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“京牌”名药谱写北京沧州“双城记”

2017-08-11 04:24:22   中国青年网

主打产品陆续转移

除了承接中药提取环节,化学原料药的生产也将成为北陆药业沧州工厂的重头戏。

“我手里拿的这瓶注射液是国内第一个研制成功的核磁共振对比剂,已经安全应用1000万例以上,年收入近2亿元。”在“市民对话一把手 砥砺奋进的北京”系列访谈节目中,北京市发改委主任谈绪祥展示的一款对比剂药品,就是由北陆药业生产的。

面对肿瘤等疾病,核磁共振增强检查有助于医生更清晰地观察病灶,这就是对比剂的作用。但此前由于进口药品价格高昂,普通百姓很难承受。随着北陆药业的对比剂产品上市,更多的患者通过检查获得精确诊断,也一度倒逼进口药品“砍掉”一半价格。直到今天,这款对比剂依然是北陆药业的拳头产品。

“药企部分生产环节从北京迁往河北,不是撤离,而是升级。”北陆药业相关负责人介绍,企业的对比剂原料药生产环节将全部迁往沧州,二期工程预计明年6月竣工并申请认证,三期工程也正在部署当中。今后,沧州将成为原料药生产和研发高端原料药的中试基地,与北京的研发中心、制剂生产基地相互配合,为企业产业链的完善与后续发展提供强劲动力。

异地监管,保留“北京身份”的药品监管创新模式,也给很多迁至沧州渤海新区的北京药企吃下一颗“定心丸”,在沧州设厂更让北京企业尝到不少甜头。

在北京春风药业公司沧州生产基地,相关负责人表示,在渤海新区建设生产,建设成本和生产成本都比北京少许多。“比如生产中使用蒸汽,在北京每立方米需要600多元,沧州渤海新区则是集中供应,每立方米仅需160元。”园区专门建设的一体化的废水、废气、废料处理设施,也在污染源头上减量控制,相关环保指标已经达到甚至超过全国最高标准。

药企共享硬件资源

研发在北京,生产却在河北沧州。扎根当地的医药产业园成为京津冀协同发展中,企业找到适合自身发展需求的良好模式。

据了解,经过两年的发展,沧州医药产业园区已签约的京津冀地区超亿元医药项目达到86个,签约项目总投资279亿元。其中,北京企业53家,包括上市公司7家、高新技术企业17家,目前6家已竣工,5家获发药品生产许可证。

如今,在京津冀三地,药品上市许可持有人制度正在国家授权试点中,产品注册与生产许可不再捆绑。也就是说,以前不具备相应生产资质的研发机构、科研人员等,可以通过合作或委托生产的方式获得药品上市许可,这也为药企在京津冀的布局提供了更多可能。

“未来,沧州工厂可以通过这种方式在京津冀甚至更广阔的范围内招揽合作者,让其他没有工厂的研发企业借助我们现有的设备进行生产,‘共享’硬件资源。这不仅有利于新药研发,也有利于提高产能利用率,共同分担车间、设备折旧支出,减少重复建设造成的资源浪费。”北陆药业相关负责人说,目前已有公司表露合作意向,正在洽谈中。

借鉴沧州生物医药产业园成功经验,京津冀三地食药监管部门正在研究制定药品生产领域异地监管措施,推动建立更加适合产业发展的监管和服务模式。此外,据北京市食药监局介绍,为适应深化医改要求,三地已就医疗机构制剂调剂使用联动达成共识,将制定调剂使用基本原则,满足三地对特色医疗机构制剂品种的临床需求,缓解医联体跨省临床用药的压力。

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