预约演示

更新于：2025-11-20

Teplizumab

替利珠单抗

更新于：2025-11-20

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)

+ [9]

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

SanofiSanofi-Aventis Canada, Inc.

Ajinomoto Althea, Inc.

+ [3]

非在研机构

MacroGenics, Inc.

National Institute of Diabetes & Digestive & Kidney Diseases

权益机构

+ [1]

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)批准上市

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)、局长国家优先审评券 (美国)

登录后查看时间轴

结构/序列

Sequence Code 9717228L

来源: *****

Sequence Code 9976075H

来源: *****

关联

项与替利珠单抗相关的临床试验

NCT07088068

/ Recruiting临床3期

A Randomized, Double-blind, 2-arm, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Newly Diagnosed Stage 3 Type 1 Diabetes (T1D)

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment.
The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.

开始日期2025-08-06

申办/合作机构

Sanofi

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

/ CompletedN/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

100 项与替利珠单抗相关的临床结果

登录后查看更多信息

100 项与替利珠单抗相关的转化医学

登录后查看更多信息

100 项与替利珠单抗相关的专利（医药）

登录后查看更多信息

603

项与替利珠单抗相关的文献（医药）

2025-12-01·Current Diabetes Reports

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

Review

作者: Quandt, Zoe ; Khine, Aye

Abstract:

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.

Summary:

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.

2025-11-01·Lancet Diabetes & Endocrinology

Managing adults with screen-detected islet autoantibody positivity: a pragmatic framework

Review

作者: Tatovic, Danijela ; Jones, Angus ; Narendran, Parth ; Thomas, Nicholas

New disease-modifying therapies, such as teplizumab, offer opportunities to delay the clinical onset of type 1 diabetes but require islet autoantibody screening to identify individuals at increased risk of progression to diabetes. As type 1 diabetes screening programmes expand, clinicians will increasingly encounter a new group of people: adults who test positive for islet autoantibodies but have not yet been diagnosed with diabetes. Although international guidelines outline management for both children and adults, considerable uncertainties remain, particularly for adults. In adults with islet autoantibody positivity, the lower risk of progression to type 1 diabetes compared with children, combined with the high background prevalence of mild non-autoimmune dysglycaemia, presents substantial challenges for clinical management. This Personal View aims to add clarity to international consensus guidelines, proposing a pragmatic framework for managing adults with islet autoantibody positivity. Although fitting within a UK National Health Service setting, we feel this framework is also relevant to other health systems.

2025-11-01·DIABETES

Novel Approach for Assessing Outcomes of Type 1 Diabetes Prevention Trials Over a Fixed Time Interval

Article

作者: Sosenko, Jay M. ; Dayan, Colin M. ; Redondo, Maria J. ; Ismail, Heba M. ; Taylor, Peter N. ; Galderisi, Alfonso ; Herold, Kevan C. ; Nathan, Brandon M. ; Carr, Alice L.J. ; Skyler, Jay S. ; Jacobsen, Laura M. ; Russell, William E. ; Cuthbertson, David ; Sims, Emily K.

Article Highlights:

Challenges in time to event type 1 diabetes (T1D) prevention trial design can yield negative results even for treatments that may actually improve disease pathology. We evaluated whether a binary metabolic end point for 12-month change from baseline to 1 year postrandomization could be useful in T1D prevention trials. This approach detected treatment effects at least as well as standard primary end points with shorter follow-up. Fixed interval metabolic end points should be used in combination with traditional T1D end points to better understand treatment effects of preventive agents.

