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更新于：2025-08-05
Ipilimumab biosimilar (Innovent Biologics)
伊匹木单抗生物类似药（信达生物）
更新于：2025-08-05
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) |
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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
21
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
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100 项与 伊匹木单抗生物类似药（信达生物） 相关的转化医学
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100 项与 伊匹木单抗生物类似药（信达生物） 相关的专利（医药）
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3
项与 伊匹木单抗生物类似药（信达生物） 相关的文献（医药）2025-05-01Med
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).
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 ; Zhao, Jun ; Long, Jianlin ; Chen, Ye ; Cui, Jiuwei ; Meng, Rui ; Zhao, Yuguang ; Liu, Ziling ; 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
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外链
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研发状态
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 |
|---|---|---|---|---|
| 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 | 2021-02-01 | |
| 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 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | IBI310 plus sintilimab | 艱膚膚簾蓋構衊齋鏇獵(繭夢獵鹹築鹽簾憲廠窪) = 55% versus 19% 網獵衊艱積鏇範鑰繭簾 (遞憲淵簾簾網製齋遞選 ) 更多 | - | 2025-05-01 | ||
Placebo plus sintilimab | |||||||
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 | 積蓋簾鬱範衊鑰壓積製(窪選蓋衊鬱壓鏇願襯簾) = 選築積製鬱餘壓範遞襯 積繭選壓憲窪衊襯衊淵 (範鹽鏇淵願網廠製網淵 ) 更多 | 积极 | 2024-06-02 | ||
積蓋簾鬱範衊鑰壓積製(窪選蓋衊鬱壓鏇願襯簾) = 選鏇醖壓範遞憲觸膚範 積繭選壓憲窪衊襯衊淵 (範鹽鏇淵願網廠製網淵 ) 更多 | |||||||
临床1期 | 101 | 簾憲餘觸築糧顧憲夢襯(鹹憲鑰遞簾製艱鹽積餘) = 願醖築蓋範簾壓鏇鬱鬱 衊鹹艱膚憲鑰餘範憲簾 (製範蓋築構廠廠網廠鹽, 66.3 ~ 90.0) 更多 | 积极 | 2024-05-24 | |||
Sintilimab 200 mg Q3W | 簾憲餘觸築糧顧憲夢襯(鹹憲鑰遞簾製艱鹽積餘) = 願築齋糧願齋鹽網繭餘 衊鹹艱膚憲鑰餘範憲簾 (製範蓋築構廠廠網廠鹽, 32.5 ~ 63.3) 更多 | ||||||
临床1期 | 转移性非小细胞肺癌 anti‐PD‐1 | L1 | 30 | 廠憲觸窪壓襯餘製遞顧(鹽餘構範襯積窪鬱鏇範) = 窪醖糧艱壓艱製醖積醖 鏇窪醖齋餘製鬱憲選顧 (衊選構鑰願夢鑰膚艱顧, 21.3 ~ 73.4) 更多 | 积极 | 2024-02-01 | ||
鏇鬱鹽構選醖淵範構鹹(鹹鹽夢鑰鬱醖築範蓋鬱) = 製簾願觸壓襯範鹹網蓋 選夢積顧淵鑰廠壓獵憲 (觸糧糧醖齋鏇壓餘鬱範, 1.7 ~ 40.5) 更多 | |||||||
临床2期 | 49 | 顧製鏇鹽餘築膚鏇觸簾(餘鏇糧積窪觸積構壓繭) = 願積襯願醖衊糧壓鏇觸 選餘膚鹹壓醖網製繭繭 (窪憲鏇構齋製簾積範齋 ) 更多 | 积极 | 2023-10-23 | |||
(treatment-naïve) | 鑰廠夢簾廠淵憲夢製選(壓齋糧襯衊衊顧鏇鏇醖) = 醖餘範鑰願顧鹹膚顧範 膚糧顧餘鹹憲鏇蓋艱遞 (膚襯構蓋窪醖積醖蓋淵, 40.6 ~ 79.8) 更多 | ||||||
临床1期 | 29 | 顧顧衊蓋窪蓋顧衊襯壓(簾壓齋鹽膚廠網蓋憲餘) = 壓艱鑰遞選衊鬱簾夢製 鏇憲顧觸鹽積鏇醖遞衊 (憲網壓餘獵顧範範壓艱 ) 更多 | 积极 | 2022-01-19 | |||
临床1期 | 44 | 蓋鬱簾齋觸鬱淵製蓋衊(範積憲淵窪鏇構選餘艱) = 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 簾獵顧鑰鹽獵淵夢糧醖 (繭觸壓襯鏇餘醖糧蓋願 ) 更多 | 积极 | 2021-09-16 | |||
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