度普利尤单抗(Dupilumab) - 药物靶点：IL-4Rα_在研适应症：大疱性类天疱疮，慢性阻塞性肺疾病，慢性荨麻疹_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Dupilumab (Genetical Recombination)、Dupilumab (genetical recombination) (JAN)、Dupilumab (USAN)

+ [10]

靶点

IL-4Rα

作用方式

抑制剂

作用机制

IL-4Rα抑制剂(白细胞介素-4受体α亚基抑制剂)

治疗领域

免疫系统疾病感染遗传病与畸形+ [6]

在研适应症

大疱性类天疱疮慢性阻塞性肺疾病慢性荨麻疹+ [26]

非在研适应症

血管性水肿慢性湿疹嗜酸性粒细胞性哮喘+ [9]

原研机构

Sanofi

在研机构

Sanofi

Regeneron Pharmaceuticals, Inc.

赛诺菲（中国）投资有限公司

+ [5]

非在研机构

Sanofi SA

Genzyme Corp.

Aimmune Therapeutics, Inc.

权益机构

Regeneron Pharmaceuticals, Inc.

Sanofi

最高研发阶段批准上市

首次获批日期

美国 (2017-03-28),

特应性皮炎

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)、孤儿药 (美国)、优先审评 (中国)、孤儿药 (澳大利亚)、临床急需境外新药 (中国)、优先审评 (澳大利亚)、孤儿药 (日本)

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结构/序列

Sequence Code 9909199H

来源: *****

Sequence Code 9931072L

来源: *****

关联

244

项与度普利尤单抗相关的临床试验

NCT07112378

/ Recruiting临床3期

A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis

This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.
The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

开始日期2026-01-13

申办/合作机构

Regeneron Pharmaceuticals, Inc.

[+1]

NCT07053423

/ Not yet recruiting临床4期

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.

LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive).
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.

开始日期2025-09-15

申办/合作机构

Sanofi

[+1]

NCT07091175

/ Not yet recruiting临床2期IIT

Singapore-Malaysian Renal Trials - Nephrotic Syndrome (SMART-NS): Dupilumab Maintenance Therapy for Steroid-dependent and Frequently Relapsing Nephrotic Syndrome

The goal of this clinical trial is to learn if dupilumab works to treat severe nephrotic syndrome in children. It will also learn about the safety of dupilumab.
The main questions it aims to answer are:
* Does dupilumab reduce the time to relapse of nephrotic syndrome?
* What medical problems do participants have when taking dupilumab?
Researchers will compare dupilumab to a placebo (a look-alike substance that contains no drug) to see if dupilumab works to treat severe nephrotic syndrome.
Participants will:
* Receive an injection of dupilumab or placebo (just under the skin) every 2 weeks (if ?30kg) or every 4 weeks (if <30kg) for 24 weeks (6 months)
* Wean down their prednisolone dose after starting the injections of dupilumab or placebo
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a nephrotic diary to record down the urine dipstick result each day, together with the dose of prednisolone taken
If protein returns in participant's urine, they will have completed the study at that point. However, if the participant is found to have received the placebo, they will be offered to receive dupilumab for up to 24 weeks.

开始日期2025-08-01

申办/合作机构

National University Hospital

[+2]

100 项与度普利尤单抗相关的临床结果

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100 项与度普利尤单抗相关的转化医学

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100 项与度普利尤单抗相关的专利（医药）

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3,950

项与度普利尤单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Frequency and clinical features of disease flares in patients with atopic dermatitis treated with dupilumab

Article

作者: Parodi, Aurora ; Salvi, Ilaria ; Battaglia, Giorgio ; Vischi, Alice ; Trave, Ilaria ; Cozzani, Emanuele

BACKGROUND:

Dupilumab, an interleukin 4 (IL-4) receptor α-antagonist approved for the treatment of atopic dermatitis, is considered effective in preventing disease recurrences. However, the incidence and characteristics od atopic dermatitis flares during treatment with dupilumab in a real-life setting have not been described in the literature.

OBJECTIVE:

This study aims to evaluate the prevalence of disease flares in patients in treatment with dupilumab and to describe the features of flares in our study population.

METHODS:

We conducted a retrospective observational study in which we collected demographic and clinical data on adult patients with a diagnosis of severe atopic dermatitis in treatment with dupilumab for a minimum of six months, who reached EASI75 within six months of treatment initiation.

