{"id":9579,"date":"2018-06-10T01:00:00","date_gmt":"2018-07-27T09:40:04","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e6%81%92%e7%91%9e%e5%b8%82%e5%80%bc%e7%aa%81%e7%a0%b43000%e4%ba%bf%ef%bc%9a%e6%b2%a1%e6%9c%89%e5%af%b9%e6%af%94%ef%bc%8c%e5%b0%b1%e6%b2%a1%e6%9c%89%e4%bc%a4%e5%ae%b3%ef%bc%9b%e5%b9%bf%e4%b8%9c\/"},"modified":"2018-07-27T17:40:05","modified_gmt":"2018-07-27T09:40:05","slug":"%e6%81%92%e7%91%9e%e5%b8%82%e5%80%bc%e7%aa%81%e7%a0%b43000%e4%ba%bf%ef%bc%9a%e6%b2%a1%e6%9c%89%e5%af%b9%e6%af%94%ef%bc%8c%e5%b0%b1%e6%b2%a1%e6%9c%89%e4%bc%a4%e5%ae%b3%ef%bc%9b%e5%b9%bf%e4%b8%9c","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/9579\/","title":{"rendered":"\u6052\u745e\u5e02\u503c\u7a81\u78343000\u4ebf\uff1a\u6ca1\u6709\u5bf9\u6bd4\uff0c\u5c31\u6ca1\u6709\u4f24\u5bb3\uff1b\u5e7f\u4e1c\u6b63\u5f0f\u5b9e\u884c\u4e24\u7968\u5236\uff0c249\u4e2a\u54c1\u79cd\u6682\u4e0d\u6267\u884c……"},"content":{"rendered":"
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<\/p>\n

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<\/p>\n

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<\/p>\n

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@\u738b\u4e38\u5b50\uff1a\u5382\u5bb6\u540d\u5b57\u4e5f\u6ca1\u516c\u5e03\uff0c\u96be\u9053\u90fd\u662f\u5728\u63d0\u5fc3\u540a\u80c6\u7684\u8fc7\u65e5\u5b50\u4e48\uff1f\u8bf4\u4e0d\u5b9a\u54ea\u4e00\u5929\u5c31\u5230\u81ea\u5df1\u5934\u4e0a\u4e86\uff0c\u4e0d\u8fc7\u8840\u6db2\u5236\u54c1\u68c0\u67e528\u5bb6\uff0c\u5168\u56fd\u8840\u6db2\u5236\u54c1\u4e5f\u6ca1\u6709\u591a\u5c11\u5bb6\u554a\u3002<\/span><\/p>\n


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<\/p>\n

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\n
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<\/span><\/p>\n<\/section>\n<\/section>\n

\n


<\/p>\n

1.\u53cc\u6210\u836f\u4e1a\u6bd4\u4f10\u5362\u5b9aANDA\u83b7FDA\u6279\u51c6<\/span><\/strong><\/span><\/p>\n


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<\/p>\n

2.\u666e\u5229\u5236\u836f\u6ce8\u5c04\u7528\u66f4\u6614\u6d1b\u97e6\u94a0\u83b7\u6279\u4e0a\u5e02<\/span><\/strong><\/span><\/p>\n


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<\/p>\n

3.\u534e\u6d77\u7f2c\u6c99\u5766\u83b7CFDA\u6279\u51c6\u4e0a\u5e02<\/span><\/strong><\/span><\/p>\n


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4<\/span><\/strong>.\u4eac\u65b0\u91cd\u9152\u77f3\u9178\u5361\u5df4\u4ed6\u6c40\u83b7\u6279\u4e0a\u5e02<\/span><\/strong><\/span><\/p>\n


<\/p>\n

6\u67085\u65e5\uff0c\u4eac\u65b0\u836f\u4e1a\u53d1\u5e03\u516c\u544a\u79f0\uff0c\u6536\u5230CFDA\u7b7e\u53d1\u7684\u6279\u51c6\u91cd\u9152\u77f3\u9178\u5361\u5df4\u4ed6\u6c40\u80f6\u56ca\u836f\u54c1\u6ce8\u518c\u6279\u4ef6\u3002\u91cd\u9152\u77f3\u9178\u5361\u5df4\u4ed6\u6c40\u662f\u7528\u4e8e\u6cbb\u7597\u8f7b\u3001\u4e2d\u5ea6\u963f\u5c14\u5179\u6d77\u9ed8\u75c7\u7684\u4e00\u7ebf\u836f\u7269\uff0c\u4eac\u65b0\u4e3a\u56fd\u5185\u9996\u5bb6\u83b7\u5f97\u91cd\u9152\u77f3\u9178\u5361\u5df4\u4ed6\u6c40\u80f6\u56ca\u751f\u4ea7\u6279\u4ef6\u7684\u5382\u5bb6\u3002<\/span><\/p>\n


