预约演示
更新于：2026-11-05
Toripalimab
特瑞普利单抗
更新于：2026-11-05
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 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚)、优先审评 (美国)、优先审评 (新加坡)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 453640391L
来源: *****
Sequence Code 524455911H
来源: *****
关联
830
项与 特瑞普利单抗 相关的临床试验NCT07907861
A Phase II, Single-center, Open-label Study of Sacituzumab Tirumotecan Combined With Toripalimab in Patients With Advanced Penile Squamous Cell Carcinoma Who Progressed On or Are Intolerant to Platinum-based Chemotherapy
NCT07853053
Efficacy and Safety of Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer: A Single-Arm Clinical Study
NCT07836049
A Phase II Study of Induction/Window of Opportunity Toripalimab Followed by Definitive Chemoradiotherapy (CRT) and Adjuvant Toripalimab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
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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742
项与 特瑞普利单抗 相关的文献（医药）2026-12-31Human Vaccines & Immunotherapeutics
Cost‑effectiveness of first‑line immunotherapy-based combination regimens for advanced renal cell carcinoma in China and the United States
Article
作者: Yan, Chunyan ; Zhao, Quan ; Li, Jiayan ; Diao, Ruigang ; Gao, Yuan ; Li, Zhengxiong
Immunotherapy‑based combination regimens provide significant clinical benefits but impose substantial economic burdens on national healthcare systems. This study assessed the cost-effectiveness of immunotherapy‑based combination regimens as first-line treatments for advanced renal cell carcinoma (aRCC) in China and the United States (US). A partitioned survival model was developed to evaluate the cost-effectiveness of all approved regimens with a lifetime horizon. The primary outcomes were total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were performed to evaluate model uncertainty. Compared to the sunitinib regimen, the ICERs for the toripalimab plus axitinib (T + A), nivolumab plus ipilimumab (N + I), lenvatinib plus pembrolizumab (L + P), pembrolizumab plus axitinib (P + A), nivolumab plus cabozantinib (N + C), avelumab plus axitinib (A + A) and atezolizumab plus bevacizumab (A + B) regimens in China were $64,536.98/QALY, $135,593.25/QALY, $174,956.58/QALY, $231,908.95/QALY, $728,876.75/QALY, $1,232,070.43/QALY, and $2,496,799.42/QALY, respectively. The ICERs for the N + I, T + A, N + C, P + A, L + P, A + A, and A + B regimens in the US were $160,243.50/QALY, $468,156.65/QALY, $804,963.69/QALY, $907,549.79/QALY, $2,170,769.66/QALY, $2,623,809.39/QALY, and $12,712,147.95/QALY, respectively. Probabilistic sensitivity analyses indicated that the probability of cost-effectiveness corresponding to N + I vs. sunitinib was 33.6% in the US. In China and the US, none of the seven first-line immunotherapy-based combination regimens was cost-effective compared with sunitinib for aRCC.
2026-12-01Global Medical Genetics
CD73 targeted combination therapy reverses PD-1 inhibitor resistance in CD73-high PD-L1-negative NSCLC: Evidence from pleural effusion organoids
Article
作者: Tang, Li-Bo ; Peng, Ying-Long ; Huang, Qian-Lin ; Deng, Yu ; Ren, Zi-Rui ; Chen, Zhi-Hong ; Lu, Chang ; Zhou, Qing ; Wu, Lv ; Li, Jia-Ting ; Lin, Yu-Jie ; Xu, Chong-Rui ; Zhu, Hong-Yi ; Cai, Dong-Xuan
Objectives:
Patients with PD-L1-negative non-small cell lung cancer (NSCLC) often exhibit inherent PD-1 inhibitor resistance, leading to poor monotherapy efficacy and unfavorable clinical outcomes. Notably, no effective stratification biomarkers are currently available to overcome this resistance. Thus, this study aimed to reverse PD-1 inhibitor resistance in PD-L1-negative NSCLC by identifying novel predictive biomarkers and developing effective targeted immunotherapeutic regimens.
Methods:
Pleural effusion-derived organoids (PEOs) were established and validated from driver gene wild-type, PD-L1-negative NSCLC patients. Four treatment groups were set: control, anti-PD-1 monotherapy (Toripalimab), anti-CD73 monotherapy (Uliledlimab), and anti-PD-1 + anti-CD73 combination (Toripalimab + Uliledlimab). ATP assay was used to detect tumor cell viability. Spearman's rank correlation analysis was applied to evaluate the association between CD73 expression and tumor inhibition rates. Flow cytometry was employed to measure T cell activation markers. Enzyme-linked Immunospot assay was used to detect IFN-γ and TNF-α secretion.
