他拉泊芬钠(Talaporfin Sodium) - 在研适应症：食管癌，脑癌，肺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Aptocine、Leserfin、Litx

+ [14]

靶点-

作用方式-

作用机制

光敏剂

治疗领域

肿瘤神经系统疾病消化系统疾病+ [1]

在研适应症

食管癌脑癌肺癌

非在研适应症

年龄相关性黄斑变性乳腺癌心血管疾病+ [20]

原研机构

Meiji Seika Pharma Co., Ltd.

在研机构

Meiji Seika Pharma Co., Ltd.

非在研机构

Light Sciences Oncology, Inc.Light Sciences, Inc.

权益机构-

最高研发阶段批准上市

首次获批日期

日本 (2003-10-16),

肺癌

最高研发阶段(中国)-

特殊审评孤儿药 (日本)

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结构/序列

分子式C38H41N5Na4O9

InChIKeyDSZWCAQEOJGGCM-LBARBQQXSA-N

CAS号220201-34-3

关联

29

项与他拉泊芬钠相关的临床试验

JPRN-jRCTs041230002

/ Suspended临床2/3期IIT

Specified clinical study of the effects of photodynamic therapy using ME2906 and PNL6405CIN for patients with cervical intraepithlial neoplasia on vaginal bacteria

开始日期2023-04-05

申办/合作机构-

JPRN-jRCT2041220118

/ Recruiting临床1/2期IIT

Phase1/2 study of endoscopic photodynamic therapy using ME2906 and ultrathin PDT probe in unresectable bile duct cancer

开始日期2023-02-03

申办/合作机构-

JPRN-jRCT2021220040

/ Recruiting临床2期IIT

Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405SCT for patients with malignant spinal cord tumor.

开始日期2023-01-12

申办/合作机构-

100 项与他拉泊芬钠相关的临床结果

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100 项与他拉泊芬钠相关的转化医学

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100 项与他拉泊芬钠相关的专利（医药）

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302

项与他拉泊芬钠相关的文献（医药）

2026-01-01·Digestive Endoscopy

Clinical Outcomes and Prognostic Factors in Patients Undergoing Salvage Endoscopic Therapy for cT1N0M0 Local Failure After Chemoradiotherapy for Esophageal Cancer: A Multicenter Retrospective Study

Article

作者: Ono, Hiroyuki ; Shinmura, Kensuke ; Inaba, Atsushi ; Sunakawa, Hironori ; Nakajo, Keiichiro ; Yano, Tomonori ; Yamashita, Hiroki ; Kadota, Tomohiro ; Minamide, Tatsunori

ABSTRACT:

Objectives:

Salvage endoscopic therapy is increasingly recommended for localized, superficial failure at the primary site after chemoradiotherapy for esophageal squamous cell carcinoma. This multicenter retrospective study aimed to evaluate the clinical outcomes and prognostic factors associated with overall survival in patients who underwent salvage endoscopic therapy for cT1N0M0 local failure after chemoradiotherapy or radiotherapy for esophageal squamous cell carcinoma.

Methods:

We retrospectively analyzed patients with cT1N0M0 local failure after chemoradiotherapy or radiotherapy who underwent endoscopic resection or photodynamic therapy using talaporfin sodium at two Japanese institutions between 2012 and 2021. Clinical outcomes and prognostic factors for overall survival were assessed using multivariate analysis.

Results:

Complete resection was achieved in 63 of 84 patients (75%) who underwent endoscopic resection, and a local complete response was achieved in 50 of 81 patients (62%) who underwent photodynamic therapy. During a median follow‐up of 34 months (range, 2–109 months), 3‐year overall survival, disease‐specific survival, local recurrence‐free survival, and esophagectomy‐free survival rates were 79%, 88%, 54%, and 79%, respectively. A high Charlson Comorbidity Index (≥ 3; hazard ratio: 3.3) was significantly associated with poor overall survival (3‐year overall survival rate: 64%), although the 3‐year disease‐specific survival in this group remained high at 94%.

Conclusions:

We clarified the clinical outcomes and prognosis of salvage endoscopic therapy for cT1 local failure. The Charlson Comorbidity Index may serve as a useful prognostic factor to aid in clinical decision‐making.

