英文药名：OPDIVO（Nivolumab[Genetical Recombination]） 中文药名：纳武单抗重组注射剂 日文药名：オプジーボ点滴静注 生产厂家：小野制药 治疗类别名称 -抗肿瘤药- 商標名 OPDIVO 一般名 ニボルマブ（遺伝子組換え） Nivolumab（Genetical Recombination） 分子量 約145,000 本質 重组人IgG4单克隆抗体与人PD-1，氨基的重链中的位置被取代为Pro的氨基酸残基221。它是具有两个轻链包含氨基酸组成的糖蛋白的残基214件和两条重链包含氨基酸残基440件由中国仓鼠卵巢细胞中产生的。 审批条件 通过实施各种情况下的使用，调查的结果，而从审判案件在全国已根据一定数量的，直到它被集成在案件极为有限，数据后市场，此药以及了解患者的使用的背景资料，收集关于此药的疗效和安全性的早期数据，采取必要的措施，正确使用此药。 药效药理 作用机理 针对人的PD-1的抗体来抑制PD-L1的结合和PD-L2是其配体PD-1的T细胞的癌症抗原特异性，Niborumabu是细胞毒性和活化增殖í认为，活性增强，而抑制肿瘤生长。 适应症： 恶性黑色素瘤的非手术治疗 剂量与用法 成年人，一次2毫克/千克静脉内输注以3周的时间间隔（体重） 包装规格 20毫克2毫升：1瓶 100毫克10毫升：1瓶 制造 小野制药有限公司 opdico(nivolumav  日文药名：オプジーボ点滴静注(ニボルマブ[遺伝子組換え]) 2014年7月9日，nivolumab已经被批准在日本上市用于治疗黑色素瘤。这种药物将以Opdivo的商业名登陆日本市场。Nivolumab是最近日本批准的唯一一个尖端药物。 Malignant melanoma development and approval of new therapeutic agents has been waiting for July 4, "Opujibo (R) intravenous infusion 20mg, 100mg (generic name: Niborumabu (genetical recombination))" Ono Pharmaceutical Co., Ltd. is human anti-PD-1 monoclonal antibody for malignant non curative resection announced that it has received an approval of production and marketing that adaptation melanoma. From that drug therapy significantly improves it did not exist until now and, very poor, development and approval of new therapeutic agents has been waiting for the prognosis of non malignant melanoma patients with resected by surgery. Approval of the world's first as PD-1 targeting drug Opujibo is, human anti-PD-1 monoclonal antibody, and was created on the basis of the joint research agreement that the United States Medarex, Inc. and Ono has concluded in May 2005. Acquired Bristol-Myers Squibb to (BMY, Inc.) in 2009 and then, development and commercial Ka-ken in North America of the same antibodies have been inherited by the BMY company Medarex. Entered into a strategic licensing agreement with BMY Inc. in September 2011, one of the region outside of North America, reserves the development and commercialization rights in Japan, Korea and Taiwan, Ono is, in the whole world case of other Opujibo I was provided to BMY Inc. exclusive development and commercialization rights. The PD-1 is a type of receptors on the lymphocyte surface, to be involved in a system that suppresses activated lymphocytes in the living body are known. Believed cancer cells, and that escape from the immune response by using this system, it is possible to suppress the action of inhibiting PD-1 and the lymphocyte, to enhance the immune response, Opujibo is against tumor and that demonstrate the validity. The approval of this time, Opujibo became the drugs as therapeutic agents that target PD-1, was obtained for the first time in the world manufacturing and marketing approval. It should be noted that, since the trial of cases in the country has been very limited, in accordance with the conditions of approval, post-marketing, data related to cases of a certain number until it is integrated, and to enforce the use results survey in all cases, and safety I have collected clinical data on the efficacy and gender, Ono is going to take the measures necessary to the proper use of the same agent. 使用完整说明书附件：http://meds.qlifepro.com/detail/622364801/ FDA授予百时美免疫疗法nivolumab突破性疗法认定 百时美施贵宝（BMS）5月14日宣布，FDA已授予实验性PD-1免疫检查点抑制剂nivolumab突破性疗法认定，用于治疗自体干细胞移植和brentuximab失败的霍奇金淋巴瘤（HL）患者的治疗。 Nivolumab突破性疗法认定的授予，是基于一项正在复发性和难治性血液系统恶性肿瘤群体中开展的Ib期研究中HL群体的队列数据。 霍奇金淋巴瘤（HL）是一种源于白细胞的淋巴系统癌症。晚期HL患者群体，5年存活率约为65%。若复发性和难治性HL患者接受自体干细胞移植后一年内病情恶化，平均存活时间仅为1.3年。 关于Nivolumab（BMS-936559）: 癌细胞可能利用“调节子（regulator）”途径，如检查点（checkpoint）途径，逃避机体免疫系统，保护肿瘤免受免疫攻击。 Nivolumab是一种实验性、全人源化IgG4、抗程序性死亡受体1（PD-1）单克隆抗体，能够抑制PD-1与程序性死亡配体1（PD-L1/B7-H1）和程序性死亡配体2（PD-L2/B7-DC）的结合。阻断PD-1与其配体的相互作用，可能使T细胞恢复抗肿瘤免疫应答。 目前，百时美施贵宝正调查nivolumab用于恶性黑色素瘤、肾癌、非小细胞肺癌及其他癌症的治疗。 nivolumab的开发项目研究总数超过25个：调查作为单药疗法或与其他药物联合用药，用于多个肿瘤类型的治疗，包括：非小细胞肺癌、小细胞肺癌、黑色素瘤、肾细胞癌、肝癌、血液癌症、三阴性乳腺癌、胃癌、胰腺癌。