{"id":307703,"date":"2019-11-29T18:19:11","date_gmt":"2019-11-30T02:19:11","guid":{"rendered":"https:\/\/nai500.com\/?p=307703"},"modified":"2019-11-29T18:19:11","modified_gmt":"2019-11-30T02:19:11","slug":"%e7%be%8e%e5%9b%bdfda-%e6%96%b0%e8%8d%af","status":"publish","type":"post","link":"https:\/\/nai500.com\/zh-hans\/blog\/2019\/11\/%e7%be%8e%e5%9b%bdfda-%e6%96%b0%e8%8d%af\/","title":{"rendered":"\u7f8e\u56fdFDA\u63d0\u524d\u6279\u51c65\u6b3e\u65b0\u836f\uff0c\u7406\u7531\u662f\u4ec0\u4e48\uff1f"},"content":{"rendered":"<p>\u8fc7\u53bb5\u5468\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u63d0\u524d\u6570\u6708\u6279\u51c65\u6b3e\u65b0\u836f\uff0c\u5206\u522b\u662f<a href=\"https:\/\/nai500.com\/zh-hans\/\u80a1\u7968\u67e5\u8be2\/?qm_symbol=GBT\">Global Blood Therapeutics Inc\uff08NASDAQ: GBT\uff09<\/a>\u7684\u9570\u72b6\u7ec6\u80de\u75c5\u521b\u65b0\u7597\u6cd5Oxbryta\uff0c<a href=\"https:\/\/nai500.com\/zh-hans\/\u80a1\u7968\u67e5\u8be2\/?qm_symbol=ALNY\">Alnylam Pharmaceuticals Inc\uff08NASDAQ: ALNY\uff09<\/a>\u7684\u809d\u6027\u535f\u5549\u75c5\u836f\u7269Givlaari\uff0c<a href=\"https:\/\/nai500.com\/zh-hans\/\u80a1\u7968\u67e5\u8be2\/?qm_symbol=NVS\">\u8bfa\u534eNovartis\uff08NYSE: NVS\uff09<\/a>\u7684\u9570\u72b6\u7ec6\u80de\u75c5\u9776\u5411\u836fAdakveo\uff0c<a href=\"https:\/\/nai500.com\/zh-hans\/\u80a1\u7968\u67e5\u8be2\/?qm_symbol=BGNE\">BeiGene Ltd\uff08NASDAQ: BGNE\uff09<\/a>\u7684\u6dcb\u5df4\u7624\u65b0\u836fBrukinsa\uff0c\u4ee5\u53ca<a href=\"https:\/\/nai500.com\/zh-hans\/\u80a1\u7968\u67e5\u8be2\/?qm_symbol=VRTX\">\u798f\u6cf0\u5236\u836fVertex Pharmaceuticals\uff08NASDAQ: VRTX\uff09<\/a>\u7684\u56ca\u80bf\u6027\u7ea4\u7ef4\u5316\u836f\u7269Trikafta\u3002<\/p>\n<p>\u8fd9\u4e9b\u836f\u7269\u63d0\u524d\u83b7\u6279\u81ea\u6709\u5176\u9053\u7406\uff0c\u800c\u5173\u4e8e\u65b0\u836f\u7533\u8bf7\u7684\u4f18\u5148\u7ea7\uff0cFDA\u4e5f\u6709\u81ea\u5df1\u7684\u8003\u91cf\u6807\u51c6\uff0c\u4ee5\u4e0b\u662f\u8fd9\u4e9b\u65b0\u6279\u836f\u7269\u7684\u4e00\u4e9b\u5171\u540c\u7279\u5f81\u3002<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"108\"><strong>\u516c\u53f8<\/strong><\/td>\n<td width=\"156\"><strong>\u836f\u7269<\/strong><\/td>\n<td width=\"108\"><strong>\u9002\u5e94\u8bc1<\/strong><\/td>\n<td width=\"94\"><strong>\u6279\u51c6\u65e5\u671f<\/strong><\/td>\n<td width=\"86\"><strong>PDUFA<\/strong><strong>\u65e5\u671f<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"108\">Global Blood Therapeutics<\/td>\n<td width=\"156\">Oxbryta (voxelotor)<\/td>\n<td width=\"108\">\u9570\u72b6\u7ec6\u80de\u75c5<\/td>\n<td width=\"94\">11\/26\/2019<\/td>\n<td width=\"86\">2\/26\/2020<\/td>\n<\/tr>\n<tr>\n<td width=\"108\">Alnylam<\/td>\n<td width=\"156\">Givlaari (givosiran)<\/td>\n<td width=\"108\">\u809d\u6027\u535f\u5549\u75c5<\/td>\n<td width=\"94\">11\/20\/2019<\/td>\n<td width=\"86\">2\/4\/2020<\/td>\n<\/tr>\n<tr>\n<td width=\"108\">\u8bfa\u534e<\/td>\n<td width=\"156\">Adakveo (crizanlizumab)<\/td>\n<td width=\"108\">\u9570\u72b6\u7ec6\u80de\u75c5\u5e76\u53d1\u75c7<\/td>\n<td width=\"94\">11\/15\/2019<\/td>\n<td