预约演示
更新于：2026-07-30
Cetuximab biosimilar (Zhangjiang Biotech)
西妥昔单抗生物类似药 (张江生物)
更新于：2026-07-30
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Cetuximab Biosimilar (Shanghai Zhangjiang Biotechnology Co. Ltd.)、cGAMP-VLP- Stimunity、西妥昔单抗β + [4] |
靶点 |
作用方式 拮抗剂 |
作用机制 EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂) |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-06-18), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 43254L
来源: *****
Sequence Code 9505399H
来源: *****
关联
7
项与 西妥昔单抗生物类似药 (张江生物) 相关的临床试验NCT07595276
A Multicenter, Randomized, Double-blind, Phase III Clinical Study Evaluating the Efficacy and Safety of Enlituo® Plus FOLFOX Versus Erbitux® Plus FOLFOX as First-line Treatment for Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.
CTR20254359
恩立妥®工艺变更前后在健康男性志愿者的随机、双盲、平行对照、单次给药药代动力学、安全性和免疫原性的比对研究
NCT07198841
The Efficacy and Safety of IBI351 Plus Cetuximab β in Untreated, Locally Advanced or Metastatic Non-small Cell Lung Cancer With KRAS G12C Mutation: A Single-arm, Prospective, Multicenter Phase II Clinical Study
100 项与 西妥昔单抗生物类似药 (张江生物) 相关的临床结果
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100 项与 西妥昔单抗生物类似药 (张江生物) 相关的转化医学
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100 项与 西妥昔单抗生物类似药 (张江生物) 相关的专利（医药）
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5
项与 西妥昔单抗生物类似药 (张江生物) 相关的文献（医药）2024-04-01Journal of pharmaceutical and biomedical analysis
Highly drug/target-tolerant neutralizing antibody (NAb) assay development through target-based drug depletion and drug-based NAb extraction for an anti-EGFR therapeutic monoclonal antibody
Article
作者: Xinyi Su ; Qingcheng Guo ; Mengjiao Xu ; Tao Liu ; Xiang Zhao ; Dapeng Zhang ; Fugui Wang ; Weizhu Qian ; Huaizu Guo ; Sheng Hou ; Jin Xu ; Jun Li ; Lusha Ji ; Rongrong Fu
The reduction of immunogenicity is fundamental for the development of biobetter Erbitux, given that the development of an immune response reduces treatment efficacy and may lead to potential side effects. One of the requirements for the clinical research of a Erbitux biobetter candidate (CMAB009) is to develop a neutralizing antibody (NAb) assay, and sufficient drug and target tolerance for the assay is necessary. Here, we describe the development of a competitive ligand binding (CLB) assay for CMAB009 with high drug and target tolerance through target-based drug depletion and drug-based NAb extraction, the integrated experimental strategy was implemented to simultaneously mitigate drug interference and enhance target tolerance. Following troubleshooting and optimization, the NAb assay was validated for clinical sample analysis with the sensitivity of 92 ng/mL, drug tolerance of 70 μg/mL and target tolerance of 798 ng/mL. The innovative drug depletion and NAb extraction achieved though the combination of drug and target beads would enable the development of reliable NAb assays for many other therapeutics that overcome drug and its target interference for more precise and sensitive NAb assessment.
2019-12-01Cancer communications (London, England)1区 · 医学
CMAB009 plus irinotecan versus irinotecan‐only as second‐line treatment after fluoropyrimidine and oxaliplatin failure in
KRAS
wild‐type metastatic colorectal cancer patients: promising findings from a prospective, open‐label, randomized, phase III trial
1区 · 医学
ArticleOA
作者: Yiping Zhang ; Xiaohui He ; Yan Sun ; Yuankai Shi ; Yigui Chen ; Wei Liu ; Feng Bi ; Yi Luo ; Guoping Sun ; Zhehai Wang ; Qiang Yao ; Ying Cheng ; Jin Li ; Li Bai ; Rongsheng Zheng ; Jianming Xu ; Shukui Qin ; Liwei Wang ; Xuenong Ouyang ; Xiaohua Hu ; Yuhong Li ; Yunpeng Liu
Abstract:
Background:
The 5
‐
fluorouracil/leucovorin plus oxaliplatin (FOLFOX) regimen is the standard first‐line treatment for metastatic colorectal cancer (mCRC), however, the optimal second‐line regimen for
KRAS
wild‐type mCRC patients is still investigational. In this study, we aimed to determine the clinical efficacy and safety of CMAB009 plus irinotecan compared to irinotecan‐only as a second‐line regimen for treating
KRAS
wild‐type mCRC patients.
Methods:
Patients with
KRAS
wild‐type mCRC who had previously failed to respond to FOLFOX treatment were randomly assigned in a 2:1 ratio, to receive CMAB009 plus irinotecan or irinotecan‐only. Patients receiving irinotecan‐only were permitted to switch to CMAB009 therapy on disease progression and were grouped as the sequential‐CMAB009 arm. The primary endpoints were overall response rate (ORR) and median progression‐free survival (PFS). The secondary endpoints were median overall survival (OS), disease control rate (DCR), clinical benefit rate (CBR), and duration of response (DOR).