2025-12-01·JOURNAL OF NEURO-ONCOLOGY

Photodynamic therapy for glioblastoma: a narrative review

Review

作者: Huq, Sakibul ; Colan, Jhair ; Hadjipanayis, Constantinos ; Frederico, Stephen C ; Rentzeperis, Frederika ; Price, Gabrielle

PURPOSE:

Glioblastoma (GBM) remains one of the most aggressive primary brain tumors with poor survival outcomes and a lack of approved therapies. A promising novel approach for GBM is the application of photodynamic therapy (PDT), a localized, light-activated treatment using tumor-selective photosensitizers. This narrative review describes the mechanisms, delivery systems, photosensitizers, and available evidence regarding the potential of PDT as a novel therapeutic approach for GBM.

METHODS:

A comprehensive review of the preclinical and clinical literature was conducted on the role of PDT for GBM. Special emphasis was placed on PDT's mechanisms of action, immunomodulatory effects, delivery systems, and combinatorial potential with other treatment regimens. All clinical trials on this topic were reviewed and described.

RESULTS:

PDT exerts tumor-specific cytotoxic effects via reactive oxygen species generation, vascular disruption, and immune activation. Photosensitizers such as 5-aminolevulinic acid (5-ALA), chlorins, and phthalocyanines demonstrate selective accumulation in glioma cells and enhance treatment precision. Preclinical studies demonstrate that PDT can induce apoptosis, improve blood-brain barrier permeability, and synergize with existing chemotherapeutics. Early-phase clinical trials, including the INDYGO and talaporfin sodium-based studies, report promising safety profiles and extended survival in newly diagnosed and recurrent GBM patients.

CONCLUSION:

PDT offers a novel targeted approach for improving local control of GBM. With continued innovation in photosensitizer design, delivery technologies, and combinatorial strategies, PDT holds promise as a viable therapeutic adjunct in GBM treatment. Further clinical validation through randomized controlled trials is warranted to establish its efficacy and gain regulatory approval with the eventual goal of integration into standard neuro-oncology practice.

2025-12-01·Clinical Journal of Gastroenterology

Metachronous esophageal squamous cell carcinoma suspected as a second malignancy arising at the site of post-radiotherapy for esophageal adenocarcinoma

Article

作者: Yamashita, Taro ; Nio, Kouki ; Hayashi, Tomoyuki ; Miyazawa, Masaki ; Yamasita, Tatsuya ; Okamoto, Koichi ; Furusawa, Hiroki ; Iida, Noriho ; Nakagawa, Hidetoshi ; Seki, Akihiro

Esophageal cancer is a prevalent malignancy with high mortality rates worldwide, often warranting aggressive treatment modalities, such as chemoradiotherapy or radiotherapy. Although these treatments are effective, they can predispose patients to secondary malignancies, posing challenges for long-term management. Here, we present a case report detailing the development and management of secondary malignancies following radiotherapy for esophageal adenocarcinoma. A 78-year-old man presented with symptoms resulting in the diagnosis of esophageal adenocarcinoma with multiple lung metastases. Complete remission was achieved through chemotherapy with docetaxel, cisplatin, and S-1, followed by intensity-modulated radiation therapy. Seven years later, surveillance revealed a squamous cell carcinoma at the post-radiotherapy site; however, endoscopic resection was deemed challenging owing to fibrotic changes. Photodynamic therapy (PDT) with talaporfin sodium was administered, resulting in complete response without complications. This case highlights the potential for secondary malignancies following radiotherapy for esophageal adenocarcinoma and the efficacy of PDT as salvage therapy. This report underscores the importance of vigilant post-treatment surveillance and the need for tailored management strategies. Future research should focus on understanding the mechanisms of radiation-induced carcinogenesis, evaluating the long-term outcomes of PDT, and developing preventive strategies to enhance patient care and outcomes.

