英文药名：ZALTRAP IV infusion（Aflibercept Beta（Genetical Recombination））

中文药名：阿柏西普重组注射溶液剂

生产厂家：赛诺菲有限公司

ザルトラップ点滴静注100mg／ザルトラップ点滴静注200mg

药物分类名称
抗肿瘤药/VEGF注）抑制剂
注）VEGF：血管内皮生长因子（血管内皮生长因子）
批准日期：2017年5月
商標名
ZALTRAP
一般名
アフリベルセプト　ベータ（遺伝子組換え）
Aflibercept Beta（Genetical Recombination）
本質
Afliuberceptaβ是一种重组融合糖蛋白，第一至第104位氨基酸是人血管内皮生长因子受体（VEGFR）1的第二个免疫球蛋白（Ig）如C2结构域，第105位至第205位人VEGFR2 第三个Ig样C2结构域和第206至432位由人IgG1的Fc结构域组成。 Afrivelesptbeta由中国仓鼠卵巢细胞产生。 Afrivelesptbeta是由432个氨基酸残基组成的2个亚基组成的糖蛋白（分子量约115,000）。
审批条件
制定药品风险管理计划并适当执行。
药效药理
1.药理作用
在皮下移植了来自人结肠/直肠癌的HT-29，COLO205和HCT116细胞系的小鼠Afibrusseptaβ显示肿瘤生长抑制作用。
2. 作用机序
Afliuberceptaβ是与人IgG1的Fc结构域融合的重组蛋白，人血管内皮生长因子受体（VEGFR）1的第二免疫球蛋白（Ig）如C2结构域和人VEGFR2的第三Ig样C2结构域 ，抑制属于血管内皮生长因子（VEGF）-A，VEGF-B和VEGF家族的胎盘生长因子（PlGF）与VEGFR之间的结合，由此抑制肿瘤中的血管生成并抑制肿瘤生长这将表明。
适应病症
复发性晚期/复发性结直肠癌，根治性不能切除
用法与用量
与伊立替康盐酸盐水合物，左氟芬酸盐和氟尿嘧啶组合，成人通常每周一次服用4mg/kg（体重），持续2周，在60分钟内用滴注方式进行非洲爪蟾（基因重组）注。 另外，根据患者的状况来减轻体重。
包装规格
输液IV
100毫克：4毫升×1瓶

200毫克：8毫升×1瓶

制造商
赛诺菲有限公司
注：以上中文资料不够完整，使用者以原处方资料为准。
完整说明书附件：http://www.info.pmda.go.jp/go/pack/4291436A1023_1_04/
VEGF inhibitor Afrivelesptbeta, approved for colorectal cancer: Sanofi
Sanofi Co., Ltd. (Headquarters: Shinjuku-ku, Tokyo, President and CEO: Jack Naton) announced on March 30, 2017 that Afrivelestepeta beta (trade name: Zal trap intravenous drip infusion 100mg/200 mg, hereinafter referred to as Zal Trap) announced that it acquired manufacture and marketing approval from the Ministry of Health, Labor and Welfare due to the efficacy and effect of "progression-free and recurrent colorectal cancer of curative resection."
Afribeptepta beta is a molecular targeted therapeutic agent that acts on VEGF-A, VEGF-B and placental growth factor (PlGF), which are involved in the growth and metastasis of cancer.
In overseas Phase III clinical trials compared with placebo in combination with FOLFIRI therapy (irinotecan, levofolinate and fluorouracil) as a second-line treatment of metastatic colorectal cancer exacerbated during or after treatment with oxaliplatin, including chemotherapy(HR: 0.817, 95.34% CI: 0.713 to 0.937, p = 0.0032) for the primary endpoint, the overall survival term (OS) was 13.50 months and the placebo group was 12.06 months .
In addition, the progression-free survival term (PFS) of the secondary endpoint has also been significantly improved (HR: 0.758, 95% CI: 0.661 to 0.869, p <0.0001).
As of March 2017, Sal Trap has been approved in more than 70 countries and regions, and in Japan, Sanofi was applying for manufacturing and marketing approval in April 2016. Sanofi will conduct manufacturing and sales in Japan, and sanofi and Yakult Honsha will jointly conduct promotion.