预约演示
更新于：2025-03-06
Ipilimumab biosimilar (Innovent Biologics)
伊匹木单抗生物类似药（信达生物）
更新于：2025-03-06
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.)、伊匹木单抗生物类似药（信达生物制药（苏州）有限公司） + [4] |
靶点 |
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 |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评突破性疗法 (中国)、优先审评 (中国) |
登录后查看时间轴
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
29
项与 伊匹木单抗生物类似药（信达生物） 相关的临床试验NCT06620822
Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial
NCT06580574
Sintilimab With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability
CTR20231430
评估IBI310 联合信迪利单抗新辅助治疗可切除的高度微卫星不稳定型（MSI-H）或错配修复缺陷型（dMMR）结肠癌的有效性和安全性的Ib/III 期研究
100 项与 伊匹木单抗生物类似药（信达生物） 相关的临床结果
登录后查看更多信息
100 项与 伊匹木单抗生物类似药（信达生物） 相关的转化医学
登录后查看更多信息
100 项与 伊匹木单抗生物类似药（信达生物） 相关的专利（医药）
登录后查看更多信息
3
项与 伊匹木单抗生物类似药（信达生物） 相关的文献（医药）2025-01-01Med
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 ; Gao, Qinglei ; Zhou, Hui ; 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 ; Zhu, Lijing ; Jiao, Xiaofei ; 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 ; Huang, Bowen ; Zhang, Youzhong ; Chen, Youguo
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).
2024-07-01The Innovation
IBI310 (anti-CTLA-4 antibody) monotherapy or in combination with sintilimab in advanced melanoma or urothelial carcinoma
Article
作者: Yang, Yue ; Shen, Yuping ; Li, Juan ; Wei, Xiaoting ; Si, Lu ; Guo, Jun ; Tang, Bixia ; Chi, Zhihong ; Zheng, Shirui ; Zhou, Li ; Mao, Lili ; Guo, Qun ; Li, Siming ; Lian, Bin ; Cui, Chuanliang ; Yan, Xieqiao ; Wang, Xuan
IBI310 is a recombinant fully human IgG1 antibody against cytotoxic T lymphocyte antigen 4. This study was conducted to evaluate IBI310 monotherapy or combination therapy with sintilimab in the patients with advanced melanoma or urothelial carcinoma (UC). Patients in phase 1a received IBI310 at 0.3/1/2/3 mg/kg intravenously (IV) every 3 weeks (Q3W) following the accelerated titration and 3 + 3 escalation design. Patients in phase 1b received IBI310 (1/2/3 mg/kg IV, Q3W) plus sintilimab (200 mg IV, Q3W) for four cycles, followed by sintilimab maintenance therapy. The phase 1b expansion of IBI310 plus sintilimab was performed in patients with advanced melanoma or UC. Overall, 53 patients were enrolled, including 10 patients with melanoma in phase 1a, 34 with melanoma, and 9 with UC in phase 1b. Overall, 94.3% of patients (50/53) experienced at least one treatment-related adverse event (TRAE) with most being grade 1-2; 26.4% of patients (14/53) experienced grade 3 or higher TRAEs. In phase 1a, the disease control rate (DCR) was 50.0% (95% confidence interval [CI], 18.7%-81.3%). In phase 1b, the objective response rate (ORR) and DCR were 17.6% (95% CI, 6.8%-34.5%) and 44.1% (95% CI, 27.2%-62.1%), respectively, for melanoma, and were 22.2% (95% CI, 2.8%-60.0%) and 66.7% (95% CI, 29.9%-92.5%), respectively, for UC. IBI310 monotherapy or combination therapy with sintilimab was well tolerated with favorable antitumor activity across patients with advanced melanoma and UC.
2024-02-01Cancer medicine
A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non‐small‐cell lung cancer who have progressed after anti‐PD ‐1/L1 therapy
Article
作者: Yao, Jun ; Long, Jianlin ; Chen, Ye ; Zhao, Jun ; Cui, Jiuwei ; Meng, Rui ; Liu, Ziling ; Zhao, Yuguang ; Li, Li ; Zang, Aimin ; Guo, Qun ; Mao, Yong ; Chen, Xiao ; Luo, Yang ; Wu, Di
Abstract:
Background:
The development of immune checkpoint inhibitors has made a significant breakthrough in the treatment of non‐small‐cell lung cancer (NSCLC). However, there remains a huge unmet clinical need for patients with acquired resistance after initial treatment response.
