4种可能改变治疗格局的新兴移植物抗宿主病疗法-动脉网

4 Emerging Graft versus Host Disease Therapies That Could Change the Treatment Landscape

CISION 等信源发布 2025-06-13 05:46



可切换为仅中文







Key companies, such as CSL Behring, Equillium, Biocon, and medac, are advancing their assets through late-stage graft versus host disease clinical trials, driving innovation in the graft versus host disease market and creating significant growth opportunities.

关键公司，如CSL Behring、Equillium、Biocon和medac，正在通过晚期移植物抗宿主病临床试验推进其资产，推动移植物抗宿主病市场的创新，并创造显著的增长机会。

LAS VEGAS

拉斯维加斯

，

June 12, 2025

2025年6月12日

/PRNewswire/ -- Graft versus host disease (GvHD) is an immune-driven disorder caused by a complex interplay between the donor's and recipient's adaptive immune systems. It typically manifests in two main forms: acute (aGvHD) and chronic (cGvHD).

/PRNewswire/ -- 移植物抗宿主病（GvHD）是一种由供体和受体适应性免疫系统之间复杂相互作用引发的免疫驱动型疾病。它通常表现为两种主要形式：急性（aGvHD）和慢性（cGvHD）。

As per DelveInsight's analysis, approximately

根据DelveInsight的分析，大约

60,000

allogeneic transplants and around

同种异体移植及周围

55,000

GvHD cases occurred in the 7MM in 2024. These numbers are projected to grow at a notable CAGR over the forecast period from 2025 to 2034.

2024年，7MM地区发生了GvHD病例。预计这些数字在2025年至2034年的预测期内将以显著的年均复合增长率增长。

Corticosteroids like

皮质类固醇如

prednisone and methylprednisolone

泼尼松和甲泼尼龙

are the primary first-line treatments, often combined with other immunosuppressants. Mild GcHD is managed with topical steroids, while systemic cases require stronger immunosuppressive therapy.

是一线主要治疗方案，常与其他免疫抑制剂联合使用。轻度GcHD采用局部类固醇治疗，而系统性病例则需要更强效的免疫抑制疗法。

Several treatments for GvHD have received FDA approval in the US, including

美国FDA已批准多种移植物抗宿主病（GvHD）的治疗方法，包括

ORENCIA (abatacept), JAKAFI/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), and REZUROCK (belumosudil)

奥伦西亚（阿巴西普）、捷凯菲/捷凯维（鲁索利替尼）、伊布替尼（依鲁替尼）和瑞祖罗克（贝鲁莫司）

, among others. In the upcoming GvHD treatment market landscape, there are a plethora of companies investigating agents in various stages of development.

，以及其他公司。在即将到来的GvHD治疗市场格局中，有众多公司正在研究处于不同开发阶段的药物。

To know more about the graft versus host disease clinical trials market, visit @

要了解更多关于移植物抗宿主病临床试验市场的信息，请访问 @

Graft versus Host Disease Market

移植抗宿主病市场

DelveInsight estimates that the market size for GvHD is expected to grow from

德尔维洞察估计，GvHD的市场规模预计将会增长，从

USD 1.4 billion

14亿美元

in 2024 with a significant

在2024年，具有重大意义的

CAGR of 8.2%

8.2% 的年均复合增长率

by 2034. This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies.

到2034年。这一预期增长是由治疗方案的进步、医疗保健覆盖范围的扩大以及该疾病患病率的上升共同推动的，这些因素共同促进了对创新和有效疗法的更高需求。

The current pipeline for graft versus host disease includes a range of drugs with diverse mechanisms of action (MoA).

当前的移植物抗宿主病治疗管道包括一系列具有不同作用机制（MoA）的药物。

CSL964 (Alpha 1 Antitrypsin), EQ001 (Itolizumab; Bmab600), MaaT013, and MC0518

CSL964（α1-抗胰蛋白酶）、EQ001（伊托珠单抗；Bmab600）、MaaT013 和 MC0518

are the most promising drugs that are in the late-stage of development for GvHD treatment. Ongoing research and current trials have the potential to change the GvHD market.