1

项与他拉泊芬钠相关的新闻（医药）

2025-05-27

·UmabsDB

再开创：第一三共开发抗体光敏偶联药物

Umabs DB作为目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用。第一三共作为第三代ADC药物的开创者，不断拓展ADC药物边界，近期继续进行开创，公开抗体光敏偶联药物相关专利（WO2025105486）。光动力疗法（PDT）是一种局部癌症治疗方法，利用光照射和光敏物质引起的光化学反应。与传统的使用激光的光凝固和汽化等物理破坏作用不同，PDT能够以低能量选择性治疗癌症病灶，并且是一种对正常组织损伤较小的微创治疗方法。当感光物质暴露在光线下时，它会吸收光能并转变为激发态（单线态）。当这种物质返回基态时，导致活性氧产生的能量转移被认为会引起细胞变性和坏死。它已被证明对肺癌、食道癌、胃癌、宫颈癌、脑肿瘤、头颈癌、前列腺癌和其他癌症有疗效，并且是备受期待的针对需要微创治疗的老年患者的癌症治疗方法。 1994年，卟吩姆钠在日本被批准为PDT治疗药物，迄今为止，世界各国已有数种光敏剂被批准为PDT治疗药物，例如他拉泊芬钠、替莫泊芬、维替泊芬帕替泊芬。具有在可见光区有强吸收的化学结构特征的卟啉骨架、具有一个还原吡咯环的二氢卟酚骨架、具有两个彼此相对的还原吡咯环的菌绿素骨架以及酞菁骨架都是被广泛研究用于PDT的光敏物质。然而，这些PDT治疗剂都是小分子药物，虽然有些具有在癌细胞中蓄积的能力，但存在癌症选择性的问题，并且还有光敏性和对受光区域造成损伤等副作用的担忧。因此，目前正在研究利用药物递送技术的改进PDT治疗药物。其代表性例子为西妥昔单抗萨拉塔罗康钠，其为抗EGFR抗体西妥昔单抗与IR700染料结合而成。此外也有文献将具有特定结构的二氢卟酚e6，通过连接子与抗HER2抗体曲妥珠单抗连接的结合物用于乳腺癌的诊断，但该结合物的抗肿瘤效果尚未得到完全证实。第一三共设计了多种光敏缀合物，通过和EpCAM抗体进行偶联，形成以下15种抗体光敏偶联药物，DAR值均为8，在不同的放射波长下，进行体外活性评估。根据后文描述应优选了结构5进行更多体内剂体外测试，表现出更优的光敏活性。同时还和PD-1抗体疗法产生一定的协同效应，未来值得期待。更多有关抗体药物研发具体信息、专利及临床等动态进展，敬请关注Umabs DB全球数据库（www.umabs.com）的更新。拓展阅读：非小细胞肺癌：信达PD-1/IL-2拟再次纳入突破疗法，或将启动首个三期临床试验胰腺癌：信诺维TF ADC拟纳入突破疗法，即将启动注册临床ASCO 2025：信达更新PD-1/IL-2非小细胞肺癌临床数据正大天晴首次公布HER2双抗ADC临床数据PD-1/VEGF双抗再加速：宜明昂科公布肺癌末线数据，instilBio暴涨58%暗盘大涨32%，恒瑞明日登陆港股CLDN18.2和FRα：上海生物制品所连续启动两款ADC临床辉瑞终出手：60.5亿美金引进三生PD-1/VEGF双抗，刚刚启动三期源自宜联平台：信诺维 CLDN18.2 ADC 拟纳入突破性疗法，即将启动三期临床辉瑞启动PD-L1 ISAC临床K药头对头：三生制药PD-1/VEGF双抗启动首个三期临床药明生物：消失的产能ORR达到60.8%：Immutep的LAG-3+PD-1联合疗法肺癌再取得突破PCSK9：安进专利/商业诉讼双输PBD先驱终止一款ADC的开发，主推Exatecan的升级平台T-DM1头对头：正大天晴HER2双抗ADC启动第二项三期临床DLL-3：石药集团第10款ADC启动临床全球首款c-Met ADC批准上市第14项三期，入组2400例：默沙东启动TROP2 ADC乳腺癌新辅助治疗临床一线HER2高表达肺癌：第一三共启动DS8201+PD-1三期临床TIGIT全剧终：iTeos更新TIGIT+PD-1联合疗法未达到临床终点简单聊聊结直肠癌：CX-2051能否成为CDH17 ADC的背景板?