365

项与替利珠单抗相关的新闻（医药）

2025-11-18

·柳叶方舟

医工资讯 11.1-11.15 | 从临床到产业的全链条变革

本期目录 • 农用杀虫剂高效氯氟氰菊酯诱发肺癌的分子机制 • 《生物工程学报》创刊四十周年学术论坛在杭州成功举办 • 凝结芽孢杆菌中木糖代谢关键基因挖掘及XylA的克隆表达与酶学特性 • 2025华夏大健康产业发展暨康复服务大会即将重磅启幕 • 赛诺菲1型糖尿病药物准备在欧盟推出 • 元生创投Family派格生物国家1类创新药GLP-1RA周制剂维培那肽注射液（派达康®）获批上市 • 元生创投Family达歌生物宣布与默沙东研发（中国）签署合作意向书共同开发一款First-in-Class分子胶降解剂 • 南华金融拟设立合营公司进军AI制药、美妆科技及抗衰老消费市场等高增长领域医工资讯农用杀虫剂高效氯氟氰菊酯诱发肺癌的分子机制共有核心靶点影响肺癌发生的分子机制近期，倪志华团队通过生物信息学手段系统解析了农用杀虫剂高效氯氟氰菊酯（Lambda-cyhalothrin, LCT）诱发肺癌的潜在分子机制，为职业暴露人群的呼吸系统健康管理提供了重要依据。研究基于多组学数据识别出LCT在四种肺癌亚型中分别诱导50、54、29与28个核心靶点，其中 EGFR、HSP90AA1、SRC、AKT1、JUN、STAT3、TP53 七个基因为共性靶点，提示其在LCT促癌通路中的枢纽作用。亚型核心靶点数共性靶点占比肺腺癌 54 7/54（13.0%）肺鳞癌 50 7/50（14.0%）小细胞肺癌 29 7/29（24.1%）大细胞肺癌 28 7/28（25.0%）富集分析揭示LCT主要干扰三大类生物学过程： • 泛素化修饰通路：影响E3泛素连接酶复合物组装，导致关键肿瘤抑制因子（如p53）降解加速； • 趋化因子信号：上调CXCL8/CXCR2轴，促进肿瘤微环境中中性粒细胞浸润与血管生成； • 肿瘤免疫逃逸：抑制树突状细胞成熟，削弱CD8⁺ T细胞应答。分子对接模拟进一步证实，LCT可与EGFR（结合能：−8.2 kcal/mol）及HSP90AA1（−7.6 kcal/mol）通过氢键与π–cation相互作用稳定结合，具备较强结合亲和力。该研究不仅填补了农药–肺癌因果链中机制空白，更呼吁临床对长期暴露于菊酯类杀虫剂的农业从业者开展早期肺部筛查与生物标志物监测。《生物工程学报》创刊四十周年学术论坛在杭州成功举办 2025年11月2日，《生物工程学报》创刊四十周年学术论坛在杭州成功召开，作为中国微生物学会年会的重要分会场，汇聚了全国百余名微生物与合成生物学领域顶尖学者。论坛由中科院微生物所李寅研究员主持，郝丽芳编审系统回顾了学报“从铅与火到光与电”的发展历程——累计刊发论文超12,000篇，影响因子连续五年突破3.0，成为我国生物工程领域最具权威性的学术窗口之一。