RESULTS:

Ninety-nine patients were enrolled. Recurrences were recorded for 38.4% of patients and 7.1% developed a second recurrence. The EASI at recurrence was always lower than the EASI before treatment initiation. The localization of disease at head and neck before treatment was associated to the same localization of disease at the first recurrence (p = 0.011). The risk of recurrence was associated to the baseline EASI score (p = 0.005). The presence of dupilumab-related conjunctivitis was significantly associated to recurrences (p = 0.02).

CONCLUSIONS:

Treatment with dupilumab does not exclude the risk of a relapse, which can be estimated around 50% within a timespan of three years. In the most cases, flares should not be regarded as treatment failures, and can be easily managed with additional treatment.

2025-12-31·Journal of Immunotoxicology

The interaction between the expression of CD23 molecule on B- lymphocytes and the level of specific IgE against molecular components of pollen in atopic dermatitis patients with and without dupilumab therapy

Article

作者: Čelakovská, J. ; Boudková, P. ; Čermáková, E.

The aim of the study here was to evaluate the association between expression of CD23 molecule on B-lymphocytes and the level of specific IgE to molecular components of birch, Bermuda grass, hazel pollen, timothy, and rye grass in atopic dermatitis (AD) patients (with and without dupilumab therapy). A total of 46 patients suffering from AD were included: 26 without dupilumab treatment and 20 with dupilumab treatment. Serum levels of specific IgE were measured by the components resolved diagnostic assay ALEX2 Allergy Xplorer, the expression of CD23 molecule on B-lymphocytes was evaluated with flow cytometry. For the statistical analysis, the Spearman's rank correlation coefficient was used. In patients treated with dupilumab, the higher association was observed between the expression of CD23 on B-lymphocytes and specific IgE to molecular components Bet v 1, Cor a 1.0103, Cor a 1.0401, and Phl p 1. This study demonstrated that the relationship between CD23 expression on B-lymphocytes and specific IgE to pollen molecular components varies depending on whether the patient was treated with dupilumab and the type of molecular component involved.

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Rosacea-like skin reaction under treatment with dupilumab for atopic dermatitis

Article

作者: Augustin, M. ; Wagner, J. N. ; Grote, C. ; Zirkenbach, F.

PURPOSE:

Dupilumab is a widely recommended treatment for moderate-to-severe atopic dermatitis (AD), with known ocular side effects but less frequent cutaneous reactions.

MATERIAL AND METHODS:

This case report details a 52-year-old female patient with atopic dermatitis treated with dupilumab. After an initially successful treatment, the patient developed a rosacea-like dermatitis. At first, dupilumab was continued alongside doxycycline, metronidazole gel and ivermectin cream.

RESULTS:

Following a worsening of her skin condition, dupilumab was discontinued. Lebrikizumab was introduced, leading to significant regression of the lesions.

CONCLUSIONS:

This case highlights a rare paradoxical skin reaction to dupilumab, potentially linked to the blockade of IL-4Rα, which may shift the immune response towards a Th1/Th17 phenotype. The findings suggest that alternative therapies, such as IL-13 inhibitors, should be considered when cutaneous side effects arise during dupilumab treatment.

