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

/ 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2024-12-20

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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315

项与盐酸六氨基-γ-酮戊酸相关的文献（医药）

2025-04-01·Photodiagnosis and Photodynamic Therapy

Bibliometric analysis of photodynamic research in bladder cancer: Trends and future directions

Review

作者: Sheng, Zhaoyang ; Zeng, Shuxiong ; Zhang, Zhensheng ; Xu, Yang ; Gao, Hongliang ; Xu, Jinshan ; Chen, Guanghua ; Xu, Xi

BACKGROUNDRecent years have seen the use of photodynamic technologies concerning the detection and therapy of bladder cancer (BC) due to their rapid development and well-established therapeutic impact. However, a thorough analysis and bibliometric assessment of photodynamic technologies publishing trends in BC has not been completed yet.METHODSRetrieving bibliographies from the Web of Science Core Collection limited the publication date to December 31, 2023, from January 1, 2004. We used VOSviewer (Version 1.6.19) and CiteSpace (Version 6.4 R1) for both statistical and visualization analysis.RESULTSWe selected a total of 870 documents for analysis. The yearly publication findings show notable upward patterns over the last two decades. The Kochi Medical School in Japan was the most productive school, while the USA was the most productive nation. Japanese researcher Inoue Keiji published the highest number of photodynamic -related articles in BC. The most quoted and prolific journals were the Photodynamic Therapy and Photodiagnosis. According to the keyword analysis, the terms "cystoscopy," "carcinoma in situ," "drug delivery," "follow-up," "hexaminolevulinate," and "impact" are all relatively recent and hot field.CONCLUSIONSOur investigation produced a bibliometric outcome for the field, potentially opening up new research opportunities. We suggest that future research concentrate on in-situ carcinoma identification, photosensitizer invention, medication delivery enhancement, and photodynamic technology follow-up in BC.

2025-02-01·Photodiagnosis and Photodynamic Therapy

Long-term outcome of photodynamic therapy with hexyl aminolevulinate, 5-aminolevulinic acid nanoemulsion and methyl aminolevulinate for low-risk Basal Cell Carcinomas

Article

作者: Grönroos, M ; Snellman, E ; Salmivuori, M ; Räsänen, J ; Tani, T ; Neittaanmäki, N

BACKGROUNDNon-surgical treatments are cost-effective options for low-risk basal cell carcinomas (BCCs) i.e. superficial or small nodular BCCs located outside the high-risk locations. Hexyl aminolevulinate (HAL) and 5-aminolevulinic acid nanoemulsion (BF-200 ALA) with enhanced penetration depth enables the use of lower concentrations compared to methylaminolevulinate (MAL) in photodynamic therapy (PDT). We have previously reported comparable short-term efficacies for MAL 16 %, BF-200 ALA 7.8 % and HAL 2 % in PDT of low-risk BCC, and here we report the long-term results.OBJECTIVESThe goal of this trial was to compare long-term outcomes of HAL and BF-200 ALA, compared to MAL in PDT of low-risk BCCs.METHODSNinety-eight histologically verified low-risk BCCs on the trunk or extremities were included and randomized into three arms to receive PDT in two sessions with MAL, BF-200 ALA or HAL. A blinded dermatologist assessed the response, cosmetic outcome, and obtained biopsies for histological verification at three months, one year and five years. Histologically verified non-responsive lesions were excised. Patients' satisfaction with the treatment was also queried.RESULTSAccording to intention-to-treat (ITT) analyses, the cumulative response rate at one year was 90.6 % for MAL, 81.3 % for BF-200 ALA, and 75.8 % for HAL, and correspondingly at five years 71.9 %, 54.6 % and 60.6 %. There were no statistically significant differences between interventions and comparator. The overall cumulative response rate for PDT was 82.5 % at one year and 62.2 % at five, and 48.6 % of the treatment failures were recorded at five years. The recurrent lesions were excised as second line treatment. No aggressive subtypes were reported, with only superficial or nodular growth in the final histopathological report. There were no significant differences in cosmetic outcome or patient satisfaction.CONCLUSIONSThis trial shows that HAL has potential for dermatological PDT. However, the long-term efficacy of PDT in the treatment of low-risk BCCs remains rather low.

