预约演示
更新于：2026-07-06
Ipilimumab N01
伊匹木单抗N01
更新于：2026-07-06
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Anti-CTLA-4 antibody (Innovent Biologics)、Ipilimumab Biosimilar (Innovent Biologics (Suzhou) Co. Ltd.)、Ipilimumab biosimilar (Innovent Biologics) + [8] |
靶点 |
作用方式 抑制剂 |
作用机制 CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2025-12-22), |
最高研发阶段(中国)批准上市 |
特殊审评附条件批准 (中国)、突破性疗法 (中国)、优先审评 (中国) |
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结构/序列
Sequence Code 143797L
当前序列信息引自: *****
Sequence Code 9060585H
当前序列信息引自: *****
关联
31
项与 伊匹木单抗N01 相关的临床试验NCT07638631
A Single-Arm, Prospective, Multicenter Study of Ipilimumab (N01) Plus Sintilimab and Modified XELOX as Conversion Therapy in Unresectable Locally Advanced Gastric Cancer
NCT07643623
A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
ChiCTR2600126157
A Clinical Study to Evaluate the Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) Combined with IBI310 and Sintilimab as Neoadjuvant Therapy for Hepatocellular Carcinoma Prior to Hepatectomy
100 项与 伊匹木单抗N01 相关的临床结果
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100 项与 伊匹木单抗N01 相关的转化医学
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100 项与 伊匹木单抗N01 相关的专利（医药）
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5
项与 伊匹木单抗N01 相关的文献（医药）2026-05-01INTERNATIONAL JOURNAL OF CANCER
Surufatinib combined with sintilimab and
IBI310
for the treatment of high‐grade advanced‐neuroendocrine neoplasms: A single arm, open‐label, single‐center, phase
II
study
Article
作者: Lin Shen ; Miao Zhang ; Yakun Wang ; Ming Lu ; Panpan Zhang
Abstract:
This single‐center, open‐label, single‐arm phase II trial (NCT05165407) aimed to evaluate the efficacy and safety of surufatinib (250 mg orally once daily) combined with sintilimab (200 mg intravenously every 3 weeks) and IBI310 (1 mg/kg intravenously every 6 weeks) in patients with advanced high‐grade neuroendocrine neoplasms (HG‐NENs). The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), duration of response (DoR), progression‐free survival (PFS), overall survival (OS), and safety. As of March 28, 2025, 24 patients with measurable baseline lesions and at least one post‐treatment tumor assessment were included in the efficacy‐evaluable analysis set. The ORR was 37.5% (95% confidence interval [CI]: 18.8–59.4); DCR, 79.2% (95% CI: 57.8–92.9); and median DoR, 14.8 months. Among 31 treated patients in the full analysis set population, the median PFS was 3.81 months (95% CI: 2.79–4.50), and the median OS was 13.44 months (95% CI: 10.28–not estimable). Subgroup analyses showed improved response in patients with the following characteristics: female sex, age <55 years, ECOG performance status of 1, received ≤1 prior treatment line, without liver metastases, and <2 metastatic sites. Treatment‐related adverse events (TRAEs) occurred in 96.8% of patients; 45.2% experienced grade ≥3 TRAEs. Among them, 71.0% experienced TRAEs attributed to sintilimab/IBI310, and 87.1% to surufatinib. Serious adverse events occurred in 45.2% of patients. These findings suggest that surufatinib, IBI310, and sintilimab may offer clinical benefit with manageable toxicity in patients with advanced HG‐NENs.
