New Drug Application supported by results from the Phase 2b SunRISe-1 study

由2b期SunRISe-1研究结果支持的新药申请

RARITAN, N.J.

拉里坦，新泽西州

,

，

July 17, 2025

2025年7月17日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review to the New Drug Application (NDA) filed for TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors..

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布，美国食品药品监督管理局 (FDA) 已授予 TAR-200 的新药申请 (NDA) 优先审查资格。TAR-200 是一种膀胱内注射的吉西他滨释放系统，用于治疗卡介苗 (BCG) 无反应的高风险非肌层浸润性膀胱癌 (HR-NMIBC) 原位癌 (CIS) 患者，无论是否伴有乳头状肿瘤。

'TAR-200 represents an innovation in drug delivery that has not been seen in decades,' said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. 'The FDA Priority Review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer.'.

“TAR-200代表了数十年来未见的药物递送创新，”约翰逊约翰逊创新医药公司全球治疗领域负责人、肿瘤学博士Yusri Elsayed（医学博士、健康科学硕士、哲学博士）表示。“TAR-200获得FDA优先审查，彰显了我们从根本上改变泌尿科医生治疗某些类型膀胱癌方式的使命。”

The regulatory submission is supported by data from the Phase 2b SunRISe-1 study, which demonstrated an 82.4 percent complete response (CR) rate with 52.9 percent of patients remaining cancer-free at least one year or more after achievement of a CR (95 percent confidence interval [CI], 72.6-89.8). The majority of adverse reactions were mild and moderate.

监管提交得到了 2b 期 SunRISe-1 研究数据的支持，该研究显示完全缓解率（CR）为 82.4%，其中 52.9% 的患者在达到完全缓解后至少一年或更长时间内无癌症（95% 置信区间 [CI]，72.6-89.8）。大多数不良反应为轻度至中度。

The most common adverse reactions (≥10 percent) included pollakiuria, dysuria, urinary tract infection, micturition urgency, hematuria, cystitis noninfective, and urinary tract pain. No systemic adverse reactions were reported. The findings were .

最常见的不良反应（≥10%）包括尿频、排尿困难、尿路感染、尿急、血尿、非感染性膀胱炎和尿路疼痛。未报告全身性不良反应。研究结果为 。

presented

呈现

during a plenary session at the April 2025 American Urological Association Annual Meeting.

在2025年4月美国泌尿协会年会的全体会议期间。

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1

Despite advancements, there has been little change in the standard of care for patients with HR-NMIBC for over 40 years, and patients have limited treatment options if initial BCG therapy does not work. TAR-200 is the first and only intravesical drug releasing system (iDRS) designed to provide sustained local delivery of a cancer treatment into the bladder.

尽管已有进展，但四十多年来，HR-NMIBC患者的治疗标准几乎没有变化，如果初始BCG治疗无效，患者可选择的治疗方法有限。TAR-200是首个也是唯一一个膀胱内药物释放系统（iDRS），旨在为膀胱提供持续的局部癌症治疗。

TAR-200 remains in the bladder for three weeks per treatment cycle..

TAR-200 每个治疗周期在膀胱内停留三周。

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1

A healthcare professional places it into the bladder using a co-packaged urinary placement catheter in an outpatient setting in less than five minutes. There is no need for general anesthesia, further monitoring, or other restrictions immediately post-insertion within the healthcare provider's office..

在门诊环境下，医疗专业人员使用同包装的导尿管在不到五分钟的时间内将其置入膀胱。无需全身麻醉，在插入后也无需进一步监测或在医疗机构内施加其他限制。

About TAR-200

关于 TAR-200

TAR-200 is an investigational intravesical gemcitabine releasing system. In January 2025, Johnson & Johnson announced the initiation of a

TAR-200 是一种在研的膀胱内吉西他滨释放系统。2025年1月，强生公司宣布启动一项研究。

new drug application

新药申请

with the FDA for TAR-200 under the Real-Time Oncology Review (RTOR) program. In December 2023, the FDA

在实时肿瘤审评（RTOR）计划下，TAR-200与FDA合作。2023年12月，FDA

granted

授予

Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with NMIBC in .