2024-11-01·Photochemistry and Photobiology

Enhancing PDT efficacy in NMIBC: Efflux inhibitor mediated improvement of PpIX levels and efficacy of the combination of PpIX‐PDT and SO‐cleavable prodrugs

Article

作者: Kumbham, Soniya ; Foster, Barbara A. ; Woo, Sukyung ; Rahman, Kazi Md Mahabubur ; Bosmajian, Caroline ; Bist, Ganesh ; You, Youngjae

AbstractProtoporphyrin IX (PpIX)‐based photodynamic therapy (PDT) has shown limited efficacy in nonmuscle‐invasive bladder cancer (NMIBC). To improve PDT efficacy, we developed singlet oxygen‐cleavable prodrugs. These prodrugs, when combined with PpIX‐PDT, induce cancer cell death through both PDT and drug release mechanisms. Inhibition of PpIX efflux was reported to be an effective strategy to improve PpIX‐PDT in certain cancer cells. Our main goal was to investigate whether adding an efflux inhibitor to the combination of PpIX and prodrugs can improve the PpIX levels in bladder cancer cells and the release of active drugs, thus improving the overall efficacy of the treatment. We treated bladder cancer cell lines with lapatinib and evaluated intracellular PpIX fluorescence, finding significantly increased accumulation. Combining lapatinib with prodrugs led to significantly reduced cell viability compared to prodrugs or PpIX‐PDT alone. The effect of lapatinib depended on the expression level of the efflux pump in bladder cancer cells. Interestingly, lapatinib increased paclitaxel (PTX) prodrug uptake by threefold compared to prodrug alone. Adding an efflux inhibitor (e.g., lapatinib) into bladder instillation solutions could be a straightforward and effective strategy for NMIBC treatment, particularly in tumors expressing efflux pumps, with the potential for clinical translation.

125

项与盐酸六氨基-γ-酮戊酸相关的新闻（医药）

2025-03-14

·PRNewswire

New BRAVO Study Publication Reinforces Clinical Benefits of BLC in Reducing Risk of Bladder Cancer Recurrence

OSLO, Norway, March 14, 2025 /PRNewswire/ -- Photocure ASA (OSE: PHO) , the Bladder Cancer Company, announces the publication of the study "Oncologic Outcomes of Blue Light Cystoscopy in an Equal Access Setting: Results of the BRAVO study" in JU Open Plus this week. The research objective was to assess if blue light cystoscopy (BLC®) aided TURBT has an impact on the clinical outcomes of patients with NMIBC*. Results of the real-world evidence study show that BLC was associated with a statistically significant 38% reduction in risk of recurrence compared to white light cystoscopy (WLC) use alone in a predominantly high-risk NMIBC patient cohort. These results are in line with prior results from multiple randomized controlled clinical trials. The BRAVO study (Bladder Cancer Recurrence Analysis in Veterans and Outcomes) is a propensity score matched, retrospective analysis evaluating clinical outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System. 626 patients were included in this study, 313 in each study arm (WLC versus BLC). Outcomes data for BRAVO was measured at a 3-year time point in a predominately high-risk patient population. Median age at diagnosis was 71 years. Median follow-up was 3.7 years. Study results include: Risk of recurrence at 3-years was significantly reduced following BLC vs. WLC (HR, 0.62; 95% CI, 0.45-0.86; p<0.01). The 38% reduction in the risk of recurrence is in line with prior results from multiple randomized controlled clinical trials. A positive trend for reduction in risk of progression was also observed (HR=0.71; 95% CI, 0.37-1.38; p=0.32) at 3-years although not statistically significant due to a low number of patients progressing on the study. The study indicates that use of BLC can drive treatment decisions that lead to improved outcomes. Specifically highlighted in the study was that BLC patients were significantly more likely to receive intravesical BCG therapy (61% vs 43%; p<0.01) or intravesical chemotherapy (48% vs 27%, p<0.01). This data supports reasoning that using BLC enhances a clinician's ability to decide on the appropriate bladder cancer therapy based on precision risk stratification and a more complete TURBT. The Veterans' Affairs (VA) Healthcare system accepts all U.S. Veterans, regardless of financial background, and retains its patients, allowing for high-quality data capture over a long-term follow-up period, therefore serving as a robust real-world model for equal access. "Bladder cancer detection plays an important role in preventing cancer recurrence and optimizing appropriate treatment pathways, as previous research has shown that WLC alone may not comprehensively detect all NMIBCs. In this propensity-score matched cohort study, we found that the use of BLC vs. WLC alone was associated with significantly decreased 38% risk of recurrence. Our results are in line with the recent Cochrane review of nearly 3,000 patients across 15 randomized trials, where the authors found that that BLC may reduce the risk of bladder cancer recurrence by 34%. These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence", said Dr. Steven Williams, Professor and Chief of the Division of Urology, at the University of Texas-Medical Branch, and one of the study authors. "The exciting long-term real-world results from the BRAVO study complement and confirm the generalizability of prior recurrence outcomes with BLC beyond the randomized controlled trial setting, reflecting a routine clinical practice patient population", said Anders Neijber, Chief Medical Officer of Photocure. Read the full publication here: An editorial to the publication can be found here: *NMIBC: Non muscle-invasive bladder cancer 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 Bladder Cancer Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3 Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike. Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4 1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: , accessed [February 2024]. 2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657 3 Sievert KD et al. World J Urol 2009;27:295–300 4 Bladder Cancer. American Cancer Society. About Hexvix®/Cysview® (hexaminolevulinate HCl) Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions. Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to for further information on our commercial partners. The following safety information is solely included to comply with U.S. regulatory requirements: Important Risk & Safety Information for Cysview® (hexaminolevulinate HCl) 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 . CONTACT: 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] 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