width=\"86\">1\/16\/2020<\/td>\n<\/tr>\n<tr>\n<td width=\"108\">Beigene<\/td>\n<td width=\"156\">Brukinsa (zanubrutinib)<\/td>\n<td width=\"108\">\u6dcb\u5df4\u7624<\/td>\n<td width=\"94\">11\/14\/2019<\/td>\n<td width=\"86\">2\/27\/2020<\/td>\n<\/tr>\n<tr>\n<td width=\"108\">\u798f\u6cf0\u5236\u836f<\/td>\n<td width=\"156\">Trikafta (elexacaftor\/ivacaftor\/tezacaftor)<\/td>\n<td width=\"108\">\u56ca\u80bf\u6027\u7ea4\u7ef4\u5316<\/td>\n<td width=\"94\">10\/21\/2019<\/td>\n<td width=\"86\">3\/19\/2020<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>\u540c\u7c7b\u9996\u521b\u65b0\u836f<\/h2>\n<p>\u60f3\u8981\u83b7\u53d6FDA\u7684\u5173\u6ce8\uff0c\u5f00\u53d1\u9488\u5bf9\u6cbb\u7597\u65b9\u6848\u6709\u9650\u4e14\u5371\u53ca\u751f\u547d\u7684\u91cd\u75c7\u75be\u75c5\u7684\u540c\u7c7b\u9996\u521b\u5019\u9009\u65b0\u836f\u662f\u6700\u4f73\u9014\u5f84\u3002\u6b64\u6b21\u83b7\u6279\u76845\u6b3e\u65b0\u836f\u5f53\u4e2d\uff0c4\u6b3e\u90fd\u5c5e\u4e8e\u8fd9\u4e00\u7c7b\u578b\u3002Givlaari\u662f\u9996\u6b3e\u83b7\u6279\u901a\u8fc7\u9776\u5411\u6c28\u57fa\u4e59\u9170\u4e19\u9178\u5408\u6210\u91761\uff08ALAS1\uff09\u6cbb\u7597\u6025\u6027\u809d\u6027\u535f\u5549\u75c5\u7684\u836f\u7269\uff0cOxbryta\u7247\u5242\u901a\u8fc7\u63d0\u5347\u8840\u7ea2\u86cb\u767d\u7684\u4eb2\u6c27\u6027\u80fd\u591f\u6709\u6548\u9632\u6b62\u7ea2\u7ec6\u80de\u53d1\u751f\u9570\u72b6\u6539\u53d8\uff0cAdakveo\u6ce8\u5c04\u5242\u80fd\u9632\u6b62\u60a3\u8005\u7684\u9570\u72b6\u7ea2\u7ec6\u80de\u51dd\u7ed3\u5e76\u5bfc\u81f4\u8840\u7ba1\u5835\u585e\uff0c\u800cTrikafta\u5bf9\u4e8e90%\u5de6\u53f3\u7684\u56ca\u80bf\u6027\u7ea4\u7ef4\u5316\u60a3\u8005\u6709\u6548\u3002<\/p>\n<h2>\u7597\u6548\u6539\u5584<\/h2>\n<p>\u9664\u4e86\u9996\u521b\u65b0\u836f\uff0c\u5982\u679c\u7533\u8bf7\u836f\u7269\u76f8\u5bf9\u73b0\u6709\u7597\u6cd5\u7597\u6548\u66f4\u4f73\uff0c\u8fd9\u4e5f\u80fd\u5438\u5f15FDA\u7684\u5173\u6ce8\u3002Beigene\u7684\u6dcb\u5df4\u7624\u65b0\u836fBrukinsa\uff08\u6cfd\u5e03\u66ff\u5c3c\uff09\u5e76\u4e0d\u662f\u9996\u4e2a\u83b7\u6279\u6cbb\u7597\u5957\u7ec6\u80de\u6dcb\u5df4\u7624\u7684\u5e03\u9c81\u987f\u6c0f\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\uff0c\u4f46\u76f8\u8f83\u73b0\u6709\u7684\u6807\u51c6\u7597\u6cd5Imbruvica\u53ef\u80fd\u7597\u6548\u66f4\u4f73\u3002\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff0c84%\u7684\u60a3\u8005\u5728\u63a5\u53d7Brukinsa\u6cbb\u7597\u540e\u80bf\u7624\u5927\u5c0f\u51fa\u73b0\u840e\u7f29\uff0c\u5176\u4e2d\u7edd\u5927\u591a\u6570\u60a3\u8005\u7684\u75c5\u60c5\u5728\u81f3\u5c1118.5\u4e2a\u6708\u7684\u65f6\u95f4\u91cc\u6ca1\u6709\u51fa\u73b0\u6076\u5316\u3002\u5728\u7c7b\u4f3c\u7684\u7814\u7a76\u4e2d\uff0c\u60a3\u8005\u7684\u80bf\u7624\u5927\u5c0f\u840e\u7f29\u5927\u7ea669%\uff0c\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u4e2d\u503c\u4e3a17.5\u4e2a\u6708\u3002<\/p>\n<h2>\u91cd\u78c5\u836f\u6f5c\u529b<\/h2>\n<p>\u5feb\u901f\u65b0\u836f\u5ba1\u6279\u7684\u53e6\u4e00\u4e2a\u7279\u5f81\u662f\u91cd\u78c5\u836f\u6f5c\u529b\uff0c\u8fd9\u5bf9\u4e8eFDA\u6765\u8bf4\u65e0\u5173\u75db\u75d2\uff0c\u4f46\u5bf9\u6295\u8d44\u8005\u6765\u8bf4\u5c31\u610f\u5473\u7740\u4e00\u5207\u3002\u4e0a\u8ff05\u79cd\u65b0\u836f\u7684\u5e74\u9500\u552e\u989d\u5747\u6709\u671b\u8d85\u8fc7$10\u4ebf\u3002<\/p>\n<p>Brukinsa\u7684\u552f\u4e00\u7ade\u4e89\u836f\u7269Imbruvica 