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AscellaHealth HUB与Abeona Therapeutics®合作,支持新型细胞基因疗法的成功上市,并为罕见病患者提供治疗机会

AscellaHealth HUB Partnership with Abeona Therapeutics® Supports Launch Success of Novel Cellased Gene Therapy and Access to Treatment for Rare Disease Patients

PHARMA FOCUS ASIA 等信源发布 2025-07-30 13:50

可切换为仅中文


AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, highlights the value of its HUB partnership with Abeona Therapeutics Inc. in the successful pre-and-post launch commercialization of ZEVASKYN™, an FDA-approved cell-based gene therapy.

AscellaHealth是一家为特殊制药行业提供可定制解决方案的全球合作伙伴,强调了其与Abeona Therapeutics Inc.的HUB合作在ZEVASKYN™(一种FDA批准的基于细胞的基因疗法)成功上市前后的商业化过程中的价值。

Working as a collaborative partner, AscellaHealth designed and executed patient-centric, end-to-end solutions to address unique clinical, operational and reimbursement needs for a new-to-world autologous cell-based gene therapy. By focusing on the requirements of patients throughout the entire therapeutic journey, AscellaHealth led the collaborative effort to build and launch AbeonaAssist™, a highly customized patient support program that creates a seamless experience for patients, caregivers and healthcare providers..

作为协作伙伴,AscellaHealth 设计并执行了以患者为中心的端到端解决方案,以满足一种全新自体细胞基因疗法的独特临床、运营和报销需求。通过关注患者在整个治疗过程中的需求,AscellaHealth 领导了合作努力,构建并推出了高度定制的患者支持项目 AbeonaAssist™,为患者、护理人员和医疗保健提供者创造无缝体验。

'Abeona’s groundbreaking cell-based gene therapy demanded a HUB partner who could build tailored infrastructure from the ground up,” said William White, Vice President of Market Access at Abeona Therapeutics. “AscellaHealth’s comprehensive expertise in navigating this complex journey, from patient and provider engagement to optimizing reimbursement for this first-of-its-kind treatment, made them the unequivocal partner of choice.

“Abeona的突破性细胞基因疗法需要一个能够从头开始构建定制基础设施的HUB合作伙伴,”Abeona Therapeutics市场准入副总裁William White表示。“AscellaHealth在应对这一复杂过程中的全面专业知识,从患者和医疗服务提供者的参与到为这种首创治疗优化报销,使他们成为毫无疑问的首选合作伙伴。”

Since launch, their unwavering commitment to a patient-centric model, which perfectly aligns with our program’s vision, has proven invaluable.”.

自推出以来,他们对以患者为中心的模式的坚定承诺,与我们项目的愿景完美契合,证明是无价的。

Bill Oldham, Chairman and President, AscellaHealth, says, “We value our strategic partnership with Abeona which is built upon an aligned vision, a foundation of shared goals and a clear understanding of what can be achieved through collaboration. Together, we have created synergies that not only benefit both organizations, but most importantly, patient access to treatment and optimized clinical outcomes.

AscellaHealth董事长兼总裁比尔·奥尔德姆表示:“我们珍视与Abeona的战略合作伙伴关系,这一关系建立在愿景一致、目标共享的基础之上,并且双方都清楚通过合作能够实现的成果。我们共同创造了不仅有利于两家机构,更重要的是有助于患者获得治疗和优化临床结果的协同效应。”

Abeona epitomizes our description of an ideal partner that is committed to open communications, trust and transparency.”.

Abeona集中体现了我们对理想合作伙伴的描述,即致力于开放的沟通、信任和透明度。

AscellaHealth’s integrated patient services and HUB model are proving instrumental in achieving optimal results for life science manufacturers launching specialty pharmaceuticals, and cell and gene therapies for individuals with complex, chronic conditions and rare disease. The results highlight enhanced compliance, retention and satisfaction rates, underscoring the effectiveness of AscellaHealth’s tailored programs that consistently deliver measurable outcomes:.

AscellaHealth的综合患者服务和HUB模式正在为生命科学制造商推出特效药、细胞和基因疗法(针对患有复杂慢性病和罕见病的个体)取得最佳效果发挥重要作用。结果表明,依从性、留存率和满意度均得到提升,突显了AscellaHealth定制化项目的一贯有效性,这些项目持续提供可衡量的成果。

About ZEVASKYN™ (prademagene zamikeracel) gene-modified cellular sheets

关于ZEVASKYN™(prademagene zamikeracel)基因修饰细胞片

ZEVASKYN is the first and only autologous cell sheet-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a severe skin disease caused by a defect in both copies of the COL7A1 gene resulting in the inability to produce functional type VII collagen.