2,020

项与度普利尤单抗相关的新闻（医药）

2025-09-04

·Biotech前瞻

接棒自免药王度普利尤单抗，赛诺菲OX40L单抗三期成功

2025 【OX40单抗】【OX40单抗】 2025年3月8日，安进与协和麒麟共同宣布，其OX40单抗Rocatinlimab在治疗特应性皮炎的两项III期试验（ROCKET-IGNITE和ROCKET-SHUTTLE）中均达到主要终点。该药物成为全球首个完成III期临床的OX40单抗，并在三项研究中均展现积极数据，有望率先获批上市。2025年4月15日，赛诺菲公布其OX40L单抗Amlitelimab治疗哮喘的II期研究（TIDE-Asthma）未达主要终点（年化恶化率未降低），但披露关键亚组数据后调整策略。近日，amlitelimab，在特应性皮炎的3期临床试验 COAST 1 （NCT06130566）中取得积极成果，每四周 (Q4W) 或每 12 周 (Q12W) 给药一次，均达到了所有主要终点和关键次要终点，这也是继安进OX40抗体Rocatinlimab后第二款相关疗法取得三期临床成功。而就在同一赛道，中国药企创响生物凭借自主开发的IMG-007（OX40单抗）在II期试验中刷新疗效纪录，并通过反向收购美股企业Ikena Oncology实现资本跃升。这场“中外双雄”对垒度普利尤单抗的战役，正在重塑全球自免药市场格局。 2025 阅读指南 1、赛诺菲丨度普利尤单抗 2、OX40单抗丨国内外快讯 3、OX40靶点及单抗整理 VIEW 看点【赛诺菲丨度普利尤单抗】 2025年上半年（H1），大卖73.12亿欧元（约80.15亿美元，+20.7%）。度普利尤单抗2024年销售额141.79亿美元，垄断特应性皮炎（AD）市场超60%份额，凭借IL-4Rα靶点“一药治多病”（获批7项适应症：特应性皮炎、哮喘、慢性鼻窦炎伴鼻息肉（CRSwNP）、节性痒疹、慢性自发性荨麻疹、酸性食管炎（EoE）和慢性阻塞性肺疾病（COPD））成为当之无愧的自免药王。 “药王”的隐忧：耐药性与依从性痛点：30%患者对度普利尤单抗失效，且需每2周注射一次，长期用药负担沉重。竞争者围剿： IL-13抑制剂（如Lebrikizumab）、JAK抑制剂（如Upadacitinib）及OX40抑制剂迅速崛起，试图分食市场。本文聚焦OX40单抗的最新国内外进展。 OX40单抗丨国内外快讯赛诺菲丨amlitelimab 近日，amlitelimab，在特应性皮炎的3期临床试验 COAST 1 （NCT06130566）中取得积极成果，每四周 (Q4W) 或每 12 周 (Q12W) 给药一次，均达到了所有主要终点和关键次要终点，这也是继安进OX40抗体Rocatinlimab后第二款相关疗法取得三期临床成功 OX40赛道升温：安进Rocatinlimab（II期）、信达IBI356（I期）加速布局，国内创响生物IMG-007（长效设计）紧随其后。安进/协和麒麟丨Rocatinlimab 2025年3月8日，安进与协和麒麟共同宣布，其OX40单抗Rocatinlimab在治疗特应性皮炎的两项III期试验（ROCKET-IGNITE和ROCKET-SHUTTLE）中均达到主要终点。 Rocatinlimab为一款OX40抗体，最初由协和发酵麒麟研发，2021年，安进引进日本外全球市场的权益，支付对价为4亿美元预付款，8.5亿美元里程碑金额，以及一定比例的销售分成。和黄/创响生物OX40单抗II期结果 2024年1月9日，创响生物公布了IMG-007在治疗中度至重度特应性皮炎（AD）患者中的二期临床试验（2a期）积极结果，同时还披露了IMG-007皮下注射（SC）制剂的一项I期临床试验结果。