Results:
The CMAB009 plus irinotecan arm demonstrated significantly improved ORR (33.2% vs. 12.8%;
P
< 0.001) and longer median PFS (169 days vs. 95 days;
P
< 0.001) as compared to the irinotecan‐only arm. Patients receiving CMAB009 plus irinotecan also demonstrated improved DCR (80.1% vs. 65.2%,
P
< 0.001), CBR (30.0% vs. 14.6%,
P
< 0.001), and DOR (210 days vs. 109 days;
P
< 0.001) as compared to irinotecan‐only. However, patients treated with CMAB009 had an increased risk of skin rash (66.9% vs. 5.5%,
P
< 0.001) and paronychia (9.8% vs. 0.0%,
P
< 0.001). Anti‐drug antibodies (ADA) were detected in 3.6% of patients, and only 0.9% of patients who received CMAB009 experienced hypersensitivity reactions. In patients receiving sequential‐CMAB009 therapy after failure with irinotecan, their median PFS was 84 days (95% CI 65 to 113 days). The median OS was 425 days for patients receiving CMAB009 plus irinotecan and 401 days for those with sequential‐CMAB009 (
P
= 0.940).
Conclusions:
Treatment with CMAB009 plus irinotecan was found to be a superior second‐line regimen in comparison to irinotecan‐only in
KRAS
wild‐type mCRC patients. Further, switching to CMAB009 can be considered as an efficient third‐line of treatment after treatment failure with second‐line irinotecan‐only.
Trial registrationClinicalTrials.gov
: NCT01550055, retrospectively registered on March 9, 2012.
2011-09-06Zhonghua yi xue za zhi
[Phase I study of anti-EGFR monoclonal antibody (CMAB009) in patients with advanced cancer].
Article
作者: Xiao-Hui He ; Sheng Yang ; Yan Qin ; Yan Sun ; Yuan-Kai Shi
OBJECTIVE:
To characterize the safety profiles and serum pharmacokinetic effects of anti-epidermal growth factor receptor monoclonal antibody (CMAB009) in advanced cancer patients and evaluate the preliminary evidence of its anti-tumor activity.
METHODS:
This phase I, single-center clinical trial had 2 phases of treatment: single-dose phase, followed by a fixed weekly dose. Subjects meeting the inclusion criteria were enrolled. The subjects were randomly assigned to receive 1 of 3 initial doses of CMAB009 (100, 250 & 400 mg/m(2)) for the purpose of single-dose pharmacokinetic evaluation. After a 28-day washout period of allowing for the characterization of pharmacokinetic end points, the eligible patients were permitted to undergo a successive multi-dose phase study. They were divided into 2 dose groups, group A with 4 weekly doses of 250 mg/m(2), group B with the initial dose of 400 mg/m(2), followed by 3 weekly doses of 250 mg/m(2). The subjects were closely monitored for adverse events throughout the trial.
RESULTS:
A total of 18 subjects were recruited, including colorectal cancer (n = 10), non-small cell lung cancer (n = 7) and gastric cancer (n = 1). CMAB009-associated toxicity was minimal. And the most commonly reported Grade 1/2 adverse events were skin rashes, fever, nausea and headache. Two patients with colorectal cancer achieved partial remission and the time to progression (TTP) was 24 and 16 weeks respectively.
CONCLUSION:
As a well-tolerated antitumor agent, CMAB009 may be safely administered by the above multi-dosing protocol.
100 项与 西妥昔单抗生物类似药 (张江生物) 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 |
|---|---|---|---|
| RAS/BRAF基因野生型结直肠癌 | 中国 | 2024-06-18 |
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 |
|---|---|---|---|---|
| RAS阳性结直肠癌 | 临床3期 | 中国 | 2026-05-11 | |
| KRAS 野生型结直肠癌 | 临床3期 | - | 2009-05-31 | |
| 转移性结直肠癌 | 临床3期 | - | 2009-05-31 |
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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 | RAS/BRAF基因野生型结直肠癌 RAS/BRAF野生型 | 505 | CMAB009 + FOLFIRI | 淵獵憲廠糧齋艱醖餘膚(願膚鹹簾淵選鹽餘積襯) = 構夢遞醖淵製製窪鬱積 繭觸製膚築廠願艱顧範 (醖選製鹹願鹽築鬱廠鹹 ) 更多 | 积极 | 2025-05-09 | |
FOLFIRI | 淵獵憲廠糧齋艱醖餘膚(願膚鹹簾淵選鹽餘積襯) = 簾獵網鹽築網鹹膚構繭 繭觸製膚築廠願艱顧範 (醖選製鹹願鹽築鬱廠鹹 ) 更多 | ||||||
临床3期 | 1,077 | 醖構積夢製鏇鏇積鹽膚(積範鑰餘願鑰選窪鏇範) = 糧蓋膚衊遞蓋構窪糧選 遞齋顧餘憲餘齋艱構餘 (壓壓淵鏇淵遞窪鏇蓋獵 ) 更多 | 优效 | 2019-05-24 | |||
醖構積夢製鏇鏇積鹽膚(積範鑰餘願鑰選窪鏇範) = 遞淵艱鏇構齋鏇餘選鹽 遞齋顧餘憲餘齋艱構餘 (壓壓淵鏇淵遞窪鏇蓋獵 ) 更多 | |||||||
临床3期 | 512 | 夢觸願鏇齋憲齋襯醖鏇(憲蓋醖鏇觸鬱襯範憲製) = 築鹽廠齋製構鏇網蓋鬱 衊糧鏇襯簾壓遞壓憲選 (糧窪艱願淵夢窪膚壓齋 ) 更多 | 积极 | 2017-05-30 | |||
夢觸願鏇齋憲齋襯醖鏇(憲蓋醖鏇觸鬱襯範憲製) = 築糧顧憲繭願網鑰鏇蓋 衊糧鏇襯簾壓遞壓憲選 (糧窪艱願淵夢窪膚壓齋 ) 更多 |
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