西妥昔单抗生物类似药 (桂林三金)(Cetuximab biosimilar(Guilin Sanjin)) - 药物靶点：EGFR_在研适应症：实体瘤，晚期恶性实体瘤_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Cetuximab Biosimilar (Guilin Sanjin Pharmaceutical)、西妥昔单抗生物类似药（Guilin Sanjin Pharmaceutical Co., Ltd.）

+ [3]

靶点

EGFR

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)

治疗领域

肿瘤

在研适应症

实体瘤晚期恶性实体瘤

非在研适应症

晚期结直肠腺癌局部晚期恶性肿瘤转移性结直肠癌+ [1]

原研机构

桂林三金药业股份有限公司

在研机构

桂林三金药业股份有限公司

宝船生物医药科技（上海）有限公司

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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序列信息

Sequence Code 43254L

当前序列信息引自: *****

Sequence Code 9505399H

当前序列信息引自: *****

关联

10

项与西妥昔单抗生物类似药 (桂林三金) 相关的临床试验

CTR20212382 / Recruiting临床1期

重组抗EGFR人鼠嵌合单克隆抗体注射液（CDP1）治疗晚期恶性实体瘤患者的安全性、耐受性和药代动力学的 I期临床研究

主要研究目的：评估 CDP1在晚期恶性实体瘤患者中的安全性和耐受性，并探索剂量限制性毒性（DLT），确定II期临床试验推荐剂量（RP2D）。次要研究目的：评估CDP1在晚期恶性实体瘤患者中的药代动力学特征；评估 CDP1在晚期恶性实体瘤患者中的免疫原性；评估 CDP1在晚期恶性实体瘤患者中和在晚期阴茎癌患者中联合TIP化疗后的初步疗效。

开始日期2021-04-09

申办/合作机构

宝船生物医药科技（上海）有限公司

NCT04739111 / Unknown status临床1期

An Exploratory Clinical Study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined With Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Malignant Tumor

This is an exploratory clinical study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in patients with advanced malignant tumor.

开始日期2021-01-29

申办/合作机构

宝船生物医药科技（上海）有限公司

[+1]

CTR20202642 / Active, not recruiting临床1期

评价全人源抗PD -L1抗体注射液（LDP）联合重组抗EGFR人鼠嵌合单克隆抗体注射液（CDP1）在晚期恶性肿瘤患者中的探索性临床研究

评估LDP联合CDP1治疗晚期恶性肿瘤患者的安全性，确定临床试验推荐剂量。

开始日期2021-01-20

申办/合作机构

宝船生物医药科技（上海）有限公司

100 项与西妥昔单抗生物类似药 (桂林三金) 相关的临床结果

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100 项与西妥昔单抗生物类似药 (桂林三金) 相关的转化医学

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100 项与西妥昔单抗生物类似药 (桂林三金) 相关的专利（医药）

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7

项与西妥昔单抗生物类似药 (桂林三金) 相关的文献（医药）

2014-10-01·Biochimica et Biophysica Acta (BBA) - General Subjects

Cysteine deleted protegrin-1 (CDP-1): Anti-bacterial activity, outer-membrane disruption and selectivity

Article

作者: Bhattacharjya, Surajit ; Mohanram, Harini

BACKGROUNDProtegin-1 (PG-1: RGGRLCYCRRRFCVCVGR-amide) assumes a rigid β-hairpin like structure that is stabilized by two disulfide bridges between Cys6-Cys15 and Cys8-Cys13. Previous studies, employing linear analogs of PG-1, with Cys to Ala mutations or modified Cys, have demonstrated that the disulfide bridges are critical for the broad spectrum and salt resistant antimicrobial activity of PG-1.METHODSIn order to understand structural and functional roles of disulfide bonds in protegrins, we have synthesized a Cys deleted variant of PG-1 or CDP-1, RGGRLYRRRFVVGR-amide, and two of its analogs, RR11, RLYRRRFVVGR-amide, and LR10, LYRRRFVVGR-amide, containing deletion of residues at the N-terminus. These peptides have been characterized for bactericidal activity and mode of action in lipopolysaccharide (LPS) using optical spectroscopy, ITC and NMR.RESULTSAntibacterial activity, against Gram-negative and Gram-positive strains, of the three peptides follows the order: CDP-1>RR11>LR10. LR10 displays only limited activity toward Gram-negative strains. CDP-1 demonstrates efficient membrane permeabilization and high-affinity interactions with LPS. CDP-1 and RR11 both assume β-hairpin like compact structures in complex with LPS, whereas LR10 adopts an extended conformation in LPS. In zwitterionic DPC micelles CDP-1 and the truncated analog peptides do not adopt folded conformations.MAJOR CONCLUSIONSDespite the absence of stabilizing disulfide bridges CDP-1 shows broad-spectrum antibacterial activity and assumes β-hairpin like structure in complex with LPS. The β-hairpin structure may be essential for outer membrane permeabilization and cell killing.