在4周的IMG-007治疗后，16周时的湿疹面积和严重度指数（EASI）平均减少77%，并且54%的患者达到了EASI-75。治疗的耐久性也表现在对炎症标志物的持久抑制上，持续时间可达24周。 IMG-007的皮下注射制剂展示了约35天的延长半衰期，表明其具备了潜在的长期给药优势。此外，IMG-007在临床研究中整体耐受性良好，没有报告发热或寒战等不良事件，进一步增强了其临床应用的可行性。创响生物的创始人兼首席执行官王健表示：“IMG-007是唯一一种能够在不耗竭T细胞的情况下，特异性阻断OX40/OX40L信号通路的临床阶段单抗。结合其延长的半衰期和持续的疗效，我们计划探索更长的给药间隔，比如每24周一次，用于AD等疾病的维持治疗。” IMG-007是创响生物的重要核心管线之一，目前正处于二期临床开发阶段。创响生物还计划在2025年第一季度启动IMG-007 SC制剂的二期b期剂量探索试验，进一步评估其在中度至重度特应性皮炎患者中的疗效。依托该产品的极大利好，2024年12月23日，创响生物宣布与Ikena Oncology达成合并协议，合并和融资完成后，创响生物将成为第一大股东，Ikena的原有股东则拥有约34.8%的股份。公司将以“ImageneBio”为新名，预计将于2025年中完成合并，并在纳斯达克以“IMA”为股票代码进行交易。值得一提的是，IMG-007来自于和黄医药，2024年2月，和黄医药发布公告称，创响生物根据2021年1月与其达成的战略合作条款，已行使由和黄医药发现的2款候选药物IMG-007（OX40单克隆抗体）和IMG-004（BTK抑制剂）授权许可相关的选择权，每款候选药物，和黄医药将获最高9250万美元开发里程碑付款和最高1.35亿美元的潜在商业销售里程碑付款，以及商业化后分成，交易总金额高达4.55亿美元。 OX40靶点及单抗整理本章节就全球OX40靶点竞争态势进行梳理。来源：Nature Reviews Clinical Oncology OX40与OX40L的结合可增强效应T细胞、NK、NK-T细胞活性，解除Treg的免疫抑制作用，既可增强特异性免疫反应，也可增强固有免疫反应，从而增强抗肿瘤免疫。 OX40单抗临床研究汇总目前，OX40激动剂已经被用于肿瘤的免疫治疗。全球有多种Anti-OX40抗体药物正在用于针对肿瘤及免疫系统疾病的临床试验，最快的已经进入临床2期。不乏有辉瑞，施贵宝，基因泰克，葛兰素史克等国际巨头，恒瑞，信达，百济神州等国内药企也有布局。 2023年12 月 25 日，据 CDE 临床试验登记与信息公示平台，信达生物 OX40L 单抗 IBI356 启动临床，用于特应性皮炎（登记号：CTR20234129）。来自：CDE 官网 2023年10 月 8 日，据 CDE 官网显示，安进 OX40 单抗 Rocatinlimab（AMG 451）国内启动新 III 期临床 ROCKET-ASCEND 试验（登记号：CTR20233073），这是一项旨在评估 Rocatinlimab 用于中度至重度特应性皮炎（AD）成人和青少年受试者的长期安全性、耐受性和有效性的多中心、双盲维持研究。目前，全球范围内尚未有OX40抗体获批上市,在肿瘤治疗领域的研究进展更为缓慢。相比阻断型抗体，激动型抗体的早期开发更为困难，临床安全性评估更为复杂，因此激动型抗体的成功相比要艰难得多！ ✦ • ✦ 【会员福利】 Biotech前瞻公众号已然制备了肿瘤基础类、研究进展类、研究设计小课堂及行业研究类幻灯。此外，ASCO和ESMO为代表的国际大会会后简版幻灯材料也会在会后一周左右时间发给会员。都为可编辑无水印资料。不定期还有会员福利惊喜赠送或享限时优惠价格哦！早购买，早获益，意愿者请联系如下。【新版会员福利】按瘤种选择基础/进展幻灯，尽享研究设计/行研幻灯