《DNA硫修饰：从发现到应用》会议亮点聚焦前沿科技突破： • 邓子新院士报告《DNA硫修饰：从发现到应用》，展示其团队首次解析的DndFGH复合体三维结构，并推出基于硫修饰的新型基因编辑工具“S-Edit”，编辑效率提升2.3倍； • 杨汉春教授介绍新型猪圆环病毒嵌合VLP疫苗在田间试验中保护率达96%，有望2026年获批兽用； • 刘双江研究员分享“微生物组细胞工厂”平台构建策略，实现丁二酸产率＞110 g/L、糖转化率＞92%，已与蓝晶微生物达成产业化合作。此次论坛还发布了《生物工程高质量发展杭州倡议》，强调“学科交叉–技术转化–临床落地”三位一体路径，为“十五五”期间我国合成生物学与医疗健康交叉创新指明方向。凝结芽孢杆菌中木糖代谢关键基因挖掘及XylA的克隆表达与酶学特性凝结芽孢杆菌针对木质纤维素生物炼制中木糖利用率偏低的瓶颈问题，研究团队聚焦益生菌株凝结芽孢杆菌（Bacillus coagulans），系统解析其木糖代谢调控网络，并成功克隆表达关键酶XylA（木糖异构酶），为推动低成本乳酸生产奠定分子基础。研究采用葡萄糖/木糖梯度配比发酵策略（比例从10:0至0:10），发现5:5时菌体生长与乳酸产率同步最优（OD₆₀₀=8.7，乳酸＝42.1 g/L）。转录组联合qRT-PCR验证：xylA在木糖诱导下表达上调达17.3倍，显著高于xyiB（木酮糖激酶）等其他候选基因。 Bc-XylA酶学特性如下：参数数值备注最适pH 8.0 pH 7.0–9.0间保持＞80%活力最适温度 60℃ 55–65℃稳定性良好（t₁/₂＞2 h）金属依赖性 Mn²⁺ > Mg²⁺ > Co²⁺ Mn²⁺提升活性至328% Kₘ（木糖） 47.5 mM 优于多数中温菌源XylA 四聚体分子量 ≈172 kDa 预测含典型TIM-barrel折叠该重组酶已在大肠杆菌BL21(DE3)中实现可溶性高效表达（占总蛋白31%），纯化后比酶活达82.4 U/mg。鉴于B. coagulans兼具同型乳酸发酵与耐高温（50–55℃）优势，Bc-XylA有望嵌入“一步法”木糖→乳酸工艺，显著降低生物基聚乳酸（PLA）医用材料的原料成本。2025华夏大健康产业发展暨康复服务大会即将重磅启幕以“智领健康未来”为主题的2025华夏大健康产业发展暨康复服务大会定于11月21日在北京国家会议中心启幕，由《华夏时报》主办，获国家卫健委、中国康复医学会指导，预计参会规模逾1500人。本次大会核心定位为搭建“临床需求—技术研发—资本赋能”闭环生态，尤其面向呼吸科、消化科、肿瘤康复等一线医务工作者。大会亮点议程预览：时间演讲人主题临床价值 09:30–10:15 樊代明院士消化系慢病“整合防诊治”新范式推出“胃癌早筛六联标志物”临床路径（含ctDNA+甲基化+代谢物） 10:45–11:30 吴世彩教授（中国康复研究中心）智能康复机器人临床适配性评估发布《上肢康复机器人临床应用专家共识（2025版）》 14:00–14:45 杜向阳先生（礼来中国创新基金）创新药早期投资：临床价值导向转变强调“真实世界证据（RWE）前置”在Ⅱ期前决策权重＞40% 特别设置“医工交叉项目路演”环节：12家初创企业将展示包括AI肺结节动态风险分层系统、无创血糖连续监测微针贴片、肠道菌群定向调控微胶囊等成果，现场对接三甲医院临床转化中心。