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  1. 我省加大力度鼓励企业合作新药研发
    [福建日报]2014-07-05字号:T | T
      省食品药品监督管理局近日下发《促进医药健康相关产业发展实施细则》,明确将鼓励新药研发和企业间合作开发新品种,大力扶持厦门、平潭生物医药经济发展,促进我省医药健康相关产业发展。
      根据细则,凡属于重大创新药械、首仿药、临床急需的品种,在标准不降、程序不减的前提下,相关部门将提前介入、专人跟踪,启动快速审查的程序,加快审评、审批进程。
      细则还明确医药流通企业或其他医药法人机构等与药品生产企业合作开发的新品种,合作各方应明确各自的权益和法律责任,双方应签署合作协议并进行公证。产品上市后,若合作双方发生纠纷而导致该品种不能正常生产的,相关部门将帮助协调解决。
      同时,我省将大力扶持厦门、平潭生物医药经济发展。省食品药品监督管理局除了对入驻厦门的台资企业采取简政放权外,还将专门开辟快速通道,将药品、保健食品、化妆品和医疗器械台资企业申请事项的受理、初审、生产许可、质量体系考核、委托加工、注册现场核查等部分权限委托厦门市局,指定专人提前介入台资招商引资、投资建厂和产品注册,给予法规和技术的专门辅导,推动更多台资“三品一械”生产企业入驻园区;并将医疗器械生产许可证、药品生产许可证和药品生产质量管理规范认证、化妆品生产企业卫生许可证等受理、检查和审查等部分职能逐步委托厦门市食品药品监督管理局在辖区内行使,由省局核发相应证书。探索在平潭小额自由贸易区内制定“三品一械”流通的负面清单,视平潭食品药品监管的能力,可参照厦门市局的监管政策逐步授权平潭综合实验区食品药品监管局。(储白珊 纪玉屏)
    http://www.fujian.gov.cn/fjyw/fjyw/201407/t20140705_755246.htm

  2. 未来药物研发的六大走向
    2014-06-27 12:03 来源:中国产业竞争情报网作者:中国产业竞争情报网字体大小:
    一个药企的投资方向、研发重点和开发策略既要强调创意,也要关注市场的变化,还需随时吸取同行成功的经验和失败的教训,并根据科学进展和临床结果进行调整,在回顾过去的同时探讨市场的发展趋势。
    日前,IMS Health发布的2013年医药市场的统计数据显示,美国医药市场受主付方影响较大,新药开发有效区分现行治疗标准日趋重要。从数据可以看出,在全球新药研发中,适应症药物、孤儿药、专科疾病等领域的研发已发生明显变化,而大众疾病领域受热程度则有所降低,治疗终点明确药物的竞争力将倍加明显。有分析指出,这些情况或也将成为今后药物研发的走向。
    支付方主导作用增大
    从IMS Health发布的数据可以看出,在所有未支付的处方药当中,约三分之二的处方是因为医保拒绝支付被取消,其中最主要的拒绝原因是医生的处方没有严格按照监管部门批准的适应症覆盖范围,以及患者没有优先使用仿制药而非品牌药等。
    另外三分之一是患者因各种原因不愿使用,这些数据和逐年提高的仿制药使用率和日益降低的品牌药支出相吻合。由此可见,支付方对未来医药市场尤其是医药的定价和销售影响越来越大。
    据了解,美国的公共医疗保健费用自上个世纪五十年代开始迅速增长,使政府和社会保障机构不堪重负,因此美国国会早在1979年就开始责成其技术评定局对公共医疗费用进行成本效用分析,限制使用一些疗效一般但价格高昂的药品。
    英国的国家卫生和保健研究院(NICE)更根据临床疗效和价格两个因素制定新药使用指南,并以此为依据拒绝支付多款新药。所以,在将来的新药开发活动中,和现行治疗标准的“有效区分”越来越重要,否则很难承受来自政府、医保、医生甚至患者的多重压力。
    适应症药物市场有变
    在2013年,抗肿瘤、降糖、精神病、呼吸系统以及止疼等前五大类药物持续占据医药销售的重要份额,分别为279、243、238、204和187亿美元,总和达到医药销售总额的三分之一。和2012年相比,抗凝血和调脂药物的销售大幅下滑,分别下降了22%和21%。
    治疗精神病、呼吸系统、降血压、多动症等疾病药物的销售也有所降低。一直以来,主要适应症药物都持续占据销售的半壁江山,但从数据来看,部分领域变化较大。
    具体而言,在治疗阿尔茨海默症、抑郁、焦虑、精神分裂、帕金斯式症等疾病领域,药物开发并没有重大进展。因为这些疾病的复杂性限制了人类对这些疾病的认识,这类新药开发不仅耗时耗力,而且只是轻微改善疗效或安全性的药物已经无法得到药监和支付部门的认同。所以,大部分大药厂已经开始远离这些投入和回报不成比例的领域。
    相反,在2013年,治疗多发性硬化症、自身免疫和肿瘤等专科适应症药物倒为销售额的增长贡献了68%,共68亿美元,甚至成为让医保费用上涨的重要原因。
    孤儿药比例明显增加
    2013年在美国开始销售的36个新分子实体(NME)当中,有17个是孤儿药,比2012年上市的孤儿药多出一倍以上。而过去5年中美国FDA一共批准了53个孤儿药,也几乎是前五年的一倍。未满足的治疗需求和提高患者的生活质量是促使监管部门批准孤儿药的主要原因。