是处于移植物抗宿主病（GvHD）治疗后期开发中最有前景的药物。正在进行的研究和当前的试验有潜力改变GvHD市场。

Keen to know how the GvHD market will evolve by 2034? Find out @

想知道GvHD市场到2034年将如何演变吗？请访问@

Graft versus Host Disease (GvHD) Market Forecast

移植物抗宿主病（GvHD）市场预测

Apart from this, several GvHD drugs currently in the early stages of development include

除此之外，一些目前处于早期开发阶段的GvHD药物包括

RLS-0071

by ReAlta Life Sciences,

由ReAlta Life Sciences公司

Vimseltinib

维姆塞替尼

by Deciphera Pharmaceuticals,

由Deciphera制药公司，

ASC-930

by ASC Therapeutics,

由ASC Therapeutics公司，

RGI-2001

by REGiMMUNE,

由REGiMMUNE公司，

CYP-001

by Cynata Therapeutics,

由Cynata Therapeutics，

arsenic trioxide (As2O3)

三氧化二砷 (As2O3)

by BioSenic (Medsenic),

由BioSenic（Medsenic）提供，

TRX103 (Tregs)

TRX103（调节性T细胞）

by Tr1X,

由Tr1X，

TCD601 (Siplizumab)

TCD601（西普利珠单抗）

by ITB-MED,

由ITB-MED，

F-652

by Evive Biotech,

由亿一生物，

RHPRG4

by Lubris BioPharma,

由Lubris生物制药公司，

XBI302

by Xbiome,

由Xbiome，

RG6287

by Genentech,

由基因泰克公司，

ALTB-168

by AltruBio, and

由AltruBio，以及

SER-155

by Seres Therapeutics.

由Seres Therapeutics公司。

Now, let's examine the late-stage pipeline therapies under investigation for GvHD treatment

现在，让我们检查一下用于治疗GvHD的晚期管线疗法。

CSL Behring's ZEMAIRA

CSL Behring的ZEMAIRA

CSL964 Alpha-1 Antitrypsin

CSL964 α-1抗胰蛋白酶

, an

，一个

Alpha1-Proteinase Inhibitor (A1-PI)

α1-蛋白酶抑制剂 (A1-PI)

developed by

由...开发

CSL Behring

, is being studied for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) and for the prevention of aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently in

，正被研究用于治疗类固醇难治性急性移植物抗宿主病 (aGvHD)，以及预防高风险患者在进行异基因造血干细胞移植 (HSCT) 时的 aGvHD。它目前处于

Phase III clinical trials

III期临床试验

for the treatment of steroid-refractory aGvHD and is also being evaluated in Phase II/III trials for its potential in preventing aGvHD.

用于治疗类固醇难治性aGvHD，并且正在II/III期临床试验中评估其预防aGvHD的潜力。

Equillium/Biocon's EQ001

Equillium/Biocon的EQ001

EQ001 (Itolizumab; Bmab600)

EQ001（伊托利珠单抗；Bmab600）

is a first-in-class

是同类中的首创

immune-modulating antibody

免疫调节抗体

that targets

针对

CD6

to suppress the activation and migration of harmful T cells responsible for releasing pro-inflammatory cytokines in autoimmune and inflammatory conditions such as GvHD, moderate-to-severe uncontrolled asthma, and lupus nephritis. By acting on the CD6-ALCAM signaling pathway, Itolizumab selectively inhibits pathogenic effector T cells (Teffs) while preserving regulatory T cells (Tregs), which are essential for immune system balance..

