PARSIPPANY, N.J. & KING OF PRUSSIA, PA.--(BUSINESS WIRE)--Ferring Pharmaceuticals and SK pharmteco today announced an agreement to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical non-replicating gene therapy ADSTILADRIN (nadofaragene firadenovec-vncg) for ensuring long-term future supply.

新泽西州帕西帕尼（PARSIPPANY）和宾夕法尼亚州普鲁士国王（KING OF PRUSSIA），宾夕法尼亚州（BUSINESS WIRE）--费林制药公司（Ferring Pharmaceuticals）和SK pharmteco公司（SK pharmteco）今天宣布达成协议，扩大费林膀胱内非复制基因治疗药物阿德替拉林（nadofaragene firadenovec vncg）的商业生产能力，以确保未来的长期供应。

Following technology transfer, SK pharmteco, a contract development manufacturing organization (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. Food and Drug Administration (FDA)..

技术转让后，合同开发制造组织（CDMO）SK pharmteco将被认定为该药物制造、测试和发布的另一来源，并获得美国食品和药物管理局（FDA）的监管批准。。

ADSTILADRIN was approved by the FDA in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.1

ADSTILADRIN于2022年12月被FDA批准用于高危卡介苗（BCG）无反应性非肌层浸润性膀胱癌（NMIBC）伴原位癌（CIS）伴或不伴乳头状肿瘤的成年患者

This additional scale up and diversification of drug substance capacity demonstrates Ferring’s commitment to securing future long-term supply of ADSTILADRIN to meet the projected commercial growth of its non-replicating gene therapy. In addition to this contract manufacturing agreement, dedicated capacity expansion of ADSTILADRIN is well underway at state-of-the-art facilities in Ferring’s existing site in Finland and its U.S.

药物生产能力的进一步扩大和多样化表明，费林致力于确保未来长期供应ADSTILADRIN，以满足其非复制基因疗法的预期商业增长。除此合同制造协议外，费林公司在芬兰及其美国现有工厂的最先进设施也在积极扩大阿德替拉丁的专用产能。

campus in Parsippany, New Jersey. Ferring will provide updates on the progress of these near-term projects later in 2024..

位于新泽西州帕西帕尼的校园。Ferring将在2024年晚些时候提供这些近期项目进展的最新信息。。

“Ferring takes its responsibilities to patients with high-risk BCG-unresponsive NMIBC very seriously – especially when pioneering in the emerging field of gene therapy commercial manufacturing,” said Bipin Dalmia, Global Head, Uro-Oncology Franchise, Ferring Pharmaceuticals. “Following our January announcement of full availability of ADSTILADRIN across the U.S.

Ferring Pharmaceuticals泌尿肿瘤特许经营全球负责人Bipin Dalmia表示：“Ferring非常认真地对待卡介苗无反应的高危NMIBC患者，尤其是在新兴的基因治疗商业制造领域开拓时。”。“在我们1月份宣布ADSTILADRIN在美国全面上市后。

and expansion of our clinical trials program, this agreement with SK pharmteco comes alongside major investments in our own manufacturing capabilities to assure the breadth of our long-term supply base. Stable and sustainable supply is a vital part of our mission to fill this unmet clinical need for the patients we serve.”.

随着我们临床试验计划的扩大，与SK pharmteco的这项协议伴随着我们对自身制造能力的重大投资，以确保我们长期供应基础的广泛性。稳定和可持续的供应是我们使命的重要组成部分，以满足我们服务的患者未满足的临床需求。”。

The need to scale up supply of strategically important medicines for bladder cancer across geographies is demonstrated by the trend of increased disease prevalence worldwide. The World Bladder Cancer Patient Coalition has reported that bladder cancer became the ninth most common cancer in the world (a rise from tenth) according to new data published in February 2024 (IARC GLOBOCAN 2022)2.

全球疾病流行率增加的趋势表明，需要在不同地区扩大膀胱癌战略重要药物的供应。根据2024年2月发布的新数据（IARC GLOBOCAN 2022），世界膀胱癌患者联盟（World Bladder Cancer Patient Coalition）报告称，膀胱癌已成为世界第九大最常见癌症（从第十位上升）2。

In the United States, it is the seventh most common cancer, fourth among men,3-4 and 75% of bladder cancer presents as NMIBC.5.

在美国，它是第七大最常见的癌症，在男性中排名第四，3-4和75%的膀胱癌表现为NMIBC。

“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy ADSTILADRIN,” said Joerg Ahlgrimm, Chief Executive Officer for SK pharmteco. “Our integrated approach, incorporating customizable clinical and commercial GMP manufacturing solutions with comprehensive in-process testing, quality control, and lot release programs, provides unparalleled support to our partners throughout their product lifecycle and is in perfect alignment with our mission of expediting the delivery of potentially life-saving therapies to patients across the globe.”.

