ZEVASKYN批准将Abeona定位为营养不良性表皮松解症市场的新锐参与者-动脉网

ZEVASKYN Approval Positions Abeona as Emerging Player in Dystrophic Epidermolysis Bullosa Market

CISION 等信源发布 2025-05-23 05:31

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Approximately a year after the FDA rejected its previous approval submission, Abeona announced that the agency had approved ZEVASKYN, its autologous cell-based gene therapy for both adult and pediatric patients with RDEB. This approval marks Abeona's entry into the commercial gene therapy market for dystrophic epidermolysis bullosa..

大约在 FDA 拒绝其之前的批准申请一年后，Abeona 宣布该机构已批准 ZEVASKYN，这是其针对 RDEB 成年和儿童患者的自体细胞基因疗法。这一批准标志着 Abeona 进入了营养不良性大疱性表皮松解症的商业基因治疗市场。

LAS VEGAS

拉斯维加斯

，

May 22, 2025

2025年5月22日

/PRNewswire/ -- Dystrophic epidermolysis bullosa (DEB) is one of the main subtypes of epidermolysis bullosa, a group of genetic skin disorders characterized by varying degrees of fragility in the skin and mucous membranes. This fragility occurs due to the absence, deficiency, or malfunction of proteins critical to maintaining skin structure.

/PRNewswire/ -- 营养不良型大疱性表皮松解症（DEB）是表皮松解症的主要亚型之一，表皮松解症是一组遗传性皮肤疾病，其特征是皮肤和黏膜表现出不同程度的脆弱性。这种脆弱性是由于维持皮肤结构的关键蛋白缺失、不足或功能异常所致。

In the 7MM, approximately .

在七大主要市场中，大约。

6,500

diagnosed prevalent cases of DEB were recorded in 2023, with

2023年记录了DEB的诊断流行病例，

the United States

美国

accounting for about

约占

50%

of these cases.

这些案例中的。

Currently, there is no cure for DEB. Management is primarily supportive, focusing on wound care, controlling pain and itching, preventing infections, providing nutritional assistance, and addressing complications that may arise.

目前，DEB尚无治愈方法。治疗主要以支持性护理为主，重点在于伤口护理、控制疼痛和瘙痒、预防感染、提供营养支持以及处理可能出现的并发症。

Learn more about the DEB therapeutic market @

了解更多关于DEB治疗市场 @

Dystrophic Epidermolysis Bullosa Treatment Market

营养不良性表皮松解症治疗市场

As of now, only four therapies, namely

截至目前，只有四种疗法，分别是

FILSUVEZ

菲苏vez

(Chiesi Farmaceutici),

(凯西制药公司)，

VYJUVEK

维尤韦克

(Krystal Biotech),

（Krystal生物技术公司），

JACE

杰斯

(Japan Tissue Engineering), and recently approved

（日本组织工程公司），并最近获得批准

ZEVASKYN

泽瓦斯基恩

(Abeona Therapeutics), have been approved for treating DEB, leaving a significant unmet need for effective and targeted dystrophic epidermolysis bullosa treatments.

（Abeona Therapeutics）已被批准用于治疗DEB，但仍然存在对有效且有针对性的营养不良性大疱性表皮松解症治疗的显著未满足需求。

FILSUVEZ (oleogel-S10)

FILSUVEZ（oleogel-S10）

, developed by

，由开发

Chiesi Farmaceutici

凯西制药

, is a plant-based medicinal product derived from birch bark triterpenes. It was granted EU-wide marketing authorization on

，是一种源自桦树皮三萜的植物性医药产品。它已被授予欧盟范围内的上市许可于

June 21, 2022

2022年6月21日

. In

。在

December 2023

2023年12月

, the FDA approved FILSUVEZ topical gel for the treatment of partial-thickness wounds in patients aged six months and older with Junctional or Dystrophic Epidermolysis Bullosa (JEB and DEB).

，FDA批准了FILSUVEZ外用凝胶用于治疗年龄在六个月及以上、患有交界性或营养不良性表皮松解症（JEB和DEB）的患者的浅表伤口。

VYJUVEK (beremagene geperpavec)

VYJUVEK（贝雷马基因基佩尔帕韦克）

, developed by

，由开发

Krystal Biotech

Krystal生物技术公司

, is a topical, repeat-dose gene therapy intended to deliver two functional copies of the COL7A1 gene directly to DEB wounds. It received FDA approval in

，是一种局部、重复剂量的基因疗法，旨在将两个功能性的COL7A1基因拷贝直接递送到DEB伤口。它获得了FDA的批准。

May 2023

2023年5月

for use in DEB patients aged six months and older. The Marketing Authorization Application (MAA) for VYJUVEK has been validated by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is currently under review.

