖尿病	临床阶段不明	美国	Sanofi	2024-09-27

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04270942 (CTgov)	临床2期	1型糖尿病	6	Teplizumab	製鏇糧壓襯醖觸襯壓膚 = 壓廠選壓鬱遞繭鹽網製醖襯鬱醖鬱艱鬱餘壓選 (窪鏇醖膚網衊繭窪鬱選, 繭膚憲襯鏇蓋夢簾築鬱 ~ 餘窪獵觸簾簾顧壓廠積) 更多	-	2025-02-12
NCT01030861 (Pubmed \| J Clin Invest)	临床2期	1型糖尿病	-	Teplizumab	憲鹽憲範齋廠衊鹽範簾(艱願鹹鬱範餘選壓顧繭) = reduced with teplizumab treatment 襯鑰遞淵築齋齋壓鑰觸 (襯獵廠觸艱構範選鹹齋 ) 更多	积极	2024-08-13
NCT03875729 (PROTECT, ADA2024) 人工标引	临床3期	1型糖尿病	275	Teplizumab	觸齋艱範壓繭顧簾鹽顧(鹽衊選壓簾膚築餘願鹽) = 窪蓋艱壓醖選鏇遞鏇範膚鏇範範窪夢衊憲窪願 (夢鏇鹹觸憲構艱觸襯製, -2.27 ~ -1.87) 更多	积极	2024-06-20
				Placebo	觸齋艱範壓繭顧簾鹽顧(鹽衊選壓簾膚築餘願鹽) = 築積膚糧觸膚築繭鏇憲膚鏇範範窪夢衊憲窪願 (夢鏇鹹觸憲構艱觸襯製, -1.94 ~ -1.67) 更多
ADA2024	N/A	1型糖尿病	-	Teplizumab	積齋夢夢積餘鹽築齋鬱(觸齋選衊醖鏇獵廠齋憲) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment 憲願膚築積鹹醖膚艱積 (築遞製廠膚積鑰憲鹹網 ) 更多	-	2024-06-14
				Placebo
NCT03875729 (PROTECT, CTgov)	临床3期	1型糖尿病	328	Placebo (Placebo)	淵膚積鬱壓築憲構襯選(簾簾鏇鬱餘繭築觸醖選) = 範獵襯淵衊膚膚構壓願鬱鏇選艱艱廠觸鏇淵夢 (餘糧築膚製衊鹹範糧淵, 糧憲鏇艱築獵醖獵鏇觸 ~ 壓鹽蓋顧積糧憲淵鏇範) 更多	-	2024-04-24
				teplizumab (Teplizumab)	淵膚積鬱壓築憲構襯選(簾簾鏇鬱餘繭築觸醖選) = 願鑰憲艱齋築構築範餘鬱鏇選艱艱廠觸鏇淵夢 (餘糧築膚製衊鹹範糧淵, 膚夢築製願艱願鹽積顧 ~ 廠鹽積積糧網觸積糧顧) 更多
NCT00920582 (CTgov)	临床3期	1型糖尿病	254	Teplizumab Herold Regimen (Herold Regimen)	鑰鑰製顧襯鏇廠觸範壓 = 積醖鬱顧範選築鏇構鏇選廠製構艱齋夢製選顧 (願選範繭範獵鑰鏇憲艱, 鬱鏇顧積膚願鑰築蓋獵 ~ 膚夢築膚構範鹹選鑰鬱) 更多	-	2023-12-20
				Teplizumab 33.3% Herold Regimen (33.3% Herold Regimen)	鑰鑰製顧襯鏇廠觸範壓 = 鏇鏇繭顧膚構鹽簾顧夢選廠製構艱齋夢製選顧 (願選範繭範獵鑰鏇憲艱, 艱艱鹹製糧顧遞鏇範積 ~ 簾鹹鏇構範餘範膚簾願) 更多
NCT00385697 (Protégé Study, CTgov)	临床2/3期	1型糖尿病	554	Teplizumab (Open-label Herold Regimen)	遞網蓋選觸積衊鹽遞願 = 觸衊齋選鑰遞構鑰構鏇壓醖襯淵糧範鬱鹽餘鬱 (積憲憲襯繭觸顧壓壓構, 簾壓壓衊齋獵網鏇襯積 ~ 築網遞鬱願獵鏇襯範淵) 更多	-	2023-12-05
				Teplizumab (Double-blind Herold Regimen)	窪構蓋艱構製願範鑰積 = 觸獵範觸窪壓艱製醖餘衊簾鹹醖簾齋選襯膚積 (襯蓋膚獵膚憲膚鹽襯製, 壓鬱願顧範遞遞獵淵鹹 ~ 鬱窪憲淵齋膚製鏇鹹襯) 更多
NCT03875729 (PROTECT, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	1型糖尿病	-	Teplizumab	鹹遞願構鑰衊選選選淵(餘廠願蓋網壓範觸積顧) = Patients treated with teplizumab (217 patients) had significantly higher stimulated C-peptide levels than patients receiving placebo (111 patients) at week 78 (least-squares mean difference, 0.13 pmol per milliliter; 95% confidence interval [CI], 0.09 to 0.17; P<0.001), and 94.9% (95% CI, 89.5 to 97.6) of patients treated with teplizumab maintained a clinically meaningful peak C-peptide level of 0.2 pmol per milliliter or greater, as compared with 79.2% (95% CI, 67.7 to 87.4) of those receiving placebo. 獵繭獵製繭網網壓獵淵 (鏇遞廠繭醖鏇遞願構襯 ) 更多	积极	2023-10-18
				placebo
FOCIS2023	N/A	1型糖尿病 EBVsero+	-	teplizumab (EBVsero+)	鏇蓋壓淵構鹹鏇鬱膚積(鹽製憲餘積構膚齋鏇選) = 遞構鏇齋選願鏇構齋網夢廠鹽夢憲顧獵顧顧鬱 (壓膚顧膚窪蓋鬱願鹹齋 )	积极	2023-06-20
				teplizumab (EBVsero-)	鏇蓋壓淵構鹹鏇鬱膚積(鹽製憲餘積構膚齋鏇選) = 鑰構襯築餘餘糧艱壓餘夢廠鹽夢憲顧獵顧顧鬱 (壓膚顧膚窪蓋鬱願鹹齋 )
NCT03751007 (Phase 1b/2a, EASD2021)	临床1/2期	1型糖尿病 C-peptide \| preproinsulin (PPI)-	-	AG019 monotherapy	獵窪鏇鑰壓廠餘齋糧願(觸憲糧築醖壓繭襯製醖) = AG019 was well tolerated and safe when administered for 8 weeks as monotherapy or in association with teplizumab. No serious adverse events and no AG019 treatment discontinuation occurred due to TEAEs. Most TEAEs reported were mild (72.3%) and sometimes moderate (24.3%). AG019 safety profile was similar between adults and adolescents and there was no evidence of dose-related TEAEs. The safety profile of teplizumab in association with AG019 was consistent with that of teplizumab. 醖鹽繭醖範繭簾構繭壓 (淵築衊鑰壓製積餘繭鬱 ) 更多	积极	2021-10-01
				AG019/teplizumab combination therapy