PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from a real-world patient cohort review of JELMYTO (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting 2024 in San Antonio, TX.

新泽西州普林斯顿市（商业新闻短讯）--UroGen Pharma Ltd.（纳斯达克：URGN）是一家致力于开发和商业化治疗尿路上皮癌和特殊癌症的新型解决方案的生物技术公司，今天重点介绍了2024年在德克萨斯州圣安东尼奥举行的美国泌尿外科协会会议上提交的对JELMYTO（丝裂霉素）肾盂肾溶液的真实患者队列评估的子分析结果。

The study includes a stepwise approach to retrograde administration of JELMYTO and reports that retrograde administration of JELMYTO in the clinic (n=20) produced a 60% complete response rate in patients and ureteral stents were placed in 25% of patients, which is lower than the rate reported in the pivotal OLYMPUS study..

该研究包括一种逐步逆行服用JELMYTO的方法，并报告说，在临床上逆行服用JELMYTO（n=20）可使患者的完全缓解率达到60%，25%的患者放置了输尿管支架，这低于奥林巴斯关键研究中报道的比率。。

“The retrograde instillation of JELMYTO for the clinical management of low-grade upper tract urothelial cancer is FDA-approved and offers a safe and efficacious mode of administration, and this study in a real-world population adds to the growing body of evidence supporting retrograde administration in appropriate patients,” said Khurshid Ridwan Ghani, MBChB, MS, FRCS, Professor of Urology, Director, Michigan Urological Surgery Improvement Collaborative.

“JELMYTO逆行滴注用于低度上尿路尿路上皮癌的临床治疗已获得FDA批准，并提供了一种安全有效的给药方式，这项在现实世界人群中进行的研究增加了越来越多的证据支持在适当患者中逆行给药，”密歇根泌尿外科改进合作组织主任泌尿学教授Khurshid Ridwan Ghani，MBChB，MS，FRCS说。

“The stepwise approach outlined in this study offers valuable insights into achieving positive efficacy and safety outcomes, in the clinic with the procedure done under local anesthesia, with notable durability of response observed.”.

“本研究中概述的逐步方法为在局部麻醉下进行的手术在临床上取得积极的疗效和安全性结果提供了有价值的见解，并观察到显着的反应持久性。”。

In the OLYMPUS study all enrolled patients (n=71) received retrograde administration of JELMYTO. In the OLYMPUS study 58% (n=41) of patients achieved a complete response, defined as the absence of tumor lesions 3 months after initiation of JELMYTO treatment assessed by urine cytology and ureteroscopy.

在OLYMPUS研究中，所有入选患者（n=71）均接受了JELMYTO的逆行给药。在奥林巴斯研究中，58%（n=41）的患者获得了完全缓解，定义为通过尿细胞学和输尿管镜检查评估的JELMYTO治疗开始后3个月没有肿瘤病变。

Ureteric obstruction* was reported in 58% (n=41) of patients treated with JELMYTO and 88% (n=36) of that subgroup went on to receive ureteral stent placement. For additional information about the retrograde administration of JELMYTO, consult the JELMYTO Instructions for Administration accompanying the Full Prescribing Information..

据报道，58%（n=41）接受JELMYTO治疗的患者出现输尿管梗阻*，其中88%（n=36）的患者继续接受输尿管支架置入术。有关JELMYTO逆行给药的更多信息，请参阅完整处方信息随附的JELMYTO给药说明。。

In this retrospective real-world study, 20 patients with a mean tumor burden of 1.67 cm received at least one dose of JELMYTO via the retrograde mode of administration, of which 16 (80%) completed six instillations. Twelve patients (60%) had a complete response and seven patients (35%) received at least one dose of monthly maintenance therapy, of which five demonstrated durability of response (4 patients remained tumor-free at 14.25-month follow-up and 1 patient at 24 months).

在这项回顾性现实世界研究中，20名平均肿瘤负荷为1.67 cm的患者通过逆行给药方式接受了至少一剂JELMYTO，其中16名（80%）完成了六次滴注。12名患者（60%）完全缓解，7名患者（35%）接受了至少一剂每月维持治疗，其中5名患者表现出持续的反应（4名患者在14.25个月的随访中无肿瘤，1名患者在24个月）。

Six patients (30%) had an adverse event related to the urinary system. Ureteral stents were placed in five patients for stenosis (25%); of which four were transient, with no subsequent obstruction. Only one patient (5%) required permanent stenting. Three patients who were unable to tolerate the retrograde approach had antegrade administration of JELMYTO via a nephrostomy tube..

六名患者（30%）发生了与泌尿系统有关的不良事件。输尿管支架置入5例狭窄患者（25%）；其中四个是短暂的，没有随后的障碍。只有一名患者（5%）需要永久性支架置入术。三名无法耐受逆行入路的患者通过肾造口管顺行给予杰米托。。

'These findings emphasize the versatility of JELMYTO administration and also underscore the significance of continuous research and innovation in elevating treatment standards for urothelial cancers,” remarked Mark Schoenberg, M.D., Chief Medical Officer at UroGen.