2013\u5e74\u9996\u6b21\u83b7\u6279\uff0c2019\u5e74\u7684\u9500\u552e\u989d\u6709\u671b\u8fbe\u5230$50\u4ebf\u3002\u7f8e\u56fd\u4e25\u91cd\u7684\u9570\u72b6\u7ec6\u80de\u75c5\u60a3\u8005\u4eba\u6570\u53ea\u6709\u5927\u7ea6100,000\u4eba\uff0c\u4f46\u7531\u4e8e\u6ca1\u6709\u5176\u4ed6\u7684\u7ade\u4e89\u836f\u7269\uff0cGlobal Blood Therapeutics\u548c\u8bfa\u534e\u53ef\u4ee5\u5236\u5b9a\u8f83\u9ad8\u7684\u8981\u4ef7\uff0cOxbryta\u548cAdakveo\u4ecd\u6709\u671b\u521b\u9020$10\u4ebf\u7ea7\u7684\u5e74\u9500\u552e\u989d\u3002Trikafta\u6240\u9488\u5bf9\u7684\u56ca\u80bf\u6027\u7ea4\u7ef4\u5316\u5728\u7f8e\u56fd\u7684\u60a3\u8005\u4eba\u6570\u4e0d\u523030,000\uff0c\u800cGivlaari\u5728\u7f8e\u56fd\u548c\u6b27\u76df\u7684\u5408\u8ba1\u60a3\u8005\u4eba\u6570\u4f30\u8ba1\u53ea\u67093,000\u3002Trikafta\u548cGivlaari 1\u5e74\u7684\u6cbb\u7597\u6210\u672c\u5206\u522b\u4e3a$311,000\u548c$442,000\u3002<\/p>\n<h2>\u5546\u4e1a\u5316\u6210\u529f\u7684\u8ff9\u8c61\uff1f<\/h2>\n<p>FDA\u7ed9\u4e88\u6700\u9ad8\u4f18\u5148\u7ea7\u7684\u836f\u7269\u5f80\u5f80\u4ef7\u683c\u9ad8\u6602\uff0c\u4f46\u5546\u4e1a\u5316\u80fd\u5426\u6210\u529f\u65e0\u6cd5\u4fdd\u8bc1\u30022017\u5e74\uff0cFDA\u63d0\u524d1\u4e2a\u591a\u6708\u6279\u51c6\u8bfa\u534e\u7684CAR-T\u836f\u7269Kymriah\u3002\u4e0d\u5e78\u7684\u662f\uff0c\u590d\u6742\u7684\u5236\u9020\u6d41\u7a0b\u5bfc\u81f4\u4e00\u7cfb\u5217\u969c\u788d\uff0c\u6700\u7ec8\u8be5\u836f\u72692019\u5e74\u7684\u9500\u552e\u989d\u9884\u8ba1\u53ea\u6709\u5927\u7ea6$2.50\u4ebf\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u8fc7\u53bb5\u5468\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u63d0\u524d\u6570\u6708\u6279\u51c65\u6b3e\u65b0\u836f\uff0c\u5206\u522b\u662fGlobal Blood Therape [&hellip;]<\/p>\n","protected":false},"author":27,"featured_media":307705,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[1521,430],"tags":[820,455,747,925,459],"class_list":["post-307703","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-1521","category-trends-strategies-zh-hans","tag-820","tag-455","tag-747","tag-925","tag-459","sectors-life-science-zh-hans","locations-us-zh-hans","exchange-nasdaq-zh-hans","exchange-nyse-zh-hans"],"acf":[],"_links":{"self":[{"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/posts\/307703","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/users\/27"}],"replies":[{"embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=307703"}],"version-history":[{"count":0,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/posts\/307703\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/media\/307705"}],"wp:attachment":[{"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=307703"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=307703"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=307703"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}