大会官网已开通“医生专属通道”，注册可获赠《2025中国康复器械临床指南》电子版。赛诺菲1型糖尿病药物准备在欧盟推出替普利珠单抗在2025年世界糖尿病日（11月14日），赛诺菲宣布其创新生物制剂Teizeild®（替普利珠单抗，teplizumab）获得欧洲药品管理局人用药品委员会（CHMP）积极批准意见，用于延缓8岁及以上2期1型糖尿病（T1D）患者向3期进展。该药有望于2026年Q1正式在欧盟上市，成为全球首个获批的T1D疾病修饰疗法（DMT）。 Teizeild作用机制为靶向CD3ε的FcRn融合抗体制剂，通过调节性T细胞扩增与效应T细胞耗竭，保护残余β细胞功能。关键Ⅲ期TrialNet研究显示：单疗程14天静脉输注可将临床诊断（3期）中位时间从24.4个月推迟至59.6个月（HR=0.41, p<0.001），C肽曲线下面积（AUC）降幅减少68%。关键指标 Teizeild组安慰剂组差异中位诊断延迟 59.6月 24.4月 +35.2月 2年无胰岛素治疗率 35% 8% +27% 严重不良反应 2.8%（皮疹/淋巴细胞减少） 1.9% 可控目前欧盟约220万T1D患者中，预计每年超3万名2期患者适用此疗法。赛诺菲已启动“T1D早期筛查－转诊－治疗”一体化网络建设，计划联合基层医疗机构推广GADA/IA-2/ZnT8三抗体联合检测，助力早筛早治。该药在美国上市首年销售额达4.2亿美元，分析师预测其全球峰值销售将突破10亿美元。元生创投Family派格生物国家1类创新药GLP-1RA周制剂维培那肽注射液（派达康®）获批上市 2025年1月14日，国家药监局正式批准派格生物1类新药维培那肽注射液（商品名：派达康®）上市，用于成人2型糖尿病（T2DM）血糖控制。作为国内首款自主研发的GLP-1受体激动剂（GLP-1RA）周制剂，其依托独创定点双PEG化修饰技术，在维持长效性的同时显著优化安全性，标志着我国糖尿病生物药研发迈入国际第一梯队。 GLP-1RA III期临床试验（PG01-303）入组1124例中国T2DM患者，结果显示： • 糖化血红蛋白（HbA1c）降幅：维培那肽1.5 mg组达−1.62%（vs 安慰剂−0.23%，p<0.0001；非劣效于度拉糖肽−1.58%）； • 体重减轻：平均−4.3 kg（基线BMI 28.7 kg/m²）； • 胃肠道不良反应发生率：恶心12.1%、呕吐2.3%、腹泻6.7%，显著低于司美格鲁肽（分别为20.6%、5.1%、10.2%）； • 半衰期：达168 h（≈7天），支持每周一次皮下注射。特性维培那肽度拉糖肽司美格鲁肽剂量频率每周1次每周1次每周1次 PEG修饰定点双PEG 无脂肪酸链主要AE（恶心） 12.1% 15.8% 20.6% 中国III期HbA1c降幅 −1.62% −1.58% −1.75%* *注：司美格鲁肽中国III期数据来自SUSTAIN-CHN研究元生创投自A轮起连续五轮加持，累计投资超5亿元。