临床3期临床2期并购上市批准临床成功

2025-09-04

·ETPharma

Sanofi sheds $13 billion in value on weak trial results for eczema drug

London: Shares in French drugmaker Sanofi fell more than 10% on Thursday, wiping nearly $13 billion off its market value, after late-stage trial data for its experimental inflammatory disease drug amlitelimab disappointed Wall Street. The company said amlitelimab, which it is developing for atopic dermatitis, a severe form of eczema, met all main goals in the Phase III study, showing statistically significant improvements in skin clearance and disease severity compared with placebo after 24 weeks. But the data looked weak against Dupixent , Sanofi's best-selling medicine, which treats the same condition and is due to lose patent protection in 2031. The company has billed amlitelimab as a potential successor to Dupixent, and Barclays analyst Emily Field told Reuters investors had viewed amlitelimab as Sanofi's lead pipeline asset to follow on from that drug ahead of the data release. "That's why we're seeing a big reaction in the stock, because of the concern that Sanofi is not going to have enough in its pipeline to replace Dupixent after patent expiry," Field said. "This is increasingly looked at as a cliff stock." Shares were down 10.3% at 0950 GMT, making Sanofi the biggest faller on Europe's blue-chip STOXX 600 index. Dupixent, which Sanofi jointly developed and co-owns with drugmaker Regeneron, is approved not only for eczema but also for other immune-related conditions, including severe asthma. With the patent expiry looming, Sanofi has doubled down on immunology, making amlitelimab a pillar of that effort. JPMorgan said the data confirmed the drug is less effective than Dupixent, which brought in about 13 billion euros ($15.22 billion) in sales for Sanofi in 2024. Analysts at Jefferies said the Phase III results fell short of its earlier trial and of rival biologic drugs, though the drug's safety profile and convenient 12-week dosing could still support its use. UBS called the drug's efficacy solid despite it being weaker than Dupixent, adding that this could be countered by the advantage of amlitelimab's less frequent dosing, which some injection-averse patients may prefer. ($1 = 0.8542 euros) (Reporting by Maggie Fick; Editing by Bernadette Baum, Jan Harvey and Muralikumar Anantharaman)

