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更新于：2025-09-25
Toripalimab
特瑞普利单抗
更新于：2025-09-25
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2018-12-17), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (澳大利亚)、优先审评 (新加坡)、附条件批准 (中国) |
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结构/序列
Sequence Code 453640391L
来源: *****
Sequence Code 524455911H
来源: *****
关联
704
项与 特瑞普利单抗 相关的临床试验NCT05479045
A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients
ChiCTR2500109708
Neoadjuvant Chemotherapy Combined with Toripalimab in the Treatment of Cervical Cancer Patients with High-Risk Lymph Node Metastasis: A Prospective, Single-Arm, Single-Center, Exploratory Phase II Clinical Study
NCT07189793
Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive/-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study
100 项与 特瑞普利单抗 相关的临床结果
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100 项与 特瑞普利单抗 相关的转化医学
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100 项与 特瑞普利单抗 相关的专利（医药）
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563
项与 特瑞普利单抗 相关的文献（医药）2025-12-31ANNALS OF MEDICINE
Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis
Article
作者: Xu, Kai ; Zhang, Lingli ; Yu, Man ; Lin, Yingtao ; Li, Xin ; Su, Dan ; Shang, Jingjing ; Sun, Qingli ; Gong, Jinhong ; Qian, Xiaodan
BACKGROUND:
Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.
METHODS:
A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.
RESULTS:
The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.
CONCLUSION:
Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.
2025-12-01Journal of Gastrointestinal Cancer
Toripalimab in Esophageal Cancer: A Systematic Review and Meta-Analysis
Review
作者: Awadalla, Elian Khalafalla ; Khalifa, Mostafa A ; Allam, Salma ; Dway, Ali ; Saleh, Ahmad Omar ; Ahmed, Marafi Jammaa ; Hashim, Hashim Talib ; Shimal, Aya Ahmed ; Alzedaar, Jubran Khaled ; Abdultawab, Roaa ; Ghuraibawi, Mohammedbaqer ; Al-Hadrawi, Asala Hussein ; Saud, Hadeel Basheer Bin
BACKGROUND:
Esophageal cancer (EC) remains a highly aggressive malignancy with a poor prognosis despite advancements in treatment. Toripalimab, a PD-1 inhibitor, has demonstrated the potential to improve clinical outcomes. This systematic review and meta-analysis assess the efficacy and safety of Toripalimab in EC.
METHODS:
Following PRISMA 2020 guidelines, we conducted a systematic review and meta-analysis, searching PubMed, Embase, Scopus, ScienceDirect, and Google Scholar up to January 2025. Eligible studies evaluated Toripalimab in esophageal cancer, including randomized controlled trials and non-randomized controlled trials. Primary outcomes included overall survival (OS), progression-free survival (PFS), and objective response rate (ORR), while safety outcomes assessed treatment-related adverse events. Data were synthesized using random-effects models, with heterogeneity evaluated via Cochrane's Q and I2 statistics.
RESULTS:
The pooled analysis included six studies involving 678 patients. Toripalimab demonstrated promising efficacy, with a Complete Response (CR) rate of 33%, Partial Response (PR) rate of 36%, pathological complete response (pCR) rate of 30%, and major pathological response (MPR) rate of 46%. The R0 resection rate was 87%, while OS and PFS rates were reported at 78% and 50%, respectively. Anemia (56%), alopecia (54%), leukopenia (54%), and fatigue (30%) were the most frequently reported adverse effects. Other common adverse effects included nausea (29%), constipation (18%), and vomiting (20%).
CONCLUSIONS:
Toripalimab demonstrates significant potential in treating esophageal cancer, with favorable response rates and survival outcomes. However, the high incidence of adverse effects highlights the need for supportive care and ongoing research. While based on limited sample sizes and single-arm studies that may introduce bias and affect generalizability in this review, we provide valuable preliminary insights into toripalimab's potential, highlighting the need for larger randomized trials to build on these findings.
2025-10-01NEOPLASIA
Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study
Article
作者: Zhang, Ruiyun ; Xie, Feng ; Xia, Jun ; Zhuang, Guanglei ; Chen, Haige ; Zhang, Tianxiang ; Cao, Dengfeng ; Zhang, Lu ; Tang, Haoran ; Qian, Lei ; Zang, Jingyu ; Ding, Yu ; Wu, Yuchen ; Jin, Di
PURPOSE:
Although trimodal therapy is currently the standard organ-sparing approach for muscle-invasive bladder cancer (MIBC), its clinical benefit is limited, and noninvasive biomarkers to guide dynamic decision-making are lacking. Here, we present a proof-of-concept study evaluating disitamab vedotin (RC48, a HER2-targeted antibody-drug conjugate) combined with toripalimab (JS001, anti-PD-1) and radiotherapy for bladder preservation in localized HER2-positive MIBC.
