{"id":314,"date":"2023-10-08T19:18:16","date_gmt":"2023-10-08T11:18:16","guid":{"rendered":"http:\/\/www.yaozhiyou.com\/?p=314"},"modified":"2023-10-19T18:54:32","modified_gmt":"2023-10-19T10:54:32","slug":"%e8%8b%8f%e9%87%91%e5%8d%95%e6%8a%97secukinumab","status":"publish","type":"post","link":"https:\/\/www.yaozhiyou.com\/?p=314","title":{"rendered":"\u82cf\u91d1\u5355\u6297Secukinumab"},"content":{"rendered":"\n
\"\u82cf\u91d1\u5355\u6297\"<\/figure>\n\n\n\n

\u836f\u54c1\u7c7b\u522b\uff1a\u76ae\u80a4\u9aa8\u75c5<\/a> <\/p>\n\n\n\n

\u9002\u7528\u75c5\u75c7\uff1a\u94f6\u5c51\u75c5\u5173\u8282\u708e\u3001\u6591\u5757\u578b\u94f6\u5c51\u75c5\u3001\u5f3a\u76f4\u6027\u810a\u67f1\u708e\u3001\u4e2d\u8f74\u578b\u810a\u67f1\u5173\u8282\u708e \u89c4\u683c\uff1a150mg<\/p>\n\n\n\n

\u82cf\u91d1\u5355\u6297\u836f\u54c1\u4ecb\u7ecd<\/h2>\n\n\n\n
\n\n\n\n

\u3000\u3000\u3010\u6700\u65b0\u8fdb\u5c55\u3011<\/strong>
\u3000\u30002020\u5e746\u6708\uff0c\u7f8e\u56fdFDA\u6279\u51c6Cosentyx\uff08Secukinumab\uff0c\u53f8\u5e93\u5947\u5c24\u5355\u6297\uff0c\u4fd7\u79f0\u201c\u82cf\u91d1\u5355\u6297\u201d\uff09\u7528\u4e8e\u6d3b\u52a8\u6027\u653e\u5c04\u5b66\u9634\u6027\u4e2d\u8f74\u578b\u810a\u67f1\u5173\u8282\u708e\uff08nr-axSpA\uff09\u60a3\u8005\u7684\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u3000\u3000Cosentyx\u662f\u5168\u7403\u9996\u4e2a\u4e5f\u662f\u552f\u4e00\u4e00\u4e2a\u7279\u5f02\u6027\u9776\u5411\u6291\u5236\u767d\u4ecb\u7d20-17A\uff08IL-17A\uff09\u7684\u5168\u4eba\u5355\u514b\u9686\u6297\u4f53\u836f\u7269\uff0c\u83b7\u6279\u9002\u5e94\u75c7\u5305\u62ec\uff1a\u94f6\u5c51\u75c5\u5173\u8282\u708e\uff08PsA\uff09\u3001\u6591\u5757\u578b\u94f6\u5c51\u75c5\uff08PsO\uff09\u3001\u5f3a\u76f4\u6027\u810a\u67f1\u708e\u4ee5\u53ca\u4e2d\u8f74\u578b\u810a\u67f1\u5173\u8282\u708e\u3002 <\/strong><\/p>\n\n\n\n

\u3000\u3000\u5728\u4e2d\u56fd\uff0c2019\u5e743\u6708\uff0c\u53ef\u5584\u633a\u00ae\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u4e2d\u91cd\u5ea6\u6591\u5757\u72b6\u94f6\u5c51\u75c5\uff08plaque psoriasis\uff0cPsO\uff09\u3002<\/p>\n\n\n\n

\u3000\u30002020\u5e7404\u6708\uff0c\u53ef\u5584\u633a\u00ae \uff08Cosentyx\uff0csecukinumab\uff0c\u53f8\u5e93\u5947\u5c24\u5355\u6297\uff09\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6279\u51c6\uff0c\u7528\u4e8e\u5e38\u89c4\u6cbb\u7597\u7597\u6548\u6b20\u4f73\u7684\u5f3a\u76f4\u6027\u810a\u67f1\u708e\uff08ankylosing spondylitis\uff0cAS\uff09\u7684\u6210\u5e74\u60a3\u8005\u3002<\/p>\n\n\n\n

\u3000\u3000\u9002\u5e94\u75c7\u548c\u7528\u9014<\/strong><\/p>\n\n\n\n

\u3000\u3000COSENTYX\u662f\u4e00\u79cd\u4eba\u767d\u4ecb\u7d20-IL-17A\u62ee\u6297\u5242\u9002\u7528\u4e3a\u5168\u8eab\u6cbb\u7597\u6216\u5149\u6cbb\u7597\u5907\u9009\u8005\u7684\u4e2d\u5ea6\u81f3\u4e25\u91cd\u6591\u5757\u6027\u94f6\u5c51\u75c5\u6210\u5e74\u5bf9\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u3000\u3000\u5242\u91cf\u548c\u7ed9\u836f\u65b9\u6cd5<\/p>\n\n\n\n

\u3000\u3000\u2474 \u63a8\u8350\u5242\u91cf\u662f300mg\u76ae\u4e0b\u6ce8\u5c04\u5728\u7b2c0\uff0c1\uff0c2\uff0c3\u548c4\u5468\u63a5\u7740300mg\u6bcf4\u5468\u3002\u5bf9\u6709\u4e9b\u60a3\u8005\uff0c\u5242\u91cf150mg\u53ef\u80fd\u88ab\u63a5\u53d7\u3002<\/p>\n\n\n\n

\u3000\u3000\u2475 \u5bf9Sensoready?\u7b14\u548c\u9884\u88c5\u6ce8\u5c04\u5668\u7684\u51c6\u5907\u89c1\u5b8c\u6574\u5904\u65b9\u8d44\u6599\u3002(2.3)<\/p>\n\n\n\n

\u3000\u3000\u2476 \u5728\u4e00\u5c0f\u74f6\u4e2d\u7528\u6ce8\u5c04\u7528\u65e0\u83cc\u6c34\u91cd\u5efaCOSENTYX\u51b0\u51bb\u5e72\u71e5\u7c89\u3002\u5e94\u7531\u536b\u751f\u4fdd\u5065\u63d0\u4f9b\u8005\u8fdb\u884c\u91cd\u5efa\u3002(2.4)<\/p>\n\n\n\n

