默克公司准备在中国投放前沿抗癌药 [美国媒体]

U.S. pharmaceutical giant Merck & Co. has applied to launch one of its core cancer drugs in China, three months after global rival Bristol-Myers Squibb (BMS) applied to sell a similar drug in the lucrative market.龙腾网 http://www.ltaaa.com

美国药业巨头默克药厂申请了在中国投放该公司的一种核心抗癌药。 而三个月前， 其竞争对手百时美施贵宝公司就已经申请了在这个利润丰厚的市场投放一种类似药品。

The China Food and Drug Administration (CFDA) this week began to process Merck’s application for Keytruda, the brand name for the injected drug pembrolizumab, according to CFDA’s pipeline database.

中国国家食品与药品监管局本周开始审核默克药厂对“齐内达”的申请。 根据食品与药品监管局的数据管道， 齐内达是注射类药物“派姆单抗”的品牌名称。 

Keytruda belongs to a group of cutting-edge biologically-based cancer drugs known as PD-1 inhibitors, shorthand for programmed cell death protein 1 inhibitor, which use a patient’s own immune system to destroy cancer cells.

齐内达属于前沿生物类抗癌药， 人们通常称这类药为PD-1抑制剂（细胞凋亡蛋白质1型抑制剂）。 它利用病人自身的免疫系统来摧毁癌细胞。

Five such drugs are now available worldwide. Besides Keytruda, the other four are Opdivo by BMS, Tecentriq from Swiss drug maker Roche AG, AstraZeneca’s Imfinzi and Bavencio, co-developed by Merck and Pfizer.

目前全世界该类药物一共有五种， 除了齐内达以外， 其余四种分别为BMS的Opdivo （有人译为纳武单抗，有人译为保疾伏）， 瑞士ROCHE AG公司的Tecentriq(有人以为阿特朱单抗)， AstraZeneca（阿斯利康）公司的 Imfinzi （药品名：Durvalumab. 商品名：度伐鲁单抗）， 以及默克公司和辉瑞公司共同开发的 Bavencio  (药品名Avelumab 阿维单抗）

So far, only Merck and BMS have eyed the China market, the latter filing its own CFDA application in late October.

到目前为止，只有默克公司和BMS公司做到了放眼中国市场。 BMS已经在去年10月向中国食品与药片监管局提交了申请。

Merck’s PD-1 inhibitor has lower global sales, but is growing faster. In 2017, sales of Keytruda surged 172% to $3.8 billion, while BMS saw sales for its product rise 31% to $4.9 billion, according to the companies’ financial results.

根据公司财务数据， 默克公司的PD-1抑制剂的市场销售量比较低， 然而它的增长速度十分快。 2017年， 齐内达的销售量猛增了172%， 达到38亿美元。 而BMS的产品销售量只增长了31%， 销售总量达49亿美元。

In China, a dozen pharmaceutical firms are carrying out clinical tests for their own similar drugs, including Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences Co. and BeiGene Ltd.

在中国，十来家制药公司都在为类似药品开展临床试验， 包括江苏恒瑞医药、上海君实生物医药科技有限公司以及百济神州等。

Jiangsu province-based biopharmaceutical firm Innovent Biologics Inc. is the only Chinese maker of a PD-1 inhibitor that has completed clinical trials and applied to launch its own drug, filing with the CFDA in December. Innovent founder Yu Dechao told state media in August that he expected the new drug to be available for patients as early as late 2018.

位于江苏省的生物医药公司信达生物制药是唯一一家已经完成DP-1抑制剂临床试验，并且申请投放自己的药品的中国生产商。 信达在去年12月在中国食品与药品监督局那里提交了材料。创始人俞德超在去年8月份向媒体透露说， 他希望新药最早可以在2018年下半年对患者开放。 

A growing number of foreign drugmakers are bringing their most cutting-edge drugs to China, catering to an increasingly affluent populace that is willing to pay for such expensive treatments. At the same time, China’s regulator is trying to speed up the approval process, following criticism that many of the world’s best drugs are only available outside China.

越来越多的外国制药商正把他们最前沿的医药引入中国， 以迎合日益富裕且愿意为如此昂贵的治疗买单的民众。与此同时， 对很多世界上最好的药物只能在国外找到， 面对人们对这一现象的批评， 中国的立法者也试图加快审批程序的速度。

Although PD-1 inhibitors have worked well in some clinical trials, some oncologists have questioned their overall efficacy, as they only cure 10% to 30% of patients with certain types of cancer. Some studies also show that the drugs can cause side effects such as fever, dizziness and even enteritis, an inflammation of the intestine.

尽管PD-1抑制剂在某些临床试验中表现很好， 却因为在针对某些类型的癌症患者只有10%到30%的治愈率而让有些肿瘤医生质疑它们的整体功效。 有些研究也表明， 该类药物会引起发烧、头晕以及肠炎（一种内脏感染）的副作用。