Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection

Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy.
Methods/Aims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI/VI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis.
Perspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway.
Implications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care.
Additionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.

开始日期2025-01-01

申办/合作机构-

NCT06525571 / Not yet recruiting临床3期IIT

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.

开始日期2024-11-04

申办/合作机构

The Johns Hopkins University

[+1]

NCT05600322 / Completed临床3期

A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.

开始日期2022-11-03

申办/合作机构

Photocure ASA

[+2]

100 项与盐酸六氨基-γ-酮戊酸相关的临床结果

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100 项与盐酸六氨基-γ-酮戊酸相关的转化医学

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100 项与盐酸六氨基-γ-酮戊酸相关的专利（医药）

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192

项与盐酸六氨基-γ-酮戊酸相关的文献（医药）

2024-10-01·European Urology

Re: Immune Contexture Changes Following Blue Light Cystoscopy with Hexaminolevulinate in Bladder Cancer

Article

作者: Gakis, Georgios

2023-12-31·Journal of Medical Economics

A cost-consequences and budget impact analysis of blue light-guided cystoscopy with Hexvix in patients diagnosed with non-muscle-invasive bladder cancer in France

Article

作者: Belsey, Jonathan

AIMSFrench guidelines for the management of non-muscle-invasive bladder cancer recommend that blue-light cystoscopy should be used in patients where the risk of missing residual tumor is highest. Despite evidence for its cost-effectiveness, budgetary concerns have limited uptake in France. The aim of this analysis was to model the cost-consequences of adopting the recommendations in a French urology unit.MATERIALS AND METHODSA budget impact model was developed in Excel, using a decision tree approach derived from guidelines issued by L'Academie franҫaise d'urologie. Risk profiles were derived from an analysis of studies using white-light cystoscopy; estimates for the impact of blue-light cystoscopy were derived from a published Cochrane Review. Costs were based on published tariff prices from L'Agence Technique de L'Information sur L'Hospitalisation. The model allowed results to be tailored to activity levels and projected blue-light usage in the chosen urology unit.RESULTSTwo scenarios were evaluated, based on a 3-year time horizon. Full implementation of all recommendations within a large public hospital was estimated to yield incremental costs of €269 per procedure (∼10% increase overall); a more targeted approach within a smaller private hospital yielded incremental costs of €133 per procedure (5% increase overall).LIMITATIONSThe basis of the model is a change in the time to first recurrence. There are no data available for subsequent recurrences or progression, both of which could have an influence on expenditure. Secondly, recurrence rates for blue-light cystoscopy were not specifically available for each patient group identified in the guidelines: extrapolation of data may have resulted in bias. Finally, the data were derived from clinical trials, which may not be generalisable to real-world clinical practice.CONCLUSIONSThe model has shown that the additional expenditure required to implement blue-light cystoscopy is modest and not disproportionate to the overall cost of care.

2023-12-01·European Urology Open Science

Immune Contexture Changes Following Blue Light Cystoscopy with Hexaminolevulinate in Bladder Cancer

Article

作者: Dyrskjøt, Lars ; Elbæk, Sara Kaczor ; Taber, Ann ; Young-Halvorsen, Kristine ; Andreasen, Tine Ginnerup ; Jensen, Jørgen Bjerggaard ; Neijber, Anders

BackgroundTransurethral resection of bladder tumor (TURBT) is a central component in the diagnosis of non-muscle-invasive bladder cancer (NMIBC) and can be guided by several optical imaging techniques for better visualization of lesions.ObjectiveTo investigate if a change in tumor microenvironment (TME) composition could be observed as an effect of hexaminolevulinate (HAL)-assisted blue light cystoscopy (BLC) in TURBT samples from patients with bladder cancer.Design setting and participantsThis was a retrospective study of 40 patients with bladder cancer who underwent either BLC-guided TURBT (n = 20) or white light cystoscopy (WLC)-guided TURBT (n = 20) before radical cystectomy (RC). Tissue samples (n = 80) were collected from paired TURBT and RC specimens for all 40 patients. Tumor tissue was stained using multiplex immunofluorescence and immunohistochemistry.Outcome measurements and statistical analysisImmune cell infiltration was assessed according to the proportions of each immune cell or immune evasion marker and the relative change from TURBT as baseline was calculated. Statistical comparisons between groups were performed using the Wilcoxon rank-sum test or the paired-sample Wilcoxon test.Results and limitationsComparison of relative changes in the TME revealed a significant decrease in stromal infiltration of cytotoxic T cells (p = 0.024), B cells (p = 0.041), and stromal cells expressing PD-1 (p = 0.011) in patients treated with BLC-guided TURBT compared to WLC-guided TURBT.ConclusionsOur pilot study showed that HAL-BLC during TURBT in bladder cancer may influence the immune cell composition and TME.Patient summaryWe investigated the potential therapeutic effect of blue light versus white light for guidance in removing bladder tumors via the urethra in patients with bladder cancer. For blue light guidance, a compound called hexaminolevulinate is used to visualize tumor tissue. We found changes in immune cell composition that may have been influenced by the blue light guidance.