\u3000\u3000\u5242\u578b\u548c\u89c4\u683c<\/p>\n\n\n\n

\u3000\u3000\u2474\u6ce8\u5c04\u6db2\uff1a\u5728\u4e00\u6b21\u6027Sensoready?\u7b14\u4e2d150mg\/mL\u6eb6\u6db2(3)<\/p>\n\n\n\n

\u3000\u3000\u2475\u6ce8\u5c04\u6db2\uff1a\u5728\u4e00\u6b21\u6027\u9884\u88c5\u6ce8\u5c04\u5668150mg\/mL\u6eb6\u6db2(3)<\/p>\n\n\n\n

\u3000\u3000\u2476\u6ce8\u5c04\u7528\uff1a\u4e3a\u91cd\u5efa\u5728\u4e00\u6b21\u6027\u5c0f\u74f6150mg\uff0c\u51b0\u51bb\u5e72\u71e5\u7c89\u53ea\u4e3a\u536b\u751f\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u4f7f\u7528(3)<\/p>\n\n\n\n

\u3000\u3000\u7981\u5fcc\u75c7<\/p>\n\n\n\n

\u3000\u3000\u5bf9\u82cf\u91d1\u5355\u6297\u6216\u5bf9\u8d4b\u5f62\u5242\u7684\u4efb\u4f55\u4e25\u91cd\u8d85\u654f\u6027\u53cd\u5e94\u3002(4)<\/p>\n\n\n\n

\u3000\u3000\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879<\/p>\n\n\n\n

\u3000\u3000\u2474 \u611f\u67d3\uff1a\u66fe\u53d1\u751f\u4e25\u91cd\u611f\u67d3\u3002\u5f53\u8003\u8651\u5728\u6709\u6162\u6027\u611f\u67d3\u6216\u590d\u53d1\u6027\u611f\u67d3\u75c5\u53f2\u60a3\u8005\u4e2dCOSENTYX\u7684\u4f7f\u7528\u65f6\u5e94\u8c28\u614e\u4ece\u4e8b\u3002\u5982\u53d1\u751f\u4e25\u91cd\u611f\u67d3\uff0c\u7ec8\u6b62COSENTYX\u76f4\u81f3\u611f\u67d3\u89e3\u51b3\u3002(5.1)<\/p>\n\n\n\n

\u3000\u3000\u2475 \u7ed3\u6838(TB)\uff1a\u5f00\u59cb\u7528COSENTYX\u6cbb\u7597\u524d\uff0c\u8bc4\u4ef7TB\u3002(5.2)<\/p>\n\n\n\n

\u3000\u3000\u2476 \u514b\u7f57\u6069\u6c0f\u75c5\uff1a\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u89c2\u5bdf\u5230\u52a0\u91cd\u3002\u5f53\u5bf9\u6709\u6d3b\u52a8\u6027\u514b\u7f57\u6069\u6c0f\u75c5\u60a3\u8005\u5904\u65b9COSENTYX\u65f6\u5e94\u8c28\u614e\u4ece\u4e8b\u3002(5.3)<\/p>\n\n\n\n

\u3000\u3000\u2477 \u8d85\u654f\u6027\u53cd\u5e94\uff1a\u5982\u53d1\u751f\u8fc7\u654f\u6027\u53cd\u5e94\u6216\u5176\u4ed6\u4e25\u91cd\u8fc7\u654f\u53cd\u5e94\uff0c\u7acb\u5373\u7ec8\u6b62COSENTYX\u548c\u5f00\u59cb\u9002\u5f53\u6cbb\u7597\u3002(5.4)<\/p>\n\n\n\n

\u3000\u3000\u4e0d\u826f\u53cd\u5e94<\/p>\n\n\n\n

\u3000\u3000\u6700\u5e38\u89c1\u4e0d\u826f\u53cd\u5e94(>1%)\u662f\u9f3b\u54bd\u708e\uff0c\u8179\u6cfb\uff0c\u548c\u4e0a\u547c\u5438\u9053\u611f\u67d3\u3002(6.1)<\/p>\n\n\n\n

\u3000\u3000\u836f\u7269\u76f8\u4e92\u4f5c\u7528<\/p>\n\n\n\n

\u3000\u3000\u4e0d\u5e94\u4e0eCOSENTYX\u7ed9\u4e88\u3002(5.6\uff0c7.1)<\/p>\n\n\n\n

\u3000\u3000\u5b8c\u6574\u5904\u65b9\u8d44\u6599<\/p>\n\n\n\n

\u3000\u30001 \u9002\u5e94\u75c7\u548c\u7528\u9014<\/p>\n\n\n\n

\u3000\u3000COSENTYXTM\u662f\u9002\u7528\u4e3a\u4e2d\u5ea6\u81f3\u4e25\u91cd\u6591\u5757\u6027\u94f6\u5c51\u75c5\u4e3a\u5168\u8eab\u6cbb\u7597\u6216\u5149\u6cbb\u7597\u88ab\u9009\u8005\u6210\u5e74\u60a3\u8005\u7684\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u3000\u30002 \u5242\u91cf\u548c\u7ed9\u836f\u65b9\u6cd5<\/p>\n\n\n\n

\u3000\u30002.1 \u63a8\u8350\u5242\u91cf<\/p>\n\n\n\n

\u3000\u3000\u63a8\u8350\u5242\u91cf\u662f300 mg\u901a\u8fc7\u76ae\u4e0b\u6ce8\u5c04\u57280\uff0c1\uff0c2\uff0c3\uff0c\u548c4\u5468\u63a5\u7740300 mg\u6bcf4\u5468\u3002\u6bcf300 mg\u5242\u91cf\u662f\u4f5c\u4e3a2\u6b21150mg\u76ae\u4e0b\u6ce8\u5c04\u7ed9\u4e88\u3002<\/p>\n\n\n\n

\u3000\u3000\u5bf9\u6709\u4e9b\u60a3\u8005\uff0c150 mg\u7684\u5242\u91cf\u53ef\u80fd\u88ab\u63a5\u53d7\u3002<\/p>\n\n\n\n