临床3期上市批准临床结果

2025-09-04

·氨基观察

OX40先驱相继上岸，但结果依然悲壮

氨基观察-创新药组原创出品作者 | 郑晓 OX40靶点再迎好消息。 9月4日，赛诺菲宣布OX40L抗体药物Amlitelimab，用于治疗特应性皮炎的III期COAST1研究，已达到所有主要终点与次要终点。早在年初，安进的Rocatinlimab也在两项III期试验中再度取得成功。只是，遗憾的是，即便领跑者相继宣布好消息，OX40靶点的处境仍然略显尴尬。面对赛诺菲公布的这一最新结果，市场并不买账——赛诺菲美股盘前跌幅接近10%。背后原因不难理解：无论是绝对疗效，还是经安慰剂校正后的疗效，Amlitelimab似乎都无法与该领域“王者”度普利尤单抗等竞品竞争。疗效比上不足，正是Amlitelimab目前面临的核心困扰。虽相继上岸，却依旧“悲壮”，这仍是OX40靶点当下最真实的写照。 / 01 / 打不过的度普利尤虽然III期临床成功，但在绝对的数据差距面前，Amlitelimab的竞争力仍然存疑。该研究的主要终点在第24周时对接受Q4W或Q12W给药的amlitelimab患者进行评估。不过，在美国以及欧洲的主要终点有所不同。具体而言，针对美国及参考国，主要终点为达到经验证研究者整体评估量表vIGA-AD评分0分（完全清除）或1分（几乎完全清除）且较基线改善≥2分的患者比例。针对欧盟、欧盟参考国及日本，共同主要终点包括vIGA-AD 0/1且较基线改善≥2分的患者比例，以及湿疹面积与严重程度指数总评分改善≥75%（EASI-75）的患者比例。最终的结果如下图所示，从无应答者填补角度（包括在第24周之前使用过抢救/禁用药物且数据缺失的患者）评估，Amlitelimab（Q4W）组、Amlitelimab（Q12W）组和安慰剂组达到vIGA-AD 0/1的患者比例分别为21.1%、22.5%和9.2%，达到EASI-75的患者比例分别为35.9%、39.1%和19.1%。若从治疗策略角度（包括在第24周之前使用过急救药物的患者）评估，Amlitelimab（Q4W）组、Amlitelimab（Q12W）组和安慰剂组达到vIGA-AD 0/1的患者比例分别为26.5%、29.1%和10.5%，达到EASI-75的患者比例分别为46.0%、50.3%和27.6%。若仅仅只是相比于安慰剂，Amlitelimab的效果足够突出。但在非头对头情况下，对比度普利尤，显然又是另外一回事。如下图所示，不管是在绝对疗效，还是经安慰剂校正后的疗效，Amlitelimab战斗力都偏弱。尤其是经安慰剂校正后的疗效，差距更大。在诸多药企虎视眈眈的特应性皮炎市场上，Amlitelimab注定要与度普利尤等众多选手竞争。而巨大的临床表现预期落差，这也难免让市场倍感失落。 / 02 / OX40靶点仍需努力 Amlitelimab的结果也预示了，在自免领域，其它后来者仍需努力。 OX40是T细胞共刺激受体，位于活化的T细胞表面，如CT4、CT8细胞等；其配体为OX40L（CD252），可在抗原提呈细胞（APC）上表达，如B细胞、树突细胞、巨噬细胞等。该靶点的具体作用是，APC细胞将抗原呈递给T细胞，使得其活化，随后T细胞表面的OX40与其配体OX40L结合，启动下游信号，延长活化T细胞存活时间。与此同时，该信号通路还有两大作用。其一，下调抑制免疫反应的细胞表达，如CTLA-4和Foxp3；其二，增加促炎症因子的分泌，如IL-2、IL-4、IL-5、IFN-γ。从上述机制来看，OX40像是免疫系统的“油门”。最开始，OX40靶点的研发主要集中在肿瘤领域，但接连碰壁，最终在自免领域燃起了新希望。而支撑预期的，正是赛诺菲的OX40L抗体Amlitelimab和安进的OX40抗体Rocatinlimab。但目前来看，不仅是赛诺菲的Amlitelimab，安进的Rocatinlimab战斗力也有限。年初，Rocatinlimab读出了ROCKET-IGNITE、ROCKET-SHUTTLE两项研究结果，均达到主要终点。 ROCKET-IGNITE针对接受过生物制剂或JAK抑制剂治疗的中重度特应性皮炎患者，而ROCKET-SHUTTLE则是联合局部皮质类固醇药物或钙调磷酸酶抑制剂（TCS/TCI）对比安慰剂联合TCS/TCI治疗中重度特应性皮炎患者的效果。但在非头对头情况下，ROCKET-SHUTTLE的潜力要远远低于度普利尤。具体来说，治疗第24周，低剂量组和高剂量组分别有25.8%和26.1%的患者达到vIGA-AD 0/1且较基线至少降低2分，与安慰剂组之间的差异分别为13.5%（p<0.001）和13.8%（p<0.001）；低剂量组和高剂量组分别有54.1%和52.3%的患者达到EASI 75，与安慰剂组之间的差异分别为30.4%（p<0.001）和28.7%（p<0.001）。而度普利尤CHRONOS研究显示，在联合TCS的情况下，QW组和Q2组EASI 75比例均超过60%，且与安慰剂组的差异均超过40%。换句话说，从目前来看，OX40(L)先驱们都打不过度普利尤单抗。 / 03 / 自免新生代的冲刺困境某种程度上，OX40靶点的境遇，也映射了自免领域新生代药物的共同困境：想要成为现有疗法的挑战者，远非易事。过去几十年，自免领域庞大的市场体量吸引了众多药企入局，靶点迭代更是层出不穷——特应性皮炎市场的竞争态势便是典型缩影。度普利尤单抗的“吸金”能力有目共睹，这让后来者们蠢蠢欲动。一方面，特应性皮炎患者规模庞大，市场基础扎实；另一方面，该疾病致病机制尚未完全明确，目前无法彻底治愈，患者需长期用药，需求具备持续性。更关键的是，现有治疗药物普遍存在明显短板：要么副作用较大，要么患者依从性不高。以度普利尤单抗为例，其需每两周给药一次，不少特应性皮炎患者会出现“针头疲劳”，尤其是儿科患者常因惧怕针头而影响用药。这些痛点，意味着特应性皮炎治疗领域仍存在极大的临床未满足需求。巨大的市场空间与未被填补的需求缺口，也让赛道内的潜在挑战者身价水涨船高。比如 Amlitelimab的原研企业Kymab，便被赛诺菲以超10亿美元收购。但显然，“狙击与被狙击、竞争与追赶” 注定是特应性皮炎市场的常态：后来者首先要跨越度普利尤单抗这座 “大山”，其次还得扛住其他竞争对手的冲击。只是现实往往更残酷——对很多挑战者来说，第一步“越过度普利尤单抗”就已难以实现，更遑论第二步。尽管近年来中至重度特应性皮炎的生物制剂疗法进展颇多，但如下图所示，2024年以来特应性皮炎领域的失败案例，覆盖了不少自免新老靶点。而OX40、IL-33几款大热的自免新靶点，也并未带来超预期的结果。随着成熟靶点逐步突破，给新靶点的突围设定了更高的标准，类似OX40靶点“冲刺失败”的故事，恐怕还会在自免赛道继续上演。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

临床结果临床3期临床成功

100 项与度普利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10354	度普利尤单抗	D11AH05	DB12159

