英文药名：Yervoy Injection（ipilimumab[Genetical Recombination]） 中文药名：易普利姆重组注射剂 生产厂家：日本百时美施贵宝 ヤーボイ点滴静注液50mg 治疗类别名称 抗肿瘤药 人抗CTLA-4的单克隆抗体 欧文商標名 YERVOY Injection 一般名： イピリムマブ（遺伝子組換え） Ipilimumab（Genetical Recombination） 本質： 易普利姆玛是针对人细胞毒性T淋巴细胞抗原4的重组人IgG1单克隆抗体。易普利姆玛是由中国仓鼠卵巢细胞产生。易普利姆玛是448 H链（γ1链）组成的两个和L链的215个氨基酸残基（κ链）的两个氨基酸残基组成的糖蛋白（分子量：约148000）是。 性状 外观 一种液体呈现无色清除或轻微乳白色浅黄色，有一个略微承认细。 pH值 6.6〜7.6 渗透压比（生理盐水之比） 药效药理 作用机序 易普利姆玛是针对细胞毒性T淋巴细胞抗原的抗体-4（CTLA-4），抗原呈递细胞上它们是CTLA-4和它的配体B7.1（CD80）和B7.2（CD86）与分子通过抑制结合，阻断抑制活化T细胞的调节肿瘤抗原特异性T细胞活化的，增殖和通过增强细胞毒活性抑制肿瘤生长。另外，这种药物，本人认为，增强肿瘤免疫应答，表明抗肿瘤作用是由于在调节性T细胞的调节性T细胞的功能障碍和肿瘤组织的数目减少（Treg细胞） 适应病症 不能切除的根治恶性黑色素瘤 用法与用量 （1）YERVOY 3mg/kg静脉历时90分钟给予每3周总共四剂。 （2）对严重不良反应永远终止 包装规格 静脉滴注液： 50mg/10mL*1小瓶 生产商：日本百时美施贵宝[联盟]小野制药有限公司 注：以上中文资料仅供参考，使用以原处方为准：http://www.info.pmda.go.jp/go/pack/4291430A1026_1_05/ YERVOY®(ipilimumab) Notification of manufacturing and marketing authorization to adapt "Yahboi (R) infusion intravenous solution 50 mg" to radical cureless malignant melanoma Notification of manufacturing and marketing authorization to adapt to curative malignant melanoma of radical cure of human type anti-human CTLA-4 monoclonal antibody "YAVOY (R) drip infusion solution 50 mg" The world's first approved immunity checkpoint inhibitor approved in Japan Bristol-Myers Co., Ltd. (Shinjuku-ku, Tokyo, President: David Piras) Regarding malignant melanoma that can not be cured remotely for human anti-human CTLA-4 monoclonal antibody "Yavoi (R) intravenous infusion solution 50 mg, hereinafter referred to as Yavoy" (generic name: ipilimumab (genetical recombination)), the Ministry of Health, Labor and Welfare We will inform you that we have obtained more manufacturing and sales approval. Yahboi reported statistically significant overall survival (OS) as compared to the control group, regardless of BRAF mutation (Note 1) in overseas Phase III trials in patients with radical cure of malignant melanoma, It is the first drug in the world to show the extension of. It is also the first medicine approved in the world as an immunity checkpoint inhibitor called cancer immunotherapy, which has attracted a great deal of attention in cancer treatment in recent years. Since March 2011, it has been approved in the United States, including Europe, Australia and Canada, has been approved in more than 50 countries since it was approved for indications of unresectable or metastatic malignant melanoma. It is also used as a standard treatment for malignant melanoma that can not be cured curable irrespective of the treatment history of anticancer drugs in many countries. Yahboi block inhibitory regulation in activated T cells by inhibiting the action of cytotoxic T lymphocyte antigen-4 (CTLA-4), a regulatory factor that suppresses the activation of T cells, It promotes antigen-specific T cell activation and proliferation, and suppresses tumor growth. It is also thought to exhibit an antitumor effect by increasing the tumor immune response by decreasing the function of regulatory T cells (Treg) and decreasing the number of Tregs in the tumor tissue. David Piras, president and Representative Director of Bristol-Myers Co., said, "With the approval of Yahboi, the addition of new treatment options that can be expected to have long-term survival to patients in Japan who are struggling with malignant melanoma, As Bristol-Myers Squibb is a world leader in cancer immunotherapy, we will continue to develop and offer innovative medicines that can make a difference to patients with serious illness. " I said. Yahboi's product overview Product name: Yavoi (R) infusion IV 50 mg Common name: ipilimumab (genetically modified) Indications/effects: Radical cure of malignant melanoma Dosage/administration: Usually, as an ipilimumab (genetical recombination) to an adult, intravenous drip infusions are given 4 times once a day at 3mg/ kg (body weight) at intervals of 3 weeks. Manufacturing marketing approval acquisition date: July 3, 2015 Manufacturer selling agency: Bristol-Myers Co., Ltd. Approval condition: 1. Formulate a pharmaceutical risk management plan and implement it appropriately. 2. Since the number of clinical trials in Japan is extremely limited, by conducting a usage result survey for all cases until data of a certain number of cases are accumulated after manufacturing and sales, In addition to grasping background information on patients using this drug, collect data on the safety and efficacy of this drug as soon as possible and take necessary measures for proper use of this drug. About malignant melanoma A malignant black specimen is a type of skin cancer, a malignant tumor that is cancerous of pigment cells (melanocytes) having the ability to produce melanin pigment, which is closely related to the color of the skin, has a high metastatic rate among skin cancers, It is considered highly malignant. It is reported that the number of malignant black species in Japan is about 4,000 (Note 2), and about 700 people (* 3) per year die from malignant black species. Especially in case of radical malignant melanoma with radical metastasis, 5-year survival rate is around 10%, poor prognosis.