\u3000\u30002.2 \u91cd\u8981\u7ed9\u836f\u6307\u5bfc<\/p>\n\n\n\n

\u3000\u3000\u5bf9COSENTYX\u6709\u4e09\u79cd\u8868\u73b0(\u5373\uff0cSensoready\u7b14\uff0c\u9884\u88c5\u6ce8\u5c04\u5668\uff0c\u548c\u4e3a\u91cd\u5efa\u5728\u5c0f\u74f6\u4e2d\u51b0\u51bb\u5e72\u71e5\u7c89)\u3002COSENTYX\u201c\u4e3a\u4f7f\u7528\u6307\u5bfc\u201d\u5bf9COSENTYX\u6bcf\u79cd\u8868\u73b0\u5bf9\u5236\u5907\u548c\u7ed9\u836f\u90fd\u5305\u542b\u66f4\u8be6\u7ec6\u6307\u5bfc[\u89c1\u4e3a\u4f7f\u7528\u6307\u5bfc]\u3002<\/p>\n\n\n\n

\u3000\u3000COSENTYX\u662f\u610f\u5411\u4e3a\u5728\u533b\u751f\u6307\u5bfc\u548c\u76d1\u7763\u4e0b\u4f7f\u7528\u3002\u9002\u5f53\u8bad\u7ec3\u5229\u7528Sensoready\u7b14\u6216\u9884\u88c5\u6ce8\u5c04\u5668\u76ae\u4e0b\u6ce8\u5c04\u6280\u672f\u540e\u548c\u5f53\u8ba4\u4e3a\u9002\u5f53\u7684\u65f6\u5019\u60a3\u8005\u53ef\u80fd\u81ea\u6211\u6ce8\u5c04\u3002\u4e3a\u91cd\u5efa\u51b0\u51bb\u5e72\u71e5\u7c89\u662f\u53ea\u4e3a\u536b\u751f\u4fdd\u5065\u63d0\u4f9b\u8005\u4f7f\u7528\u3002\u6bcf\u6b21\u6ce8\u5c04\u5728\u4ee5\u524d\u6ce8\u5c04\u4e0e\u4e00\u4e2a\u4e0d\u540c\u89e3\u5256\u4f4d\u7f6e\u7ed9\u4e88(\u4f8b\u5982\u4e0a\u81c2\uff0c\u817f\u6216\u8179\u90e8\u4efb\u4f55\u56db\u5206\u4e4b\u4e00\u8c61\u9650)\uff0c\u548c\u4e0d\u8981\u4e3b\u4efb\u533a\u57df\u76ae\u80a4\u662f\u8106\u5f31\uff0c\u7600\u4f24\uff0c\u7ea2\u6591\uff0c\u6709\u786c\u7ed3\u6216\u53d7\u94f6\u5c51\u75c5\u4fb5\u72af\u3002COSENTYX\u5728\u4e0a\uff0c\u5916\u4fa7\u81c2\u7ed9\u4e88\u53ef\u80fd\u7531\u770b\u62a4\u6216\u536b\u751f\u4fdd\u5065\u63d0\u4f9b\u8005\u8fdb\u884c\u3002.<\/p>\n\n\n\n

\u3000\u30002.3 \u4e3a\u4f7f\u7528COSENTYX Sensoready?\u7b14\u548c\u9884\u88c5\u6ce8\u5c04\u5668\u5236\u5907<\/p>\n\n\n\n

\u3000\u3000\u6ce8\u5c04\u524d\uff0c\u4ece\u51b0\u7bb1\u53d6\u51faCOSENTYX Sensoready\u7b14\u6216COSENTYX\u9884\u88c5\u6ce8\u5c04\u5668\u548c\u5141\u8bb8COSENTYX\u8fbe\u5230(15to30\u5206\u949f)\u6ca1\u6709\u53bb\u6389\u9488\u5e3d\u3002<\/p>\n\n\n\n

\u3000\u3000COSENTYX Sensoready\u7b14\u548cCOSENTYX\u9884\u88c5\u6ce8\u5c04\u5668\u542b\u5929\u7136\u6a61\u80f6\u4e73\u80f6\u53ef\u79fb\u53bb\u5e3d\u548c\u4e0d\u5e94\u88ab\u5bf9\u4e73\u80f6\u654f\u611f\u4e2a\u4f53\u5904\u7f6e[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.5)]\u3002<\/p>\n\n\n\n

\u3000\u3000\u7ed9\u836f\u524d\u8089\u773c\u89c2\u5bdfCOSENTYX\u6709\u65e0\u9897\u7c92\u7269\u8d28\u548c\u53d8\u8272\u3002COSENTYX\u6ce8\u5c04\u6db2\u662f\u6e05\u6f88\u81f3\u7565\u5fae\u4e0d\u900f\u660e\uff0c\u65e0\u8272\u81f3\u7565\u5fae\u9ec4\u6eb6\u6db2\u3002\u5982\u6db2\u4f53\u542b\u80af\u4ef6\u9897\u7c92\uff0c\u662f\u53d8\u8272\u6216\u4e91\u96fe\u72b6\u4e0d\u8981\u4f7f\u7528\u3002COSENTYX\u4e0d\u542b\u9632\u8150\u5242\uff0c\u56e0\u6b64\uff0cSensoready\u7b14\u6216\u9884\u88c5\u6ce8\u5c04\u5668\u5728\u4ece\u51b0\u7bb1\u53d6\u51fa\u540e\u57281\u5c0f\u65f6\u5185\u7ed9\u836f\u3002\u9057\u5f03\u4fdd\u7559\u5728Sensoready\u7b14\u6216\u9884\u88c5\u6ce8\u5c04\u5668\u5185\u4efb\u4f55\u672a\u4f7f\u7528\u4ea7\u54c1\u3002<\/p>\n\n\n\n

\u3000\u30002.4 \u91cd\u5efa\u548c\u7684\u51c6\u5907COSENTYX\u51b0\u51bb\u5e72\u71e5\u7c89<\/p>\n\n\n\n