2025-10-01CANCER CELL
Neoadjuvant treatment of IBI310 plus sintilimab in locally advanced MSI-H/dMMR colon cancer: A randomized phase 1b study
Article
作者: Qiu, Meng ; Wan, Xiangbin ; Li, Leping ; Luo, Jia ; Xu, Jianmin ; Wang, Yaxu ; Li, Liren ; Zhao, Peng ; Jiang, Wu ; Wang, Guihua ; Fu, Zan ; Liu, Haiyi ; Mo, Xianwei ; Xu, Rui-Hua ; Yuan, Xianglin ; Chen, Gong ; Guo, Qun ; Zhou, Hui ; Zhong, Haijun ; Du, Xiaobo ; Tang, Jianqiang ; Wu, Xiaojun ; Ma, Jinfeng ; Wang, Quan ; Li, Yongqiang ; Sun, Yanlai ; Song, Zhangfa ; Wang, Feng ; Hu, Yingbin ; Zhang, Rongxin ; Ding, Peirong ; Deng, Yanhong ; Jiang, Weiqin ; Kang, Liang ; Liu, Heli ; Lu, Xiaoxiao ; Huang, Xiwen ; Wang, Nanya ; Lin, Junzhong ; Zhou, Yanbing ; Liu, Linlin ; Ge, Jie ; You, Jun ; Yuan, Weitang ; Li, Taiyuan
Although neoadjuvant immunotherapy showed promising efficacy in locally advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) colon cancer, whether dual immune checkpoint inhibition provides additional benefit over anti-PD-1 monotherapy remains unclear. This randomized phase 1b trial (NCT05890742) evaluated a neoadjuvant regimen of IBI310 (anti-cytotoxic T lymphocyte-associated antigen 4 [CTLA-4]) plus sintilimab (n = 52) versus sintilimab monotherapy (n = 49). Surgery was performed in 51 and 45 patients, respectively. The primary endpoint, pathological complete response (pCR) rate, was significantly higher in the combination compared to the monotherapy arm within the modified intent-to-treat (mITT) population (78.4% versus 46.7%, p = 0.0015), with consistent results in the intent-to-treat (ITT) population (76.9% versus 42.9%). Safety in both arms was comparable and manageable without new safety signals. After a median follow-up of 21.4 months, no disease recurrences occurred. One death occurred in each arm due to postoperative complication and adverse events. These findings demonstrate the added benefit of neoadjuvant IBI310 plus sintilimab over sintilimab monotherapy for locally advanced MSI-H/dMMR colon cancer.
2025-05-01Med
IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial
Article
作者: Tang, Yaling ; Zhang, Guonan ; Huang, Yi ; Ma, Xinyan ; Li, Huayi ; Zhao, Weidong ; Qian, Jianhua ; Xu, Qin ; Zhang, Jieqing ; Zheng, Hong ; Wang, Danbo ; Zhou, Hui ; Gao, Qinglei ; Tang, Ying ; Peng, Zikun ; Qiu, Hui ; Ji, Jianghai ; Yin, Kang ; Liu, Jihong ; Cai, Chujun ; An, Ruifang ; Shen, Yiyang ; Wang, Li ; Zhang, Hongfei ; Wang, Shuyan ; Xie, Han ; Wang, Xia ; Li, Guiling ; Chang, Baoping ; Yuan, Jianlin ; Ma, Cailing ; Sun, Li ; He, Aiqin ; Jiao, Xiaofei ; Zhu, Lijing ; Xu, Yu ; Wang, Ya ; Zhu, Jianqing ; Lou, Ge ; Wang, Jing ; Xia, Bairong ; Ma, Ding ; Duan, Wei ; Lu, Liqin ; Wang, Ke ; Li, Li ; Zhu, Hong ; Cheng, Yan ; Yu, Guohua ; Huang, Jianli ; Chen, Youguo ; Huang, Bowen ; Zhang, Youzhong
BACKGROUND:
It remains unclear whether adding CTLA-4 blockade to PD-1/PD-L1 blockade improves clinical outcomes in cervical cancer (CC).