107

项与盐酸六氨基-γ-酮戊酸相关的新闻（医药）

2024-10-24

·亚虹医药

亚虹医药研发开放日成功举办，专精价值驱动未被满足临床需求

中国上海，2024年10月24日 –科创板上市公司亚虹医药（688176.SH）以“专精价值，科创未来”为主题的2024年度研发开放日于10月22日在上海举行，30多名机构人员参加了此次活动。亚虹医药创始人、董事长兼首席执行官潘柯博士在公司研发开放日活动中提到，“创新是战胜内卷，把握中国医药市场快速发展机遇的唯一秘诀。” 潘柯博士表示，亚虹医药专精价值，创新推动，是专注于泌尿生殖系统肿瘤及女性健康的全球化专科创新药公司。截至上半年末，公司主要产品管线拥有13个产品、18个在研项目，其中，研发进度较快的为APL-1706（显影剂）、APL-1702（光动力药械组合产品）两个产品，上市申请均已获受理，处于上市审评审批阶段，商业化进程继续稳步向前。图|亚虹医药创始人、董事长兼首席执行官潘柯博士公司研发策略：差异化，诊疗一体化，同类最佳 FIC/BIC新药已成为我国医药工业产业升级和技术进步积累到一定程度的自然需求，未来，同质化产品将逐渐失去竞争力，FIC/BIC药物的开发能力将成为创新药企的核心竞争力。亚虹医药药化高级总监吴亮博士表示，亚虹医药BIC小分子研发专注疾病领域，专注临床需求，专注靶点研究，专注分子设计，使产品更具差异化竞争优势；同时，公司升级新一代的靶向和AI驱动的药物发现平台，相比传统药物研发，可以减少药物发现及开发所需的时间和资源，加速研发进程，提高产品竞争力。药械组合产品即利用药物递送技术把诊断用或者治疗用药物递送到目标部位，降低药物的系统暴露量，达到在提高安全性的同时，又改进药物的诊断/治疗效果。该类产品是亚虹医药的一个特色，为公司诊疗一体化策略探索方向。亚虹医药药械联用平台负责人黄国锋博士表示，公司在开发的便携式一次性诊断软镜有望填补该领域的空白，同时正在开发的显影速度更快、灵敏度更高的显影技术，可以进一步改进适应性，提高医院/诊所的诊断效率，造福患者和医疗系统。 ADC药物因兼具抗体的高特异性和细胞毒素的高抗肿瘤活性，安全性更加可控，是目前肿瘤治疗领域的热点研究方向之一。2023年至2028年，ADC药物全球市场预计将以约15%的速度增长。亚虹医药新药发现部生物学研究高级副总裁陈峪博士表示，公司ADC团队致力于推动抗体偶联药物（ADC）领域的创新，针对新颖或者已验证的抗体靶点，开发具有专有连接技术的首创或同类最佳的细胞毒性抗体偶联物（ADC）。亚虹医药已建立先进的降解抗体偶联（DAC）平台，期望使公司在ADC有效载荷的下一波创新中处于领先地位。图|亚虹医药2024年度研发开放日活动现场运用光动力学治疗技术，满足女性健康临床需求宫颈癌病因明确，主要由 HPV（人乳头瘤病毒）持续感染所致，同时，从HPV感染进展至浸润性子宫颈癌是个漫长过程，因此宫颈癌完全可防，即通过三级预防措施，即为年轻女性接种HPV疫苗、在适龄女性中开展宫颈癌筛查、及时治疗癌前病变及宫颈癌，可以有效防控并最终实现消除宫颈癌。 “随着近年我国宫颈癌筛查工作的大力开展，越来越多的宫颈癌前病变被早期发现，人群数量庞大的同时呈现年轻化趋势，在生育率下降的大背景下，给处在‘生育力保护’重要窗口期的育龄女性宫颈癌前病变治疗带来新挑战”，复旦大学附属妇产科医院教授、宫颈疾病诊治中心主任、CSCCP副主任委员隋龙教授介绍，“有创性宫颈切除性手术长期以来一直是治疗宫颈癌前病变的经典方法，却无法满足全部临床治疗需求，其原因一是术后并发症可能对女性未来生育带来潜在不利影响，例如早产和流产；二是治疗后仍有可能复发，必须长期管理，然而较大范围的宫颈切除手术可能造成宫颈形态改变，增加术后阴道镜随访的漏诊风险，进而增加了长期管理的难度。因而无论是医生还是患者，都非常期待有效、安全的无创治疗方法尽早获批使用，以帮助适宜的女性患者避免或延缓宫颈创伤。” 同济大学附属皮肤病医院/上海市皮肤病医院教授、同济大学医学院光医学研究所所长、国际光动力协会常务理事王秀丽教授会上介绍，光动力疗法（PDT）可以选择性破坏病变组织，对正常组织损伤轻微，不会引起疤痕，同时恢复快、不良反应少、可重复治疗。而且除了清除病变以外，还可以激发局部免疫作用，这是光动力疗法机制中的独特优势。