临床结果

2025-02-27

·行舟Drug

中国创新药崛起，2025年这些突破值得期待

点击上方的行舟Drug ▲ 添加关注一、国产创新药国际化：从“引进来”到“走出去” 1. License-out爆发式增长，全球价值获认可2024年成为中国创新药出海的关键年份，国内药企License-out（对外授权）项目数量首次超过License-in（引进授权），交易金额屡创新高。如：百利天恒的EGFR/HER3双抗ADC药物BL-B01D1，以8亿美元首付款授权给BMS，创下国产ADC单药交易纪录；康方生物的PD-1/VEGF双抗依沃西单抗，以50亿美元总金额授权给Summit Therapeutics，刷新国产双抗出海纪录；科伦博泰的TROP2 ADC药物SKB264，通过与默沙东合作，首付款达4700万美元，潜在里程碑付款超百亿美元。 2. 全球竞争力显著提升2024年全球医药交易TOP10中，恒瑞医药、礼新医药、纳里制药三家中企首次上榜。国产项目在MNC（跨国药企）合作中的占比从2020年的不足5%跃升至30%，尤其在ADC、双抗等前沿领域，中国已成为全球重要创新策源地。二、技术突破：ADC、双抗、基因治疗引领全球浪潮 1. ADC药物：从“魔法子弹”到实体瘤克星ADC（抗体偶联药物）通过“精准递送+高效杀伤”机制，成为肿瘤治疗新利器。2024年JPM大会上，中国企业的表现尤为突出：第三代技术主导：国产ADC普遍采用全人源化抗体+DNA损伤剂（如DXd）组合，显著提升疗效。科伦博泰的SKB264、荣昌生物的维迪西妥单抗等已进入全球研发第一梯队。适应症拓展：从血液瘤转向乳腺癌、肺癌等大适应症。恒瑞医药的HER2 ADC药物SHR-A1811、信达生物的CLDN18.2 ADC药物IBI343等，均在实体瘤治疗中展现潜力。联合治疗突破：ADC与PD-1、化疗等联用方案大幅提升响应率。荣昌生物维迪西妥单抗联合PD-1治疗尿路上皮癌，客观缓解率达75%，疾病控制率超90%。 2. 双抗：中国领跑PD-(L)1赛道双特异性抗体通过同时靶向两个抗原，实现“1+1>2”疗效。中国在PD-(L)1双抗领域已占据先发优势：康方生物的卡度尼利单抗（PD-1/CTLA-4双抗）和依沃西单抗（PD-1/VEGF双抗）双双进入医保，2024年销售额分别突破14亿元和12亿元。临床数据碾压单抗：依沃西单抗一线治疗PD-L1阳性非小细胞肺癌的III期试验中，中位无进展生存期（mPFS）达11.14个月，较K药（帕博利珠单抗）提升91%，疾病进展风险降低49%。 3. 基因治疗：CAR-T、核酸药物突破瓶颈 CAR-T攻克实体瘤：Allogene公司的同种异体CAR-T产品ALLO-316针对肾细胞癌，客观缓解率达18%，为实体瘤治疗打开新路径。