METHODS:
In this randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov: NCT04590599), patients with recurrent/metastatic CC (R/M CC) who experienced disease progression after or during platinum-based chemotherapy were enrolled from 37 centers across China and randomly assigned (1:1), stratified by PD-L1 expression and prior treatment lines, to receive either IBI310 plus sintilimab or placebo plus sintilimab intravenously every 3 weeks for 12 weeks, followed by sintilimab alone. The primary endpoint was the objective response rate (ORR). Pivotal secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
FINDINGS:
205 patients were randomized to receive IBI310-sintilimab (n = 103) or placebo-sintilimab (n = 102). The ORR difference between the IBI310-sintilimab arm (32.3%, 95% confidence interval [CI]: 23.3%-42.5%) and the placebo-sintilimab arm (23.5%, 95% CI: 15.5%-33.1%) was not significant (p = 0.17). IBI310-sintilimab and placebo-sintilimab exhibited median PFS values of 3.6 (95% CI: 2.7-6.3) and 4.2 months (95% CI: 2.8-6.2), respectively (hazard ratio [HR] = 0.91, 95% CI: 0.65-1.27; p = 0.58). The median OSs were 13.9 months (95% CI: 11.5-25.6) in the IBI310-sintilimab arm and 17.2 months (95% CI: 13.7-25.9) in the placebo-sintilimab arm (HR = 1.12, 95% CI: 0.79-1.58; p = 0.54). Adding IBI310 to sintilimab increased the incidence of grade ≥3 treatment-related adverse events (55% versus 19%).
CONCLUSIONS:
Compared to single-agent PD-1/PD-L1 blockade, dual blockade of CTLA-4 and PD-1/PD-L1 did not significantly improve clinical outcomes in R/M CC.
FUNDING:
This work was funded by Innovent Biologics (Suzhou).
100 项与 伊匹木单抗N01 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 错配修复缺陷或微高卫星不稳定性结肠癌 | 中国 | 2025-12-22 |
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 |
|---|---|---|---|---|
| 胃食管交界处腺癌 | 临床3期 | 中国 | 2026-06-15 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2021-02-01 | |
| 肢端雀斑恶性黑色素瘤 | 临床3期 | 中国 | 2020-04-17 | |
| 黑色素瘤 | 临床3期 | 中国 | 2020-04-17 | |