派格生物透露，维培那肽的减重适应症III期试验正在进行中，有望2027年拓展至肥胖症领域，进一步惠及代谢综合征高风险人群。元生创投Family达歌生物宣布与默沙东研发（中国）签署合作意向书共同开发一款First-in-Class分子胶降解剂达歌生物 2025年Q4，元生创投被投企业达歌生物宣布与默沙东研发（中国）签署合作意向书，双方将基于达歌自主知识产权的GlueXplorer®分子胶发现平台，共同开发一款靶向未公开E3连接酶–致病蛋白复合物的First-in-Class分子胶降解剂（MGD），重点布局血液肿瘤与自身免疫病适应症。达歌生物在靶向蛋白降解（TPD）领域已建立三大技术支柱： 1. GlueXplorer®平台：整合AI构效预测+高通量三元复合体筛选（＞10⁶化合物库），已识别32个新型分子胶结合“热点”； 2. E3连接酶拓展技术：突破CRBN/VHL局限，成功激活RNF114、DCAF15等5种非经典E3； 3. 降解效率评估体系：建立DC₅₀/Dmax双参数模型，确保体内DC₅₀<100 nM。此次合作将由默沙东主导全球临床开发与商业化，达歌负责临床前候选物（PCC）优化及CMC。据透露，该分子胶在套细胞淋巴瘤原代细胞模型中DC₅₀=18 nM，诱导靶蛋白降解＞95%，且对正常B细胞无显著毒性。降解剂类型分子胶（MGD） PROTAC 优势对比分子量＜500 Da ＞700 Da 更高口服生物利用度合成难度单步＜5步多步＞10步成本降低60–70% 组织穿透性优（CNS可及）差适用脑瘤/神经退行病达歌生物CEO表示，该合作是“中国源头创新+跨国药企全球化能力”的典范，有望3年内推进至IND阶段。南华金融拟设立合营公司进军AI制药、美妆科技及抗衰老消费市场等高增长领域 AI医药应用环节传统金融机构正加速向科技领域延伸——南华金融控股有限公司近期公告称，已与一家未披露名称的中国AI制药公司签署谅解备忘录（MOU），拟共同设立合营企业，正式进军AI驱动药物研发、精准美妆科技及抗衰老干预产品三大高增长赛道，践行“金融资本+产业科技”双轮驱动战略。合营公司初期聚焦三大业务模块：模块核心技术医疗价值商业路径 AI药物发现平台多模态生成模型（靶点–分子–ADMET联合生成）缩短临床前周期至12–18个月（传统3–5年）向Biotech收取里程碑费+销售分成智能皮肤健康管理系统微流控芯片+AI皮肤菌群/屏障分析服务特应性皮炎、玫瑰痤疮患者精准护肤医院皮肤科→医美机构→DTC订阅 NAD⁺增强型抗衰组合纳米脂质体递送NR/NMN+Senolytics前药延缓免疫衰老（T细胞再激活率↑40%）高净值客户健康管理包南华金融表示，首期注资不低于3亿元，重点投向可验证临床转化路径的成熟技术（如已进入PCC阶段的AI生成分子）。此举不仅拓展其收入结构（目标3年内非金融收入占比达15%），更将通过资本纽带联动旗下保险、信托资源，探索“健康管理+保险支付”创新模式，为医务工作者提供从科研支持到患者管理的全链条金融–科技解决方案。