鼻咽癌：乐普启动EGFR ADC+PD-1三期临床试验BioNtech：高DAR值VHH-Fc ADC的开发抗体偶联扩展代谢领域：博安及Regeneron公布相关专利潜在最佳：武田启动CD38抗体IgAN肾病三期临床齐鲁以13.45亿引进明慧B7H3 ADC，宜联该如何期待？CLDN6：齐鲁首个自研ADC启动临床再添一项三期临床成功：阿斯利康完成早期膀胱癌治疗拼图快速打脸：武田终止两款屏蔽肽TCE开发EGFR/CD3：Vir启动第三款屏蔽肽TCE临床拥抱AI：百济神州任命新的CTOSutro发表综述文章：双毒素ADC的设计和未来2025 AACR上的新型ADC (一)FDA任命新的CBER负责人，引发美股医药大跌明慧医药：全球第四款启动临床三期的B7H3 ADC药物中位OS达到17.6个月，股票大涨45%：Immutep更新LAG-3联合K药头颈鳞癌数据胰腺癌：康方启动PD-1/VEGF+CD47联合疗法第二项三期临床第13项三期，入组1123例：默沙东启动TROP2 ADC+PD-1子宫内膜癌头对头临床映恩启动B7H3 ADC+PD-L1/VEGF双抗或TROP-2 ADC联合疗法临床HER2低表达：百利天恒HER2 ADC启动乳腺癌第3项三期临床当康方成交额超过腾讯：致敬所有的中国创新药企三生制药或启动CD3/CD28/MUC17三抗临床Zymeworks：临床前预测ADC药物血液毒性石药公布EGFR ADC肺癌一期临床数据，已启动三期临床结直肠癌：岸迈EGFR/c-Met双抗公开首个临床数据HR值0.777：康方公布AK112单药一线肺癌OS中期数据，summit大跌36%百利天恒启动第10款ADC药物临床康方PD-1/VEGF双抗一线肺癌获批上市恒瑞获批四项ADC+贝伐珠+PD-L1+CTLA-4联合治疗临床试验Araris公布三毒素ADC专利赛诺菲2025Q1：IL-4R抗体首次环比下滑罗氏2025Q1：TL1A狂做加法，TIGIT再做减法肿瘤免疫大咖再创业新型ADC公司最高可达DAR 40：日本兴和公布EGFR ADC药物首次挑战PD-1耐药后线治疗：康方启动AK112+多西他赛肺癌三期临床谁的胜利：Trodelvy+K药一线三阴乳腺癌三期临床成功Biogen启动CD38抗体IgAN肾病三期临床，天境生物拥有中国权益翰森制药：B7H3 ADC获非小细胞肺癌突破性疗法，即将启动第三项3期临床最高可达DAR30：普众公开高DAR值多毒素ADC开发引进橙帆医药眼科双抗的Ollin Biosciences什么来头？聚创：复宏汉霖召开全球研发日荣昌生物：继CLDN18.2和c-Met，再次消失DR5 ADC药物的开发信达公布IL-4Rα/TSLP双抗专利Sutro公布双毒素ADC专利AI制药逐步照进现实，华深智药两款自免双抗授权赛诺菲国内首个：恒瑞CD79b ADC启动淋巴瘤头对头三期临床康方TROP-2/Nectin-4双抗ADC启动澳洲一期临床强生2025Q1：CAR-T、双抗双向增长1440例：默沙东B7H3 ADC启动前列腺癌三期临床四项临床获批：百利EGFR/HER3双抗ADC加速推进老骥伏枥：BMS的PD-1+CTLA-4组合疗法一周双击Bolt启动全球首个CLDN18.2 ISAC药物临床FDA发布减少临床前安全性研究中动物实验的路线图第5款：普米斯递交EGFR/HER3双抗ADC临床试验申请FDA宣布计划逐步取消单抗和其他药物的动物试验要求BioNtech全速推进PD-L1/VEGF+ADC策略平常心之双抗合集审美疲劳之ADC合集关于Umabs DBUmabs DB是目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用，更多信息可联系info@umabs.com