\u3000\u3000\u5e94\u88ab\u7ecf\u8fc7\u8bad\u7ec3\u536b\u751f\u4fdd\u5065\u63d0\u4f9b\u8005\u7528\u65e0\u83cc\u672f\u548c\u65e0\u4e2d\u65ad\u7528\u6ce8\u5c04\u7528\u65e0\u83cc\u6c34COSENTYX\u51b0\u51bb\u5e72\u71e5\u7c89\u5236\u5907\u548c\u91cd\u5efa\u3002\u5236\u5907\u65f6\u95f4\u4ece\u7a7f\u523a\u585e\u5b50\u76f4\u81f3\u91cd\u5efa\u7ed3\u675f\u5e73\u5747\u82b120\u5206\u949f\u548c\u4e0d\u5e94\u8d85\u8fc790\u5206\u949f\u3002<\/p>\n\n\n\n

\u3000\u3000a) \u4ece\u51b0\u7bb1\u53d6\u51faCOSENTYX\u51b0\u51bb\u5e72\u71e5\u7c89\u5c0f\u74f6\u548c\u5141\u8bb8\u653e\u7f6e15\u81f33\u5206\u949f\u8fbe\u5230\u5ba4\u6e29\u3002\u786e\u4fdd\u6ce8\u5c04\u7528\u65e0\u83cc\u6c34\u662f\u5728\u5ba4\u6e29\u3002<\/p>\n\n\n\n

\u3000\u3000b) \u7f13\u6162\u6ce8\u51651 mL\u6ce8\u5c04\u7528\u65e0\u83cc\u6c34\u81f3\u542bCOSENTYX\u51b0\u51bb\u5e72\u71e5\u7c89\u5c0f\u74f6\u548c\u6ce8\u5c04\u7528\u65e0\u83cc\u6c34\u6c34\u6d41\u76f4\u63a5\u5bf9\u51b0\u51bb\u5e72\u71e5\u7c89\u3002<\/p>\n\n\n\n

\u3000\u3000c) \u503e\u659c\u5c0f\u74f6\u5728\u89d2\u5ea6\u7ea645\u5ea6\u548c\u5728\u6307\u5c16\u95f4\u8f7b\u8f7b\u65cb\u8f6c\u5171\u7ea61\u5206\u949f\uff0c\u4e0d\u8981\u6447\u52a8\u6216\u5012\u7f6e\u5c0f\u74f6\u3002<\/p>\n\n\n\n

\u3000\u3000d) \u8ba9\u5c0f\u74f6\u5728\u5ba4\u6e29\u653e\u7f6e\u5171\u7ea610\u5206\u949f\u5141\u8bb8\u6eb6\u89e3\u3002\u6ce8\u610f\u53ef\u80fd\u5b58\u5728\u8d77\u6ce1\u3002<\/p>\n\n\n\n

\u3000\u3000e) \u503e\u659c\u5c0f\u74f6\u5728\u89d2\u5ea6\u7ea645\u5ea6\u548c\u5728\u6307\u5c16\u95f4\u8f7b\u8f7b\u65cb\u8f6c\u5171\u7ea61\u5206\u949f\uff0c\u4e0d\u8981\u6447\u52a8\u6216\u5012\u7f6e\u5c0f\u74f6\u3002<\/p>\n\n\n\n

\u3000\u3000f) \u8ba9\u5c0f\u74f6\u5728\u5ba4\u6e29\u4e0d\u53d7\u5e72\u6270\u653e\u7f6e\u5171\u7ea65\u5206\u949f\u3002\u91cd\u5efaCOSENTYX\u6eb6\u6db2\u5e94\u57fa\u672c\u4e0a\u65e0\u53ef\u89c1\u9897\u7c92\uff0c\u900f\u660e\u81f3\u4e0d\u900f\u660e\uff0c\u548c\u65e0\u8272\u81f3\u7565\u5fae\u9ec4\u3002\u5982\u51b0\u51bb\u5e72\u71e5\u7c89\u672a\u5b8c\u5168\u6eb6\u89e3\u6216\u5982\u6db2\u4f53\u542b\u53ef\u89c1\u9897\u7c92\uff0c\u662f\u4e91\u72b6\u6216\u53d8\u8272\u4e0d\u8981\u4f7f\u7528\u3002<\/p>\n\n\n\n

\u3000\u3000g) \u51c6\u5907\u9700\u8981\u7684\u5c0f\u74f6\u6570(\u5bf9150 mg\u5242\u91cf1\u5c0f\u74f6\u6216\u5bf9300 mg\u5242\u91cf2\u5c0f\u74f6)\u3002<\/p>\n\n\n\n

\u3000\u3000h) COSENTYX\u91cd\u5efa\u6eb6\u6db2\u57281 mL\u6eb6\u6db2\u542b150 mg\u4f9d\u90a3\u897f\u666e\u3002\u91cd\u5efa\u540e\uff0c\u7acb\u5373\u4f7f\u7528\u6eb6\u6db2\u6216\u8d2e\u5b58\u5728\u51b0\u7bb1 \u57282oC\u81f38oC(36oF\u81f346oF)\u81f324\u5c0f\u65f6\u3002\u4e0d\u8981\u51bb\u7ed3\u3002<\/p>\n\n\n\n

\u3000\u3000i) \u5982\u8d2e\u5b58\u57282oC\u81f38oC(36oF\u81f346oF)\uff0c\u7ed9\u836f\u524d\u5141\u8bb8\u91cd\u5efaCOSENTYX\u6eb6\u6db2\u8fbe\u5230\u5ba4\u6e29(15\u81f330\u5206\u949f)\u3002COSENTYX\u4e0d\u542b\u9632\u8150\u5242; \u56e0\u6b64\uff0c\u4ece2oC\u81f38oC(36oF\u81f346oF) \u8d2e\u5b58\u53d6\u51fa\u540e1\u4e2a\u5c0f\u65f6\u5185\u7ed9\u4e88\u3002<\/p>\n\n\n\n

\u3000\u30003 \u5242\u578b\u548c\u89c4\u683c<\/p>\n\n\n\n

\u3000\u3000\u6ce8\u5c04\u6db2\uff1a150 mg\/mL\u6eb6\u6db2\u5728\u4e00\u6b21\u6027Sensoready\u7b14<\/p>\n\n\n\n

\u3000\u3000\u6ce8\u5c04\u6db2\uff1a150 mg\/mL\u6eb6\u6db2\u5728\u4e00\u6b21\u6027\u9884\u88c5\u6ce8\u5c04\u5668<\/p>\n\n\n\n