用于治疗六个月及以上的DEB患者。VYJUVEK的上市许可申请（MAA）已获得欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的验证，目前正在审查中。

JACE

杰斯

, developed by

，由开发

Japan Tissue Engineering

日本组织工程

, is a combination product featuring a human autologous epidermal cell sheet created using Green's technique. In

，是一种结合了使用Green技术创造的人类自体表皮细胞片的组合产品。在

December 2018

2018年12月

，

Japan's

日本的

Ministry of Health, Labour and Welfare (MHLW) granted additional approval for JACE, expanding its use to include both JEB and DEB.

厚生劳动省（MHLW）授予JACE额外批准，扩大其使用范围以包括JEB和DEB。

Dive deep into the treatment for dystrophic epidermolysis bullosa @

深入研究营养不良性表皮松解症的治疗方法 @

Dystrophic Epidermolysis Bullosa Drugs Market

营养不良性表皮松解症药物市场

Recently, in

最近，在

April 2025

2025年4月

，

Abeona Therapeutics Inc.

Abeona治疗公司

announced that the FDA had approved

宣布FDA已批准

ZEVASKYN (pz-cel)

泽瓦斯金 (pz-cel)

, marking it as the first and only autologous, gene-modified cell therapy for treating wounds in both adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB)—a severe, inherited skin disorder with no known cure. ZEVASKYN is currently the only FDA-approved therapy for RDEB wounds that works with just a single application..

，这标志着它成为首个且唯一的自体基因修饰细胞疗法，用于治疗成人和儿童隐性营养不良型大疱性表皮松解症（RDEB）患者的伤口——这是一种严重且无已知治愈方法的遗传性皮肤病。ZEVASKYN 是目前唯一获得 FDA 批准的 RDEB 伤口疗法，仅需一次应用即可生效。

The approval was granted based on results from the

基于以下结果，批准已授予

Phase III VIITAL study

III期VIITAL研究

(NCT04227106), a multi-center, randomized, intrapatient-controlled trial. The study successfully met its two main goals, showing significant wound healing (50% or more from baseline) and a reduction in pain, as measured by the Wong-Baker FACES scale, at six months post-treatment.

(NCT04227106)，一项多中心、随机、患者内对照试验。该研究成功达到了两个主要目标，显示在治疗后六个月，伤口愈合显著（从基线起减少50%或更多），并且根据Wong-Baker面部表情量表测量，疼痛有所减轻。

ZEVASKYN is anticipated to become available in Q3 2025 through ZEVASKYN Qualified Treatment Centers (QTCs)—specialized facilities across the U.S. with expertise in treating epidermolysis bullosa and administering cell and gene therapies, ensuring broad patient access.

预计ZEVASKYN将于2025年第三季度通过ZEVASKYN合格治疗中心（QTCs）上市，这些中心是遍布美国的专门设施，拥有治疗表皮松解症和实施细胞与基因疗法的专业知识，确保广大患者能够获得治疗。

To know more about the treatment for dystrophic epidermolysis bullosa in children, visit @

要了解更多关于儿童营养不良性表皮松解症的治疗，请访问 @

Dystrophic Epidermolysis Bullosa Drugs

营养不良性表皮松解症药物

Companies across the globe are diligently working toward the development of novel DEB treatment therapies with considerable amount of success over the years. Some of the drugs in the pipeline include

全球各地的公司正在积极努力开发新的DEB治疗方法，并在多年来取得了显著的成功。一些正在研发中的药物包括

Dabocemagene autoficel

达博塞马基恩自体细胞

(Castle Creek Biosciences),

（城堡溪生物科学），

ABCB5+ MSCs

ABCB5+ 间充质干细胞

(RHEACELL), and

（RHEACELL），以及

ALLO-ASC-SHEET

同种异体脂肪干细胞片

(Anterogen), among others.

（Anterogen），以及其他。

Discover which therapies are expected to grab major DEB therapeutics market share @

发现哪些疗法有望占据主要的DEB治疗市场份额 @

Dystrophic Epidermolysis Bullosa Drugs Market

营养不良性表皮松解症药物市场

D-Fi

, also referred to as FCX-007 (dabocemagene autoficel), is an investigational autologous gene therapy designed to treat dystrophic epidermolysis bullosa (DEB). It involves using the patient's own dermal fibroblasts, which are genetically engineered using a self-inactivating (SIN) lentiviral vector carrying the COL7A1 gene to produce type VII collagen (COL7).