<\/span><\/p>\n

5. \u6d77\u6b63\u76d0\u9178\u8868\u67d4\u6bd4\u661f\u83b7\u6279\u4e0a\u5e02<\/span><\/span><\/strong><\/span><\/p>\n


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<\/span><\/p>\n

6. \u8f89\u745etalazoparib\u83b7\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c<\/span><\/span><\/strong><\/span><\/p>\n


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<\/span><\/p>\n

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7.\u767d\u8840\u75c5\u83b7\u6279\u65b0\u7597\u6cd5<\/span><\/strong><\/span><\/p>\n

<\/span><\/p>\n


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6\u67089\u65e5\uff0c\u827e\u4f2f\u7ef4\u4e0e\u57fa\u56e0\u6cf0\u514b\u5ba3\u5e03\uff0cFDA\u5df2\u6279\u51c6\u8fd9\u4e24\u5bb6\u516c\u53f8\u7684\u91cd\u78c5\u836f\u7269Venclexta\uff08venetoclax\uff09\u4e0eRituxan\uff08rituximab\uff09\u8054\u5408\u4f7f\u7528\uff0c\u6cbb\u7597\u7ecf\u6cbb\u7684\u6162\u6027\u6dcb\u5df4\u6027\u767d\u8840\u75c5\u6216\u5c0f\u6dcb\u5df4\u7ec6\u80de\u6027\u6dcb\u5df4\u7624\u60a3\u8005\u3002Venclexta\u662f\u4e00\u6b3e\u9009\u62e9\u6027\u7684BCL-2\u6291\u5236\u5242\uff0c\u6291\u5236\u5728\u6162\u6027\u6dcb\u5df4\u6027\u767d\u8840\u75c5\u4e2d\u8fc7\u91cf\u8868\u8fbe\u7684BCL-2\u86cb\u767d\u3002<\/span><\/p>\n


<\/span><\/p>\n

8.\u524d\u6cbf\u751f\u7269\u957f\u6548\u827e\u6ecb\u75c5\u65b0\u836f\u827e\u535a\u97e6\u6cf0\u83b7\u6279\u4e0a\u5e02<\/span><\/strong><\/span><\/p>\n

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<\/p>\n

9.\u590d\u5b8f\u6c49\u9716\u5b8c\u6210\u6fb3\u5927\u5229\u4e9a\u4e34\u5e8a\u8bd5\u9a8c\u5907\u6848<\/span><\/strong><\/span><\/p>\n


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\u8fd1\u65e5\uff0c\u590d\u5b8f\u6c49\u9716\u6b63\u5f0f\u83b7\u5f97\u6fb3\u5927\u5229\u4e9a\u536b\u751f\u90e8\u6240\u5c5e\u7684 Therapeutic Goods Administration\u5b8c\u6210\u81ea\u4e3b\u7814\u53d1\u7684HLX20\uff08\u5373\u91cd\u7ec4\u6297PD-L1\u5168\u4eba\u5355\u514b\u9686\u6297\u4f53\u6ce8\u5c04\u6db2\uff09\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5907\u6848\uff0c\u8be5\u65b0\u836f\u4e3b\u8981\u7528\u4e8e\u5b9e\u4f53\u7624\u6cbb\u7597\u3002\u590d\u5b8f\u6c49\u9716\u62df\u4e8e\u8fd1\u671f\u5728\u6fb3\u5927\u5229\u4e9a\u5f00\u5c55\u8be5\u65b0\u836f\u4e34\u5e8a I \u671f\u8bd5\u9a8c\u3002<\/span><\/p>\n


<\/span><\/p>\n

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10. \u57fa\u56e0\u6cf0\u514b\u5229\u59a5\u6614\u5355\u6297\u83b7\u6279\u7528\u4e8ePV<\/span><\/strong><\/span><\/p>\n


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\u8fd1\u65e5\uff0c\u57fa\u56e0\u6cf0\u514b\u5ba3\u5e03\uff0cFDA\u6279\u51c6rituximab\uff08\u5229\u59a5\u6614\u5355\u6297\uff09\u7528\u4e8e\u6cbb\u7597\u4e2d\u5ea6\u81f3\u91cd\u5ea6\u5bfb\u5e38\u578b\u5929\u75b1\u75ae \uff08PV\uff09\u3002\u5229\u59a5\u6614\u5355\u6297\u662fFDA\u6279\u51c6\u7684\u9996\u4e2a\u7528\u4e8ePV\u7684\u751f\u7269\u7597\u6cd5\uff0c\u4e5f\u662f\u8be5\u75be\u75c5\u6cbb\u7597\u9886\u57df60\u591a\u5e74\u6765\u7684\u9996\u4e2a\u91cd\u5927\u8fdb\u5c55\u3002<\/span><\/p>\n