2001-08-01·Therapeutic Drug Monitoring3区 · 医学

Fluorescence Polarization Immunoassay: Can It Result in an Overestimation of Vancomycin in Patients Not Suffering From Renal Failure?

3区 · 医学

Article

作者: Sym, Donna ; Lehrer, Michael ; Meenan, Gerry ; Smith, Candace

It has been reported in scientific data that fluorescence polarization immunoassay (FPIA) results in overestimation of vancomycin in patients with renal failure. This overestimation is caused by interference of the degradation product, CDP-1, in this assay. Increases in vancomycin levels have also been reported in patients not suffering from renal failure (nonrenal failure patients) who are receiving vancomycin therapy for approximately 10 days or more. The authors tested whether this increase in vancomycin in nonrenal failure patients is a result of CDP-1 interfering with FPIA or a change in the pharmacokinetics of the drug. Serum vancomycin peak and trough samples were obtained from 10 adult (mean age +/- SD: 55.9 years +/- 17.5) nonrenal failure patients (mean ClCr +/- SD: 76.2 mL/min +/- 29.20) receiving vancomycin therapy for at least 10 days. These peaks and troughs were obtained at steady state and again at approximately 10 days of therapy. All serum samples were analyzed initially by fluorescence polarization immunoassay (FPIA, TDx) (Abbot Diagnostics; Irving, TX) and again by enzyme multiplied immunoassay (EMIT Vancomycin Assay) (Dade Behring; San Jose, CA). Statistical analysis (Wilcoxon signed-rank test) determined that there was no difference between the values obtained from the two assays. This demonstrates that the increase in vancomycin levels is not caused by the accumulation of CDP-1 and may be the result of a change in the pharmacokinetics of the drug.

1998-04-01·Journal of Pharmaceutical and Biomedical Analysis3区 · 医学

Quantitation of vancomycin and its crystalline degradation product (CDP-1) in human serum by high performance liquid chromatography

3区 · 医学

Article

作者: Dorothy W Backes ; Hoda I Aboleneen ; Janice A Simpson

The delayed clearance of vancomycin results in accumulation of vancomycin crystalline degradation product, CDP-1, in the bodies of renally impaired patients. The 2 isomers, CDP-1-M (major) and CDP-1-m (minor), of CDP-1 are antibiotically inactive but cross-react with some immunoassays that use polyclonal antibodies resulting in falsely elevated results. A high performance liquid chromatographic (HPLC) method was developed to quantitate vancomycin and CDP-1 in the serum of renal patients. After solid phase extraction of 200 microliters serum, the separation of vancomycin, the 2 isomers of CDP-1 and the internal standard (cefazolin) was accomplished by gradient HPLC on a reversed phase C18 column with detection at 210 nm. Linearity was established from 1 to 25 and 25 to 100 micrograms ml-1 vancomycin and 1 to 25 micrograms ml-1 CDP-1. Coefficients of variation for vancomycin and CDP-1 were 3.3-8.6% (n = 10) and 2.8-5.2% (n = 8).

100 项与西妥昔单抗生物类似药 (桂林三金) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC06	DB00002

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
实体瘤	临床2期	中国	宝船生物医药科技（上海）有限公司	2022-01-30
局部晚期恶性肿瘤	临床2期	中国	宝船生物医药科技（上海）有限公司	2021-01-29
晚期结直肠腺癌	临床2期	中国	宝船生物医药科技（上海）有限公司	2018-07-01
头颈部鳞状细胞癌	临床2期	中国	宝船生物医药科技（上海）有限公司	2018-07-01
转移性结直肠癌	临床2期	中国	桂林三金药业股份有限公司	2017-04-19
晚期恶性实体瘤	临床1期	中国	桂林三金药业股份有限公司	2019-12-23