核酸药物递送革新：Intellia公司利用CRISPR-Cas9基因编辑技术，直接体内敲除致病基因，治疗遗传性血管性水肿的临床试验中，患者发作率降低98%。国产小核酸崛起：石药集团与阿斯利康合作的ANGPTL3 siRNA药物YS2302018，已进入全球III期临床，有望成为首款国产代谢领域核酸药物。三、政策与商业化：从“实验室”到“患者床边” 1. 医保支付改革释放红利2023年创新药医保支出达900亿元，占比提升至3.19%。2024年国家医保局推动“双通道”机制，加速创新药入院。例如：康方生物的卡度尼利单抗通过医保谈判降价60%，但销量增长300%，实现“以价换量”。 2025年拟推出“双类目录”，商保覆盖高价值创新药（如CAR-T、ADC），进一步缓解支付压力。 2. 企业商业化能力跃升百济神州：2024年前三季度营收191亿元，同比增长49%，泽布替尼全球销售额突破50亿元。信达生物：PD-1信迪利单抗持续放量，2024年新增3个适应症纳入医保，全年营收预计超80亿元。 Biotech盈利拐点：百利天恒凭借ADC授权首付款，2024H1净利润达46.66亿元，实现扭亏为盈。四、2025年展望：这些重磅产品即将上市 2025年预计有超30款国产创新药获批，涵盖肿瘤、自免、代谢等重大领域：恒瑞医药：7款药物冲刺上市，包括HER2 ADC（SHR-A1811）、JAK1抑制剂（SHR0302）。信达生物：GLP-1R/GCGR双靶点药物玛仕度肽（减重适应症）、IL-23单抗（中重度银屑病）。科伦博泰：HER2 ADC（A166）二线治疗乳腺癌、PD-L1单抗（泰特利单抗）治疗鼻咽癌。突破性疗法：亚虹医药的光动力药物APL-1702（宫颈癌前病变）、海创药业的氘代恩扎卢胺（前列腺癌）。五、投资与风险 1. 三大投资主线出海领先者：已实现海外临床或商业化的企业，如百济神州、康方生物、科伦博泰。技术突破型：布局ADC、双抗、基因编辑等前沿领域，如荣昌生物、石药集团、信达生物。商业化放量：2025年医保新品，如恒瑞医药SHR-A1811、迈威生物8MW0511（升白药）。 2. 风险地缘政治风险：美国《生物安全法案》可能限制中国CXO企业；研发失败风险：创新药临床成功率不足10%，需关注管线进展；支付端压力：医保控费常态化，部分品种可能面临降价压力。结语：中国创新药的“黄金十年” 从PD-1内卷到ADC、双抗引领全球，中国药企正完成从“仿制跟随”到“源头创新”的蜕变。政策、资本、人才的三重共振下，2025年或将成为中国创新药国际化的爆发元年。未来，能否诞生世界级药企，不仅取决于技术突破，更需构建从研发到商业化的全产业链能力。中国创新药的“DeepSeek时刻”，已然到来。文章信息源于公众号小白学药，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug 每日更新欢迎订阅+ 医药大数据|行业动态|政策解读