Results:
PEO models recapitulated the biological features of primary pleural effusion. Toripalimab monotherapy showed no antitumor efficacy in PD-L1-negative subgroup regardless of CD73 expression levels, whereas Toripalimab + Uliledlimab combination significantly reversed PD-1 inhibitor resistance in CD73-high PD-L1-negative NSCLC patients. Furthermore, a significant positive correlation was observed between CD73 expression levels and tumor inhibition rates.
Conclusion:
This study validates CD73 as a potential predictive biomarker for stratifying PD-L1-negative NSCLC patients and establishes anti-PD-1+ anti-CD73 combination regimen that effectively reverses PD-1 inhibitor resistance in CD73-high PD-L1-negative NSCLC patients.
2026-12-01CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
Immunopharmacological advances in HBV associated hepatocellular carcinoma and EBV-related nasopharyngeal carcinoma in China: Mechanisms, therapies, and clinical perspectives
Review
作者: Liu, Xiaochen ; Wang, Ligen
Oncogenic viruses continue to be a significant cause of cancer in China, with a significant proportion of malignancies caused by hepatitis B virus (HBV) and Epstein-Barr virus (EBV). HBV is the dominant etiological factor for HCC in China, accounting for approximately 85-92% of cases. EBV is closely implicated in non-keratinizing undifferentiated nasopharyngeal carcinoma (NPC), especially in endemic areas. The use of conventional treatment methods, such as surgery, radiotherapy, and chemotherapy, has not been very effective, especially at advanced stages of the disease, underscoring the need to incorporate more effective treatment approaches. Immunopharmacological interventions have emerged as a revolutionary practice in this regard. This review provides an overview of existing immunopharmacology in HBV-related HCC and EBV-associated NPC, including how the tumour immune microenvironment is modulated, the mechanisms of action of immune-based therapies, and the major clinical advances in China. Domestically developed anti-PD-1 antibodies, such as sintilimab, camrelizumab, tislelizumab, and toripalimab, have received regulatory approval based on large-scale clinical trials and are currently used as first-line treatment for unresectable HCC and for recurrent or metastatic NPC. Simultaneously, adoptive cellular therapies using EBV antigens (including EBV-specific cytotoxic T lymphocytes and engineered T-cell receptor strategies) have shown promising clinical potential. Moreover, combination regimens with immune checkpoint blockade and targeted therapies or locoregional therapies have demonstrated better survival rates, especially in HBV-infected people. Despite these improvements, there are still issues, such as therapeutic resistance, immune-related adverse events, and inconsistent biomarker performance. Future initiatives must focus on biomarker-directed treatment decisions, combination regimen optimization, and the wider clinical use of new cellular therapies.
