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AIDS全球市场欲破300亿美元,国内企业纷纷抢食

发布时间: 2017-12-04





12月1日,刚好是第30个“世界艾滋病日”,今年的宣传主题是“共担防艾责任,共享健康权利,共建健康中国”。众所周知,HIV是引发艾滋病的元凶,曾经人们“谈艾色变”,但是抗HIV感染药物已经把艾滋病从一个令人生畏的超级绝症逐渐变成为可以控制的慢性病。






 

微信图片_20171201225207

 

据统计,2016年全球抗HIV药物销售额为230.23亿美元,2011-2016年复合增速为8.4%,显著高于全球药物市场3.5%左右的平均增长率。而随着价格约束、专利失效、仿制药的冲击等因素,未来HIV治疗市场将进入一个较为平稳的增长期,预计到2022年市场价值将增长到320亿美元。

 

据CDE的数据统计,截至11月29日,已经有42个品规报CFDA补充申请仿制药一致性评价,其中成都倍特生产的富马酸替诺福韦二吡呋脂就包含在内。富马酸替诺福韦二吡呋脂属于核苷酸类反转录酶抑制剂(NRTIs),是治疗艾滋病和慢性乙型肝炎药物,原研厂家是美国吉利德。

 


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国际“鸡尾酒疗法”是主流





 

 

目前已经正式批准上市的艾滋病用药共有六大类,分别为核苷(酸)类反转录酶抑制剂(NRTIs)、非核苷类反转录酶抑制剂(NNRTIs)、蛋白酶抑制剂(PIs)、整合酶抑制剂(INSTIs)、融合抑制剂、辅助受体拮抗剂,除此之外,还有不同类别药品所组成的复合制剂。

 

由于HIV极易突变且攻击人类的免疫系统,单一药物无法很好地控制病毒在人体的增殖,治疗艾滋病的方法一般是把几种机理不同的药物混合起来联合用药(即“鸡尾酒疗法”)。刚刚于11月21日获FDA批准上市的抗艾新药Juluca,就是由杜鲁特韦(INSTIs)和利匹韦林(NNRTIs)组成的二合一艾滋病复方新药,也是FDA批准的首个治疗这一适应症的双药疗法。由此可见,联合用药已成为抗艾药研发的重点对象,小分子复方制剂将在未来抗HIV药物市场上占据统治地位。

 

从2016年抗HIV药销售前10名来看(表1),联合用药占据5席,并且排名均较靠前,合计销售额为97.11亿美元,占前10名用药金额的51.3%。

 

表1:2016年全球抗HIV药物销售额TOP10产品

 

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资料来源:前瞻产业研究院整理

 


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Genvoya有望成全球榜首





 

 

由表1可知,2016年全球HIV药物前十产品销售额均超过10亿美元,其中吉利德的复方药物Truvada销售额最高,达到3566百万美元。此外,该TOP10产品中复方药物有吉利德的Atripla、Truvada和Stribild、Genvoya、恩曲利替,GSK/辉瑞的Triumeq;单药方面有强生的达芦那韦、默沙东的拉替拉伟、GSK的多替拉韦、吉利德的替诺福韦二吡呋脂。从这一组数据中不难看出,吉利德可谓领跑抗HIV药物市场!  

 

根据最新财报数据,2017年上半年抗HIV药销售额最高的是吉利德的Genvoya,为16.26亿元,同比增长了230%,2017年全年销售额有望达到35亿美元左右,成为新的最畅销抗HIV药;而Truvada销售额同比减少17%至15.26亿美元,排名第二;增速较快的还有Triumeq和Tivicay,均同比增长了55%以上。

 

Genvoya于2015年获得美国FDA批准上市,是吉利德抗HIV鸡尾酒疗法管线类最新获批药,属于四合一复方药,由抗病毒药物elvitegravir(埃替拉韦)、emtricitabine (恩曲他滨),药物增效剂cobicistat(考比嗪特)及前体药物tenofovir alafenamide(替诺福韦艾拉酚胺富马酸,TAF)组成,适用于从未服用过抗HIV药或病毒被抑制的HIV-1型患者。

 


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国内抗艾市场待扩容





 

 

我国实行了抗艾滋病病毒药品定点生产、统一集中采购,纳入国家药品储备,统一分配调拨,并通过全国疾病预防控制网络逐级分发的制度。因此,国内抗艾药物市场主要由两部分构成,一是医院使用,二是政府采购。由于在医院接受治疗的患者很少,政府采购占据市场的主要份额。

 

中国HIV药物市场相对较小,有数据显示,2016年全球HIV药物销售额为230.23亿美元,而国内抗艾药物市场规模仅为20亿~30亿元,与欧美国家市场存在巨大的差距。

 

表2:国内现有的抗HIV药物

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此外,据报道,经美国FDA批准上市的抗艾新药至少有90种以上,而我国已批上市的抗艾药物仅有20多种,其中常用的抗HIV一线药物有齐多夫定、拉米夫定、司他夫定、奈韦拉平和依非韦伦,二线药物主要有克力芝和替诺福韦。

 


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国内企业纷纷布局





 

 

近年,越来越多的药企纷纷加入竞争。由东北制药生产的齐多夫定片剂和胶囊剂上市,它是我国批准生产的第一个国产抗艾滋病药品。随后,药监部门又批准国产去羟肌苷与司他夫定,它标志着国内抗艾滋病药品市场开始启动。

 

2016年11月30日,由成都倍特药业申报的富马酸替诺福韦二吡呋酯片获得新药生产批件,成为国内首家获得这一品种仿创资格的厂商。而今年年底富马酸替诺福韦二吡呋酯(商品名:韦瑞德)专利即将到期,国内市场上预计会有更多生产替诺福韦酯的厂家出现。

 

表3:2017年富马酸替诺福韦二吡呋酯获得优先审评

 

微信图片_20171201225218

资料来源:CFDA药品审评中心

 

另一个优先审评抗艾滋病进口新药值得关注,是葛兰素史克的多替阿巴拉米片,7月26日被CFDA批准上市。

 

由于抗艾滋病药品的研发成本比较高,目前疗效好的抗艾药品的知识产权大多掌握在国外公司手中(包括默沙东、葛兰素史克、罗氏、雅培等国际制药巨头),因此,只有开发出中国自己拥有知识产权的抗艾药品,才能迅速降低药品价格,使国内药品生产厂家具有市场竞争力。

此文来源于网络~