\u3000\u3000\u6ce8\u5c04\u7528\uff1a150 mg\uff0c\u51b0\u51bb\u5e72\u71e5\u7c89\u5728\u4e00\u6b21\u6027\u5c0f\u74f6\u4e3a\u91cd\u5efa(\u53ea\u4e3a\u536b\u751f\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u4f7f\u7528)<\/p>\n\n\n\n

\u3000\u30004 \u7981\u5fcc\u75c7<\/p>\n\n\n\n

\u3000\u3000\u5728\u6709\u4ee5\u524d\u4e25\u91cd\u8d85\u654f\u6027\u53cd\u5e94\u5bf9\u4f9d\u90a3\u897f\u666e\u6216\u5bf9\u8d4b\u5f62\u5242\u7684\u4efb\u4f55\u60a3\u8005\u7981\u5fccCOSENTYX[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.4)]\u3002<\/p>\n\n\n\n

\u3000\u30005 \u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879<\/p>\n\n\n\n

\u3000\u30005.1 \u611f\u67d3<\/p>\n\n\n\n

\u3000\u3000COSENTYX\u53ef\u80fd\u589e\u52a0\u611f\u67d3\u7684\u98ce\u9669\u3002\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u88abCOSENTYX\u6cbb\u7597\u53d7\u8bd5\u8005\u4e0e\u88ab\u5b89\u6170\u5242\u6cbb\u7597\u53d7\u8bd5\u8005\u6bd4\u8f83\u89c2\u5bdf\u5230\u611f\u67d3\u8f83\u9ad8\u7387\u3002\u5728\u5b89\u6170\u5242-\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e38\u89c1\u611f\u67d3\u4f8b\u5982\u9f3b\u54bd\u708e(11.4%\u76f8\u6bd4\u8f838.6%)\uff0c\u4e0a\u547c\u5438\u9053\u611f\u67d3(2.5%\u76f8\u6bd4\u8f830.7%)\u548c\u76ae\u80a4\u7c98\u819c\u611f\u67d3\u6709\u5ff5\u73e0\u83cc(1.2%\u76f8\u6bd4\u8f830.3%)\u7528COSENTYX\u4e0e\u5b89\u6170\u5242\u6bd4\u8f83\u89c2\u5bdf\u5230\u8f83\u9ad8\u7387\u3002\u5728\u4e34\u5e8a\u7814\u7a76\u6709\u4e9b\u7c7b\u578b\u611f\u67d3\u7684\u53d1\u751f\u7387\u4f3c\u4e4e\u662f\u4f9d\u8d56\u5242\u91cf[\u89c1\u4e0d\u826f\u53cd\u5e94(6.1)]\u3002<\/p>\n\n\n\n

\u3000\u3000\u5728\u6709\u6162\u6027\u611f\u67d3\u6216\u590d\u53d1\u6027\u611f\u67d3\u75c5\u53f2\u60a3\u8005\u4e2d\u5f53\u8003\u8651\u4f7f\u7528COSENTYX\u8c28\u614e\u4ece\u4e8b\u3002<\/p>\n\n\n\n

\u3000\u3000\u6307\u5bfc\u60a3\u8005\u5bfb\u6c42\u533b\u7597\u54a8\u8be2\u5982\u4f53\u5f81\u548c\u75c7\u72b6\u53d1\u751f\u4e00\u79cd\u611f\u67d3\u63d0\u793a\u3002\u5982\u4e00\u4f8b\u60a3\u8005\u53d1\u751f\u67d0\u79cd\u4e25\u91cd\u611f\u67d3\uff0c\u60a3\u8005\u5e94\u88ab\u5bc6\u5207\u76d1\u89c6\u548c\u76f4\u81f3\u611f\u67d3\u89e3\u51b3COSENTYX\u5e94\u88ab\u7ec8\u6b62\u3002<\/p>\n\n\n\n

\u3000\u30005.2 \u5bf9\u7ed3\u6838\u9884\u6cbb\u7597\u8bc4\u4ef7<\/p>\n\n\n\n

\u3000\u3000\u5f00\u59cb\u7528COSENTYX\u6cbb\u7597\u524d\u8bc4\u4ef7\u60a3\u8005\u5bf9\u7ed3\u6838(TB)\u611f\u67d3\u3002\u5bf9\u6709\u6d3b\u52a8\u6027\u60a3\u8005\u4e0d\u8981\u7ed9COSENTYX\u3002\u7ed9\u4e88COSENTYX\u524d\u5f00\u59cb\u6cbb\u7597\u6f5c\u4f0fTB\u3002\u5728\u6709\u6f5c\u4f0f\u6216\u6d3b\u52a8\u6027TB\u8fc7\u53bb\u75c5\u53f2\u60a3\u8005\u4e0d\u80fd\u786e\u8bc1\u5176\u6cbb\u7597\u9002\u5f53\u7597\u7a0b\u5728COSENTYX\u5f00\u59cb\u524d\u8003\u8651\u6297-TB\u6cbb\u7597\u3002\u63a5\u53d7COSENTYX\u60a3\u8005\u6cbb\u7597\u671f\u95f4\u548c\u540e\u5e94\u5bc6\u5207\u76d1\u89c6\u6d3b\u52a8\u6027TB\u7684\u4f53\u5f81\u548c\u75c7\u72b6\u3002<\/p>\n\n\n\n

\u3000\u30005.3 \u514b\u7f57\u6069\u6c0f\u75c5\u7684\u52a0\u91cd<\/p>\n\n\n\n

\u3000\u3000\u5bf9\u6709\u6d3b\u52a8\u6027\u514b\u7f57\u6069\u6c0f\u75c5\u60a3\u8005\u5f53\u5904\u65b9COSENTYX\u8c28\u614e\u4ece\u4e8b\uff0c\u56e0COSENTYX-\u6cbb\u7597\u60a3\u8005\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u89c2\u5bdf\u5230\u514b\u7f57\u6069\u6c0f\u75c5\u7684\u52a0\u91cd\uff0c\u6709\u4e9b\u75c5\u4f8b\u4e25\u91cd\u3002\u7528COSENTYX\u6cbb\u7597\u548c\u6709\u6d3b\u52a8\u6027\u514b\u7f57\u6069\u6c0f\u75c5\u60a3\u8005\u5e94\u88ab\u5bc6\u5207\u76d1\u89c6[\u89c1\u4e0d\u826f\u53cd\u5e94(6.1)]\u3002<\/p>\n\n\n\n

