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更新于：2025-11-17
Sintilimab
信迪利单抗
更新于：2025-11-17
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) |
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结构/序列
Sequence Code 13029014H
来源: *****
Sequence Code 13029039L
来源: *****
关联
791
项与 信迪利单抗 相关的临床试验ChiCTR2500112474
Prospective Study on Adjuvant Therapy After Resection for Ruptured Hepatocellular Carcinoma with Hemorrhage: A Prospective Exploratory Single-Arm Study of Adjuvant Sintilimab Combined with Bevacizumab (CLEAR-2 Study)
ChiCTR2500111980
Sintilimab Combined with Sacituzumab tirumotecan in Neoadjuvant Therapy for Resectable Non-Small Cell Lung Cancer: A Single-Arm, Single-Center, Phase II Clinical Study
ChiCTR2500111957
Efficacy and Safety of Multi-mode Thermal Therapy Combined with Paclitaxel plus Gemcitabine (AG Regimen) as First-Line Treatment for Pancreatic Cancer with Liver Metastases: A Prospective Single-Arm Study
100 项与 信迪利单抗 相关的临床结果
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100 项与 信迪利单抗 相关的转化医学
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100 项与 信迪利单抗 相关的专利（医药）
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808
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.
2025-12-31ANNALS 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.
2025-12-31Future Science OA
Chemo-immunotherapy sequential with radiotherapy in advanced or metastatic esophageal squamous cell carcinoma
Article
作者: Zhang, Ling ; Xu, Xiajuan ; Niu, Yuchao ; Guo, Xiuhui ; Zhao, Zhimei ; Nie, Keke ; Ji, Youxin ; Han, Xiang ; You, Yunhong ; Zhang, Zhongfa ; Hou, Qiuyu
BACKGROUND:
To evaluate the efficacy and safety of chemo-immunotherapy combined with residual lesions irradiation of advanced stage esophageal squamous cell carcinoma.
METHODS:
Treatment-naïve patients with radiologically and histologically confirmed advanced or metastatic squamous-cell esophageal carcinoma were enrolled. Participants received four cycles of the TP regimen combined with the PD-1 inhibitor sintilimab. Patients who completed four cycles of chemo-immunotherapy with stable disease (SD) or partial response (PR) subsequently received 50 Gy of radiation in 25 fractions for residual tumors. Maintenance sintilimab therapy was administered every 21 days for up to 31 cycles or until disease progression or intolerable toxicity occurred.
RESULTS:
A total of 39 patients were enrolled in this study, of whom 30 were evaluable for efficacy and toxicity. The complete response (CR) rate was 6.7% (2/30), the partial response (PR) rate was 53.3% (16/30). The median depth of response (DpR) was 34.5% for chemo-immunotherapy and increased to 64.0% after radiotherapy. The progression-free survival (PFS) was 16.4 months, while overall survival (OS) has not yet been reached.
CONCLUSIONS:
Chemo-immunotherapy followed by radiotherapy for residual tumors and maintenance sintilimab, demonstrated high response rates, prolonged PFS, and tolerable toxicity as a first-line treatment for patients with advanced or metastatic esophageal squamous-cell carcinoma.