TAR-200获得突破性疗法认定（BTD），用于治疗对BCG无反应的高风险非肌层浸润性膀胱癌（HR-NMIBC）伴原位癌（CIS）的成年患者，这些患者不适合或选择不接受根治性膀胱切除术。TAR-200的安全性和有效性正在针对非肌层浸润性膀胱癌（NMIBC）患者的二期和三期研究中进行评估。

SunRISe-1

太阳升起-1

,

，

SunRISe-3

太阳升起-3

and

和

SunRISe-5

太阳升起-5

and muscle-invasive bladder cancer (MIBC) in

肌肉浸润性膀胱癌 (MIBC) 在

SunRISe-4

太阳升起-4

.

。

About SunRISe-1, Cohort 2

关于SunRISe-1，第二队列

SunRISe-1 (

日出一号 (

NCT04640623

NCT04640623

), Cohort 2, is a single arm, open-label Phase 2b clinical study evaluating the safety and efficacy of TAR-200 monotherapy for  BCG-unresponsive HR-NMIBC patients with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for, or elected not to undergo, radical cystectomy. The primary endpoint for Cohort 2 is complete response (CR) rate at any time point, and secondary endpoints include duration of response (DOR), safety, overall survival and quality of life..

），队列2，是一项单臂、开放标签的2b期临床研究，评估TAR-200单药治疗对于卡介苗（BCG）无反应的高危非肌层浸润性膀胱癌（HR-NMIBC）伴原位癌（CIS）患者（无论是否伴有乳头状肿瘤）且不适合或选择不接受根治性膀胱切除术的安全性和有效性。队列2的主要终点是任意时间点的完全缓解（CR）率，次要终点包括缓解持续时间（DOR）、安全性、总生存期和生活质量。

About High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)

关于高风险非肌层浸润性膀胱癌（HR-NMIBC）

High-risk non-muscle invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to muscle invasive bladder cancer compared to low-risk NMIBC.

高风险非肌层浸润性膀胱癌 (HR-NMIBC) 是一种非侵袭性膀胱癌，与低风险 NMIBC 相比，它更容易复发或扩散到膀胱内膜（称为尿路上皮）以外，并进展为肌层浸润性膀胱癌。

2,3

2，3

HR-NMIBC is characterized by a high-grade, large tumor size, presence of multiple tumors, and carcinoma in situ (CIS). HR-NMIBC with CIS makes up approximately 10 percent of patients with NMIBC.

高危非肌层浸润性膀胱癌（HR-NMIBC）的特征是高级别、肿瘤体积大、存在多个肿瘤以及原位癌（CIS）。伴有CIS的HR-NMIBC约占NMIBC患者的10%。

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Bacillus Calmette-Guérin (BCG), is an intravesical medication administered directly into the bladder that patients have to hold for a few hours.

卡介苗（BCG）是一种直接注入膀胱的腔内药物，患者需要保留几个小时。

5,6

5，6

BCG is a weakened form of the bacteria found in tuberculosis treatment, and though effective, some patients become unresponsive to it and experience tolerability challenges.

BCG是结核病治疗中使用的一种减毒细菌形式，虽然有效，但部分患者对其失去反应并面临耐受性挑战。

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Radical cystectomy is currently recommended for HR-NMIBC patients who fail BCG therapy; it is a life-altering surgery with a high degree of morbidity and impact on life, and has a post-surgery mortality rate of three to eight percent.

目前，根治性膀胱切除术被推荐用于BCG治疗失败的高危非肌层浸润性膀胱癌患者；这是一种改变生命的手术，具有高度的发病风险和对生活的影响，术后死亡率为3%至8%。

8,9

8,9

Given that HR-NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.