通过作用于CD6-ALCAM信号通路，伊托珠单抗选择性抑制致病效应T细胞（Teffs），同时保留对免疫系统平衡至关重要的调节性T细胞（Tregs），从而抑制在移植物抗宿主病（GvHD）、中重度未控制哮喘及狼疮性肾炎等自身免疫和炎症性疾病中释放促炎性细胞因子的有害T细胞的活化与迁移。

Currently, EQ001 is undergoing a

目前，EQ001正在经历一个

Phase III clinical trial

III期临床试验

in combination with corticosteroids as a first-line therapy for GvHD.In

与皮质类固醇联合作为GvHD的一线治疗。

March 2025

2025年3月

, Equillium reported topline Phase III EQUATOR trial results for itolizumab in first-line aGVHD. While the study did not show a meaningful difference in CR or ORR at Day 29 versus placebo, itolizumab demonstrated statistically significant and clinically meaningful improvements in longer-term outcomes, including CR at Day 99, duration of response, and failure-free survival.

Equillium 报告了 itolizumab 在一线 aGVHD 的 III 期 EQUATOR 试验的初步结果。虽然该研究在第 29 天时未显示出与安慰剂相比在完全缓解（CR）或总缓解率（ORR）上有显著差异，但 itolizumab 在更长期的结果中表现出统计学上显著且临床意义重大的改善，包括第 99 天的完全缓解、缓解持续时间以及无失败生存期。

In .

在。

April 2025

2025年4月

, the FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab, citing limitations in the EQUATOR study data.

，FDA以EQUATOR研究数据的局限性为由，拒绝授予itolizumab突破性疗法认定或支持其加速审批途径。

Discover which therapies are expected to grab major GvHD market share @

发现哪些疗法有望占据主要的GvHD市场份额 @

Graft versus Host Disease Treatment Market

移植物抗宿主病治疗市场

MaaT Pharma's MaaT013

MaaT Pharma的MaaT013

MaaT013

is a standardized, donor-derived microbiome ecosystem therapy characterized by high richness and diversity. It includes BUTYCORE, a consortium of bacterial species known for producing anti-inflammatory short-chain fatty acids. The therapy is designed to reestablish the balance between the patient's gut microbiome and immune system, aiming to enhance immune tolerance and responsiveness, thereby addressing steroid-resistant, gastrointestinal-dominant aGvHD.

是一种标准化的、供体来源的微生物组生态系统疗法，具有高丰富度和多样性。该疗法包含BUTYCORE，这是一种由多种以产生抗炎短链脂肪酸著称的细菌菌种组成的联合体。该疗法旨在重新建立患者肠道微生物组与免疫系统之间的平衡，提高免疫耐受性和反应性，从而应对类固醇抵抗型、以胃肠道为主的急性移植物抗宿主病（aGvHD）。

MaaT013 has been granted .

MaaT013 已被授予。

Orphan Drug Designation (ODD)

孤儿药认定 (ODD)

by both the US FDA and the EMA.

同时受到美国FDA和EMA的监管。

在

December 2024

2024年12月

, MaaT Pharma shared encouraging updated results from its Early Access Program at the ASH 2024 Annual Meeting. Subsequently, in

在 ASH 2024 年会上，MaaT Pharma 分享了其早期访问计划的鼓舞人心的更新结果。随后，在

January 2025

2025年1月

, the company announced promising topline findings from the

，该公司宣布了来自

Phase III ARES trial

III期ARES试验

, where MaaT013 achieved a 62% overall gastrointestinal response rate by Day 28, marking a significant advancement as a third-line treatment for GI-aGvHD.

，其中 MaaT013 在第 28 天达到了 62% 的总体胃肠道反应率，标志着其作为 GI-aGvHD 的三线治疗取得了显著进展。

medac's MC0518

medac的MC0518

MC0518

is an investigational

是一种调查性药物

mesenchymal stromal cell (MSC) therapy

间充质基质细胞（MSC）治疗

developed by Medac GmbH, currently undergoing clinical trials for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) following allogeneic hematopoietic stem cell transplantation. This therapy leverages the immunomodulatory properties of MSCs to mitigate the severe inflammatory responses characteristic of SR-aGvHD, a condition where the donor's immune cells attack the recipient's tissues despite steroid treatment..