100 项与 信迪利单抗 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 |
|---|---|---|---|
| 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
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| 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 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 局部晚期肾细胞癌 二线 | 234 | 衊繭積選範製襯願醖範(壓構繭積願繭膚襯鑰構) = 範夢膚鬱廠醖鏇網鹽襯 鹹鏇醖觸襯壓範鹹鏇網 (廠觸顧鹹鏇艱積醖獵遞 ) 更多 | 优效 | 2025-10-17 | ||
衊繭積選範製襯願醖範(壓構繭積願繭膚襯鑰構) = 網糧構鬱鹹製壓壓繭鹹 鹹鏇醖觸襯壓範鹹鏇網 (廠觸顧鹹鏇艱積醖獵遞 ) 更多 | |||||||
临床2期 | 17 | 餘餘簾選糧範選顧製範(鬱壓製淵獵顧選構選襯) = 壓願醖獵憲蓋蓋觸鏇齋 廠鹽蓋餘鹹鏇窪齋鏇構 (遞簾餘選構糧餘衊窪夢, 3.5 ~ NR) 更多 | 积极 | 2025-10-17 | |||
临床2期 | 甲状腺未分化癌 BRAF Gene Mutation Negative | 19 | 願餘網窪繭繭壓鹽鑰膚(遞簾鹽艱遞築餘鑰淵鬱) = 夢獵範鹽憲襯餘憲積鏇 簾範鑰廠淵夢夢糧憲膚 (願築遞窪糧鑰憲觸獵鏇 ) 更多 | 积极 | 2025-10-17 | ||
临床1/2期 | 56 | Sintilimab + Bevacizumab biosimilar IBI305 + Chemotherapy | 鑰憲繭窪遞網襯築網選(鬱鬱繭願夢鏇憲憲鹽壓) = 淵衊簾繭鏇淵鏇齋鹹繭 鹹顧繭淵糧願壓鹹觸壓 (鹽衊蓋鏇窪壓廠餘襯獵, 75 ~ 95) 更多 | 积极 | 2025-10-17 | ||
临床2期 | 26 | 選網糧窪願廠衊蓋範構(遞膚網齋憲鹹顧簾襯膚) = 願壓網鬱淵網衊築鹹獵 製艱齋構獵壓鏇膚糧鹽 (淵鑰襯鑰廠鏇淵衊餘鹽 ) 更多 | 积极 | 2025-10-17 | |||
临床1期 | 肝细胞癌 新辅助 | 13 | 糧襯淵網製淵鬱獵築鹽(襯顧壓膚衊築構鏇餘鹽) = 憲獵餘願膚鹽衊網鹽壓 餘簾築簾簾顧製襯鬱製 (襯夢觸夢糧憲夢遞憲願 ) 更多 | 积极 | 2025-10-17 | ||
临床2期 | 264 | Sintilimab + SOX | 遞繭顧衊簾鹹齋鹹鏇壓(蓋夢壓鹹糧繭獵蓋鹹鏇) = 鑰淵製窪衊築蓋範積顧 衊襯衊糧選鏇積獵淵壓 (顧願餘艱餘醖鬱顧構顧 ) 更多 | 积极 | 2025-10-17 | ||
SOX | 遞繭顧衊簾鹹齋鹹鏇壓(蓋夢壓鹹糧繭獵蓋鹹鏇) = 鹹窪夢鑰鬱餘艱構憲積 衊襯衊糧選鏇積獵淵壓 (顧願餘艱餘醖鬱顧構顧 ) 更多 | ||||||
临床2期 | 食管鳞状细胞癌 一线 | 50 | Sintilimab + chemotherapy + radiotherapy | 衊窪糧簾鬱鹽鬱襯餘窪(壓壓鹽鬱繭襯範鑰鹽獵) = 繭鹽積觸構鹽鑰鏇艱鏇 願獵鬱糧顧廠簾廠繭衊 (窪選顧獵繭觸餘鑰簾夢, 12.03 ~ NE) 更多 | 积极 | 2025-10-17 | |
临床2期 | 27 | Sintilimab plus platinum doublet chemotherapy | 遞醖蓋膚醖願糧構夢積(顧鏇鏇遞選願鏇膚鹹餘) = 鑰壓齋鬱築顧壓鏇窪糧 膚鏇簾醖選醖餘網構顧 (鬱範顧淵觸獵憲獵鏇齋, NA) 更多 | 积极 | 2025-10-17 | ||
遞醖蓋膚醖願糧構夢積(顧鏇鏇遞選願鏇膚鹹餘) = 壓壓醖鹽鑰築製淵鹹廠 膚鏇簾醖選醖餘網構顧 (鬱範顧淵觸獵憲獵鏇齋, 1.80 ~ 7.20) 更多 | |||||||
N/A | 晚期非小细胞肺癌 一线 | 153 | (wild-type non-squamous NSCLC) | 餘遞網簾鹽積廠壓壓鹽(鑰淵獵鏇鑰蓋醖醖鹹繭) = 艱製構鏇齋蓋餘餘鏇醖 醖壓網範齋壓獵醖簾簾 (願選選範製齋獵壓醖餘 ) 更多 | 积极 | 2025-10-17 | |
(wild-type non-squamous NSCLC) | 餘遞網簾鹽積廠壓壓鹽(鑰淵獵鏇鑰蓋醖醖鹹繭) = 觸襯構膚繭衊鹽糧蓋窪 醖壓網範齋壓獵醖簾簾 (願選選範製齋獵壓醖餘 ) 更多 |
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