预约演示
更新于：2025-09-08
Sintilimab
信迪利单抗
更新于：2025-09-08
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2018-12-24), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、特殊审批 (中国)、附条件批准 (中国) |
登录后查看时间轴
结构/序列
Sequence Code 13029014H
来源: *****
Sequence Code 13029039L
来源: *****
关联
709
项与 信迪利单抗 相关的临床试验NCT07156019
A Prospective, Single-center, Single-arm Phase II Study of Sintilimab in Combination With Surufatinib and Temozolomide in the Treatment of Advanced Neuroendocrine Carcinoma
NCT07018063
Efficacy and Safety of Neoadjuvant Nab-Paclitaxel Combined With Oxaliplatin, S-1, and Sintilimab in Patients With Locally Advanced Resectable Early-onset Gastric Cancer: A Phase II, Single-Arm, Open-Label Clinical Trial
NCT07147101
A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics
100 项与 信迪利单抗 相关的临床结果
登录后查看更多信息
100 项与 信迪利单抗 相关的转化医学
登录后查看更多信息
100 项与 信迪利单抗 相关的专利（医药）
登录后查看更多信息
824
项与 信迪利单抗 相关的文献（医药）2025-12-31Hematology
Sintilimab for treating progressive multifocal leukoencephalopathy caused by human polyomavirus 2 virus infection following allogeneic hematopoietic cell transplantation: a case report
Article
作者: Zhong, Xushu ; Liu, Qinyu ; Jin, Xuelian ; Chen, Xinchuan
BACKGROUND:
Progressive multifocal leukoencephalopathy (PML) is characterized by demyelination in the central nervous system. It is caused by infection with human polyomavirus 2 and has a poor prognosis. Therapeutic strategies involve restoring immune function and/or discontinuing immunosuppressive treatment. Immune checkpoint inhibitors such as those targeting programmed death receptor-1 (PD-1) can alleviate PML by restoring T cell function. There are no case reports on the use of the PD-1 inhibitor, Sintilimab, for treating PML. Here, we report a case of successful treatment of PML with sintilimab following allogeneic hematopoietic stem cell transplantation.
CASE PRESENTATION:
A 35-year-old woman with high-risk acute myeloid leukemia underwent allogeneic hematopoietic stem cell transplantation after induced remission and developed PML 12 months after transplantation. She received five courses of 100 mg every 4 weeks with monitoring by magnetic resonance imaging (MRI) and viral load in the cerebrospinal fluid, showing clinical improvement, resolution of neurological symptoms, and reduced viral load. MRI showed initial exacerbation of lesions but significant improvement after five courses of treatment. No graft-versus-host disease occurred, but manageable immune reconstitution inflammatory syndrome was observed.
CONCLUSION:
Sintilimab, a PD-1 inhibitor, might be used to treat PML in patients with hematologic malignancies undergoing allo-HSCT, which needs further investigation.
2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Hedgehog pathway inhibitors (HHI) combined with radiotherapy and immunotherapy for advanced basal cell carcinoma: a case report
Article
作者: Wei, Gao ; Yao, Zhijian ; Li, Longshan ; Ruan, Zhuren ; Zhao, Chen ; Li, Xianghui
PURPOSE:
Basal cell carcinoma (BCC) is one of the most common skin cancers. Most BCCs can be treated with surgery excision. For advanced BCC unsuitable for curative surgery, the combination of radiotherapy and Hedgehog pathway inhibitors (HHI) are effective systemic treatment options. However, there is a scarcity of evidence-based guidelines for the management of patients with advanced or metastatic BCC, particularly those who develop resistance to HHI therapy.
MATERIALS AND METHODS:
We report the case of a patient with advanced BCC of the head and neck, which originated from a nevus sebaceous.
RESULTS:
The patient initially responded well to sonidegib, an HHI, but resistance emerged within a month. We then modified the systemic therapy to include a combination of radiotherapy and the anti-PD-1 agent sintilimab.
CONCLUSIONS:
This adjusted treatment regimen led to effective long-term clinical responses without significant adverse events.
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: Zhang, Lingli ; Xu, Kai ; 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.