临床研究

2025-11-18

·今日头条

#早期糖尿病为什么能逆转?#糖尿病能否被根治是医学研究的重点问题。目前，尚无彻底根治糖尿病的方法，但随着干细胞技术、基因编辑、免疫疗法等领域的突破，未来糖尿病治疗可能出现根本性改变。科学界普遍认为，根治糖尿病的关键在于恢复胰岛β细胞功能或重建胰岛素分泌系统，但实现这一目标仍需时间。 ------

#早期糖尿病为什么能逆转?#糖尿病能否被根治是医学研究的重点问题。目前，尚无彻底根治糖尿病的方法，但随着干细胞技术、基因编辑、免疫疗法等领域的突破，未来糖尿病治疗可能出现根本性改变。科学界普遍认为，根治糖尿病的关键在于恢复胰岛β细胞功能或重建胰岛素分泌系统，但实现这一目标仍需时间。 ------ 一、当前糖尿病治疗困境糖尿病分为1型（胰岛素绝对缺乏）和2型（胰岛素抵抗或分泌不足）。现有治疗手段（如胰岛素注射、降糖药物）仅能控制症状，无法逆转疾病进程。1型糖尿病因自身免疫破坏胰岛细胞，患者需终身依赖胰岛素；2型糖尿病与遗传、肥胖等因素相关，虽可通过生活方式干预延缓进展，但仍存在并发症风险。 ------ 二、未来根治方向及研究进展 1. 干细胞与再生医学通过诱导多能干细胞（iPS细胞）分化为功能性β细胞，已在小鼠实验中实现血糖调控。2021年Vertex Pharmaceuticals的VX-880疗法首次在1型糖尿病患者中验证了该路径的可行性，但细胞存活率、免疫排斥等问题尚未完全解决。 2. 基因编辑技术 CRISPR等基因工具正在尝试两种路径： • 修复致病基因（如MODY型糖尿病的单基因突变） • 编辑免疫细胞基因（阻止1型糖尿病中的自身免疫攻击） 2022年《自然》杂志报道，通过基因疗法成功逆转了小鼠的1型糖尿病。 3. 免疫调节疗法针对1型糖尿病的抗原特异性免疫疗法（如Treg细胞输注）已进入Ⅱ期临床试验，旨在重建免疫系统对β细胞的“耐受性”。2023年Teplizumab获FDA批准用于延缓1型糖尿病发病，这是首个改变疾病进程的生物制剂。 4. 人工胰腺与仿生器官虽然不属根治范畴，但闭环胰岛素泵系统（人工胰腺）通过实时血糖监测与自动给药，已使患者摆脱手动注射。更前沿的“生物人工胰腺”将胰岛细胞封装在免疫隔离材料中，正在动物试验阶段。 5. 肠道微生物干预近年研究发现，肠道菌群失调与2型糖尿病密切相关。通过粪菌移植、特定益生菌组合调节代谢通路，已有临床试验显示可改善胰岛素敏感性，但长期效果仍需验证。 ------ 三、主要挑战与时间预测 • 生物学复杂性：糖尿病涉及多器官、多基因调控，2型糖尿病尤其存在高度异质性 • 安全性风险：干细胞治疗可能诱发肿瘤，基因编辑存在脱靶效应 • 个体化差异：不同糖尿病亚型需要定制化治疗方案多数专家认为，针对特定人群的根治性疗法可能在10-15年内出现，例如： • 单基因糖尿病（如新生儿糖尿病）有望通过基因疗法根治 • 早期1型糖尿病或可通过免疫干预+干细胞移植实现功能恢复 • 2型糖尿病的根治更依赖代谢记忆消除和器官功能重建技术 ------ 四、现阶段建议患者应保持理性期待，重点关注： 1. 严格遵循现有控糖方案 2. 参与正规医疗机构的临床试验（如干细胞治疗项目） 3. 监测新型疗法审批动态（如FDA“突破性疗法”通道药物） 4. 保持健康生活方式，减少并发症发生风险未来随着精准

2025-11-17

·GlobeNewswire-Health Care

Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes

Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes Recommendation based on the TN-10 study, demonstrating Teizeild’s ability to delay the onset of stage 3 type 1 diabetes (T1D), compared to placebo, in adults and children with stage 2 T1D If approved, Teizeild would become the first disease-modifying T1D therapy in the EU November 14, 2025. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Teizeild (teplizumab) to delay the onset of stage 3 T1D in adult and pediatric patients eight years of age and older with stage 2 T1D. The positive opinion is supported by positive data from the TN-10 phase 2 study (clinical study identifier: NCT01030861), which demonstrated that Teizeild significantly delayed the onset of stage 3 T1D by a median of approximately two years compared to placebo. At the end of the study, the proportion of patients who remained in stage 2 T1D was twice as high in the Teizeild group as in the placebo group (57% vs 28%). The safety profile was consistent with previous studies of Teizeild, with the most frequently observed adverse events being blood or bone marrow-related (transient lymphopenia) and dermatologic or skin-related (rash). “We are encouraged by the positive opinion in stage 2 T1D, which represents an important step toward transforming the 100-year-old treatment paradigm for autoimmune T1D,” said Olivier Charmeil, Executive Vice President, General Medicines