<\/span><\/p>\n

11.\u5b89\u8fdb\u57f9\u975e\u683c\u53f8\u4ead\u9996\u4e2a\u751f\u7269\u7c7b\u4f3c\u836f\u83b7\u6279<\/span><\/strong><\/span><\/p>\n


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\u8fd1\u65e5\uff0cFDA\u6279\u51c6Fulphila\uff08pegfilgrastim-jmdb\uff09\u7528\u4e8e\u63a5\u53d7\u9aa8\u9ad3\u6291\u5236\u6027\u5316\u7597\u7684\u975e\u9aa8\u9ad3\u764c\u75c7\u60a3\u8005\uff0c\u4ee5\u964d\u4f4e\u53d1\u70ed\u6027\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u75c7\uff08FN\uff09\u7684\u53d1\u751f\u7387\uff0cFulphila\u662fNeulasta\u7684\u7b2c\u4e00\u4e2a\u751f\u7269\u7c7b\u4f3c\u7269\uff0c\u4e5f\u662fFDA\u6279\u51c6\u7684\u7b2c10\u4e2a\u751f\u7269\u7c7b\u4f3c\u7269\u3002<\/span><\/p>\n


<\/p>\n

\n
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<\/span><\/p>\n<\/section>\n<\/section>\n


<\/p>\n

12.\u6765\u51ef\u533b\u836f\u5b8c\u62101850\u4e07\u7f8e\u5143A\u8f6e\u878d\u8d44<\/span><\/span><\/strong><\/span><\/p>\n


<\/span><\/p>\n

6\u67084\u65e5\uff0c\u6765\u51ef\u533b\u836f\u5ba3\u5e03\u5b8c\u62101850\u4e07\u7f8e\u5143\u7684A\u8f6e\u878d\u8d44\uff0c\u7531\u5965\u535a\u4e9a\u6d32\u9886\u6295\uff0c\u5b89\u9f99\u57fa\u91d1\u7b49\u8ddf\u6295\u3002\u672c\u8f6e\u878d\u8d44\u5c06\u4e3b\u8981\u7528\u4e8e\u63a8\u8fdb\u7814\u7a76\u7ba1\u7ebf\u4e2d\u7684\u65b0\u836f\u9879\u76ee\uff0c\u5e76\u6269\u5927\u4ea7\u54c1\u7ebf\u7ec4\u5408\u3002\u6765\u51ef\u533b\u836f\u62e5\u6709\u4e09\u4e2a\u5904\u4e8e\u4e34\u5e8aI-II\u671f\u9636\u6bb5\u7684\u6297\u80bf\u7624\u65b0\u836f\uff0c\u4e3b\u8981\u9488\u5bf9\u4e2d\u665a\u671f\u80bf\u7624\uff0c\u5305\u62ec\u524d\u5217\u817a\u764c\u3001\u5375\u5de2\u764c\u3001\u4e73\u817a\u764c\u548c\u80c3\u764c\u7b49\uff0c\u6765\u51ef\u4e5f\u5728\u5f00\u5c55\u65e9\u671f\u7684\u6297\u80bf\u7624\u548c\u809d\u75c5\u7684\u65b0\u836f\u7814\u53d1\uff0c\u5305\u62ec\u9488\u5bf9\u975e\u9152\u7cbe\u6027\u8102\u80aa\u6027\u809d\u708e\uff08NASH\uff09\u548c\u809d\u7ea4\u7ef4\u5316\u7b49\u75be\u75c5\u9886\u57df\u3002<\/span><\/p>\n


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13.\u00a0\u5955\u5b89\u6d4e\u4e16\u5b8c\u62103500\u4e07\u7f8e\u5143B+\u8f6e\u878d\u8d44<\/span><\/span><\/strong><\/p>\n