引进/卖出临床3期抗体药物偶联物免疫疗法细胞疗法

2025-02-19

·PRNewswire

Photocure ASA: Results for the fourth quarter of 2024

OSLO, Norway, Feb. 19, 2025 /PRNewswire/ -- Photocure ASA (OSE:PHO) today reported Hexvix®/Cysview® revenues of NOK 128.6 million in the fourth quarter of 2024 (Q4 2023: NOK 114.2 million) and EBITDA of NOK 8.5 million (NOK 29.9 million). Photocure expects product revenue growth in the range of 7% to 11% and year-over-year EBITDA improvement in 2025. While the company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestones this year. "We delivered strong performance in the fourth quarter of 2024 with 13% growth in Hexvix/Cysview revenue, 11% unit sales growth, and EBITDA of NOK 8.5 million. For the full-year 2024, we grew product revenue by 10% and generated EBITDA of NOK 49.2 million. We continue to execute on growing our Hexvix/Cysview business and have consistently produced positive EBITDA over the last 7 quarters," says Dan Schneider, President & Chief Executive Officer of Photocure. Photocure reported total group revenues of NOK 141.7 million in the fourth quarter of 2024 (NOK 142.5 million), and EBITDA* of NOK 8.5 million (Q4 2023: NOK 29.9 million), while Hexvix/Cysview revenues grew to NOK 128.6 million in the quarter (NOK 114.2 million). The EBIT was NOK 1.2 million (NOK 22.5 million) and the cash balance at the end of the period was NOK 293.8 million (NOK 259.5 million). At the end of the fourth quarter of 2024, the installed base of rigid blue light cystoscopy (BLC®) systems in the U.S. was 390, up 11% since the same period in 2023. This includes 18 ForTec Medical mobile towers. Photocure estimates that 25 flexible BLC towers remain in the U.S. market. During the quarter, Olympus launched its high-definition blue light cystoscopy upgrade for its state-of-the-art Viscera Elite III endoscopic platform, which Photocure believes will increase the use of Hexvix in certain Nordic countries and elsewhere in Europe. Also, subsequently in February, Photocure provided an update from its collaboration with Richard Wolf disclosing that a flexible BLC interim solution is now available in Europe. "We remain focused on the growth of our business and investing in opportunities that can take Photocure to the next level in 2025. Supporting our expected growth this year, our U.S. business is performing well as we continue to increase the base of active accounts using BLC, and mobile tower adoption is anticipated to outweigh remaining declines in flexible BLC usage. New therapeutics entering the market to treat NMIBC** are expected to continue raising the awareness of precision bladder cancer management and emphasizing the importance of better detection with BLC and Hexvix/Cysview. Additionally, the launch of Olympus' upgraded BLC equipment in Europe is now underway, and our partnership with Richard Wolf is progressing well with a flexible BLC interim solution available sooner than expected," Schneider adds. Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. Photocure expects product revenue growth in the range of 7% to 11% and YoY EBITDA improvement in 2025. While the Company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestones this year. "We reported our strongest revenue ever in Q4 2024, and our full year revenue and EBITDA results demonstrate Photocure's ability to execute through headwinds, generate growth and create significant opportunities for the Company," Schneider concludes. Please find the full financial report and presentation enclosed. EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the fourth quarter 2024 financial report on page 23. The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at . Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CET. The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through The presentation is scheduled to conclude at 14:45 CET. NMIBC**: Non muscle-invasive bladder cancer For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl Chief Financial Officer Tel: +47 450 55 000 Email: [email protected] David Moskowitz Vice President of Investor Relations Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] 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 . All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This stock exchange announcement was published by Tolv Hillestad, Group Controller, Photocure ASA, on 19 February 2025 at 08:00 CET. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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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

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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	瑞典	Photocure ASA	2005-03-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
宫颈上皮内瘤样病变	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	Trettiosjucorp AB	2024-05-11
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
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	Fresenius Kabi Austria GmbH	2023-11-29
非肌层浸润性膀胱肿瘤	临床前	加拿大	Photocure ASA	2005-01-01
非肌层浸润性膀胱肿瘤	临床前	德国	Photocure ASA	2005-01-01
非肌层浸润性膀胱肿瘤	临床前	荷兰	Photocure ASA	2005-01-01

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临床结果

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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