100 项与 信迪利单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 晚期子宫内膜癌 | 中国 | 2024-12-01 | |
| 典型霍奇金淋巴瘤 | 中国澳门 | 2024-02-22 | |
| 非小细胞肺癌 | 中国澳门 | 2024-02-22 | |
| EGFR阳性非鳞状非小细胞肺癌 | 中国 | 2023-05-06 | |
| 胃食管交界处腺癌 | 中国 | 2022-06-23 | |
| 胃癌 | 中国 | 2022-06-23 | |
| 食管鳞状细胞癌 | 中国 | 2022-06-16 | |
| 肝细胞癌 | 中国 | 2021-06-28 | |
| 非鳞状非小细胞肺癌 | 中国 | 2021-02-03 | |
| 霍奇金淋巴瘤 | 中国 | 2018-12-24 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局部晚期肾细胞癌 | 申请上市 | 中国 | 2025-06-05 | |
| 转移性肾细胞癌 | 申请上市 | 中国 | 2025-06-05 | |
| 错配修复缺陷或微高卫星不稳定性结肠癌 | 申请上市 | 中国 | 2025-02-22 | |
| EGFR-T790M 突变非小细胞肺癌 | 申请上市 | 中国 | 2022-01-30 | |
| 食管癌 | 申请上市 | 中国 | 2021-09-22 | |
| 不能切除的大肠癌 | 临床3期 | 中国 | 2024-11-27 | |
| 非小细胞肺癌IIIB期 | 临床3期 | 中国 | 2024-03-15 | |
| 可切除非小细胞肺癌 | 临床3期 | 中国 | 2024-03-15 | |
| 局部晚期食管鳞状细胞癌 | 临床3期 | 中国 | 2022-11-01 | |
| 晚期肾细胞癌 | 临床3期 | 中国 | 2022-10-27 |
登录后查看更多信息
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 | 晚期胆道癌 AKT | YAP | 80 | 繭網膚壓鹽顧艱蓋繭齋(夢繭衊齋糧網糧蓋襯積) = 壓醖遞願廠網淵齋鹽醖 鬱製夢餘蓋願遞窪憲鏇 (遞蓋鏇蓋願醖壓膚顧獵 ) 更多 | 积极 | 2025-07-01 | ||
Chemotherapy alone (GC) | 繭網膚壓鹽顧艱蓋繭齋(夢繭衊齋糧網糧蓋襯積) = 鑰製選襯憲醖範鑰淵壓 鬱製夢餘蓋願遞窪憲鏇 (遞蓋鏇蓋願醖壓膚顧獵 ) 更多 | ||||||
临床2期 | 29 | 艱憲鑰繭衊蓋夢夢襯鹽(鹹淵憲壓鹹壓鹹願願鹹) = 艱顧糧鹽淵蓋鏇築糧窪 淵鹽蓋構構遞艱積選襯 (鑰齋窪製襯繭齋艱選艱, 49.0% ~ 85.0) | 积极 | 2025-07-01 | |||
临床2期 | 47 | (part A) | 糧顧夢淵廠築遞遞獵範(製構壓鑰餘鹹製範衊醖) = 鏇顧願構齋廠夢繭網衊 襯齋艱糧繭積鹹夢壓範 (齋壓艱鏇糧鹹繭製艱願 ) 更多 | 积极 | 2025-05-30 | ||
(part A+part B) | 糧顧夢淵廠築遞遞獵範(製構壓鑰餘鹹製範衊醖) = 夢願廠鬱網鬱選鏇遞製 襯齋艱糧繭積鹹夢壓範 (齋壓艱鏇糧鹹繭製艱願 ) 更多 | ||||||
临床2期 | 肝细胞癌 新辅助 | 40 | Sintilimab 200 mg Q3W and Lenvatinib 8 mg QD | 鬱構選襯襯艱蓋壓壓鏇(衊選齋鹹糧鬱繭簾築選) = 膚遞淵範醖衊遞廠顧製 淵遞齋窪遞製鬱窪製鏇 (簾顧網選獵壓餘顧鏇遞 ) | - | 2025-05-30 | |
(HAIC-FOLFOX) | 窪築淵蓋鑰憲構獵淵憲(襯築願醖築網膚獵憲壓) = 壓範壓鹽鑰膚鑰選衊網 範襯糧窪膚選壓廠觸築 (構齋壓膚簾襯範醖窪窪, 5.3% ~ 21.1%) | ||||||
N/A | 75 | 糧範鏇顧餘鑰淵壓憲窪(願選憲鬱艱願窪膚獵鹽) = 39.7% (29/73) experienced Grade 3-4 hematological TRAEs, mainly including granulocytopenia and anemia 鹹遞構獵鹽壓餘餘壓積 (顧構鏇願獵鹹獵繭衊鬱 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 难治性神经母细胞瘤 MYCN-amplified NB | 34 | Naxitamab+GM-CSF+Sintilimab | 鏇蓋網築淵積鏇蓋遞膚(艱獵夢網選壓糧積遞築): PFS = 76.9, P-Value = 0.059 更多 | 积极 | 2025-05-30 | |
Naxitamab+GM-CSF | |||||||
临床3期 | 81 | Sintilimab plus ICE | 鹹襯窪製鏇夢築夢廠鹽(願顧顧構遞鬱鏇顧顧憲) = 範襯鹹製鏇觸艱壓淵憲 憲網築積選鹹蓋鬱遞膚 (憲憲製齋窪衊願簾蓋網 ) 更多 | 积极 | 2025-05-30 | ||
Placebo plus ICE | 鹹襯窪製鏇夢築夢廠鹽(願顧顧構遞鬱鏇顧顧憲) = 壓遞糧獵鬱繭餘夢範鑰 憲網築積選鹹蓋鬱遞膚 (憲憲製齋窪衊願簾蓋網 ) 更多 | ||||||
临床2期 | 局部晚期胃食管交界处腺癌 新辅助 | 26 | Sintilimab + XELOX chemotherapy | 顧襯憲憲蓋膚齋顧憲觸(構淵網簾餘憲憲鹽憲淵) = 壓構鹽齋築構淵鏇鏇簾 憲願廠獵醖糧淵廠廠窪 (壓遞簾構餘繭繭觸鬱簾 ) 更多 | 积极 | 2025-05-30 | |
临床2期 | 结直肠癌肝转移 新辅助 | 36 | 鑰窪鑰淵廠糧製憲遞築(觸齋淵網鏇網鬱範範糧) = the median OS had not yet been reached 鹹淵廠淵鹽網積壓夢鏇 (網廠廠選襯繭餘醖餘淵 ) 更多 | 积极 | 2025-05-30 | ||
N/A | - | 齋艱襯網構憲壓醖膚顧(糧獵醖網積獵願蓋艱鏇) = 鹹鹽窪壓網鑰遞鬱顧網 淵簾觸顧鬱製窪鏇鹹鏇 (襯夢願願廠積範築築網 ) 更多 | 积极 | 2025-05-14 | |||
齋艱襯網構憲壓醖膚顧(糧獵醖網積獵願蓋艱鏇) = 選醖鑰構艱選觸襯簾壓 淵簾觸顧鬱製窪鏇鹹鏇 (襯夢願願廠積範築築網 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用