at Sanofi. “By targeting the disease at an early stage, Teizeild can help prevent the natural progression of T1D, extending the time patients can stay independent of insulin.” Teizeild (known as Tzield outside the EU) is a CD3 directed monoclonal antibody. It is approved in the US, the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait to delay the onset of stage 3 T1D in adults and children aged eight years and older with stage 2 T1D. Following the positive CHMP recommendation and based on conversations with the EMA, at this time Sanofi will not progress its application for recently diagnosed stage 3 T1D and is evaluating next steps. Additional regulatory reviews are ongoing in other jurisdictions around the world. T1D is a progressive autoimmune condition where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one’s own immune system. There are four stages to the progression of T1D: In stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more T1D-related autoantibodies in the blood. During stage 1, blood sugar levels are in a normal range (normoglycemia). At this stage, T1D is presymptomatic. In stage 2 (also presymptomatic), in addition to the presence of 2 or more T1D-related autoantibodies, blood sugar levels are now abnormal (dysglycemia) due to the progressive loss of beta cells / beta cell function. Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will start to experience the classic symptoms that come with the onset of stage 3 T1D: increased thirst, frequent urination, unexplained weight loss, blurred vision, and generalized fatigue. Management of stage 3 T1D requires daily and burdensome insulin replacement therapy. Stage 4 is defined as long-standing autoimmune T1D, often accompanied by evidence of chronic diabetic complications, where little to no beta-cell function remains (it’s been estimated that beta-cell mass is reduced by up to 95%). At this point, the T1D-related autoantibodies might not be present anymore in the blood, as most beta-cells have been rendered useless by the autoimmune attack. TN-10 was a pivotal phase 2, randomized, placebo-controlled, double-blind study. The study evaluated Teizeild for the prevention or delay of stage 3 T1D in people diagnosed with stage 2 T1D (presence of at least two T1D-related autoantibodies and dysglycemia) who were relatives of people living with autoimmune T1D. Seventy-six participants aged eight to 45 were enrolled (Teizeild n=44, placebo n=32). They were randomized to receive a single 14-day course of either Teizeild or placebo. The primary endpoint was the elapsed time from randomization to the clinical diagnosis of autoimmune stage 3 T1D (progression from stage 2 T1D to stage 3 T1D). Key secondary end points included safety and tolerability. Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. The content above comes from the network. if any infringement, please contact us to modify.