NCT04484415 (NEWS) 人工标引	临床3期	宫颈鳞状上皮内病变	-	APL-1702	(膚醖糧淵築繭艱鏇構餘) = 襯鬱製積艱齋齋齋築鬱遞齋繭糧鹹憲鑰遞鑰觸 (餘齋糧衊製製糧獵選淵 ) 更多	积极	2024-11-12
				Placebo	(膚醖糧淵築繭艱鏇構餘) = 顧蓋製壓觸齋簾醖憲簾遞齋繭糧鹹憲鑰遞鑰觸 (餘齋糧衊製製糧獵選淵 ) 更多
NCT05600322 (CTgov)	临床3期	膀胱癌	158	Richard Wolf Photodynamic Diagnostic Equipment (PDD) system+Hexaminolevulinate Hydrochloride	遞壓網築範範鬱糧醖製(簾製願糧壓製襯獵蓋襯) = 壓遞衊網餘遞網窪積簾範遞齋範壓顧築壓廠淵 (鏇鹽糧衊範鑰糧憲廠窪, 鏇壓衊齋簾範鬱積獵鹹 ~ 選夢鹽獵齋鹹簾膚築壓) 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)	襯壓艱壓網遞壓願願憲(餘齋鹽簾廠壓蓋醖顧蓋) = 選觸築築繭廠艱蓋淵選鬱繭鹹餘夢築範鬱醖壓 (鏇築窪廠遞夢蓋鹽觸鑰 ) 更多	积极	2024-09-29
				PBO (Age ≥20 and <30)	襯壓艱壓網遞壓願願憲(餘齋鹽簾廠壓蓋醖顧蓋) = 艱選積鹽襯廠壓鹹醖廠鬱繭鹹餘夢築範鬱醖壓 (鏇築窪廠遞夢蓋鹽觸鑰 ) 更多
Company_Website 人工标引	临床3期	宫颈鳞状上皮内病变	-	APL-1702	(夢顧鹹襯憲選鬱襯築選) = 簾齋鹽齋淵鹹餘餘醖積餘鏇構觸齋衊網窪壓鹹 (醖簾醖窪糧夢膚製廠簾 ) 更多	积极	2024-09-17
				Placebo	(夢顧鹹襯憲選鬱襯築選) = 鏇鬱範鹽膚廠構製廠範餘鏇構觸齋衊網窪壓鹹 (醖簾醖窪糧夢膚製廠簾 ) 更多
NCT04484415 (PRNewswire) 人工标引	临床3期	鳞状上皮内病变	402	Cevira (APL-1702)APL-1702)	(憲窪齋積構範觸簾餘鏇) = 繭醖觸鬱築網願構夢積淵窪窪願構鹹構窪鏇淵 (艱積顧壓夢襯醖廠醖糧 ) 更多	积极	2024-03-18
				Placebo	(憲窪齋積構範觸簾餘鏇) = 繭廠憲廠鏇鹽蓋襯鹽獵淵窪窪願構鹹構窪鏇淵 (艱積顧壓夢襯醖廠醖糧 ) 更多
NCT04484415 (APRICITY, Biospace) 人工标引	临床3期	鳞状上皮内病变	402	Cevira (APL-1702)	(淵鬱製獵願艱選艱膚齋) = 廠憲艱鏇壓醖觸衊簾築淵簾繭築鏇糧範遞鏇製 (憲艱願襯衊積觸製憲構 ) 更多	积极	2024-03-18
				Placebo	(淵鬱製獵願艱選艱膚齋) = 獵夢顧繭膚糧襯築餘艱淵簾繭築鏇糧範遞鏇製 (憲艱願襯衊積觸製憲構 ) 更多
NCT03058705 (CTgov)	N/A	膀胱癌	10	Near Infrared Fluorescence (NIRF)+Hexaminolevulinate HCL	齋醖餘鑰觸衊壓糧網憲(觸醖築廠願築廠蓋簾獵) = 蓋廠願觸壓鹹築壓餘網夢鬱壓積願鬱願願窪願 (築繭願膚蓋觸築醖憲鹽, 願願鏇憲遞簾淵選網艱 ~ 鏇網醖膚網鑰觸糧繭範) 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	壓選襯觸選艱淵夢醖願(構艱糧選鹹鏇製醖壓製) = 齋廠憲築鹹願選築觸餘糧願網觸製糧獵鑰糧獵 (觸餘膚鏇繭淵壓範鬱獵 ) 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	餘窪範選鹹選艱鹽遞蓋(鹹願醖製網衊艱夢顧鏇) = 選鹹壓餘壓簾遞願鹹鏇醖網獵選遞壓築鬱醖觸 (築鹽鑰鹹糧艱鏇獵獵窪, 鏇廠鏇衊糧廠壓顧襯鑰 ~ 範廠襯醖廠選夢鹽窪鬱) 更多	-	2018-07-02
NCT02560584 \| NCT02660645 (Pubmed \| J Urol)	临床3期	膀胱癌	304	Hexaminolevulinate (Blue light flexible cystoscopy)	積衊觸鏇鑰簾醖蓋網鹽(顧鹹醖膚襯齋鹽構艱鏇) = 構積構鹹觸鹹觸艱繭廠憲糧衊鑰獵簾網顧壓壓 (鹹鬱衊襯艱窪淵獵餘廠, 17.2 ~ 55.7) 更多	-	2018-05-01
				Hexaminolevulinate (White light flexible cystoscopy)	遞餘製蓋醖鑰壓窪鹽窪(淵獵選築觸構糧淵簾範) = 淵遞簾獵獵觸餘襯遞網繭選鹹鹽築夢襯築鑰鬱 (壓蓋獵構鹹鏇蓋觸鬱獵 )