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从“一致性评价”和“优先审评”中寻医药股机会

2017-12-20 顾惠忠 证券时报网

医药行业整体估值喜忧参半,目前水平大约在36倍左右,同比下降,可能是受到诸多省份对抗菌药物、中药注射剂、辅助性药品、营养性药品等药品的限用、停用的影响。2018年,随着一些公司提前通过仿制药一致性评价和新药申报进入优先审评,预计行业估值会得到一定提升,大概保持在10%左右的增长。

时至年末,在讨论明年行情时,较多机构看好明年医药股的行情,有的甚至认为明年医药股的机会会类似于今年的白酒股。纵观医药政策,利好和利空因素并存,加上新技术影响,明年医药行业调整或大于今年,医药行业也将迎来结构性行情。

明年医药行业

或现冰火两重天

整体来看,2014年医药行业的增长出现拐点,2015年增速降到10%以下(规模以上医药工业增加值同比增长9.8%)。2017年上半年,增速有所恢复。同期,医药行业整体估值水平下降,目前大约36倍左右。笔者预计,明年行业大概率保持10%左右的增长,行业估值水平有提升的空间。

但是,我们注意到,最近药品控费趋严,已有20多个省份对辅助用药、中药注射液等展开重点监控,并明确提出了对这类药品要限用、停用。同时,人社部也开始释放新的信号,明确表示,在准入条件和使用管理方面,对只有安全性无显着有效性的“神药”坚定予以限制,确立价值导向的医保用药需求,“补缺、选优、支持创新、鼓励竞争”。有行业人士认为,目前国内医院销售的前100名用量大的药品中,没有循证证据或严重超适应症滥用的产品占据了差不多一半的水平,其中,一些药品年销售额达到几十亿元。预计明年会有更多的省份加强对抗菌药物、中药注射剂、辅助性药品、营养性药品等药品的限用、停用,类似步长制药那样只有单一大品种的公司将遭遇重大危机。我们需要重点关注明年全国医保目录动态调整中是否剔除一些辅助药、营养药,或如福建那样将医保分成治疗、辅助、营养三类,并给予不同的报销标准。

当然,有忧则有喜。在国家鼓励提高药品质量、鼓励创新药研制的背景下,一些仿制药一致性评价靠前和新药申报进入优先审评名单的公司将受益。

“一致性评价”

靠前的十大公司

一致性评价是国家提升药品质量的一项重大举措,即仿制药需在质量与药效上达到与原研药一致的水平。国务院明确:通过一致性评价的药品,在医保支付方面予以适当支持,医疗机构应优先采购并在临床中优先选用。同品种药品通过一致性评价的生产企业达到3家以上的,在药品集中采购等方面不再选用未通过一致性评价的品种。所以,能否通过或率先通过一致性评价对药企至关重要,谁先通过一致性评价谁就占得市场先机。

目前,医院药品采购中还有一项重要原则:一品两规四剂,意思是一个药品只采购两家厂商的四个剂型,即一家医院甚至一个省份,一个药品只选择两家企业的产品。从这个角度来看,谁率先通过一致性评价谁就拥有更多的优势。

12月初,正大天晴第一个拿到一致性评价的批文(通过一致性评价的仿制药证),截至12月6日,通过生物等效性试验向药监总局申报一致性评价申请的有45个(受理号,下同)、由地方药监局转到总局的有10个、已在海外上市转到国内申请上市的15个、撤回仿制药申请重新按一致性评价标准申报的有9个。10家上市公司在这个名单中(具体见附表),其中,京新药业有瑞舒伐他汀钙片、左乙拉西坦片、盐酸舍曲林片3个,康恩贝有阿莫西林胶囊1个,信立泰有硫酸氢氯吡格雷片1个,科伦药业有草酸艾司西酞普兰片1个,华海药业有奈韦拉平片、盐酸柏罗西汀片、福辛普利钠片、厄贝沙坦片(海正辉瑞也已申报)、赖诺普利片、氢沙坦钾片、利培酮片、厄贝沙坦氢氯噻嗪片8个,恒瑞医药有注射用替莫唑胺、盐酸氨溴索片2个,海正药业有他克莫司胶囊、厄贝沙坦片2个,石药集团(01093)有盐酸曲马多片、阿莫西林胶囊(申报的已达到3家)、阿奇霉素片、卡托普利片5个,国药一致有头孢克肟颗粒、头孢呋辛酯片2个,中国生物制药旗下的正大天晴有注射用盐酸苯达莫司汀(申报的已达到3家)、厄贝沙坦氢氯噻嗪片(华海药业也有申报)、瑞舒伐他汀钙片(京新药业也有申报)3个,复星医药旗下的重庆药友有阿法骨化醇片1个,上海医药旗下的常州制药有卡托普利片1个,联邦制药有阿西莫林胶囊1个。顺利的话,这些品种2018年极有可能拿到药证,从而开始领先之旅。如阿莫西林胶囊,如果目前申报的3家顺利通过一致性评价,意味着其他药企就没份了。