由Medac GmbH开发，目前正在进行临床试验，用于治疗异基因造血干细胞移植后出现的类固醇难治性急性移植物抗宿主病（SR-aGvHD）。该疗法利用间充质干细胞（MSCs）的免疫调节特性，减轻SR-aGvHD特有的严重炎症反应，这是一种即使在类固醇治疗下供体免疫细胞仍攻击受体组织的情况。

The

IDUNN trial

IDUNN 试验

, a pivotal Phase III study, is evaluating the efficacy and safety of MC0518 compared to the best available therapy (BAT) in pediatric and adolescent patients. The primary endpoint is the overall response rate (ORR) at Day 28, with secondary objectives including overall survival (OS) up to 24 months and freedom from treatment failure (FFTF) within six months.

，一项关键的III期研究，正在评估MC0518与最佳现有疗法（BAT）在儿童和青少年患者中的疗效和安全性。主要终点是第28天的总体缓解率（ORR），次要目标包括长达24个月的总生存期（OS）和六个月内无治疗失败（FFTF）。

Preclinical assessments have demonstrated that MC0518 is well-tolerated, with no evidence of tumorigenicity or significant adverse effects in animal models..

临床前评估表明，MC0518耐受性良好，在动物模型中未发现致瘤性或显著不良反应。

Discover more about drugs for GvHD in development @

了解更多关于正在开发的GvHD药物 @

Graft versus Host Disease Clinical Trials

移植物抗宿主病临床试验

The anticipated launch of these emerging therapies for GvHD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth..

这些新兴疗法预计将在未来几年内推出，有望改变GvHD市场的格局。随着这些前沿疗法不断成熟并获得监管批准，它们预计将重塑GvHD市场，提供新的治疗标准，并为医疗创新和经济增长带来机遇。

DelveInsight's latest published market report, titled as

德莱夫洞察最新发布的市场报告，标题为

Graft versus Host Disease Market Insight, Epidemiology, and Market Forecast – 2034

移植物抗宿主病市场洞察、流行病学与市场预测 – 2034

，

will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential.

将帮助您发现哪个市场领导者将占据最大的市场份额。该报告提供了对GvHD国家特定治疗指南、患者群体分析和流行病学预测的全面洞察，以帮助理解关键机会并评估市场的潜在价值。

The GvHD market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:.

GvHD市场报告提供了2020年至2034年期间在7MM中的流行病学分析，分为以下部分：。

Total allogenic transplant cases

异体移植总病例数

Total Graft Versus Host Disease Cases

总移植物抗宿主病病例数

Type-specific Cases of Graft Versus Host Disease

移植物抗宿主病的类型特异性病例

Acute Graft Versus Host Disease Cases by Grading

急性移植物抗宿主病病例按分级分类

Acute Graft Versus Host Disease Cases by Organ Involvement

急性移植物抗宿主病按器官受累的病例

Chronic Graft Versus Host Disease Cases by Grading

慢性移植物抗宿主病分级病例

Chronic Graft Versus Host Disease Cases by Organ Involvement

慢性移植物抗宿主病按器官受累分类的病例

Total Treated Cases of Graft Versus Host Disease

移植物抗宿主病的总治疗病例数

Mortality Adjusted Treated Cases of Graft Versus Host Disease

调整死亡率后的移植物抗宿主病治疗病例数

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GvHD market. Highlights include:

该报告通过了解影响和推动七大市场GvHD市场的趋势，为制定商业策略提供了优势。亮点包括：

10-year Forecast

10年预测

7MM Analysis

7MM分析

Epidemiology-based Market Forecasting

基于流行病学的市场预测

Historical and Forecasted Market Analysis upto 2034

历史和预测市场分析至2034年

Emerging Drug Market Uptake

新兴药物市场吸收率

Peak Sales Analysis

销售峰值分析

Key Cross Competition Analysis

关键交叉竞争分析

Industry Expert's Opinion

行业专家意见

Access and Reimbursement

准入与报销

Download this GvHD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GvHD market. Also, stay abreast of the mitigating factors to improve your market position in the GvHD therapeutic space..