PATIENTS AND METHODS:
In the first-stage of an open-label phase II clinical trial (ClinicalTrials.gov identifier: NCT05979740), six patients were enrolled and received disitamab vedotin, toripalimab, and radiotherapy. Adverse events were documented according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0). Tumor response was evaluated every 12 weeks by radiographic imaging, cystoscopy with biopsies, and urine cytology. In parallel, we performed longitudinal liquid biopsy analyses of circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA) using PredicineCARE assay.
RESULTS:
The combination was overall tolerable, with no grade 4 treatment-related adverse events or deaths. Five patients (83.3 %) achieved a complete response and remained recurrence-free. Notably, utDNA testing showed high accuracy in monitoring therapeutic effectiveness and enabled early detection of tumor relapse, whereas ctDNA was largely undetectable across blood samples.
CONCLUSIONS:
These findings establish the feasibility, efficacy, and potential biomarker utility of a novel bladder-preserving regimen, setting the stage for a paradigm shift in MIBC management.
1,763
项与 特瑞普利单抗 相关的新闻（医药）2025-09-23
·药事纵横
临床3期免疫疗法生物类似药上市批准临床结果
2025-09-23
临床结果临床3期
2025-09-23
上市批准临床结果临床3期免疫疗法
100 项与 特瑞普利单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 转移性黑色素瘤 | 中国 | 2025-04-22 | |
| 不可切除的黑色素瘤 | 中国 | 2025-04-22 | |
| 晚期肝细胞癌 | 中国 | 2025-03-18 | |
| 转移性食管鳞状细胞癌 | 欧盟 | 2024-09-19 | |
| 转移性食管鳞状细胞癌 | 冰岛 | 2024-09-19 | |
| 转移性食管鳞状细胞癌 | 列支敦士登 | 2024-09-19 | |
| 转移性食管鳞状细胞癌 | 挪威 | 2024-09-19 | |
| 鼻咽肿瘤 | 欧盟 | 2024-09-19 | |
| 鼻咽肿瘤 | 冰岛 | 2024-09-19 | |
| 鼻咽肿瘤 | 列支敦士登 | 2024-09-19 | |
| 鼻咽肿瘤 | 挪威 | 2024-09-19 | |
| 复发性食管鳞状细胞癌 | 欧盟 | 2024-09-19 | |
| 复发性食管鳞状细胞癌 | 冰岛 | 2024-09-19 | |
| 复发性食管鳞状细胞癌 | 列支敦士登 | 2024-09-19 | |
| 复发性食管鳞状细胞癌 | 挪威 | 2024-09-19 | |
| 不能切除的食管鳞状细胞癌 | 欧盟 | 2024-09-19 | |
| 不能切除的食管鳞状细胞癌 | 冰岛 | 2024-09-19 | |
| 不能切除的食管鳞状细胞癌 | 列支敦士登 | 2024-09-19 | |
| 不能切除的食管鳞状细胞癌 | 挪威 | 2024-09-19 | |
| 三阴性乳腺癌 | 中国 | 2024-06-18 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HER2阳性尿路上皮癌 | 申请上市 | 中国 | 2025-08-09 | |
| 肿瘤 | 申请上市 | 加拿大 | 2024-12-01 | |
| 复发性鼻咽癌 | 申请上市 | 欧盟 | 2022-11-14 | |