\u3000\u30005.4 \u8d85\u654f\u6027\u53cd\u5e94<\/p>\n\n\n\n

\u3000\u3000\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2dCOSENTYX-\u6cbb\u7597\u60a3\u8005\u4e2d\u53d1\u751f\u8fc7\u654f\u53cd\u5e94\u548c\u8368\u9ebb\u75b9\u75c5\u4f8b\u3002\u5982\u53d1\u751f\u8fc7\u654f\u53cd\u5e94\u6216\u5176\u4ed6 \u4e25\u91cd\u8fc7\u654f\u53cd\u5e94\uff0c\u5e94\u7acb\u5373\u7ec8\u6b62COSENTYX\u7684\u7ed9\u4e88\u548c\u5f00\u59cb\u9002\u5f53\u6cbb\u7597[\u89c1\u4e0d\u826f\u53cd\u5e94(6.1)]\u3002<\/p>\n\n\n\n

\u3000\u30005.5 \u5728\u80f6\u4e73-\u654f\u611f\u4e2a\u4f53\u4e2d\u8d85\u654f\u6027\u7684\u98ce\u9669<\/p>\n\n\n\n

\u3000\u3000COSENTYX Sensoready\u7b14\u548cCOSENTYX\u9884\u88c5\u6ce8\u5c04\u5668\u7684\u53ef\u79fb\u53bb\u5e3d\u542b\u5929\u7136\u6a61\u80f6\u4e73\u80f6\uff0c\u5728\u80f6\u4e73-\u654f\u611f\u4e2a\u4f53\u4e2d\u53ef\u80fd\u5f15\u8d77\u8fc7\u654f\u53cd\u5e94\u3002\u5c1a\u672a\u5728\u80f6\u4e73-\u654f\u611f\u4e2a\u4f53\u4e2d\u7814\u7a76COSENTYX Sensoready\u7b14\u6216\u9884\u88c5\u6ce8\u5c04\u5668\u7684\u5b89\u5168\u4f7f\u7528\u3002<\/p>\n\n\n\n

\u3000\u30005.6 \u75ab\u82d7\u63a5\u79cd<\/p>\n\n\n\n

\u3000\u3000\u7528COSENTYX\u5f00\u59cb\u6cbb\u7597\u524d\uff0c\u8003\u8651\u6309\u7167\u5f53\u524d\u514d\u75ab\u63a5\u79cd\u6307\u5bfc\u539f\u5219\u5b8c\u6210\u6240\u6709\u5e74\u9f84\u9002\u5f53\u514d\u75ab\u63a5\u79cd \u3002\u7528COSENTYX\u6cbb\u7597\u60a3\u8005\u4e0d\u5e94\u63a5\u53d7\u6d3b\u75ab\u82d7\u3002<\/p>\n\n\n\n

\u3000\u3000COSENTYX\u7684\u7597\u7a0b\u671f\u95f4\u63a5\u53d7\u975e-\u6d3b\u75ab\u82d7\u63a5\u79cd\u53ef\u80fd\u4e0d\u4f1a\u5f15\u8d77\u8db3\u4ee5\u9884\u9632\u75be\u75c5\u7684\u4e00\u79cd\u514d\u75ab\u53cd\u5e94\u3002<\/p>\n\n\n\n

\u3000\u30006 \u4e0d\u826f\u53cd\u5e94<\/p>\n\n\n\n

\u3000\u3000\u5728\u8bf4\u660e\u4e66\u5176\u4ed6\u5904\u66f4\u8be6\u7ec6\u8ba8\u8bba\u4ee5\u4e0b\u4e0d\u826f\u53cd\u5e94\uff1a<\/p>\n\n\n\n

\u3000\u3000\u611f\u67d3[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.1)]<\/p>\n\n\n\n

\u3000\u3000\u514b\u7f57\u6069\u6c0f\u75c5\u7684\u52a0\u91cd[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.3)]<\/p>\n\n\n\n

\u3000\u3000\u8d85\u654f\u6027\u53cd\u5e94[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.4)]<\/p>\n\n\n\n

\u3000\u30006.1 \u4e34\u5e8a\u8bd5\u9a8c\u7ecf\u9a8c<\/p>\n\n\n\n

\u3000\u3000\u56e0\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u662f\u5728\u5e7f\u6cdb\u4e0d\u540c\u60c5\u51b5\u4e0b\u8fdb\u884c\u7684\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u89c2\u5bdf\u5230\u4e0d\u826f\u53cd\u5e94\u7387\u4e0d\u80fd\u4e0e\u53e6\u4e00\u79cd\u836f\u4e34\u5e8a\u8bd5\u9a8c\u53d1\u751f\u7387\u76f4\u63a5\u6bd4\u8f83\u800c\u4e14\u53ef\u80fd\u4e0d\u53cd\u6620\u5b9e\u8df5\u4e2d\u89c2\u5bdf\u5230\u7684\u53d1\u751f\u7387\u3002<\/p>\n\n\n\n

\u3000\u3000\u5728\u5bf9\u7167\u548c\u975e\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u603b\u51713430\u4f8b\u6591\u5757\u6027\u94f6\u5c51\u75c5\u53d7\u8bd5\u8005\u88ab\u7528COSENTYX\u6cbb\u7597\u3002\u5176\u4e2d1641\u4f8b \u53d7\u8bd5\u8005\u88ab\u66b4\u9732\u5171\u81f3\u5c111\u5e74\u3002<\/p>\n\n\n\n

\u3000\u3000\u56db\u9879\u5b89\u6170\u5242-\u5bf9\u71673\u671f\u8bd5\u9a8c\u4e2d\uff0c\u5728\u8bd5\u9a8c1\uff0c2\uff0c3\u548c4\u4e2d\u6591\u5757\u6027\u94f6\u5c51\u75c5\u53d7\u8bd5\u8005\u88ab\u5408\u5e76\u8bc4\u4ef7COSENTYX\u7684\u5b89\u5168\u6027\u4e0e\u5b89\u6170\u5242\u6bd4\u8f83\u81f3\u6cbb\u7597\u5f00\u59cb\u540e12\u5468\u3002\u603b\u5171\uff0c2077\u4f8b\u53d7\u8bd5\u8005\u88ab\u8bc4\u4ef7(691\u81f3COSENTYX 300 mg\u7ec4\uff0c692\u81f3COSENTYX 150 mg\u7ec4\uff0c\u548c694\u4f8b\u81f3\u5b89\u6170\u5242\u7ec4)[\u89c1\u4e34\u5e8a\u7814\u7a76(13)]\u3002<\/p>\n\n\n\n