，也被称为FCX-007（dabocemagene autoficel），是一种研究性的自体基因疗法，旨在治疗营养不良性表皮松解症（DEB）。该疗法利用患者自身的真皮成纤维细胞，通过使用携带COL7A1基因的自我失活（SIN）慢病毒载体进行基因工程改造，以产生VII型胶原蛋白（COL7）。

The therapy is delivered via intradermal injection directly into the superficial papillary dermis of persistent wounds, where COL7 helps form anchoring fibrils essential for skin integrity..

该疗法通过皮内注射直接递送至持续性伤口的浅层乳头状真皮，其中COL7有助于形成对皮肤完整性至关重要的锚定纤维。

ABCB5-positive mesenchymal stem cells (ABCB5+ MSCs)

ABCB5阳性的间充质干细胞（ABCB5+ MSCs）

represent a novel and promising therapeutic option for DEB. These cells possess anti-inflammatory properties through interaction with immune cells, triggering their reprogramming. Administered systemically via infusion, ABCB5+ MSCs migrate to wound sites, reduce inflammation, and aid in tissue repair by releasing and depositing type VII collagen.

代表了一种新颖且有前景的DEB治疗选择。这些细胞通过与免疫细胞的相互作用具有抗炎特性，触发其重新编程。通过输注系统性给药后，ABCB5+ MSCs会迁移到伤口部位，减轻炎症，并通过释放和沉积VII型胶原蛋白帮助组织修复。

This therapy targets both external and internal wounds and has received Orphan Drug Designation (ODD) from both the FDA and EMA for the treatment of RDEB. RHEACELL is currently running a Phase III clinical trial to evaluate the effectiveness of ABCB5+ MSCs in patients with RDEB..

该疗法针对外部和内部伤口，并已获得FDA和EMA授予的治疗RDEB的孤儿药资格（ODD）。RHEACELL目前正在开展一项III期临床试验，以评估ABCB5+ MSCs在RDEB患者中的有效性。

Discover more about DEB drugs in development @

了解更多关于正在开发的DEB药物 @

Dystrophic Epidermolysis Bullosa Clinical Trials

营养不良性表皮松解症临床试验

The anticipated launch of these emerging dystrophic epidermolysis bullosa treatments 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 dystrophic epidermolysis bullosa market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth..

这些新兴的营养不良性大疱性表皮松解症治疗方法预计将在未来几年内彻底改变市场格局。随着这些前沿疗法不断成熟并获得监管机构的批准，它们有望重塑营养不良性大疱性表皮松解症的市场版图，提供新的护理标准，并为医疗创新和经济增长带来机遇。

DelveInsight estimates that the dystrophic epidermolysis bullosa market size in the 7MM is expected to grow from

德尔维洞察估计，营养不良性表皮松解症在七大市场的市场规模预计将会增长。

USD 550 million

5亿5000万美元

in 2023 at a significant CAGR by 2034. According to DelveInsight's analysis, the growth of the dystrophic epidermolysis bullosa market is expected to be mainly driven by increasing prevalence, patient awareness, and robust clinical pipeline during the forecast period (2025–2034).

在2023年到2034年间，市场预计将以显著的复合年增长率增长。根据DelveInsight的分析，营养不良型大疱性表皮松解症市场在预测期（2025-2034年）的增长预计将主要受到患病率上升、患者意识增强以及强大的临床研发管线推动。

DelveInsight's latest published market report titled

德维尔洞察最新发布的市场报告标题为

Dystrophic Epidermolysis Bullosa Market Insight, Epidemiology, and Market Forecast – 2034

营养不良性表皮松解症市场洞察、流行病学与市场预测——2034年

will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the dystrophic epidermolysis bullosa 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获得最大的市场份额。该报告提供了关于营养不良性大疱性表皮松解症的国别治疗指南、患者群体分析和流行病学预测的全面见解，以帮助理解关键机会并评估市场的潜在潜力。

The dystrophic epidermolysis bullosa market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:.