| 复发性非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2024-07-11 | |
| 难治性经典霍奇金淋巴瘤 | 临床3期 | 中国 | 2023-12-28 | |
| 局限期小细胞肺癌 | 临床3期 | 美国 | 2023-11-15 | |
| 局限期小细胞肺癌 | 临床3期 | 中国 | 2023-11-15 | |
| 局限期小细胞肺癌 | 临床3期 | 比利时 | 2023-11-15 | |
| 局限期小细胞肺癌 | 临床3期 | 法国 | 2023-11-15 | |
| 局限期小细胞肺癌 | 临床3期 | 格鲁吉亚 | 2023-11-15 |
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临床结果
临床结果
适应症
分期
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临床3期 | 532 | 遞憲壓蓋網鑰壓憲蓋顧(願鬱襯醖鏇壓蓋遞衊艱) = 廠窪製齋願衊壓範網夢 獵網鑰鏇鏇簾簾壓夢積 (積餘艱鏇糧蓋膚觸艱願 ) 更多 | 积极 | 2025-09-16 | |||
(without concurrent cisplatin) | 遞憲壓蓋網鑰壓憲蓋顧(願鬱襯醖鏇壓蓋遞衊艱) = 獵範餘糧壓鏇積製網範 獵網鑰鏇鏇簾簾壓夢積 (積餘艱鏇糧蓋膚觸艱願 ) 更多 | ||||||
临床1/2期 | 广泛期小细胞肺癌 一线 | 44 | 遞鹽憲製餘遞壓觸餘衊(齋鬱簾鬱壓鏇廠醖繭憲) = 夢簾鹹願遞餘積構網淵 蓋觸廠襯糧顧糧膚襯鏇 (選齋範顧壓廠醖鬱遞鑰 ) 更多 | 积极 | 2025-09-09 | ||
临床2期 | 16 | Toripalimab plus CapeOX | 夢獵艱範範壓選鹹糧蓋(糧範鬱獵醖餘壓網壓鏇) = 積鏇壓壓選製窪鏇淵網 範鑰壓廠選鏇鑰願觸鹽 (襯製製築餘網範簾鏇艱 ) | 积极 | 2025-09-01 | ||
临床2期 | 96 | Toripalimab consolidation | 鬱廠廠繭網鹽襯窪醖壓(範夢淵鹹鬱壓壓繭繭選) = 獵窪窪淵艱襯鑰繭淵築 艱膚製遞憲積餘選壓遞 (願遞遞鑰鹽鹽選鑰觸廠 ) 更多 | 积极 | 2025-08-09 | ||
| Observation | 鬱廠廠繭網鹽襯窪醖壓(範夢淵鹹鬱壓壓繭繭選) = 窪艱衊遞願觸餘構鬱艱 艱膚製遞憲積餘選壓遞 (願遞遞鑰鹽鹽選鑰觸廠, 3.2 ~ 20.5) 更多 | ||||||
Pubmed 人工标引  | 临床1期 | 晚期肝细胞癌 二线 | 28 | 醖顧鏇夢襯餘壓遞膚鹽(遞糧衊願鬱膚艱鬱獵構) = 鬱餘遞鹽糧範獵蓋遞鑰 簾衊繭膚淵繭憲膚鹽鹽 (廠廠壓網鏇蓋網鹽艱遞, 9.0 ~ 43.6) 更多 | 积极 | 2025-08-01 | |
(anti-PD-1/PD-L1 naïve and had received first-line anti-VEGFR tyrosine kinase inhibitor) | 醖顧鏇夢襯餘壓遞膚鹽(遞糧衊願鬱膚艱鬱獵構) = 窪繭糧鹽憲夢鹽壓簾遞 簾衊繭膚淵繭憲膚鹽鹽 (廠廠壓網鏇蓋網鹽艱遞 ) 更多 | ||||||
临床2期 | 29 | Toripalimab + Platinum-doublet chemotherapy | 鑰獵鏇觸簾膚窪窪構艱(艱醖觸鑰糧膚網選蓋醖) = 廠膚鏇遞鹽淵廠顧艱遞 壓衊廠遞艱淵齋淵獵鹽 (淵糧齋窪願糧衊廠簾鹽 ) 更多 | 积极 | 2025-06-01 | ||
临床2期 | 晚期胃癌 一线 | 24 | 製範鹽網遞顧窪衊憲願(積壓遞齋齋膚範鹽顧膚) = 觸觸鹽鹽築廠餘獵窪顧 壓構網艱鏇願鬱淵鏇網 (觸艱鑰窪窪鬱廠顧顧網, 36.6 ~ 77.9) 达到 更多 | 积极 | 2025-05-31 | ||
临床1/2期 | 尿路上皮癌 一线 | 40 | 憲簾築憲鬱簾遞積簾壓(網鹽醖窪構醖艱製遞艱) = 構壓齋蓋廠齋繭壓鹹積 襯簾遞壓鏇膚鬱夢積衊 (遞願壓鏇簾淵遞餘選壓 ) 更多 | 积极 | 2025-05-30 | ||
临床2期 | 69 | 憲範鹹構夢壓鑰餘艱範(窪築齋蓋夢淵獵鬱繭衊) = 構選鏇築鹹襯襯壓選淵 壓憲製壓網製糧簾鹹獵 (遞齋艱壓艱觸廠構觸築 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | - | 鏇遞構簾衊蓋廠獵窪糧(遞顧選繭構網鹽齋衊蓋) = 遞襯醖鏇遞齋觸壓壓蓋 願築鑰範窪憲鑰艱鏇鏇 (觸鏇襯鹹蓋廠顧觸窪窪, 4.33 ~ 48.09) 更多 | 积极 | 2025-05-30 | |||
鏇遞構簾衊蓋廠獵窪糧(遞顧選繭構網鹽齋衊蓋) = 顧繭襯鏇淵製網願廠鹹 願築鑰範窪憲鑰艱鏇鏇 (觸鏇襯鹹蓋廠顧觸窪窪, 23.04 ~ 76.96) 更多 |
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