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6\u67086\u6708\u3002\u5955\u5b89\u6d4e\u4e16\u5ba3\u5e03\u987a\u5229\u5b8c\u62103500\u4e07\u7f8e\u5143\u7684B+\u8f6e\u878d\u8d44\u3002\u6b64\u6b21B+\u8f6e\u7531\u9ad8\u74f4\u8d44\u672c\u9886\u6295\uff0c\u73b0\u6709\u80a1\u4e1c\u6de1\u9a6c\u9521\u3001\u793c\u6765\u4e9a\u6d32\u57fa\u91d1\u3001ARCH Venture Partners\u3001\u6cf0\u5eb7\u53ca\u4e2d\u94f6\u6d59\u5546\u5171\u540c\u51fa\u8d44\u5b8c\u6210\u3002\u5305\u62ec\u6b64\u8f6e\u878d\u8d44\u5728\u5185\uff0c\u5955\u5b89\u6d4e\u4e16\u4ece\u521b\u7acb\u81f3\u4eca\u878d\u8d44\u603b\u989d\u5df2\u8d85\u8fc71.4\u4ebf\u7f8e\u5143\u3002<\/span><\/p>\n


<\/p>\n

14.<\/span><\/strong><\/span>\u00a0\u4e2d\u73e0\u533b\u7597\u6536\u8d2d\u5eb7\u6cfd\u836f\u4e1a74.5262%\u80a1\u4efd<\/span><\/span><\/span><\/strong><\/p>\n


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15.\u5f90\u8bfa\u836f\u4e1a\u5b8c\u6210B\u8f6e\u878d\u8d44<\/span><\/strong><\/span><\/p>\n


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16.\u5723\u8bfa\u5236\u836f\u5b8c\u62102500\u4e07\u7f8e\u5143C1\u8f6e\u878d\u8d44<\/span><\/strong><\/span><\/p>\n


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<\/span><\/p>\n

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17.\u00a0\u8d1d\u8fbe\u6536\u8d2dEquinox Science<\/span>\u7684<\/span>50%<\/span>\u80a1\u6743<\/span><\/span><\/span><\/strong><\/span><\/p>\n


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6\u67081\u65e5\uff0c\u8d1d\u8fbe\u836f\u4e1a\u516c\u544a\u79f0\uff0c\u540c\u610f\u901a\u8fc7\u5168\u8d44\u5b50\u516c\u53f8\u8d1d\u8fbe\u6295\u8d44\u4ee5\u5408\u8ba1\u00a02000\u00a0\u4e07\u7f8e\u5143\u6536\u8d2d\u00a0Tyrogenex\u6301\u6709\u7684\u00a0Equinox Science\u768450%\u80a1\u6743\u3002\u5e76\u53d6\u6d88\u516c\u53f8\u5168\u8d44\u5b50\u516c\u53f8\u5361\u5357\u5409\u548c\u00a0Tyrogenex\u00a0\u65e9\u671f\u7b7e\u7f72\u7684\u00a0X-82\u00a0\u72ec\u5bb6\u8bb8\u53ef\u534f\u8bae\u4e2d\u6709\u5173\u9500\u552e\u63d0\u6210\u8d39\u7684\u6761\u6b3e\uff0c\u672c\u6b21\u6536\u8d2d\u5b8c\u6210\u540e\uff0c\u516c\u53f8\u6301\u6709\u00a0Equinox100%\u80a1\u6743\uff0c\u62e5\u6709\u00a0Vorolanib\u00a0\u5316\u5408\u7269\uff08X-82\uff09\u80bf\u7624\u9002\u5e94\u75c7\u5728\u6d77\u5916\u7684\u6743\u76ca\u3002<\/span><\/p>\n

\n
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18.\u6d77\u6b63\u8f89\u745e\u66f4\u540d\u4e3a\u701a\u6656\u5236\u836f<\/span><\/span><\/strong>
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19. \u6881\u6021\u5165\u804c\u518d\u9f0e\u533b\u836f<\/span><\/span><\/strong><\/span><\/p>\n


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20. FDA\u6216\u5c06\u201c\u5b9e\u65f6\u5ba1\u8bc4\u5236<\/span>\u201d<\/span><\/strong><\/span><\/p>\n


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<\/p>\n

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\u672c\u55b5\u6b63\u5728\u767d\u4e91\u673a\u573a\u5019\u673a\uff0c\u7b49\u98de\u673a\u635e\u51fa\u6765\uff0c\u667e\u4e00\u667e\u5c31\u53ef\u4ee5\u98de\u4e86\u2026\u2026\u5c0f\u4f19\u4f34\u513f\u4eec\uff0c\u6765\u4e86\u89e3\u4e00\u4e0b\u672c\u5468\u533b\u836f\u5708\u53d1\u751f\u7684\u65b0\u9c9c\u4e8b\u5427~ \u4e00\u5468 […]<\/p>\n","protected":false},"author":1,"featured_media":9580,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9579"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=9579"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9579\/revisions"}],"predecessor-version":[{"id":9584,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9579\/revisions\/9584"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/9580"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=9579"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=9579"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=9579"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}