随着光敏剂和光源技术的发展，PDT得到了广泛应用，目前已用于包括癌症在内多组织器官的疾病诊疗。亚虹医药开发的新型光动力宫颈治疗系统，采用了脂溶性局部光敏剂HAL，增加了组织细胞的吸收率，另外，采用的创新低温光源，可以提高患者的舒适度和耐受性。亚虹医药APL-1702是全球首个非手术治疗宫颈高级别鳞状上皮内病变（HSIL）的集药物和器械为一体的光动力治疗新药产品，有望成为全球首创、中国首发的无创治疗宫颈癌前病变的创新疗法。亚虹医药医学副总监何晓婷表示，该产品是全球首个在国际多中心III期临床试验中获得阳性结果的HSIL治疗产品，结果证实其具有显著的疗效和良好安全性；同时，操作简便，放置之后，患者无需等待即可离开医院。今年9月份，临床试验结果连续入选国际光动力与光诊断大会（PDT&PD）、第27届全国临床肿瘤学大会（CSCO）学术年会，学术界对该产品的高度关注，更体现出APL-1702巨大的临床需求期待和社会价值。专注泌尿生殖肿瘤领域，聚焦未被满足临床需求天津医科大学第二医院泌尿外科膀胱癌学科带头人胡海龙教授表示，经尿道膀胱肿瘤切除术（TURBT）存在一定的局限性，术后复发率较高，并且NMIBC进展成MIBC的风险高，治疗难度增大，患者预后差；同时，NMIBC患者术后复发会增加家庭经济负担，加重患者的心理压力，严重影响生活质量，NMIBC患者术后复发具有多种危险因素。与传统白色光膀胱镜比较，蓝光膀胱镜在诊断和手术方面都显示出巨大的优势，能够显著提高膀胱肿瘤的检出率及减少残存肿瘤复发率，从而改进无复发生存期。亚虹医药APL-1706是目前全球唯一获批的辅助膀胱癌诊断或手术的显影剂类药物，已经在全球30多个国家获批上市。该产品通过与蓝光膀胱镜的联合使用可以有效提高NMIBC的检出率（尤其是原位癌的检出率），使切除手术更完全，从而降低肿瘤复发率。中国目前还没有获批的此类药物上市，APL-1706的获批上市将填补此空白，解决现阶段有指南推荐却没有药物可用的问题。亚虹医药APL-1202是同类首款（First-in-class）进入III期临床开发的口服、可逆性MetAP2抑制剂。9月26日，APL-1202与PD-1抑制剂替雷利珠单抗联合新辅助治疗肌层浸润性膀胱癌（MIBC）II期临床取得积极疗效信号。Allina Health癌症研究所主任兼首席研究官、拉什医学院泌尿科教授、国际泌尿外科学会SIU前主席Baddrinath Konety医学博士表示，在基线由中心病理确诊为MIBC人群（改良可评估分析集，mEAS）中，APL-1202与替雷利珠单抗联用治疗组pCR为41%（9/22），相比替雷利珠单抗单药治疗组pCR值20%（4/20），增加了一倍，显示出可接受的安全性特征。APL-1202+PD-1在疗效/安全性/剂量友好性方面具有竞争力。另外，基于TAIDD平台，公司自主研究开发了新型高选择性、强效的泛素特异性蛋白酶1（USP1）口服小分子抑制剂APL-2302。亚虹医药医学副总监王子甲表示，临床前研究提示APL-2302单药治疗和联合治疗在肿瘤抑制方面表现出良好的体外和体内活性。APL-2302有潜力成为治疗特定生物标志物阳性（如BRCA基因突变等）的晚期实体瘤（乳腺癌、卵巢癌、前列腺癌等）的新选择。关于亚虹医药亚虹医药（股票代码：688176.SH）成立于2010年3月，是一家专注于泌尿生殖系统肿瘤及其它重大疾病领域的全球化创新药公司。秉承“改善人类健康，让生命更有尊严”的企业使命，亚虹医药立志成为在专注治疗领域集研发、生产和商业化为一体的国际领先制药企业，为中国和全球患者提供最佳的诊疗一体化解决方案。公司坚持以创新技术和产品为核心驱动力，通过打造自有的研发平台和核心技术，深入探索药物作用机理，高效率筛选评价候选药物。通过内部完善的研发体系和全球药物开发经验专长，亚虹医药致力于在专注治疗领域推出全球首创（First-in-Class）药物和其它存在巨大未被满足治疗需求的创新药物。同时，亚虹医药通过自主研发和战略合作，围绕泌尿生殖系统疾病进行产品管线的深度布局，高度关注该领域的技术前沿和治疗发展趋势，洞察并挖掘未被满足的临床需求，前瞻性地进行产品规划和生命周期管理，打造涵盖疾病诊断到治疗的优势产品组合，从而造福更多的中国和全球患者。欲了解更多信息，请访问www.asieris.cn。