11月28日,国家药监局仿制药质量与疗效一致性评价办公室通知,将对一致性评价申请的研制现场、生产现场或临床试验数据进行有因检查或抽样。也就是说,这些申报走在前面的药品也存在不确定性,笔者将持续跟踪。

受益“优先审评”红利的12家公司

目前,市场普遍看好创新药。12月11日,港股金斯瑞生物科技子公司南京传奇CAR-T疗法临床申请获得国家药监局受理,由此引来了一轮细胞治疗概念股的炒作。12月12日,国务院总理李克强在武汉协和医院针对肿瘤专家提到的抗肿瘤药物“审批速度慢、转化时间长”等问题,表示,“药品审批方面的问题要加快推进,但必须要保证药物绝对安全”。

本轮药改的重要内容之一就是药品审评审批提速,其中,2016年1月至今,国家食药监管局药品审评中心(CDE)累计公示24批拟纳入优先审评审批药品,最终266个药品进入优先审评“绿色通道”,其中涉及抗肿瘤药50个,12个已“加速”获批上市,如双鹭药业的来那度胺。入选优先审评名单中的公司值得重点关注,进入优先审评名单审批速度快,最快用了17天就完成整个审批流程,能进入名单的均是临床急需的好品种。

经过对这266个药品梳理,目前,12家上市公司的相关品种处于“在审评审批中”(具体名单见附表),其中,恒瑞医药有10个品种,中国生物制药有7个,远大医药、华海药业各有4个(华海包括1个仿制药一致性评价品种),丽珠集团有3个,华邦健康有2个,翰宇药业、海正药业、泰格医药、复星医药各有1个。优先审评是从2016年10月正式启动的,预计明年会有一批获得最终的审批结果。

在一致性评价与优先审批中,华海药业、恒瑞医药、中国生物制药、复星医药都有相关品种,其中,华海药业和中国生物制药较多。

新药投资最佳介入时机

在介入创新药时机上,笔者也有自己的理解。新药研发风险大,一些新药最终并不能拿到药证。最佳的介入时机,应该是通过了国家药监局的技术审评,转而进入行政审批程序中。

新药能否上市,审批的核心是技术审评。通过了技术审评,基本上就通过了审批。而且,审批进程是可以通过国家药监局网站查询的,即能及时公开地获取信息。在取得新药证书后,要关注其销售情况,因为有些预期的重磅品种,在实际销售中并不能很快打开市场,甚至几年后的市场表现仍会很差。

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    2018-01-01 1771ae4158m

    学习一下很不错

    0

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    2018-09-10 zhanfl
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    2017-12-24 1771ae4158m

    学习一下很不错

    0

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    2017-12-22 cathymary
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    2017-12-22 huagfeg
  7. [GetPortalCommentsPageByObjectIdResponse(id=1634758, encodeId=e38a1634e58ee, content=<a href='/topic/show?id=6da725e314e' target=_blank style='color:#2F92EE;'>#优先审评#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25731, encryptionId=6da725e314e, topicName=优先审评)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4be222283241, createdName=ms5822920152752585, createdTime=Mon Jun 25 02:38:00 CST 2018, time=2018-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=274448, encodeId=55ba2e444810, content=学习一下很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/11/23/ac01daf0962458a9eb8c0b1e2f6ce5bc.jpg, createdBy=04b81710322, createdName=1771ae4158m, createdTime=Mon Jan 01 10:18:06 CST 2018, time=2018-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1906855, encodeId=65261906855ce, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Mon Sep 10 22:38:00 CST 2018, time=2018-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=272077, encodeId=90422e207739, content=学习一下很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/11/23/ac01daf0962458a9eb8c0b1e2f6ce5bc.jpg, createdBy=04b81710322, createdName=1771ae4158m, createdTime=Sun Dec 24 10:25:05 CST 2017, time=2017-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1409231, encodeId=69bc140923172, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Fri Dec 22 01:38:00 CST 2017, time=2017-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444310, encodeId=128e1444310c7, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Fri Dec 22 01:38:00 CST 2017, time=2017-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=270882, encodeId=16b52e088251, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NcXNhUvfhzd2VdicMnaLeK2Im5gKx4Ucxd8Bwu6S7RG0uILBFQx5HTW2bU4VricDYlQqN20ibASSMYAeGrZrrTpy2Q/0, createdBy=353a2047758, createdName=137****9095, createdTime=Wed Dec 20 11:41:42 CST 2017, time=2017-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=270871, encodeId=18a52e08710d, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NcXNhUvfhzd2VdicMnaLeK2Im5gKx4Ucxd8Bwu6S7RG0uILBFQx5HTW2bU4VricDYlQqN20ibASSMYAeGrZrrTpy2Q/0, createdBy=80d11516357, createdName=139****0239, createdTime=Wed Dec 20 11:38:30 CST 2017, time=2017-12-20, status=1, ipAttribution=)]
    2017-12-20 137****9095

    henhao

    0

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    2017-12-20 139****0239

    henhao

    0

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