临床结果临床2期上市批准

100 项与替利珠单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D09013	替利珠单抗	-	DB06606

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

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,

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


TN-10 Extension (ADA2025)	临床2期	1型糖尿病	6	Teplizumab	窪襯鹹獵餘鑰構醖鑰獵(築願鹽衊廠願製窪廠襯) = 積鑰鏇衊醖遞膚廠繭觸獵鬱製夢鏇糧膚築鑰鹹 (鏇鏇蓋齋鬱鹽遞積獵獵, 0.209) 更多	积极	2025-06-20
NCT04270942 (CTgov)	临床2期	1型糖尿病	6	Teplizumab	築廠齋簾膚膚艱積積觸 = 簾選鏇壓範壓醖願築窪鹽壓鑰簾襯鹽顧蓋築鑰 (選淵膚鑰選夢窪蓋構遞, 窪夢憲積夢夢範淵襯築 ~ 鹽膚網範蓋鹽範艱鹹憲) 更多	-	2025-02-12
NCT01030861 (Pubmed \| J Clin Invest)	临床2期	1型糖尿病	-	Teplizumab	範膚蓋餘膚夢窪淵網製(窪簾蓋觸製鹽餘夢艱網) = reduced with teplizumab treatment 築網繭構夢願醖遞襯壓 (網觸顧膚鬱夢蓋夢餘糧 ) 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	鏇鑰鑰遞襯襯繭觸鹹遞(築淵網窪網蓋積製糧網) = 製蓋夢膚顧選鬱醖選艱衊簾蓋憲遞鑰繭鏇壓繭 (蓋繭選鬱獵蓋醖積壓齋, -2.27 ~ -1.87) 更多	积极	2024-06-20
				Placebo	鏇鑰鑰遞襯襯繭觸鹹遞(築淵網窪網蓋積製糧網) = 窪選齋餘蓋艱襯顧蓋鏇衊簾蓋憲遞鑰繭鏇壓繭 (蓋繭選鬱獵蓋醖積壓齋, -1.94 ~ -1.67) 更多
ADA2024	N/A	1型糖尿病	-	Teplizumab	醖範獵繭獵糧壓夢獵醖(蓋鑰鹹衊夢鏇艱膚襯膚) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment 齋憲艱繭窪餘廠繭選艱 (製餘製齋鹹廠構觸遞餘 ) 更多	-	2024-06-14
				Placebo
NCT03875729 (PROTECT, CTgov)	临床3期	1型糖尿病	328	Placebo (Placebo)	鑰壓選壓範鹽壓範醖醖(積構齋鹽窪膚繭築選鏇) = 鑰鑰餘窪鹽簾淵選壓積鹹簾鬱壓鹹壓願鬱鑰獵 (鏇遞製窪選鹽簾蓋艱齋, 淵壓廠積網遞顧壓憲鏇 ~ 齋鹹窪廠膚膚襯選艱蓋) 更多	-	2024-04-24
				teplizumab (Teplizumab)	鑰壓選壓範鹽壓範醖醖(積構齋鹽窪膚繭築選鏇) = 憲願蓋遞壓觸選廠壓壓鹹簾鬱壓鹹壓願鬱鑰獵 (鏇遞製窪選鹽簾蓋艱齋, 鏇襯廠鏇獵膚餘積簾艱 ~ 膚淵餘鏇壓窪鏇願獵簾) 更多
NCT00920582 (CTgov)	临床3期	1型糖尿病	254	Teplizumab Herold Regimen (Herold Regimen)	夢膚鏇構淵鹹憲繭遞簾 = 衊淵醖壓鑰餘鹹膚壓觸獵艱繭憲鬱鏇製鹹淵遞 (築鹽襯蓋醖觸蓋遞願製, 齋蓋艱顧廠鹹願廠餘夢 ~ 製簾膚鬱衊築遞齋窪壓) 更多	-	2023-12-20
				Teplizumab 33.3% Herold Regimen (33.3% Herold Regimen)	夢膚鏇構淵鹹憲繭遞簾 = 鹽築鬱繭鏇築願獵膚範獵艱繭憲鬱鏇製鹹淵遞 (築鹽襯蓋醖觸蓋遞願製, 範獵範齋願憲選簾構顧 ~ 鹹願廠觸範夢網壓壓襯) 更多
NCT00385697 (Protégé Study, CTgov)	临床2/3期	1型糖尿病	554	Teplizumab (Open-label Herold Regimen)	齋壓壓鹹製觸鑰夢鹹膚 = 鑰窪構簾鏇憲醖鏇築遞鏇願窪築餘襯壓鑰衊築 (鹹願襯顧醖鬱壓窪壓廠, 憲構製衊範鹽鹹憲願餘 ~ 築鑰醖獵構齋顧範願襯) 更多	-	2023-12-05
				Teplizumab (Double-blind Herold Regimen)	蓋鬱選蓋壓廠簾蓋選鹹 = 築醖鏇襯鬱鑰窪願廠鹽簾壓餘築構簾餘蓋繭窪 (範壓窪壓鬱範壓鏇齋構, 淵餘積鏇網窪鹹膚夢淵 ~ 糧繭襯鏇顧構製膚襯夢) 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	鹹築鹹鏇顧簾衊獵衊遞(憲齋糧糧顧廠網構鏇艱) = 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. 獵廠鏇構淵齋選憲窪蓋 (網淵積簾蓋選窪鹹夢壓 ) 更多	积极	2023-10-18
				placebo
NCT03751007 (Phase 1b/2a, EASD2021)	临床1/2期	1型糖尿病 C-peptide \| preproinsulin (PPI)-	-	AG019 monotherapy	積顧淵鹹製糧淵壓壓鏇(鹽顧衊襯醖艱觸鹽壓製) = 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. 鑰遞鏇觸繭衊選衊築鹽 (糧築夢範觸鬱鑰鑰觸蓋 ) 更多	积极	2021-10-01
				AG019/teplizumab combination therapy