Methods:
This study evaluated the combination of IBI310 (an anti‐cytotoxic T lymphocyte‐associated antigen‐4 [CTLA‐4] antibody) and sintilimab (an anti‐programmed death 1 [PD‐1]) antibody) in NSCLC patients who have previously been treated with anti‐PD‐1/ligand (L)1 and acquired resistance. The patients were randomly assigned to receive either a lower dose of IBI310 (1 mg/kg Q3W, cohort A) or a higher dose of IBI310 (3 mg/kg Q3W, cohort B) in combination with sintilimab (200 mg Q3W). The primary endpoints of the study were objective response rate (ORR) assessed by RECISTv1.1 and safety, while secondary endpoints included disease control rate (DCR), progression‐free survival (PFS), and overall survival (OS).
Results:
As of November 2, 2023, the study had enrolled 30 patients, with 15 patients in each cohort. The ORR was 13.3% (2/15, 95% confidence interval [CI], 1.7–40.5) in cohort B. DCR were 46.7% (95% CI, 21.3–73.4) and 66.7% (95% CI, 38.4–88.2) in cohorts A and B, respectively. In cohorts A and B of this trial, the median follow‐up times were 4.2 and 5.6 months, respectively. Median PFS was 1.45 (95% CI, 1.35–2.73) versus 2.73 (95% CI, 1.41–4.90) months for cohort A versus B; the median OS was 7.03 (95% CI, 3.09–not calculable [NC]) months in cohort A and 8.90 (95% CI, 5.13–NC) months in cohort B. Of the 30 patients, 86.7% in both cohorts experienced treatment‐related adverse events (TRAEs) with Grade ≥3 TRAEs occurring in 40% and 53.3% of patients in cohorts A and B, respectively.
Conclusion:
IBI310 3 mg/kg Q3W plus sintilimab was effective in a small number of previously treated anti‐PD‐1/L1‐resistant NSCLC patients.
100 项与 伊匹木单抗生物类似药（信达生物） 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
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 |
|---|---|---|---|---|
| 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 | |
| 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 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2021-02-07 | |
| 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 | 2023-03-10 | |
| 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 |
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1期 | 错配修复缺陷或微卫星高度不稳定性结直肠癌 Deficient DNA Mismatch Repair (dMMR) | MSI-High | 101 | 膚範顧餘壓網遞淵膚鏇(網壓蓋網衊艱築糧積艱) = 顧範觸鹽鏇鏇獵網壓餘 齋廠廠廠製鹹鏇鹽鏇顧 (淵蓋選觸積夢鑰構餘鏇 ) 更多 | 积极 | 2024-06-02 | ||
膚範顧餘壓網遞淵膚鏇(網壓蓋網衊艱築糧積艱) = 鹽選壓鬱糧簾窪壓網顧 齋廠廠廠製鹹鏇鹽鏇顧 (淵蓋選觸積夢鑰構餘鏇 ) 更多 | |||||||
临床1期 | 101 | 廠憲構範艱願範艱餘築(壓餘糧顧積願鹹壓範醖) = 鑰餘醖鹽鹹憲憲醖壓淵 願網積壓鹽壓積蓋網構 (壓選鹹衊膚壓膚構鑰憲, 66.3 ~ 90.0) 更多 | 积极 | 2024-05-24 | |||
Sintilimab 200 mg Q3W | 廠憲構範艱願範艱餘築(壓餘糧顧積願鹹壓範醖) = 艱積鹽選鏇範壓積選糧 願網積壓鹽壓積蓋網構 (壓選鹹衊膚壓膚構鑰憲, 32.5 ~ 63.3) 更多 | ||||||
临床2期 | 49 | 膚鑰壓壓夢衊構齋遞衊(齋窪夢糧餘簾選鬱壓簾) = 襯糧繭獵顧窪鑰壓衊衊 願襯範壓繭蓋醖網築顧 (網糧淵願襯醖範鬱窪襯 ) 更多 | 积极 | 2023-10-23 | |||
(treatment-naïve) | 顧壓繭獵獵廠觸艱鏇範(糧繭鹹簾衊蓋製餘顧餘) = 醖簾範壓餘齋壓夢網膚 築鹽繭蓋衊鑰醖鏇觸網 (蓋鏇顧範選鏇觸鹹鏇簾, 40.6 ~ 79.8) 更多 | ||||||
临床1期 | 29 | 鹹鹹築醖壓構觸廠廠簾(願齋夢顧艱鹽構願簾鏇) = 襯壓積選餘顧壓網餘廠 蓋構獵範獵膚觸鬱艱鏇 (淵蓋鏇網襯遞糧鬱鬱艱 ) 更多 | 积极 | 2022-01-19 | |||
临床1期 | 44 | 網積鹹壓醖壓觸糧淵醖(繭築獵觸鏇獵鬱簾艱選) = 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 範鏇獵鏇鹽簾顧衊構鏇 (夢餘簾願網鑰範鏇餘築 ) 更多 | 积极 | 2021-09-16 | |||
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
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
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