{"id":82439,"date":"2024-05-11T01:02:10","date_gmt":"2024-05-10T17:02:10","guid":{"rendered":"http:\/\/www.gocpmall.com\/?p=82439"},"modified":"2024-05-11T01:02:10","modified_gmt":"2024-05-10T17:02:10","slug":"%e6%81%92%e7%91%9e%e5%8c%bb%e8%8d%af%e4%b8%a4%e6%ac%be%e8%8d%af%e7%89%a9%e8%8e%b7%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e6%89%b9%e5%87%86-_-%e4%b8%9c%e6%96%b9%e8%b4%a2%e5%af%8c%e7%bd%91","status":"publish","type":"post","link":"https:\/\/www.gocpmall.com\/?p=82439","title":{"rendered":"\u6052\u745e\u533b\u836f\u4e24\u6b3e\u836f\u7269\u83b7\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6 _ \u4e1c\u65b9\u8d22\u5bcc\u7f51"},"content":{"rendered":"

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5月8日晚间， 恒瑞医药 （600276）发布公告称，子公司成都盛迪医药有限公司和福建盛迪医药有限公司分别收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，并将于近期开展临床试验。 其中一款药物为注射用HRS5580。公告显示，经审查，2月7日受理的注射用HRS5580临床试验申请符合药品注册的有关要求，国家药监局同意本品开展临床试验，申请的适应症为预防术后恶心和呕吐。 恒瑞医药 表示，注射用HRS5580通过拮抗NK-1受体发挥止吐作用，具有溶解度高、安全性好的优点。目前，国内尚无同类注射剂产品上市。注射用HRS5580相关项目累计已投入研发费用约2087万元。 另一款药物为HRS-5965胶囊，也获得同意开展临床试验。该药物申请的适应症为：拟用于治疗IgA肾病、特发性膜性肾病、C3肾病和狼疮性肾炎等补体参与介导的原发性或继发性肾小球疾病；补体参与介导的溶血性贫血。 公司表示，HRS-5965胶囊可通过抑制补体系统的过度激活，抑制补体系统介导的溶血。临床前显示其在补体介导的溶血模型中起到了显著的抑制作用，安全性良好。经查询，国内暂无同类产品获批上市。截至目前，HRS-5965相关项目累计已投入研发费用约6407万元。 恒瑞医药 表示，根据相关法律法规要求，药物在获得临床试验批准通知书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。同时，药品从研制、临床试验报批到投产的周期长、环节多，药品研发及上市容易受到一些不确定性因素的影响。 （文章来源： 证券 时报）
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5月8日晚间， 恒&#29 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-82439","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=\/wp\/v2\/posts\/82439","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=82439"}],"version-history":[{"count":0,"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=\/wp\/v2\/posts\/82439\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=82439"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=82439"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.gocpmall.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=82439"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}