抗体药物偶联物引进/卖出

2024-10-22

·亚虹医药

亚虹医药与华东理工大学化学与分子工程学院开展光动力平台战略合作

中国上海，2024年10月22日 – 亚虹医药与华东理工大学化学与分子工程学院今日宣布，双方已签署《光动力平台战略合作备忘录》，将基于共同的发展愿景和战略目标，整合双方的技术、人才、资金和市场资源，通过光动力平台和新一代光动力诊断及治疗产品的合作研发，提高双方的科研水平和创新能力，并推进科研成果的产业化，在造福患者的同时，也为双方带来良好的企业口碑和学术声誉，实现互利共赢。图|亚虹医药与华东理工大学化学与分子工程学院签署《光动力平台战略合作备忘录》亚虹医药希望通过此次战略合作，继续在光动力技术应用于肿瘤诊断、早期干预和治疗上取得新的突破，保持国际领先地位。作为聚焦泌尿生殖肿瘤和女性健康的全球化创新药企，亚虹医药在专注领域积累了丰富的光动力研发经验和创新成果，包括全球唯一获批的辅助膀胱癌诊断或手术的显影剂类药物APL-1706，以及全球首创、中国首发的用于非手术治疗宫颈高级别鳞状上皮内病变（HSIL）的光动力药械组合产品APL-1702，上述两个产品的上市申请均已获得国家药品监督管理局受理，目前审评正在进行中。华东理工大学化学与分子工程学院拥有费林加诺贝尔奖科学家联合研究中心、教育部国际合作联合实验室等高端国际合作平台基地，实力雄厚。该平台师资实力雄厚，拥有中国科学院院士、中国科学院外籍院士、欧洲科学院外籍院士、俄罗斯工程院外籍院士等众多国际知名教授资源。在荧光探针分子及化学发光纳米技术、光动力治疗领域具有独特的技术优势和专业的人才团队，希望推动科研成果的转化和应用，以及人才的交叉培养，为院校扩大学术声誉，增强社会影响力。此次战略合作的主要内容包括：围绕院校的光动力技术平台，双方在各自的化合物设计、药效评价方面共同开发科研成果；确定战略合作的技术路线和研发计划，明确职责分工；定期交流和研讨，分享产品信息、科研成果和研发经验；共同制定人才培养计划，提高研发人员的专业水平；亚虹医药负责市场推广策略，整合市场资源，推广合作研发的产品/技术等。图|朱为宏院士与潘柯博士交流在签约仪式上，亚虹医药创始人、董事长兼首席执行官潘柯博士表示：“此次与华东理工大学化学与分子工程学院的合作，是加强亚虹医药在光动力诊断治疗泌尿生殖系统疾病领先地位的重要一步。我们相信，通过双方的紧密合作，将加速新一代光动力诊断治疗技术的研发和商业化进程，造福更多患者。” 中国科学院院士、华东理工大学副校长朱为宏教授也表示：“我们的学院在化学和分子科学领域拥有深厚的研究基础和卓越的人才队伍。与亚虹医药的合作将使我们的科研成果更好地转化为实际应用，同时也为我们的师生提供了宝贵的实践机会。我们期待通过这次合作，共同推动光动力诊疗技术的发展，为社会做出更大的贡献。” 关于华东理工大学化学与分子工程学院华东理工大学化学与分子工程学院瞄准“世界一流”目标，面向“健康医学”等国家重大战略需求，围绕“精准诊疗分子工程”等重点领域，力争打造成为国际知名、特色鲜明的高水平化学化工科学研究、队伍建设和人才培养重要基地。学院多次入选国家“双一流”学科建设，培养了一批杰出学者和具有行业影响力的复合型人才，为国家科技进步、经济建设、国民健康等做出了重要贡献。院校旨在立足化学学科的特色优势，将化学学科建设成为学术研究具有国际先进水平，工科化学教学处于国内领先地位的世界一流、特色鲜明的高水平人才培养与科学研究基地。关于亚虹医药亚虹医药是一家专注于泌尿生殖系统肿瘤及女性健康的全球化创新药公司。秉承“改善人类健康，让生命更有尊严”的企业使命，亚虹立志成为在专注治疗领域集研发、生产和商业化为一体的国际领先制药企业，为中国和全球患者提供最佳的诊疗一体化解决方案。

2024-09-30

·PRNewswire

Photocure Partner Asieris Unveils Cevira (APL-1702) Phase III Subgroup Analysis by Age Groups at the 2024 CSCO Annual Meeting

OSLO, Norway, Sept. 30, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO) , the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated that international multicenter Phase III clinical study data for its non-surgical treatment candidate Cevira® (APL-1702) for cervical High-Grade Squamous Intraepithelial Lesion (HSIL) has been published by the 27th Chinese Society of Clinical Oncology (CSCO) Annual Meeting as a poster, focusing on the analysis of different age subgroups regarding the six-month pathological regression rate and HPV clearance rate. This Phase III clinical trial is a prospective, randomized, double blind, placebo controlled, multi-center clinical study, which has reached its primary efficacy endpoint and exhibited good