UroGen首席医学官马克·勋伯格（Mark Schoenberg）医学博士表示：“这些发现强调了杰尔米托（JELMYTO）给药的多功能性，也强调了不断研究和创新在提高尿路上皮癌治疗标准方面的重要性。”。

The limitations of this sub-analysis include the small sample size, the retrospective design, lack of a control group, and the lack of a centralized pathology review and standardized clinicopathologic assessment.

该子分析的局限性包括样本量小，回顾性设计，缺乏对照组，以及缺乏集中的病理学检查和标准化的临床病理学评估。

To further explore the full potential of JELMYTO for the treatment of patients with upper tract urothelial cancers (UTUC), investigators are in the process of enrolling the prospective and retrospective uTRACT Registry to capture data in a large-scale, standardized manner to report further on patient outcomes following JELMYTO treatment including longitudinal follow-up..

为了进一步探索JELMYTO治疗上尿路上皮癌（UTUC）患者的全部潜力，研究人员正在招募前瞻性和回顾性uTRACT登记处，以大规模，标准化的方式获取数据，进一步报告JELMYTO治疗后患者的结果，包括纵向随访。。

*Includes hydronephrosis, obstructive uropathy, pelvic-ureteric obstruction, ureteric obstruction, ureteric stenosis, and urinary tract obstruction.

*包括肾积水，梗阻性尿路疾病，骨盆输尿管梗阻，输尿管梗阻，输尿管狭窄和尿路梗阻。

About JELMYTO

关于杰尔米托

JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with low grade-UTUC (LG-UTUC). JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding.

用于肾盂肾溶液的JELMYTO®（丝裂霉素）是一种含有丝裂霉素的反向热凝胶，每毫升凝胶含有4毫克丝裂霉素，用于治疗低度UTUC（LG-UTUC）的成年患者。JELMYTO在冷却时是粘性液体，在体温下变成半固体凝胶。该药物在滴注后4至6小时内缓慢溶解，并通过正常的尿流和排尿从尿路中排出。

It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow..

它被批准通过输尿管导管逆行给药或通过肾造口管顺行给药。输送系统允许初始液体涂覆并符合上尿路解剖结构。最终的半固体凝胶允许化学消融疗法在收集系统中保留四到六个小时，而不会立即被尿液稀释或冲走。。

About Upper Tract Urothelial Cancer (UTUC)

关于上尿路上皮癌（UTUC）

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as UTUC. In the U.S., there are approximately 6,000 - 7,000 new or recurrent LG-UTUC patients annually.

尿路上皮癌是全球第九大常见癌症，也是美国男性第八大致命肿瘤。原发性尿路上皮癌的5%至10%起源于输尿管或肾盂，统称为UTUC。在美国，每年约有6000至7000名新发或复发性LG-UTUC患者。

Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse..

大多数病例被诊断为70岁以上的患者，这些老年患者经常面临合并症。UTUC的治疗选择有限，最常见的是内镜手术或肾输尿管切除术（切除整个肾脏和输尿管）。这些治疗可能导致高复发率。。

About UroGen Pharma Ltd.

关于UroGen制药有限公司

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs.

UroGen是一家生物技术公司，致力于开发和商业化治疗尿路上皮癌和特殊癌症的创新解决方案，因为患者应该得到更好的选择。UroGen开发了RTGel®反向热水凝胶，这是一种专有的缓释水凝胶平台技术，有可能改善现有药物的治疗效果。

UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat LG-UTUC and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means.

UroGen的缓释技术旨在使泌尿道组织更长时间暴露于药物，使局部治疗成为潜在的更有效的治疗选择。我们的第一个治疗LG-UTUC的产品和用于低级别非肌肉浸润性膀胱癌患者膀胱内溶液的研究性治疗UGN-102（丝裂霉素）旨在通过非手术手段消融肿瘤。

UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X (Twitter), @UroGenPharma..

UroGen总部位于新泽西州普林斯顿，在以色列运营。访问www.urogen.com了解更多信息，或在X（推特），@UroGenPharma上关注我们。。

APPROVED USE FOR JELMYTO

批准用于JELMYTO

JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

JELMYTO®是一种处方药，用于治疗患有上尿路衬里癌症（包括肾脏）的成年人，称为低度上尿路尿路上皮癌（LG-UTUC）。

IMPORTANT SAFETY INFORMATION

重要安全信息

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

如果你的膀胱或上尿路有洞或撕裂（穿孔），你不应该接受杰米托。

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

在接受杰尔米托之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否：

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.

怀孕或计划怀孕。杰尔米托会伤害你的未出生婴儿。在用杰米托治疗期间，你不应该怀孕。如果您怀孕了，或者认为您在使用杰米托治疗期间可能怀孕了，请立即告诉您的医疗保健提供者。能够怀孕的女性：在使用杰米托治疗期间和最后一剂后6个月内，应使用有效的节育（避孕）。

Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose..

正在接受杰米托治疗的男性：如果你有一位能够怀孕的女性伴侣，你应该在使用杰米托治疗期间以及最后一剂后3个月内使用有效的节育（避孕）。。

are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.