鉴于高危非肌层浸润性膀胱癌 (HR-NMIBC) 通常会影响老年患者，许多患者可能不愿意或不适合接受根治性膀胱切除术。

About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

在强生，我们相信健康就是一切。我们在医疗创新方面的实力使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且更少侵入性，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们具备独特的优势，能够在当今整个医疗解决方案领域进行创新，以提供明日的突破性成果，并对人类健康产生深远影响。

Learn more at .

了解更多，请访问。

https://www.jnj.com/

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

www.innovativemedicine.jnj.com

. Follow us at

关注我们

@JNJInnovMed

@JNJInnovMed

. Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A. and Janssen Scientific Affairs, LLC are Johnson & Johnson companies.

杨森-西拉格国际公司、杨森研发有限责任公司、杨森生物技术公司、杨森全球服务有限责任公司、杨森-西拉格股份有限公司和杨森科学事务有限责任公司均为强生公司旗下企业。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TAR-200. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.

本新闻稿包含《1995年私人证券诉讼改革法》中定义的关于产品开发以及TAR-200潜在益处和治疗影响的“前瞻性声明”。读者被警告不要依赖这些前瞻性声明。这些声明是基于对未来事件的当前预期。

If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A., Janssen Scientific Affairs, LLC and/or Johnson & Johnson.

如果基本假设被证明不准确，或者已知或未知的风险或不确定性成为现实，实际结果可能会与杨森-西拉格国际公司、杨森研究与发展有限责任公司、杨森生物科技公司、杨森全球服务有限责任公司、杨森-西拉格股份有限公司、杨森科学事务有限责任公司和/或强生公司的预期和预测有重大差异。

Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性以及获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手获得的新产品和专利；专利挑战；产品功效或安全隐患导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q.

这些风险、不确定性和其他因素的进一步列表和描述，请参见强生公司最近的年度报告表格10-K，包括标题为“关于前瞻性声明的警示说明”和“项目1A.风险因素”的部分，以及强生公司随后的季度报告表格10-Q。

http://www.sec.gov

http://www.sec.gov

,

，

http://www.jnj.com

http://www.jnj.com

, or on request from

，或应要求从

Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A., Janssen Scientific Affairs, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments..

强生公司。杨森-西拉格国际股份有限公司、杨森研发有限责任公司、杨森生物科技公司、杨森全球服务有限责任公司、杨森-西拉格股份有限公司、杨森科学事务有限责任公司以及强生公司均不承担因新信息、未来事件或发展而更新任何前瞻性声明的责任。

1

1

Jacob, J., et al. TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. 2025 American Urological Association Annual Meeting. April 26, 2025.

Jacob, J. 等。TAR-200 单药治疗卡介苗无反应的高风险非肌层浸润性膀胱癌原位癌患者的 1 年持久性及患者报告结果：SunRISe-1 研究。2025 年美国泌尿协会年会，2025 年 4 月 26 日。

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2

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Grab-Heyne K, Henne C, Mariappan P, 等。中高危非肌层浸润性膀胱癌：流行病学、负担与未满足需求的概述。《肿瘤学前沿》。2023年；13:1170124。

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Lieblich A, Henne C, Mariappan P, Geiges G, Pöhlmann J, Pollock RF。非肌层浸润性膀胱癌的管理：欧洲和英国指南的比较。《泌尿外科杂志》。2018;11(2):144-148。

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美国癌症协会。治疗膀胱癌。引用日期：2025年6月。

https://www.cancer.org/cancer/bladder-cancer/treating.html

https://www.cancer.org/cancer/bladder-cancer/treating.html

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8

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EAU指南。2025年马德里EAU年会发布版。ISBN 978-94-92671-29-5

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9

Marqueen KE, et al.

马奎恩 KE，等。

JNCI Cancer Spectr.

JNCI癌症谱。

2018;2:pky075

2018;2:pky075

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来源：强生公司