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 announced the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)..

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，今天宣布美国食品和药物管理局（FDA）接受该公司针对UGN-103的研究性新药（IND）申请，UGN-103是一种用于治疗低度中度风险非肌肉浸润性膀胱癌（LG-IR-NMIBC）的下一代新型丝裂霉素制剂。。

The UGN-103 formulation uses UroGen’s RTGel® platform technology, a proprietary sustained-release, reverse-thermal hydrogel that can improve the therapeutic profiles of existing drugs. UGN-103 is anticipated to provide several advantages related to production, cost, supply, and product convenience if approved.

UGN-103制剂使用UroGen的RTGel®平台技术，这是一种专有的缓释反向热水凝胶，可以改善现有药物的治疗效果。如果获得批准，UGN-103预计将在生产、成本、供应和产品便利性方面提供多项优势。

UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 for the treatment of LG-IR-NMIBC, a highly recurrent disease..

UroGen计划于2024年启动一项3期研究，以探索UGN-103治疗高度复发性疾病LG-IR-NMIBC的安全性和有效性。。

“We are delighted by the FDA's acceptance of our IND for UGN-103, marking a significant step forward in our mission,” said Liz Barrett, President and Chief Executive Officer of UroGen. “We eagerly anticipate commencing a clinical trial with UGN-103 this year, as we strive to continually advance and develop treatments for patients with high unmet need.”.

UroGen总裁兼首席执行官利兹·巴雷特（LizBarrett）表示：“我们很高兴FDA接受了我们针对UGN-103的IND，这标志着我们的使命向前迈出了重要的一步。”。“我们热切期望今年开始UGN-103的临床试验，因为我们努力不断推进和开发针对高度未满足需求患者的治疗方法。”。

UGN-103 is planned to follow the anticipated FDA approval and launch of UGN-102 (mitomycin) for intravesical solution for LG-IR-NMIBC. UroGen intends to complete the rolling new drug application (NDA) submission for UGN-102 in September 2024, with a potential FDA decision as early as the first quarter of 2025 if priority review is granted by FDA..

UGN-103计划遵循预期的FDA批准并推出用于LG-IR-NMIBC膀胱内溶液的UGN-102（丝裂霉素）。UroGen计划于2024年9月完成UGN-102的滚动新药申请（NDA）提交，如果FDA批准优先审查，最早可能在2025年第一季度做出FDA决定。。

About UGN-103

关于UGN-103

UGN-103 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin being developed for the treatment of LG-IR-NMIBC. UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024. Anticipated advantages of UGN-103 include a new 80 mg mitomycin dosage strength that may considerably shorten the manufacturing process, simplify the reconstitution procedure, and potentially extend intellectual property protection until as late as December 2041.

用于膀胱内溶液的UGN-103（丝裂霉素）是一种创新的丝裂霉素药物制剂，正在开发用于治疗LG-IR-NMIBC。UroGen计划在2024年启动一项3期研究，以探索UGN-103的安全性和有效性。UGN-103的预期优势包括新的80 mg丝裂霉素剂量强度，这可能会大大缩短制造过程，简化重组程序，并可能将知识产权保护延长至2041年12月。

UGN-103 will utilize UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means..

UGN-103将利用UroGen专有的RTGel®技术，这是一种基于水凝胶的缓释制剂，旨在使膀胱组织更长时间暴露于丝裂霉素，从而能够通过非手术手段治疗肿瘤。。

About UGN-102

关于UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

用于膀胱内溶液的UGN-102（丝裂霉素）是丝裂霉素的创新药物制剂，目前处于用于治疗LG-IR-NMIBC的3期开发中。UGN-102利用UroGen专有的RTGel®技术，一种基于水凝胶的缓释制剂，旨在使膀胱组织更长时间暴露于丝裂霉素，从而能够通过非手术手段治疗肿瘤。

UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting an NDA for UGN-102 in September 2024 and a potential FDA decision as early as the first quarter of 2025..

UGN-102在门诊使用标准导尿管输送给患者。假设ENVISION第三阶段研究的反应终点的持久性得到了积极的发现，UroGen预计将于2024年9月提交UGN-102的NDA，并最早于2025年第一季度提交FDA的潜在决定。。

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。