营养不良性大疱性表皮松解症市场报告提供了2020-2034年期间在7个主要市场的流行病学分析，分为以下部分：。

Diagnosed Prevalent Cases of DEB

DEB的诊断流行病例

Age-Specific Cases of DEB

不同年龄组的DEB病例数

Type-specific Cases of DEB

DEB的类型特定案例

Severity-specific Cases of DEB

DEB的严重性特定病例

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

该报告通过了解影响和推动七大市场营养不良性大疱性表皮松解症市场的趋势，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

峰值销售分析

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

准入和报销

Download this dystrophic epidermolysis bullosa 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 dystrophic epidermolysis bullosa market. Also, stay abreast of the mitigating factors to improve your market position in the dystrophic epidermolysis bullosa therapeutic space..

下载这份关于营养不良性表皮松解症市场的报告，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，并确定导致营养不良性表皮松解症市场变化的因素。此外，及时掌握缓解因素，以提升您在营养不良性表皮松解症治疗领域的市场地位。

Related Reports

关联报告

Recessive Dystrophic Epidermolysis Bullosa Pipeline

隐性营养不良型表皮松解症管线

Recessive Dystrophic Epidermolysis Bullosa Pipeline Insight

隐性营养不良性表皮松解症管线洞察

– 2025

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

报告提供了关于研发管线的全面见解，包括临床和非临床阶段产品的管线药物概况，以及关键的RDEB公司，包括

Abeona Therapeutics, Inc., Castle Creek Biosciences, LLC., RHEACELL GmbH & Co. KG,

Abeona Therapeutics公司、Castle Creek Biosciences有限责任公司、RHEACELL有限公司及合伙公司

among others.

其中包括。

Dystrophic Epidermolysis Bullosa Pipeline

营养不良性表皮松解症管线

Dystrophic Epidermolysis Bullosa Pipeline Insight

营养不良性表皮松解症管线洞察

– 2025

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

报告提供了关于管线格局、管线药物概况（包括临床和非临床阶段产品）以及主要的DEB公司（包括）的全面见解。

Phoenix Tissue Repair, Castle Creek Biosciences, Phoenicis Therapeutics, Aegle Therapeutics, RHEACELL GmbH & Co. KG, Anterogen Co., Ltd., Abeona Therapeutics, Inc., InMed Pharmaceuticals, BridgeBio Inc., Eloxx Pharmaceuticals, Relief Therapeutics, Quoin Pharmaceuticals,

凤凰组织修复、城堡溪生物科学、凤凰治疗、Aegle治疗、RHEACELL有限公司、Anterogen有限公司、Abeona治疗公司、InMed制药、BridgeBio公司、Eloxx制药、Relief治疗、Quoin制药

among others.

其中包括。

Epidermolysis Bullosa Market

表皮松解症市场

Epidermolysis Bullosa Market Insights, Epidemiology, and Market Forecast

表皮松解症市场洞察、流行病学与市场预测

– 2034

report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key epidermolysis bullosa companies including

报告提供了对疾病、历史和预测流行病学的深入理解，以及市场趋势、市场驱动因素、市场障碍和包括关键表皮松解症公司在内的相关信息。

Abeona Therapeutics, Castle Creek Biosciences, RHEACELL, Ishin Pharma, Holostem Terapie Avanzate, BridgeBio (Phoenix Tissue Repair), InMed Pharmaceuticals, Shionogi, Anterogen

Abeona Therapeutics、Castle Creek Biosciences、RHEACELL、Ishin Pharma、Holostem Terapie Avanzate、BridgeBio（Phoenix Tissue Repair）、InMed Pharmaceuticals、Shionogi、Anterogen

，

among others.

其中包括。

Epidermolysis Bullosa Pipeline

表皮松解症管线

Epidermolysis Bullosa Pipeline Insight

表皮松解症管道洞察

– 2025

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

报告提供了关于研发管线的全面见解，包括临床和非临床阶段产品的管线药物概况，以及关键的表皮松解症公司，包括

Abeona Therapeutics, InMed Pharmaceuticals, BioMendics, RHEACELL, Castle Creek Biosciences, BPGbio, Eloxx Pharmaceuticals, Phoenicis Therapeutics, Aegle Therapeutics, Amryt Pharma,

Abeona Therapeutics，InMed Pharmaceuticals，BioMendics，RHEACELL，Castle Creek Biosciences，BPGbio，Eloxx Pharmaceuticals，Phoenicis Therapeutics，Aegle Therapeutics，Amryt Pharma，

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.

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升其业绩。通过我们的订阅平台PharmDelve，轻松获取所有医疗保健和制药市场研究报告。

。

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