5,241
项与 特瑞普利单抗 相关的新闻（医药）2026-11-04
2026-11-04
2026-11-04
申请上市ASH会议
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 |
|---|---|---|---|
| HER2阳性尿路上皮癌 | 中国 | 2026-05-19 | |
| 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 |
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 |
|---|---|---|---|---|
| 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 | 2024-04-03 | |
| 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 | 荷兰 | 2023-11-15 | |
| 局限期小细胞肺癌 | 临床3期 | 西班牙 | 2023-11-15 | |
| 局限期小细胞肺癌 | 临床3期 | 中国台湾 | 2023-11-15 | |
| 局限期小细胞肺癌 | 临床3期 | 土耳其 | 2023-11-15 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 肾盂和输尿管尿路上皮癌 新辅助 | 59 | 淵襯糧窪鑰鹹憲餘壓鬱(繭壓鑰壓選窪淵壓選齋) = 淵積積醖獵壓獵願襯膚 衊製獵夢構鏇繭窪膚範 (壓獵餘夢窪願鹽衊範鏇 ) 更多 | 积极 | 2026-10-23 | ||
| - | 淵襯糧窪鑰鹹憲餘壓鬱(繭壓鑰壓選窪淵壓選齋) = 鬱膚遞廠顧選襯壓餘獵 衊製獵夢構鏇繭窪膚範 (壓獵餘夢窪願鹽衊範鏇 ) | ||||||
临床2期 | Vater壶腹癌 一线 | 20 | 遞蓋鏇簾憲簾壓鏇膚衊(構鏇鏇構窪衊網襯窪窪) = 鏇網選範淵觸憲襯淵遞 構構齋齋築獵積糧製觸 (鹹膚簾醖壓願蓋蓋構獵 ) 更多 | 积极 | 2026-10-23 | ||
临床2期 | HER2阳性肌层浸润性膀胱癌 HER2-positive | 19 | 遞淵顧範築獵鬱醖壓顧(艱築觸願遞窪繭獵醖網) = 鏇鑰製構鏇鏇鹽襯衊壓 鬱憲遞衊鏇製齋醖衊膚 (鹽壓襯糧蓋窪遞蓋餘鑰, 74.0 ~ 99.9) 更多 | 积极 | 2026-10-23 | ||
临床2期 | 23 | 齋選觸艱顧蓋積積艱簾(簾繭鑰糧遞膚窪網衊壓) = The overall incidence of adverse events was 100%, common AEs included hypertension, hand-foot skin reaction and mouth pain. 網鏇齋蓋遞艱壓壓蓋範 (鹹鏇製簾網製襯糧鏇選 ) | 积极 | 2026-10-23 | |||
临床2期 | 黏膜黑色素瘤 辅助 | 145 | 範積鹹選獵醖壓淵觸網(積範獵遞襯衊顧遞憲膚) = 簾醖範網簾範齋憲願艱 鹽鏇淵遞艱壓鹽顧範醖 (蓋鏇鹽壓鹹選衊廠獵網, 8.3 ~ 19.0) 更多 | 不佳 | 2026-10-23 | ||
High-dose interferon-α2b | 範積鹹選獵醖壓淵觸網(積範獵遞襯衊顧遞憲膚) = 壓齋膚製獵遞醖鬱簾獵 鹽鏇淵遞艱壓鹽顧範醖 (蓋鏇鹽壓鹹選衊廠獵網, 8.2 ~ 21.3) 更多 | ||||||
临床2期 | 局部晚期食管鳞状细胞癌 新辅助 | 24 | Toripalimab + chemotherapy | 鹹鑰簾夢襯壓觸艱衊遞(糧鏇獵憲鏇夢襯鬱選築) = 壓鏇獵選願積鑰窪選壓 膚繭積齋淵鏇遞範構醖 (範艱艱憲憲顧繭醖積膚 ) 更多 | 积极 | 2026-10-23 | |
临床2期 | 晚期肾细胞癌 新辅助 | 23 | 遞範齋簾鑰範廠積糧蓋(糧鑰鏇鬱齋醖壓齋憲遞) = 蓋憲廠醖積構鹽選範膚 膚繭鹹範顧觸築餘鹹鏇 (窪顧構膚願網糧觸蓋築 ) 更多 | 积极 | 2026-10-23 | ||
N/A | 44 | (achieved cCR) | 選餘觸製艱鬱觸鬱築鏇(鬱夢願鹽網糧壓蓋醖糧) = After neoadjuvant therapy, both CTC and HER-2+ CTC counts were significantly lower in the cCR group (P=0.006 and <0.001, respectively). All pts with negative post-treatment CTC achieved cCR, whereas detectable post-treatment CTCs were observed in all non-cCR pts and all recurrent cCR cases. 醖遞齋鬱衊餘製齋蓋醖 (鏇顧襯觸膚鑰醖築齋顧 ) 更多 | 积极 | 2026-10-23 | ||
临床2期 | 非小细胞肺癌 新辅助 | 118 | Toripalimab plus chemotherapy with tifcemalimab | 選鹹壓壓窪範壓鏇築築(憲夢積窪憲積齋蓋範醖) = 選糧蓋襯網艱憲壓鏇襯 網餘觸齋壓築齋餘簾糧 (壓蓋憲鹹鑰顧糧鹽壓願 ) 更多 | 积极 | 2026-10-23 | |
Toripalimab plus chemotherapy without tifcemalimab | 選鹹壓壓窪範壓鏇築築(憲夢積窪憲積齋蓋範醖) = 網選願鹹壓製蓋襯艱壓 網餘觸齋壓築齋餘簾糧 (壓蓋憲鹹鑰顧糧鹽壓願 ) 更多 | ||||||
临床2期 | 阴茎鳞状细胞癌 巩固 | 一线 | 新辅助 | 25 | 壓鏇醖選積淵糧糧壓衊(範憲夢鹹築築衊構選觸) = 繭鹽襯積顧窪鏇鬱製遞 鹽構築遞範夢簾廠遞醖 (構構選艱鹽鹹壓顧壓顧 ) 更多 | 积极 | 2026-10-23 |
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