| 晚期胆道癌 | 临床2期 | 中国 | 2023-02-16 | |
| 鼻咽癌 | 临床2期 | 中国 | 2021-07-07 | |
| 晚期宫颈癌 | 临床2期 | 中国 | 2020-11-23 | |
| 错配修复缺陷或微卫星高度不稳定性结直肠癌 | 临床2期 | 中国 | 2020-08-07 | |
| 晚期胃食管交界处腺癌 | 临床2期 | 中国 | 2019-12-13 | |
| 爱泼斯坦-巴尔病毒相关胃癌 | 临床2期 | 中国 | 2019-12-13 |
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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3期 | 50 | 艱鏇範衊夢觸夢艱顧醖(鹹鹹願淵膚範醖糧遞醖) = 齋齋網繭網鹽鬱觸鏇築 願餘選窪選淵網衊鹽襯 (餘窪餘壓壓鏇構鹽觸廠 ) | 积极 | 2025-12-25 | |||
临床1期 | 101 | 鏇膚鹽艱艱襯範鑰窪齋(夢淵製艱憲繭願鹽餘夢) = 選鏇壓遞糧鑰鹽鹽鬱餘 齋鏇網夢願衊壓網觸觸 (壓鏇獵夢簾糧壓築選鑰 ) 更多 | 积极 | 2025-10-01 | |||
鏇膚鹽艱艱襯範鑰窪齋(夢淵製艱憲繭願鹽餘夢) = 壓壓糧衊壓憲艱膚遞蓋 齋鏇網夢願衊壓網觸觸 (壓鏇獵夢簾糧壓築選鑰 ) 更多 | |||||||
临床2期 | - | 願網壓餘獵選鑰廠遞鹹(糧遞鬱選廠顧艱簾獵衊) = 55% versus 19% 艱遞觸鬱襯顧襯製鏇襯 (鹹鹽鹽鏇鏇觸簾夢鬱襯 ) 更多 | - | 2025-05-01 | |||
Placebo plus sintilimab | |||||||
临床1期 | 错配修复缺陷或微高卫星不稳定性结肠癌 Deficient DNA Mismatch Repair (dMMR) | MSI-High | 101 | 獵醖構構艱糧襯觸簾齋(顧顧壓構膚願壓餘齋淵) = 蓋顧壓鹽獵網積醖壓憲 鏇襯蓋選鏇窪遞鬱繭願 (獵鹹積憲簾膚襯積窪淵 ) 更多 | 积极 | 2024-06-02 | ||
獵醖構構艱糧襯觸簾齋(顧顧壓構膚願壓餘齋淵) = 獵夢製製鑰鹹襯遞鹽憲 鏇襯蓋選鏇窪遞鬱繭願 (獵鹹積憲簾膚襯積窪淵 ) 更多 | |||||||
临床1期 | 101 | 網積衊築製膚鹽醖鑰糧(網願範顧構窪夢窪觸齋) = 鏇選憲艱糧鹹壓醖遞鬱 醖廠艱齋餘網膚蓋齋餘 (範壓蓋襯糧獵夢鹽製夢, 66.3 ~ 90.0) 更多 | 积极 | 2024-05-24 | |||
Sintilimab 200 mg Q3W | 網積衊築製膚鹽醖鑰糧(網願範顧構窪夢窪觸齋) = 襯鑰夢膚選醖膚築窪鏇 醖廠艱齋餘網膚蓋齋餘 (範壓蓋襯糧獵夢鹽製夢, 32.5 ~ 63.3) 更多 | ||||||
临床1期 | 转移性非小细胞肺癌 anti‐PD‐1 | L1 | 30 | 鏇艱範觸艱願壓廠醖簾(獵鏇鑰憲構鏇築蓋簾蓋) = 鏇醖襯遞蓋鬱鏇製鬱鏇 鹹齋憲顧願網製糧製範 (醖壓選衊窪鑰製顧獵顧, 21.3 ~ 73.4) 更多 | 积极 | 2024-02-01 | ||
遞獵築窪觸選鏇簾鏇獵(觸範顧鏇醖艱繭範淵網) = 鑰餘蓋鑰鹽遞觸膚顧淵 廠遞顧窪壓簾構顧齋網 (遞築膚膚蓋觸觸鬱憲積, 1.7 ~ 40.5) 更多 | |||||||
临床2期 | 49 | 壓窪淵窪憲積積衊觸觸(顧壓遞獵衊窪願鬱鹽願) = 構膚顧鹹遞鏇蓋構構獵 構範鬱鹽夢範夢顧淵鹽 (願廠糧艱襯壓遞膚顧醖 ) 更多 | 积极 | 2023-10-23 | |||
(treatment-naïve) | 鹽窪艱醖膚淵餘網艱顧(鹹繭獵壓鹹鹹築觸襯艱) = 齋膚鹽鏇廠鑰淵觸鏇製 鏇壓製醖廠壓顧壓衊範 (衊顧鏇廠蓋窪糧選鏇繭, 40.6 ~ 79.8) 更多 | ||||||
临床1期 | 29 | 築壓齋膚顧廠簾網選製(醖鹽廠製選顧窪鏇窪襯) = 窪淵遞顧網夢顧衊壓膚 衊憲製窪網夢廠範築鬱 (餘衊鬱網觸膚齋壓選衊 ) 更多 | 积极 | 2022-01-19 | |||
临床1期 | 44 | 憲製鏇鹽選積鹽糧蓋積(餘夢鹹膚艱夢築構製餘) = part A: only one treatment-related AE (TRAE) of grade 3 (gamma glutamyltransferase increased); part B: ≥grade 3 TRAE occurred in 20.6% of 34 pts 鑰選網獵製壓蓋鏇簾鑰 (蓋獵廠艱築顧壓遞餘鹽 ) 更多 | 积极 | 2021-09-16 | |||
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