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终于要来了!国产新冠疫苗正式申请上市,概念股闻声涨停
格隆汇 11-25 16:36

来源:同花顺金融研究中心

11月25日,国药股份直线拉起,盘中涨幅一度接近9%,午后继续上行,一封住涨停,截至收盘,成交额达24.6亿。

消息上,新华财经称,中国医药集团有限公司副总经理石晟怡表示,中国国药集团已向国家药监局提交了新冠疫苗上市申请。

受消息刺激后,国药集团旗下其他上市公司也纷纷拉升。其中,深交所上市的国药一致涨4.64%。

此外,港股国药控股也涨逾5%。

国药疫苗接种者无一例感染

事实上,国药疫苗申请上市似乎早已有“铺垫”。

11月19日,CDE官网发布了关于《药品附条件批准上市技术指导原则(试行)》的通告。根据该指导原则,药物临床试验期间,符合两种特定情形的药品,可以申请附条件批准。

附条件批准上市是指用于严重危及生命且尚无有效治疗手段的疾病、公共卫生方面急需的药品,现有临床研究资料尚未满足常规上市注册的全部要求,但已有临床试验数据显示疗效并能预测其临床价值,在规定申请人必须履行特定条件的情况下基于替代终点、中间临床终点或早期临床试验数据而批准上市。通告显示,该文件自发布之日起施行。

有分析认为,该政策的发布将加速我国特定药品及疫苗产品的上市。随着我国新冠疫苗研发进度的推进,大概率未来将通过附条件批准的申请,或将实现加速上市。

虽然国药集团研发的新冠疫苗还未正式上市,但此前已纳入紧急使用,市场表现良好。

11月17日,中国国药集团有限公司党委书记、董事长刘敬桢曾公开表示。国药集团研发的新冠疫苗在紧急使用中已有近百万人接种,目前无一例严重不良反应。接种后到世界150多个国家工作学习的人员,无一例感染。

在11月6日第三届进博会上,刘敬桢还公开表示。到今年年底,国药集团新冠疫苗产能大概能达到1亿剂左右。按照国家要求,明年产能要超10亿剂,“明年能保证尤其是中国人民使用。”

于此同时,国外疫苗进展也颇为顺利。近期辉瑞、莫德纳频传利好,二者在研的新冠疫苗有效性均在90%以上。阿斯利康也在随后表示,其与牛津大学研发的新冠疫苗平均有效性为70%。

头部企业有望最先兑现利润

随着冬季的到来,海外疫情反弹,美国新冠肺炎确诊病例更是超1240万例。国内也出现零星的感染病例,因此,民众对于疫苗的需求愈发迫切。

据专家统计,全球群体免疫仍任重道远,群体免疫作为阻断新冠疫情蔓延的终极解决方案,全球或需百亿剂新冠疫苗。

根据公开资料整理,目前全球三期临床阶段新冠疫苗2021年累计产能将超100亿剂,我国累计产能有望突破20亿剂。

中泰证券研报指出,新冠病毒疫苗即将进入兑现期,研发进展快、有产能、成本低的企业更容易最早兑现收入和利润,拔得头筹。考虑新冠病毒疫苗的高知晓率、预期接种人群数巨大,我们认为研发进度靠前的头部企业有望最先兑现利润。

中邮证券认为,在特殊审批上市程序启动之后,国产灭活苗已开始针对特殊人群接种,预计正式上市也已不远。机构推算,综合国内外定价机制,预计新冠疫苗价格将超过100元/人份,国内+国外市场空间将超千亿元,对研发成功的企业而言,利润空间足够。

具体到A股投资上,兴业证券建议关注两大方向:

(1)具有体系化优势的头部企业,有望实现强者恒强:康泰生物、智飞生物、华兰生物、沃森生物;

(2)具有出众创新能力的后起之秀,有望实现弯道超车:康希诺、万泰生物、百克生物/长春高新、康华生物。

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