下载这份GvHD市场报告，评估流行病学预测，了解患者旅程，知晓关键意见领袖（KOL）对即将到来的治疗模式的看法，并确定推动GvHD市场变化的因素。同时，紧跟缓解因素，以提升您在GvHD治疗领域的市场地位。

Related Reports

相关报告

Graft versus Host Disease Epidemiology Forecast

移植物抗宿主病流行病学预测

Graft versus Host Disease Epidemiology Forecast – 2034

移植物抗宿主病流行病学预测 – 2034

report delivers an in-depth understanding of the disease, historical and forecasted GvHD epidemiology in the 7MM, i.e.,

报告深入介绍了该疾病，并提供了7MM中GvHD的历史和预测流行病学，即

the United States

美国

, EU4 (

，欧盟4（

Germany

德国

，

Spain

西班牙

，

Italy

意大利

，

France

法国

) and the

）和

United Kingdom

英国

, and

，以及

Japan

日本

。

Graft versus Host Disease Pipeline

移植物抗宿主病管线

Graft versus Host Disease Pipeline Insight

移植物抗宿主病管线洞察

– 2025

report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GvHD companies, including

报告全面洞察了研发管线情况、管线药物概况（包括临床和非临床阶段产品）以及主要的移植物抗宿主病 (GvHD) 公司，包括

Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical, CTI BioPharma, ViGenCell, Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen

Abbisko Therapeutics、Equillium、Theriva Biologics、Seres Therapeutics、CytoMed Therapeutics、北京泰德制药、CTI BioPharma、ViGenCell、Lipella Pharmaceuticals、Cellestia Biotech、Seres Therapeutics、江苏恒瑞医药、Genentech、AltruBio、Orca Bio、GSK、Amgen

，

among others.

其中包括。

Acute Graft versus Host Disease Pipeline

急性移植物抗宿主病管线

Acute Graft versus Host Disease Pipeline Insight

急性移植物抗宿主病管线洞察

– 2025

report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute GvHD companies, including

报告全面洞察了研发管线的格局、管线药物概况，包括临床和非临床阶段产品，以及关键的急性GvHD公司，包括

MaaT Pharma, Medac, CSL Behring, Humanigen, Ironwood Pharmaceuticals, ReAlta Life Sciences, Roche, Incyte Corporation

MaaT制药、Medac、CSL贝林、Humanigen、Ironwood制药、ReAlta生命科学、罗氏、Incyte公司

，

among others.

其中包括。

Ocular Graft versus Host Disease Pipeline

眼移植物抗宿主病管线

Ocular Graft versus Host Disease Pipeline Insight

眼部移植物抗宿主病管线洞察

– 2025

report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ocular GvHD companies, including

报告全面洞察了研发管线的前景、管线药物概况，包括临床和非临床阶段产品，以及关键的眼部GvHD公司，包括

Cambium Medical Technologies, Glia LLC., Ocular Discovery, Selagine

康比亚医疗技术公司，格利亚有限责任公司，奥库拉发现，塞拉金

，

among others.

其中包括。

About DelveInsight

关于DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

德尔维洞察（DelveInsight）是一家领先的商业咨询和市场研究公司，专注于生命科学领域。它通过提供全面的端到端解决方案来支持制药公司以提高其绩效。通过我们基于订阅的平台 PharmDelve，您可以轻松获取所有医疗保健和制药市场研究报告。

。

联系我们

Shruti Thakur

info@delveinsight.com

+14699457679

Logo:

标志：

https://mma.prnewswire.com/media/1082265/DelveInsight_Logo.jpg

SOURCE DelveInsight Business Research, LLP

来源：DelveInsight商业研究公司

WANT YOUR COMPANY'S NEWS