\u3000\u3000\u88681\u603b\u7ed3\u53d1\u751f\u7387\u81f3\u5c111%\u548c\u5b89\u6170\u5242-\u5bf9\u7167\u8bd5\u9a8c\u768412-\u5468\u5b89\u6170\u5242-\u5bf9\u7167\u9636\u6bb5\u671f\u95f4\u5728COSENTYX\u7ec4\u6bd4\u5b89\u6170\u5242\u7ec4\u53d1\u751f\u8f83\u9ad8\u7387\u7684\u4e0d\u826f\u53cd\u5e94\u3002<\/p>\n\n\n\n

\u3000\u3000\u5728\u8bd5\u9a8c1\uff0c2\uff0c3\uff0c\u548c4\u81f312\u5468\u7684\u5b89\u6170\u5242-\u5bf9\u7167\u9636\u6bb5\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7387\u4f4e\u4e8e1%\u5305\u62ec\uff1a\u7aa6\u708e\uff0c\u8db3\u85d3\uff0c\u7ed3\u819c\u708e\uff0c\u6241\u6843\u4f53\u708e\uff0c\u53e3\u8154\u5ff5\u73e0\u83cc\u75c5\uff0c\u8113\u75b1\u75ae\uff0c\u4e2d\u8033\u708e\uff0c\u5916\u8033\u708e\uff0c\u708e\u75c7\u6027\u80a0\u75c5\uff0c\u589e\u9ad8\u7684\u809d\u8f6c\u6c28\u9176\u548c\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11.<\/p>\n\n\n\n

\u3000\u3000\u611f\u67d3<\/p>\n\n\n\n

\u3000\u3000\u5728\u6591\u5757\u6027\u94f6\u5c51\u75c5\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5b89\u6170\u5242-\u5bf9\u7167\u9636\u6bb5(\u603b\u51711382\u4f8b\u7528COSENTYX\u6cbb\u7597\u53d7\u8bd5\u8005\u548c694\u4f8b\u7528\u5b89\u6170\u5242\u6cbb\u7597\u53d7\u8bd5\u8005\u81f312\u5468)\uff0c\u7528COSENTYX\u6cbb\u7597\u53d7\u8bd5\u8005\u62a5\u9053\u611f\u67d328.7%\u4e0e\u4e4b\u6bd4\u8f83\u7528\u5b89\u6170\u5242\u6cbb\u7597\u53d7\u8bd5\u800518.9%\u3002\u7528COSENTYX\u6cbb\u7597\u60a3\u8005\u4e25\u91cd\u611f\u67d3\u53d1\u751f0.14%\u548c\u7528\u5b89\u6170\u5242\u6cbb\u7597\u60a3\u80050.3%[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.1)]\u3002<\/p>\n\n\n\n

\u3000\u3000\u8de8\u8d8a\u5b8c\u6574\u6cbb\u7597\u9636\u6bb5(\u7528COSENTYX\u6cbb\u7597\u53d7\u8bd5\u8005\u603b\u51713430\u4f8b\u6591\u5757\u6027\u94f6\u5c51\u75c5\u5171\u81f352\u5468\u5bf9\u591a\u6570\u53d7\u8bd5\u8005)\uff0c\u7528COSENTYX\u6cbb\u7597\u53d7\u8bd5\u8005\u88ab\u62a5\u9053\u611f\u67d347.5%( 0.9\u6bcf\u60a3\u8005-\u968f\u8bbf\u5e74)\u3002\u7528COSENTYX\u6cbb\u7597\u53d7\u8bd5\u8005\u4e25\u91cd\u611f\u67d3\u88ab\u62a5\u90531.2% (0.015\u6bcf\u60a3\u8005-\u968f\u8bbf\u5e74)\u3002<\/p>\n\n\n\n

\u3000\u30003\u671f\u6570\u636e\u663e\u793a\u5bf9\u6709\u4e9b\u7c7b\u578b\u611f\u67d3\u968f\u4f9d\u90a3\u897f\u666e\u8840\u6e05\u6d53\u5ea6\u589e\u52a0\u800c\u589e\u52a0\u8d8b\u52bf\u3002\u5ff5\u73e0\u83cc\u611f\u67d3\uff0c\u75b1\u75b9\u75c5\u6bd2\u611f\u67d3\uff0c\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83cc\u76ae\u80a4\u611f\u67d3\uff0c\u548c\u5f53\u4f9d\u90a3\u897f\u666e\u8840\u6e05\u6d53\u5ea6\u589e\u52a0\u9700\u8981\u6cbb\u7597\u611f\u67d3\u589e\u52a0\u3002<\/p>\n\n\n\n

\u3000\u3000\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u89c2\u5bdf\u5230\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3002\u4f9d\u90a3\u897f\u666e-\u5173\u8054\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u7684\u5927\u591a\u6570\u75c5\u4f8b\u662f\u77ed\u6682\u548c\u53ef\u9006\u6027\u3002\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u75c5\u4f8b\u4e0d\u4f34\u968f\u4e25\u91cd\u611f\u67d3\u3002<\/p>\n\n\n\n

\u3000\u3000\u514b\u7f57\u6069\u6c0f\u75c5\u7684\u52a0\u91cd<\/p>\n\n\n\n

\u3000\u3000\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u5728COSENTYX\u548c\u5b89\u6170\u5242\u88ab\u6cbb\u7597\u60a3\u8005\u90fd\u89c2\u5bdf\u5230\u514b\u7f57\u6069\u6c0f\u75c5\u7684\u52a0\u91cd\uff0c\u5728\u6709\u4e9b\u75c5\u4f8b\u4e2d\u4e25\u91cd\u3002\u5728\u94f6\u5c51\u75c5\u8ba1\u5212\u4e2d\uff0c\u67093430\u4f8b\u60a3\u8005\u66b4\u9732\u4e8eCOSENTYX\u67093\u4f8b\u514b\u7f57\u6069\u6c0f\u75c5\u52a0\u91cd[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.3)]\u3002<\/p>\n\n\n\n