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
大疱性类天疱疮	美国	Regeneron Pharmaceuticals, Inc.	2025-06-18
慢性阻塞性肺疾病	欧盟	Sanofi Winthrop Industrie SA	2024-07-03
慢性阻塞性肺疾病	冰岛	Sanofi Winthrop Industrie SA	2024-07-03
慢性阻塞性肺疾病	列支敦士登	Sanofi Winthrop Industrie SA	2024-07-03
慢性阻塞性肺疾病	挪威	Sanofi Winthrop Industrie SA	2024-07-03
慢性荨麻疹	日本	Sanofi KK	2024-02-09
慢性荨麻疹	日本	Regeneron Pharmaceuticals, Inc.	2024-02-09
嗜酸粒细胞性食管炎	加拿大	Sanofi	2018-02-06
结节性痒疹	澳大利亚	Sanofi	2018-01-24
哮喘	欧盟	Sanofi Winthrop Industrie SA	2017-09-26
哮喘	冰岛	Sanofi Winthrop Industrie SA	2017-09-26
哮喘	列支敦士登	Sanofi Winthrop Industrie SA	2017-09-26
哮喘	挪威	Sanofi Winthrop Industrie SA	2017-09-26
慢性鼻窦炎伴鼻息肉	欧盟	Sanofi Winthrop Industrie SA	2017-09-26
慢性鼻窦炎伴鼻息肉	冰岛	Sanofi Winthrop Industrie SA	2017-09-26
慢性鼻窦炎伴鼻息肉	列支敦士登	Sanofi Winthrop Industrie SA	2017-09-26
慢性鼻窦炎伴鼻息肉	挪威	Sanofi Winthrop Industrie SA	2017-09-26
特应性皮炎	美国	Regeneron Pharmaceuticals, Inc.	2017-03-28

未上市

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适应症	最高研发状态	国家/地区	公司	日期
瘙痒	临床3期	美国	Sanofi	2022-02-15
瘙痒	临床3期	中国	Sanofi	2022-02-15
瘙痒	临床3期	日本	Sanofi	2022-02-15
瘙痒	临床3期	阿根廷	Sanofi	2022-02-15
瘙痒	临床3期	澳大利亚	Sanofi	2022-02-15
瘙痒	临床3期	加拿大	Sanofi	2022-02-15
瘙痒	临床3期	克罗地亚	Sanofi	2022-02-15
瘙痒	临床3期	德国	Sanofi	2022-02-15
瘙痒	临床3期	希腊	Sanofi	2022-02-15
瘙痒	临床3期	匈牙利	Sanofi	2022-02-15

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临床结果

适应症

分期

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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