    如干粉吸入式妥布霉素(tobramycin)是治疗囊性纤维化(CF)铜绿假单胞菌(PA)的首个干粉吸入式抗生素,解决了之前需要复杂的存储和管理条件的雾化器治疗。每天一次注射的短肠综合征的药物teduglutide解决了之前的每天长达12小时静脉注射液和肠外营养,明显地提高了患者的生活质量。
    每天注射两次的Signifor的上市,代表着库欣病的治疗向前跨越了一大步,用于治疗那些因无法手术治疗的因皮质醇在体内生产过剩引起的良性垂体瘤。凝血酶原复合物Kcentra被批准用于因使用如抗凝血药物华法林等引起的大出血的解药,处理因为必要使用抗凝血因子时因大出血造成的紧急事件。
    相比重磅药物聚集的大众药物,孤儿药通常针对基因变异单一的患者群,更容易观察到明显的疗效。再加上很多罕见病无药可用,药监和支付部门也更愿意批准和支付高额药价,这使很多孤儿药都成了大产品,比如很多孤儿药收费高达20-30万美元/年,这样的药物只要5000病人就可以达到10亿美元的年销售额。
    在无可用药物和高药价这两个主要因素的引诱下,大量研发资本将会持续流向罕见病药物的开发。再加上多种疾病从分子生物学角度被进一步分组、细化,这些患者亚群的人数越来越少,导致未来开发更多的孤儿药。
    渐远离大众疾病领域
    资料表明,在2013年上市的只有7个属于全新机制的创新药,和前一年的11个相比有所减少。由于新药的开发活动和销售有长达十多年的滞后,所以这个结果并不表明今天创新药开发活动的降低。相反,因为监管部门和支付方对已知作用机理新药开发的要求日趋严格,全球制药巨头已经渐渐离开me-too药的开发领域,投资的重心越来越向全新机制的创新药方向偏移。
    另外,在过去的一年里针对大众常见病的研发活动也逐渐减少。究其原因,一方面因为现在大多常见病已有一些有效药物,而只是轻微改善疗效或安全性的药物已经无法得到药监部门的承认。
    另一方面因为大众疾病患者人群的背景复杂,通常需要大型的临床实验才能验证其疗效和安全性。所以这类开发十分耗时耗力,且达到注册要求的临床实验动辄几亿美元的药物,令大药厂也感到力不从心。
    除此之外,这些药物对应的通常是慢性病领域,药物的安全性门槛更高。如现在的糖尿病和减肥药物必须排除心脏病风险,而这类费用高昂的安全性实验通常是在本来已经很昂贵的疗效实验之外的附加要求,再者,大众疾病通常有多种药物选择,除非疗效、安全性和给药的便携性远远优于现有疗法,否则无法获得支付方的认可,而这些都导致此类新药开发的投资和回报不成比例。
    专科疾病份额持续提高
    受到经济危机的重创,美国经济虽然开始复苏,但依然处于较低水平的增长。而公共医疗的保健费用却一直处于极高的水平,政府、保险公司和社会保障机构早已不堪重负,无法承受更高的医疗费用。所以未来医药市场还会持续低迷,在保证消费总额相等的同时趋向追求格局的变化,达到健康需求和卫生资源供求矛盾的平衡。
    所以尽管和2012年相比,2013年因专利悬崖给美国医药市场的影响要小得多,从2012年的290亿美元降至2013年的190亿美元,再加上因药价上升而得到的40亿美元的额外收益,但为医药支付的总额还是处于和2012年几乎同等的水平。总的趋势是支付方对那些有多种选择的药物收费还会进一步压榨,余额用于支付那些疗效很好但价格更高的优质药品。
    因此,在医疗花费增长缓慢的压力下,药企必须用高品质的产品去争夺有限的资源。换言之,高品质/高药价的支付模式加上医疗花费总量相对恒定的现实决定了价值平庸的药物将被挤出药品市场。有限的医疗预算会被少数真正有价值的药品所瓜分,这个大趋势将对未来制药工业的项目选择产生深远影响。
    治疗终点明确药物
    竞争力明显
    和2012年相比,全球医药销售额在2013年增长了4.5%,从前一年的8746亿美元增长到2013年的8571亿美元。不同治疗领域的药物花费及增长率和美国相比类似,但抗生素、降血压、止疼以及皮肤用药等销售额的次序差别较大。比如抗生素从美国销售额的排名第14位一跃成为全球销售额第5位,这和发达国家对抗生素使用的严格控制一致。
    在销售额占前10名的处方药当中生物药和小分子药平分秋色,各占5个。中枢神经类药物的销售额和2012年相比持续走高,占有全球销售额前10名当中的两个。当然,这并不表明CNS类药物研发活动的成功,相反,如上所说的,止痛、抑郁、焦虑、精神分裂、帕金斯式症几乎没有什么太重要的进展,而以前这些所谓重磅炸弹药物聚集的领域如今已经是门可罗雀。
    受到来自中国、印度、巴西、和俄罗斯市场的带动,未来全球医药市场的增长将继续高于美国,IMS Health预测到2017年全球销售额将逼近12000亿美元,尤其是中国医药市场在未来的三年里平均增长将高达14%-17%。在如此庞大的全球市场中,由于各地区监管、文化、消费习惯、医生水平等复杂因素的影响,不可能每个战略都适合所有市场。
    因此,部分产品尤其是治疗终点明确的药物如抗癌药会在全球市场有相对一致的表现,不少产品会在不同市场有截然不同的竞争力。总的来说,药品的区域化既是机会也是挑战。
    信源地址:http://www.chinacir.com.cn/2014_hyzx/418704.shtml