正在母乳喂养或计划母乳喂养。不知道杰米托是否会进入你的母乳。在用JELMYTO治疗期间和最后一次给药后1周内不要母乳喂养。

Tell your healthcare provider if you take water pills (diuretic).

如果你服用水丸（利尿剂），请告诉你的医疗保健提供者。

How will I receive JELMYTO?

我将如何接收杰尔米托？

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.

您的医疗保健提供者会告诉您在每次治疗前服用一种名为碳酸氢钠的药物。

You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

您将每周1次从您的医疗保健提供者处获得JELMYTO剂量，持续6周。重要的是，您必须根据医疗保健提供者的说明接受所有6剂杰米托。如果您错过任何预约，请尽快致电您的医疗保健提供者，重新安排您的预约。

Your healthcare provider may recommend up to an additional 11 monthly doses..

您的医疗保健提供者可能会建议每月增加11剂。。

JELMYTO is given to your kidney through a tube called a catheter.

杰尔米托是通过一种叫做导管的管子送入肾脏的。

During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

在使用杰米托治疗期间，您的医疗保健提供者可能会告诉您服用其他药物或改变您目前服用药物的方式。

After receiving JELMYTO:

收到JELMYTO后：

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.

杰尔米托可能会导致你的尿液颜色从紫色变为蓝色。避免皮肤和尿液接触至少6小时。

To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

要小便，男性和女性应该坐在马桶上，用完后冲洗几次。上完卫生间后，用肥皂和水好好洗手、大腿内侧和生殖器部位。

Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

与尿液接触的衣物应立即清洗，并与其他衣物分开清洗。

JELMYTO may cause serious side effects, including:

杰尔米托可能会引起严重的副作用，包括：

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain.

将尿液从肾脏输送到膀胱的管子肿胀和变窄（输尿管梗阻）。如果您出现肿胀和狭窄，并且为了保护肾脏免受损害，您的医疗保健提供者可能会建议在输尿管中放置一个小塑料管（支架），以帮助肾脏引流。

Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO..

如果您在使用杰米托治疗期间出现侧面疼痛或发烧，请立即告知您的医疗保健提供者。。

Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO..

骨髓问题。JELMYTO会影响你的骨髓，并会导致你的白细胞、红细胞和血小板计数下降。您的医疗保健提供者将在每次治疗前进行血液检查，以检查您在使用杰米托治疗期间的血细胞计数。如果您在使用JELMYTO治疗期间出现骨髓问题，您的医疗保健提供者可能需要暂时或永久停止JELMYTO。。

The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

杰米托最常见的副作用包括：尿路感染、尿中有血、副作用、恶心、排尿困难、肾脏问题、呕吐、疲倦、胃（腹部）疼痛。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1800FDA1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

鼓励您向FDA报告处方药的负面副作用。访问www.fda.gov/medwatch或致电1800FDA1088。您也可以致电1-855-987-6436向UroGen Pharma报告副作用。

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

有关更多信息，请参阅JELMYTO完整的处方信息，包括患者信息。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the results from the real-world study of the retrograde instillation of JELMYTO enhancing the prospects of favorable patient outcomes; the enrollment of the prospective and retrospective data from the uTRACT Patient Registry and plans to analyze and report on such data; the estimated patient population for UTUC and LG-UTUC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options.

本新闻稿包含1995年《私人证券诉讼改革法案》中定义的前瞻性声明，包括但不限于关于JELMYTO逆行滴注的现实世界研究结果的声明，以增强有利患者预后的前景；从uTRACT患者登记处登记前瞻性和回顾性数据，并计划分析和报告这些数据；UTUC和LG-UTUC的估计患者人数；UroGen专有RTGel技术改善现有药物治疗效果的潜力；与其他治疗方案相比，UroGen的缓释技术使局部分娩可能更有效。

These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: results from the real-world study of the retrograde instillation of JELMYTO may not be indicative of results that may be observed in future clinical practice and may differ from additional analysis of the data from the study or uTRACT Patient Registry; potential safety and other complications from JELMYTO use in diverse UTUC patient types; the ability to maintain regulatory approval; the ability to obtain and maintain adequate intellectual property rights and adequately protect and enforce such rights; complications associated with commercialization activities; UroGen’s RTGel technology may not perform as expected; and UroGen may not successfully develop and receive regulatory approval of any other product that incorporates UroGen’s RTGel technology.

这些陈述受到许多风险，不确定性和假设的影响，包括但不限于：JELMYTO逆行滴注的现实世界研究结果可能无法表明未来临床实践中可能观察到的结果，并且可能不同于对研究或uTRACT患者登记处数据的额外分析；JELMYTO在不同UTUC患者类型中使用的潜在安全性和其他并发症；保持监管批准的能力；获得和维护适当知识产权的能力，以及充分保护和执行此类权利的能力；与商业化活动相关的并发症；UroGen的RTGel技术可能无法按预期运行；UroGen可能无法成功开发并获得监管部门批准的任何其他包含UroGen RTGel技术的产品。

In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Annual Report on Form 10-K for the year.

鉴于这些风险和不确定性，以及UroGen年度报告10-K表中风险因素部分描述的其他风险和不确定性。