SK pharmteco首席执行官Joerg Ahlgrimm表示：“SK pharmteco很荣幸能与Ferring Pharmaceuticals合作，成为突破性基因疗法ADSTILADRIN的制造商。”。“我们的综合方法将可定制的临床和商业GMP制造解决方案与全面的过程中测试、质量控制和批次发布计划相结合，在我们的合作伙伴的整个产品生命周期中为其提供无与伦比的支持，并且与我们加快向全球患者提供潜在的挽救生命疗法的使命完全一致。”。

SK pharmteco was selected based on their competencies and alignment on core values across the two companies following a thorough assessment of potential CDMOs with gene therapy development and GMP manufacturing capabilities.

在对具有基因治疗开发和GMP制造能力的潜在CDMO进行全面评估后，SK pharmteco是根据两家公司的能力和核心价值观进行选择的。

About ADSTILADRIN

关于ADSTILADRIN

ADSTILADRIN® (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

ADSTILADRIN®（nadofaragene firadenovec vncg）是FDA批准的第一种也是唯一一种膀胱内非复制基因疗法，用于治疗成人高危卡介苗（BCG）-无反应性非肌层浸润性膀胱癌（NMIBC）原位癌（CIS）伴或不伴乳头状肿瘤。

It is a non-replicating adenovirus vector-based therapy containing the gene interferon alpha-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high quantities of interferon alpha-2b protein, a naturally-occurring protein the body uses to fight cancer.

这是一种基于非复制腺病毒载体的疗法，含有干扰素α-2b基因，每三个月通过导管直接进入膀胱局部作为单一疗法给药。该载体进入膀胱壁细胞，释放活性基因，使膀胱细胞壁分泌大量干扰素α-2b蛋白，这是人体用于抗癌的天然蛋白质。

This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer..

这种方法实质上是将膀胱壁细胞转化为干扰素微工厂，增强人体自身对癌症的自然防御能力。。

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-grade, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849).6.

ADSTILADRIN已经在一项临床试验计划中进行了研究，该计划包括157名高度BCG无反应的NMIBC患者，这些患者之前曾接受过足够的BCG治疗，并且没有从额外的BCG治疗中获益（完整纳入标准发表在clinicaltrials.gov上：NCT02773849）。

About Non-Muscle Invasive Bladder Cancer (NMIBC)

关于非肌层浸润性膀胱癌（NMIBC）

NMIBC is a form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.7 In the United States, bladder cancer is the seventh most common cancer, fourth among men3-4, and it is estimated that there will be approximately 83,190 new cases of bladder cancer in the U.S.

NMIBC是一种膀胱癌，存在于膀胱的浅层，没有深入膀胱或扩散到身体的其他部位。7在美国，膀胱癌是第七大最常见的癌症，在men3-4中排名第四，据估计，美国将有大约83190例新发膀胱癌病例。

in 2024.8 Historically, 75% of bladder cancer presents as NMIBC.5 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.8 Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).9.

在2024.8年，历史上，75%的膀胱癌表现为NMIBC。在高危NMIBC患者中，膀胱内卡介苗仍然是一线护理标准。然而，超过50%接受卡介苗初始治疗的患者将在一年内经历疾病复发和进展，许多患者发展为卡介苗无反应性疾病[8]。目前卡介苗无反应患者的治疗选择非常有限，国家综合癌症网络（NCCN）指南建议膀胱切除术（部分或完全切除膀胱）。

INDICATION

指示

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

ADSTILADRIN是一种基于非复制腺病毒载体的基因疗法，适用于治疗高危卡介苗（BCG）-无反应性非肌肉浸润性膀胱癌（NMIBC）伴原位癌（CIS）伴或不伴乳头状肿瘤的成年患者。

About Ferring Pharmaceuticals

关于Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics.

Ferring Pharmaceuticals是一家私营、以研究为导向的专业生物制药集团，致力于建立家庭，帮助人们过上更好的生活。在美国，费林是生殖医学和孕产妇健康以及胃肠病学和骨科领域的领导者。

We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees..

我们处于基于微生物组的治疗和泌尿肿瘤膀胱内基因治疗创新的前沿。我们公司成立于1950年，总部位于瑞士圣普雷克斯。Ferring在全球拥有7000多名员工，其药品在100多个国家销售。Ferring USA总部位于新泽西州帕西帕尼，拥有900多名员工。。

About SK pharmteco

关于SK制药

SK pharmteco is a global contract development and manufacturing organization (CDMO) with 13 offices and manufacturing facilities across the U.S., Europe, and Korea. The company partners with biopharmaceutical companies of all sizes to manufacture Active Pharmaceutical Ingredients (API) and intermediates, cell and gene therapy technologies, registered starting materials, and analytical services for the biopharmaceutical industry worldwide.

SK pharmteco是一家全球合同开发和制造组织（CDMO），在美国、欧洲和韩国设有13个办事处和制造设施。该公司与各种规模的生物制药公司合作，为全球生物制药行业生产活性药物成分（API）和中间体、细胞和基因治疗技术、注册原料和分析服务。