ZEVASKYN 是首个也是唯一的基于自体细胞片的基因疗法,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。RDEB 是一种严重的皮肤病,由 COL7A1 基因的两个拷贝均存在缺陷引起,导致无法产生功能性 VII 型胶原蛋白。

Without functional type VII collagen and anchoring fibrils, the skin is fragile and blisters easily, leading to wounds that continually open and close, or fail to heal altogether. Patients often have large open wounds that can lead to serious life-threatening complications. ZEVASKYN incorporates the functional type VII collagen-producing COL7A1 gene into a patient’s own skin cells, ex vivo, using a replication-incompetent retroviral vector to produce functional type VII collagen in treated wounds.

由于缺乏功能性 VII 型胶原蛋白和锚定纤维,皮肤变得脆弱并容易起水泡,导致伤口不断开裂或难以完全愈合。患者通常会有大面积的开放性伤口,可能引发严重危及生命的并发症。ZEVASKYN 使用复制缺陷型逆转录病毒载体将产生功能性 VII 型胶原蛋白的 COL7A1 基因整合到患者自身的皮肤细胞中,在体外处理使伤口产生功能性 VII 型胶原蛋白。

ZEVASKYN has demonstrated clinically meaningful wound healing and pain reduction with a single surgical application. For more information, visit www.ZEVASKYN.com..

ZEVASKYN 已经通过单次手术应用显示出具有临床意义的伤口愈合和疼痛减轻。欲了解更多信息,请访问 www.ZEVASKYN.com。

Indication

指示

ZEVASKYN™ (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

ZEVASKYN™(prademagene zamikeracel)是一种基于自体细胞片的基因疗法,用于治疗患有隐性营养不良性大疱性表皮松解症(RDEB)的成人和儿童患者的伤口。

Important Safety Information

重要安全信息

This is not a complete list of side effects. Patients should call their care team for medical advice about side effects. Side effects may be reported to Abeona at 1-844-888-2236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

这不是副作用的完整列表。患者应致电他们的护理团队,以获取有关副作用的医疗建议。副作用可向Abeona报告,电话为1-844-888-2236,或向FDA报告,电话为1-800-FDA-1088,也可以访问www.fda.gov/medwatch。

See full Prescribing Information.

查看完整的处方信息。

About AscellaHealth

关于AscellaHealth

AscellaHealth is a global partner that delivers proven end-to-end solutions to both life sciences and healthcare companies to enhance the quality of life for patients with complex, chronic conditions. A dedicated team gets critical healthcare products from manufacturers to patients while ensuring an efficient flow of funds between payers and pharma.

AscellaHealth 是一家全球合作伙伴,为生命科学和医疗保健公司提供经过验证的端到端解决方案,以改善患有复杂慢性病的患者的生活质量。 一支专门的团队将关键的医疗产品从制造商送到患者手中,同时确保支付方与制药商之间的资金流动高效顺畅。

Visit www.AscellaHealth.com..

访问 www.AscellaHealth.com。

About Abeona Therapeutics

关于Abeona Therapeutics

Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN™ (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Abeona Therapeutics Inc.是一家商业阶段的生物制药公司,致力于开发用于严重疾病的细胞和基因疗法。Abeona的ZEVASKYN™(prademagene zamikeracel)是首个也是唯一一个用于治疗隐性营养不良型大疱性表皮松解症(RDEB)成人和儿童患者伤口的自体细胞基因疗法。

The Company’s fully integrated cGMP cell and gene therapy manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company’s development portfolio features adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical need.

公司位于俄亥俄州克利夫兰的完全集成的cGMP细胞和基因治疗生产设施是ZEVASKYN商业化生产的生产基地。公司开发管线包括针对眼科高未满足医疗需求的基于腺相关病毒(AAV)的基因疗法。

Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. For more information, visit www.abeonatherapeutics.com..

Abeona的新一代AAV衣壳正在被评估,以改善多种严重疾病的趋向性特征。欲了解更多信息,请访问www.abeonatherapeutics.com。

ZEVASKYN™, Abeona Assist™, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.

ZEVASKYN™、Abeona Assist™、Abeona Therapeutics® 及其相关标志是 Abeona Therapeutics Inc. 的商标。

Media:

媒体:

Caroline Chambers

卡罗琳·钱伯斯

CPR Communications

心肺复苏通讯

cchambers@cpronline.com

cchambers@cpronline.com

201.641.1911 x 21

201.641.1911 分机 21

Source: globenewswire.com

来源:globenewswire.com