NCT04180488 (LIBERTY-CSU CUPID Study C \| LIBERTY-CSU CUPID \| LIBERTY-CUPID-Study A \| LIBERTY-CUPID-Study B \| LIBERTY-CSU CUPID Study A \| LIBERTY-CUPID \| Liberty-Cupid C \| CUPID, CTgov)	临床3期	慢性荨麻疹	397	placebo+dupilumab+omalizumab (Study A: Placebo)	築蓋遞餘淵獵構鬱願壓(構網鹽簾鹽顧範鑰窪選) = 構鑰壓衊衊願繭範顧襯蓋顧鑰鹽壓簾齋齋餘範 (鹽鹽選獵選鏇廠膚鏇鹹, 0.94) 更多	-	2025-08-20
				Dupilumab (Study A: Dupilumab)	築蓋遞餘淵獵構鬱願壓(構網鹽簾鹽顧範鑰窪選) = 淵壓構蓋衊壓選構鹽艱蓋顧鑰鹽壓簾齋齋餘範 (鹽鹽選獵選鏇廠膚鏇鹹, 0.91) 更多
NCT06369467 (NEWS)	临床1期	食物过敏	1	Linvoseltamab+Dupilumab	製繭製鏇獵鹽簾鬱齋範(築壓選製積獵淵製艱膚) = 簾衊衊獵襯襯糧餘鬱製範顧夢構選膚顧窪齋壓 (遞膚蓋齋艱餘襯鑰選繭 )	积极	2025-08-01
NCT04206553 (ADEPT, FDA_CDER) 人工标引	临床2/3期	大疱性类天疱疮	106	DUPIXENT 300 mg Q2W + OCS	願顧醖構獵製簾選繭顧(製顧遞餘廠獵衊鹽淵壓) = 廠鬱顧醖願簾鏇艱願鏇鑰範構鏇廠鹹壓範廠範 (選鏇網繭網鏇膚蓋鏇窪 ) 更多	积极	2025-06-18
				Placebo + OCS	願顧醖構獵製簾選繭顧(製顧遞餘廠獵衊鹽淵壓) = 願鹹構積齋夢夢願衊製鑰範構鏇廠鹹壓範廠範 (選鏇網繭網鏇膚蓋鏇窪 ) 更多
NCT04998604 (EVEREST, Company_Website) 人工标引	临床4期	哮喘 \| 慢性鼻窦炎伴鼻息肉	360	Dupixent 300 mg every two weeks	艱齋糧夢齋壓簾獵膚鑰(齋鏇蓋簾願鏇網膚夢築) = 壓醖蓋壓衊獵獵製鏇蓋網艱選築蓋鹽淵遞廠窪 (襯構廠鑰膚願築範繭夢 ) 更多	积极	2025-06-15
				Xolair	-
NCT05590585 (DISCOVER, NEWS) 人工标引	临床4期	特应性皮炎	120	Dupixent	餘膚餘餘餘憲糧顧簾鏇(壓觸鏇憲齋餘鹹顧觸顧) = 76% of patients achieved at least a 75% improvement 醖製衊遞選獵餘蓋鹹窪 (獵繭餘壓鬱遞夢齋夢獵 ) 更多	积极	2025-06-12
ASCO2025	N/A	大疱性类天疱疮	17	Dupilumab	鑰糧艱鬱醖構鏇鑰膚醖(遞獵蓋淵壓糧鬱築鬱鹽) = 簾糧鹹壓夢鬱鏇鏇顧鬱築獵構蓋齋鹽餘願艱顧 (壓築鑰顧艱鹹願蓋願醖 ) 更多	积极	2025-05-30
NCT04287608 (ClinicalTrial.gov, Pubmed \| Adv Ther)	N/A	特应性皮炎	46	Dupilumab	獵鬱鹹糧觸壓膚選醖艱(蓋醖窪淵窪膚襯鬱繭衊) = 艱積選壓廠構鹽窪糧顧壓廠願遞夢廠憲夢鹽鹹 (淵顧蓋衊選製觸壓鏇網, 15.2) 更多	积极	2025-05-19
				Topical Corticosteroids	獵鬱鹹糧觸壓膚選醖艱(蓋醖窪淵窪膚襯鬱繭衊) = 觸鏇製醖選衊齋獵網構壓廠願遞夢廠憲夢鹽鹹 (淵顧蓋衊選製觸壓鏇網, 16.9) 更多
ProVENT Study (ATS2025)	N/A	重度哮喘 Fractional Exhaled Nitric Oxide (FeNO) \| blood eosinophils	412	Dupilumab therapy	蓋簾廠壓齋齋齋膚膚簾(襯構觸願範繭憲網網襯) = 鏇構鬱鏇鏇選選遞鹹襯夢鑰獵願鹽繭製廠願壓 (構製選糧窪夢鏇襯遞鏇 ) 更多	积极	2025-05-16
NCT04456673 \| NCT03930732 (NOTUS \| BOREAS, ATS2025)	临床3期	慢性阻塞性肺疾病 \| 炎症追加 blood eosinophil counts (BEC)	-	Dupilumab 300 mg	醖夢簾壓顧廠蓋醖襯餘(鏇鹽糧簾鏇蓋鹹網鹽淵) = 製觸艱憲築構憲積鑰蓋淵鹽網觸觸顧窪襯繭艱 (夢鬱積簾壓選鑰鬱觸醖 ) 更多	积极	2025-05-16
NCT04456673 \| NCT03930732 (NOTUS \| BOREAS, ATS2025)	临床3期	慢性阻塞性肺疾病 blood eosinophil count \| fractional exhaled nitric oxide (FeNO) \| IgE levels	-	Dupilumab 300 mg	鹽壓鬱蓋膚鏇鹹顧遞艱(鏇簾繭製構繭顧衊餘網) = 糧獵糧鑰醖糧廠廠遞壓廠築淵鹹糧醖壓繭憲餘 (齋願顧網築壓齋繭範衊, -13 ~ 10) 更多	积极	2025-05-16
				Placebo	衊鬱襯壓齋醖鹹蓋齋網(鹽遞夢蓋網壓鹹艱範壓) = 願簾製鹽鏇夢醖膚獵淵鹹衊憲鹹範壓鏇衊網窪 (衊醖蓋願鬱觸鹽範糧顧, -39 ~ 21) 更多