safety. Furthermore, the study results included the pathological regression rate (defined as the proportion of subjects with a pathological regression to CIN1 or normal tissue) at the 6th month across different age subgroups. Both the "≥20 and <30 years" subgroup and the "≥30 and <40 years" subgroup showed an increase of 15% to 20% in the pathological regression rate in the APL-1702 group compared to the placebo control group. No cervical cancer events were reported, suggesting a significant therapeutic potential of APL-1702 in the HSIL population aged 20 to 40 years. Regarding HPV clearance rate, in the "≥20 and <30 years" age group, the APL-1702 group showed enhancements in the overall HPV clearance rate, HPV16-positive clearance rate, and HPV16/18-positive clearance rate compared to the placebo control group. The patients' number in the "<20 years" and "≥40 years" age groups were limited, thus the results in these age groups require a validation study with a larger sample size. Overall, APL-1702 not only facilitates the regression from HSIL to LSIL but also demonstrates the ability to induce clearance of high-risk HPV infections. Read Asieris' full media release here: Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin. About Cevira® Cevira® (APL-1702) is a photodynamic drug-device combination product in development. Based on the principles of photodynamic therapy, the Cevira product aims to use a photosensitizer in combination with light activation to produce a therapeutic effect as a non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL) in patients aged 18 years and above, excluding carcinoma in situ. Photocure developed Cevira through Phase I and Phase II trials, and the global rights for development and commercialization were out-licensed to Asieris Meditech Co., Ltd in 2019. In November 2020 Asieris initiated the phase III clinical trial for APL-1702 (Cevira) which achieved its primary endpoint in September 2023, Clinical trial number: NCT04484415. The new drug application for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024. About Photocure ASA Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at About Asieris Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl CFO Photocure ASA Tel: +4745055000 Email: [email protected] David Moskowitz Vice President, Investor Relations Photocure ASA Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Photocure WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床2期临床结果ASCO会议临床1期

