nivolumab在日本获得上市批准

施贵宝与日本Ono公司合作在亚洲推广肿瘤免疫疗法
来源：生物谷 2014-07-27 17:11


2014年7月27日讯 /生物谷BIOON/ --最近制药巨头施贵宝公司与日本的Ono医药公司签订协议合作在日本、韩国和台湾地区推广肿瘤免疫疗法。根据协议，双方将携手推广刚刚比准上市的nivolumab以及治疗黑色素瘤药物ipilimumab（商品名Yervoy）。而Ono公司将获得nivolumab在日本的独家销售权。同时施贵宝和Ono公司还将合作进行Yervoy、lirilumab、urelumab以及BMS-986016在上述地区的临床研究。

本月早些时候nivolumab在日本获得上市批准，这也是目前世界上第一个已经获得批准的PD-1检验点抑制剂药物。这种药物能够使肿瘤细胞在免疫系统面前无所遁形，从而更好的激发机体自身免疫系统将其清除。

Nivolumab是2005年由Ono公司与Medarex公司合作开发的PD-1药物，四年后施贵宝收购Medarex公司并获得了这一药物在日本、韩国和台湾地区以外市场的销售权。目前这一药物最大的竞争者是默沙东的pembrolizumab，该药物目前在美国正处于申请流程，欧洲医药管理部门也正在审核这一药物。（生物谷Bioon.com）

详细英文报道：

In a deal that will build on their existing mutual relationship, Bristol-Myers Squibb ($BMY) and Ono Pharmaceutical have formed a pact to bring immunotherapies to market in Japan, South Korea and Taiwan.

Under the agreement, Bristol-Myers and Japan's Ono will jointly develop and commercialize nivolumab and the melanoma drug ipilimumab--marketed asYervoy--across a broad range of tumor types. Prior to the deal, Ono had exclusive Japanese rights to nivolumab, and, in exchange for cutting Bristol-Myers in, the company gets a share of three additional early-stage clinical immune-oncology products from its partner's portfolio--lirilumab, urelumab and BMS-986016.

Using nivolumab as the base therapy, Bristol-Myers and Ono plan to test combination regimens with Yervoy, lirilumab, urelumab and BMS-986016 in clinical trials in Japan, South Korea and Taiwan.

"Bristol-Myers Squibb's collaboration with Ono supports our goal to maximize the full potential of our immuno-oncology portfolio for patients worldwide," Bristol-Myers CEO Lamberto Andreotti said in a statement.

Nivolumab became the first among a new class of immuno-oncology therapies to win the good graces of government regulators earlier this month. Approved in Japan to treat unresectable melanoma, the PD-1 checkpoint inhibitor will be sold there as Opdivo.

Ono first got involved with the drug through a deal with nivolumab inventor Medarex back in 2005. Four years later, Bristol-Myers bought Medarex, leaving the American drug giant all rights to the drug outside of Japan, Korea and Taiwan, until now.

Designed to disable the cloaking mechanism that cancer cells use to remain hidden from the immune system, nivolumab is one of the shining immuno-oncology drugs in the global pipeline. Its main competition is with Merck's ($MRK) pembrolizumab (MK-3475), which is involved in a rolling submission in the U.S. and is under review in Europe.

As the immunotherapy class comes of age, Bristol-Myers has been making deals left and right in the field, including two earlier this year with Incyte ($INCY) andCytomX, to keep up with competitors Merck, AstraZeneca ($AZN), and Roche ($RHHBY).