记者1日从湖南有色凯铂生物药业有限公司获悉，4月初该公司获批的抗禽流感新药帕拉米韦已通过GMP(药品生产管理质量规范)认证，但尚无投产时间表。

Press 1, from the hunan province nonferrous kay platinum biological pharmaceutical co., LTD,At the beginning of April, the company approved the avian flu drugs of peramivir has passed the GMP(Pharmaceutical production management quality standard)certification,But there is no production timetable.

　　上月初，为应对人感染H7N9禽流感疫情，国家食品药品监督管理总局和药品审评中心快速部署并批准中国自主研发的新药帕拉米韦上市。根据有关程序，在帕拉米韦通过GMP认证后，即可投入生产。

At the beginning of last month,In response to the infection H7N9 bird flu outbreaks,State food and drug administration and drug approval center rapid deployment and approval of the Chinese independent research and development new drugs peramivir listed.According to the relevant procedures,After palmer peramivir passed GMP certification,Can be put into production.

　　不过，湖南有色凯铂有关负责人1日对记者表示，帕拉米韦具体什么时候投产正在规划中，要根据市场情况研究后再定。

but,Hunan nonferrous platinum kay about 1 head told reporters,When palmer peramivir concrete production is under plan,According to the market research before you decide.

　　据了解，帕拉米韦是抗禽流感药物的原料药，要用于人体，还需制成制剂——氯化钠帕拉米韦注射液。根据国家食品药品监督管理总局消息，湖南有色凯铂获批生产的是帕拉米韦三水合物原料药，广州南新制药有限公司获批生产的是帕拉米韦三水合物氯化钠注射液。而广州南新制药正是湖南有色凯铂的控股子公司。也就是说，湖南有色凯铂实际上是中国目前首家获批生产帕拉米韦的药企。

We have learned,Palmer peramivir is avian flu drug active pharmaceutical ingredients,To be used for the body,Still need palmer peramivir pills - sodium chloride injection.According to the state food and drug supervision and management of the administration,Hunan nonferrous kay platinum is approved the production of peramivir trihydrate API,Guangzhou ranbaxy co., LTD. Of the approved production is peramivir trihydrate sodium chloride injection.And guangzhou ranbaxy is subsidiary of hunan nonferrous kay platinum.That is to say,Hunan nonferrous kay platinum is, in fact, China is now the first batch of production palmer peramivir drug firms.

　　临床研究表明，帕拉米韦注射液能够有效对抗耐奥司他韦的流感病毒，且剂型为注射液，适应流感危重病人和对其他神经氨酸酶抑制剂疗效不佳患者的救治。该药品的上市将为H7N9禽流感患者提供新的治疗手段。

Clinical studies have shown that,Palmer peramivir injection can be effective against influenza viruses resistant to oseltamivir,And dosage forms for injection,To adapt to the flu, critical care and for other neuraminidase inhibitors poor curative effect in patients with treatment.The drug listing will provide new treatment for H7N9 bird flu patients.

　　帕拉米韦由军事医学科学院毒物药物研究所从2005年开始研发，2011年完成临床研究，2012年12月通过药审中心技术审评待批上市。湖南有色凯铂在2009年引进该项目，在浏阳医药园开始试生产。(记者阳建）

Palmer peramivir toxic by military academy of medical sciences institute of drug development since 2005,Completed clinical study in 2011,2012年1In February通过药审中心技术审评待批上市.Hunan nonferrous kay platinum in 2009 introduction of the project,Mass production started in liuyang medicine garden.(Reporter Yang building)