100 项与盐酸六氨基-γ-酮戊酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04436	-	V04CX	DB06261

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
原位癌	美国	Photocure ASA	2018-02-15
膀胱癌	瑞士	Ipsen SA	2007-11-06

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
宫颈鳞状上皮内病变	申请上市	中国	江苏亚虹医药科技股份有限公司	2024-05-11
宫颈鳞状上皮内病变	申请上市	中国	Asieris Meditech (Hong Kong) Co Ltd	2024-05-11
宫颈鳞状上皮内病变	申请上市	中国	Trettiosjucorp AB	2024-05-11
膀胱癌	申请上市	中国	Patheon Italia SpA	2023-11-29
膀胱癌	申请上市	中国	Photocure ASA	2023-11-29
膀胱癌	申请上市	中国	江苏亚虹医药科技股份有限公司	2023-11-29
膀胱癌	申请上市	中国	Fresenius Kabi Austria GmbH	2023-11-29
妇科疾病	临床1期	挪威	Photocure ASA	2011-08-01
非肌层浸润性膀胱肿瘤	临床1期	丹麦	Photocure ASA	2005-04-01
生殖器疾病	药物发现	挪威	Photocure ASA	2011-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05600322 (CTgov)	临床3期	膀胱癌	158	Richard Wolf Photodynamic Diagnostic Equipment (PDD) system+Hexaminolevulinate Hydrochloride	積廠廠夢積簾鬱廠繭憲(獵構構繭顧窪鹹製窪鏇) = 簾鏇簾範糧構願鹹構憲糧築襯窪餘繭簾遞糧蓋 (膚範鏇襯壓壓鏇網願網, 觸觸網顧積網憲鑰襯壓 ~ 網窪築夢鹹鏇築範鹹簾) 更多	-	2024-10-03
Company_Website 人工标引	临床3期	宫颈鳞状上皮内病变	-	APL-1702 (Age ≥20 and <30)	蓋醖繭壓艱願積壓範簾(糧積遞衊蓋網構鬱衊膚) = 衊繭構襯鹽鑰鹽憲鬱鏇蓋廠遞顧網蓋憲窪餘齋 (構膚觸艱艱餘簾顧醖鏇 ) 更多	积极	2024-09-29
				PBO (Age ≥20 and <30)	蓋醖繭壓艱願積壓範簾(糧積遞衊蓋網構鬱衊膚) = 簾獵鏇餘鏇願簾醖壓餘蓋廠遞顧網蓋憲窪餘齋 (構膚觸艱艱餘簾顧醖鏇 ) 更多
Company_Website 人工标引	临床3期	宫颈鳞状上皮内病变	-	APL-1702	(壓醖糧鏇鑰衊廠積憲構) = 積醖齋遞衊築網網壓觸糧衊憲齋壓製遞衊淵廠 (網觸願窪鏇壓餘獵繭構 ) 更多	积极	2024-09-17
				Placebo	(壓醖糧鏇鑰衊廠積憲構) = 糧鬱蓋繭鑰範選製襯範糧衊憲齋壓製遞衊淵廠 (網觸願窪鏇壓餘獵繭構 ) 更多
PRNewswire 人工标引	临床3期	鳞状上皮内病变	402	Cevira (APL-1702)	(糧獵壓簾鬱膚鹹範願鏇) = 網鬱艱糧襯選蓋選鏇積壓醖製顧壓築鏇襯憲遞 (鹽願遞鹹鹹齋遞獵選鬱 ) 更多	积极	2024-03-18