100 项与他拉泊芬钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01985	他拉泊芬钠	L01	DB11812

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
食管癌	日本	Meiji Seika Pharma Co., Ltd.	2015-05-20
脑癌	日本	Meiji Seika Pharma Co., Ltd.	2013-09-20
肺癌	日本	Meiji Seika Pharma Co., Ltd.	2003-10-16

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
结直肠癌	临床3期	奥地利	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	波斯尼亚和黑塞哥维那	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	克罗地亚	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	德国	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	印度	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	意大利	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	拉脱维亚	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	波兰	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	罗马尼亚	Light Sciences Oncology, Inc.	2007-02-01
结直肠癌	临床3期	俄罗斯	Light Sciences Oncology, Inc.	2007-02-01

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临床结果

适应症

分期

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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


UEGW2023	N/A	复发性食管鳞状细胞癌	-	PDT with Talaporfin Sodium	範齋鏇簾鑰顧壓壓艱範(襯蓋積蓋鹽積遞範獵選) = 獵廠鹽築鬱獵窪憲艱鹽鹽襯範積積觸鹽憲艱壓 (鏇範簾鹽繭製鬱鹹壓鹹 ) 更多	-	2023-10-15
SNO2017	临床2期	胶质母细胞瘤	-	PDT group (Talaporfin sodium and semiconductor laser)	淵範獵膚選觸獵網顧繭(網淵觸顧淵憲壓簾積淵) = 糧夢窪選淵鑰網積淵糧齋糧範繭廠壓顧網顧選 (蓋鑰觸膚廠觸範築遞構 ) 更多	积极	2017-11-06
SNO2017	临床2期	胶质母细胞瘤	-	Control group (surgical removal of tumor without PDT)	淵範獵膚選觸獵網顧繭(網淵觸顧淵憲壓簾積淵) = 鹹積網範築醖鬱鑰獵夢齋糧範繭廠壓顧網顧選 (蓋鑰觸膚廠觸範築遞構 ) 更多	积极	2017-11-06
ACTR-39 (SNO2016)	临床2期	胶质母细胞瘤	-	PDT with Talaporfin sodium and semiconductor laser	艱艱鑰構簾繭顧願壓醖(艱鬱醖範製艱襯餘選襯) = 艱衊膚廠艱廠蓋網齋積獵鹽繭獵獵糧廠鹽願齋 (鹽衊糧鏇繭獵壓蓋簾鏇 ) 更多	积极	2016-11-07
ACTR-39 (SNO2016)	临床2期	胶质母细胞瘤	-	Talaporfin sodium (Surgical resection)	餘遞獵願築鏇艱襯糧夢(製憲構醖願夢糧醖遞構) = 淵艱網壓簾構獵鏇壓艱積網憲糧顧願蓋艱簾網 (鏇鹽淵廠鬱鬱鑰齋衊襯 ) 更多	积极	2016-11-07
NCT00440310 (CTgov)	临床3期	肝转移 \| 结直肠癌 \| 局部肿瘤复发	483	Interstitial light emitting diodes+leucovorin+irrinotecan+oxaliplatin+fluorouracil+Talaporfin sodium (Litx + Chemotherapy)	艱壓壓築膚觸鹽壓餘鏇(艱齋選網艱簾糧憲觸獵) = 獵壓壓簾願艱繭製鏇蓋膚醖艱網積範構製餘網 (淵網積衊範蓋繭鑰夢艱, 壓壓網範鹽構襯構製獵 ~ 襯積構鹽鑰糧積鑰醖願) 更多	-	2015-08-25
NCT00440310 (CTgov)	临床3期	肝转移 \| 结直肠癌 \| 局部肿瘤复发	483	leucovorin+irrinotecan+oxaliplatin+fluorouracil (Chemotherapy Alone)	艱壓壓築膚觸鹽壓餘鏇(艱齋選網艱簾糧憲觸獵) = 顧鹽壓顧窪窪淵繭鏇糧膚醖艱網積範構製餘網 (淵網積衊範蓋繭鑰夢艱, 鹹憲鬱鑰鬱壓餘壓壓壓 ~ 糧築糧憲鬱觸積製廠積) 更多	-	2015-08-25
JPRN-UMIN000003970 (ASCO_GI2012)	临床1期	复发性食管鳞状细胞癌 \| 食管癌	9	Talaporfin sodium-based PDT	壓鹹構膚鬱願製鹹簾壓(鑰鹹艱醖顧糧衊繭餘簾) = 醖蓋蓋鬱窪願築範窪獵衊網膚膚顧糧艱廠遞製 (顧繭遞鹽淵蓋衊築鏇窪 )	-	2012-02-01
ASCO2005	临床2期	结直肠癌肝转移	10	Talaporfin sodium + intratumoral placement of LEDs	夢蓋夢構鹽鏇願艱鏇憲(夢積餘襯廠廠襯憲觸製) = 壓遞齋衊襯衊鑰餘廠蓋鹹顧簾遞構醖襯遞鹹範 (顧襯鹹醖餘憲鏇選齋艱 )	-	2005-06-01