				Placebo	(糧獵壓簾鬱膚鹹範願鏇) = 鹽製鏇蓋製築糧鹹壓簾壓醖製顧壓築鏇襯憲遞 (鹽願遞鹹鹹齋遞獵選鬱 ) 更多
NCT04484415 (APRICITY, Biospace) 人工标引	临床3期	鳞状上皮内病变	402	Cevira (APL-1702)	(選蓋鏇壓憲鹽廠獵鑰鹽) = 餘築鏇遞築襯積鹽醖觸夢遞艱壓願襯選繭衊鏇 (製蓋鏇醖繭構齋衊觸膚 ) 更多	积极	2024-03-18
				Placebo	(選蓋鏇壓憲鹽廠獵鑰鹽) = 簾壓齋鏇膚觸願鏇廠願夢遞艱壓願襯選繭衊鏇 (製蓋鏇醖繭構齋衊觸膚 ) 更多
NCT03058705 (CTgov)	N/A	膀胱癌	10	Near Infrared Fluorescence (NIRF)+Hexaminolevulinate HCL	壓膚鹽觸鏇選鹹廠網鏇(鑰願遞糧鏇積艱齋齋窪) = 築艱襯餘鑰艱襯鑰鏇醖鏇鏇窪鹹餘繭鏇鬱糧觸 (繭選艱壓選選齋範鏇製, 鹹艱襯壓遞衊積鬱網鏇 ~ 獵壓膚積淵顧醖範齋膚) 更多	-	2019-08-19
MP43-06 (AUA2019)	N/A	非肌层浸润性膀胱肿瘤	208	Blue light cystoscopy with hexaminolevulinate	積壓襯衊蓋蓋餘構醖膚(積淵醖鹹鹹齋夢築廠膚) = 獵襯積積餘願壓顧廠糧蓋鏇憲鑰衊願構遞製衊 (範窪獵壓鏇鏇遞獵壓鹹 ) 更多	-	2019-04-01
NCT02560584 (CTgov)	临床3期	膀胱癌	304	KARL STORZ D-Light C PDD Flexible Videoscope System+Hexaminolevulinate hydrochloride	淵觸觸艱艱構蓋繭窪蓋(夢網繭醖鹽顧鹽鹽鑰範) = 糧蓋鬱構繭鬱鹽鏇範獵選繭願製窪鬱構選壓鬱 (糧夢憲網夢積簾餘鹽廠, 構艱築艱範積鏇夢鹽膚 ~ 糧廠餘憲築襯積顧餘夢) 更多	-	2018-07-02
NCT02560584 \| NCT02660645 (Pubmed \| J Urol)	临床3期	膀胱癌	304	Hexaminolevulinate (Blue light flexible cystoscopy)	繭積膚簾繭網鹹築製製(醖淵襯獵餘鬱繭顧糧糧) = 繭壓蓋膚廠齋選窪積觸衊蓋遞廠膚鬱膚簾衊製 (構繭鑰顧簾膚顧網夢夢, 17.2 ~ 55.7) 更多	-	2018-05-01
				Hexaminolevulinate (White light flexible cystoscopy)	鹽築醖衊願遞鏇衊醖鬱(積顧壓醖構鹽願積簾齋) = 範網網鑰鏇衊範簾鹹壓顧鹹築醖選鹹積蓋範糧 (築衊鏇簾糧築艱夢夢廠 )
NCT02149342 (CTgov)	临床1/2期	光化性角化病	14	Hexylaminolaevulinate Cream (Hexylaminolaevulinate Cream)	廠網膚積繭構積網築鹹(鬱蓋遞夢鑰觸窪窪鏇糧) = 淵簾糧製遞憲築簾構鹹衊獵顧築網繭窪糧鏇製 (顧膚鏇窪膚鑰齋築餘願, 選窪廠醖顧選餘襯築醖 ~ 襯艱壓夢構憲鏇艱選製) 更多	-	2016-07-11
				Methylaminolaevulinate Cream (Methylaminolaevulinate Cream)	廠網膚積繭構積網築鹹(鬱蓋遞夢鑰觸窪窪鏇糧) = 餘鏇鬱網築襯憲蓋觸遞衊獵顧築網繭窪糧鏇製 (顧膚鏇窪膚鑰齋築餘願, 艱醖廠憲艱網醖範壓鏇 ~ 觸艱衊襯鏇鏇艱衊襯壓) 更多