\u3000\u3000\u8d85\u654f\u6027\u53cd\u5e94<\/p>\n\n\n\n

\u3000\u3000\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2dCOSENTYX-\u6cbb\u7597\u60a3\u8005\u4e2d\u53d1\u751f\u8fc7\u654f\u53cd\u5e94\u548c\u8368\u9ebb\u75b9\u75c5\u4f8b[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.4)]\u3002<\/p>\n\n\n\n

\u3000\u30006.2 \u514d\u75ab\u539f\u6027<\/p>\n\n\n\n

\u3000\u3000\u5982\u540c\u6240\u6709\u6cbb\u7597\u6027\u86cb\u767d\uff0c\u5b58\u5728\u514d\u75ab\u539f\u6027\u6f5c\u80fd\u3002\u7528\u4e00\u79cd\u57fa\u4e8e\u7535\u5316\u5b66\u53d1\u5149\u6865\u63a5\u514d\u75ab\u5206\u6790\u8bc4\u4ef7COSENTYX\u7684\u514d\u75ab\u539f\u6027\u3002\u81f352\u5468\u6cbb\u7597\u4f4e\u4e8e1%\u7528COSENTYX\u6cbb\u7597\u53d7\u8bd5\u8005\u53d1\u751f\u5bf9\u4f9d\u90a3\u897f\u666e\u6297\u4f53\u3002\u4f46\u662f\uff0c\u6b64\u5206\u6790\u6709\u5b58\u5728\u4f9d\u90a3\u897f\u666e\u65f6\u68c0\u6d4b\u6297\u4f9d\u90a3\u897f\u666e\u6297\u4f53\u7684\u9650\u5236\uff1b\u56e0\u6b64\u6297\u4f53\u53d1\u5c55\u7684\u53d1\u751f\u7387\u53ef\u80fd\u6ca1\u6709\u88ab\u53ef\u9760\u6d4b\u5b9a\u3002\u53d1\u751f\u6297\u836f\u6297\u4f53\u53d7\u8bd5\u8005\u4e2d\uff0c\u7ea6\u4e00\u534a\u6709\u6297\u4f53\u88ab\u5206\u7c7b\u4e3a\u4e2d\u548c\u3002\u4e2d\u548c\u6297\u4f53\u4e0d\u4f34\u968f\u4e27\u5931\u7597\u6548\u3002<\/p>\n\n\n\n

\u3000\u3000\u6297\u4f53\u5f62\u6210\u7684\u68c0\u6d4b\u662f\u9ad8\u5ea6\u4f9d\u8d56\u4e8e\u5206\u6790\u7684\u7075\u654f\u5ea6\u548c\u7279\u5f02\u6027\u3002\u6b64\u5916\uff0c\u5728\u67d0\u4e2a\u5206\u6790\u4e2d\u89c2\u5bdf\u5230\u6297\u4f53\u9633\u6027\u53d1\u751f\u7387(\u5305\u62ec\u4e2d\u548c\u6297\u4f53)\u53ef\u80fd\u53d7\u51e0\u79cd\u56e0\u7d20\u5f71\u54cd\u5305\u62ec\u5206\u6790\u65b9\u6cd5\u5b66\uff0c\u6837\u54c1\u5904\u7f6e\uff0c\u91c7\u6837\u65f6\u95f4\uff0c\u540c\u65f6\u836f\u7269\uff0c\u548c\u6240\u60a3\u75be\u75c5\u3002\u56e0\u4e3a\u8fd9\u4e9b\u7406\u7531\uff0c\u6bd4\u8f83\u5bf9COSENTYX \u6297\u4f53\u53d1\u751f\u7387\u4e0e\u5176\u4ed6\u4ea7\u54c1\u6297\u4f53\u7684\u53d1\u751f\u7387\u53ef\u80fd\u662f\u8bef\u5bfc\u3002<\/p>\n\n\n\n

\u3000\u30007 \u836f\u7269\u76f8\u4e92\u4f5c\u7528<\/p>\n\n\n\n

\u3000\u3000\u672a\u66fe\u7528COSENTYX\u8fdb\u884c\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u8bd5\u9a8c\u3002<\/p>\n\n\n\n

\u3000\u30007.1 \u6d3b\u75ab\u82d7<\/p>\n\n\n\n

\u3000\u3000\u7528COSENTYX\u6cbb\u7597\u60a3\u8005\u53ef\u80fd\u4e0d\u63a5\u53d7\u6d3b\u75ab\u82d7\u63a5\u79cd[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.6)]\u3002<\/p>\n\n\n\n

\u3000\u30007.2 \u975e-\u6d3b\u75ab\u82d7<\/p>\n\n\n\n

\u3000\u3000\u7528COSENTYX\u6cbb\u7597\u60a3\u8005\u53ef\u80fd\u63a5\u53d7\u975e-\u6d3b\u75ab\u82d7\u63a5\u79cd\u3002\u5728\uff0c\u5065\u5eb7\u4e2a\u4f53\u75ab\u82d7\u63a5\u79cd\u5355\u6b21150 mg\u5242\u91cfCOSENTYX\u524d2\u5468\u63a5\u53d7\u975e\u7f8e\u56fd\u6279\u51c6\u7ec4C\u8111\u819c\u708e\u53cc\u7403\u83cc\u805a\u591a\u7cd6\u7ed3\u5408\u75ab\u82d7\u548c\u4e00\u4e2a\u975e\u7f8e\u56fd\u6279\u51c6\u7684\u706d\u6d3b\u5b63\u8282\u6027\u6d41\u611f\u75ab\u82d7\uff0c\u4e0e\u75ab\u82d7\u63a5\u79cd\u524d\u6ca1\u6709\u63a5\u53d7COSENTYX\u4e2a\u4f53\u6bd4\u8f83\u6709\u76f8\u4f3c\u6297\u4f53\u53cd\u5e94\u3002\u5728\u7528COSENTYX\u8fdb\u884c\u6cbb\u7597\u60a3\u8005\u4e2d\u672a\u66fe\u8bc4\u4f30\u8111\u819c\u708e\u53cc\u7403\u83cc\u548c\u6d41\u611f\u75ab\u82d7\u7684\u4e34\u5e8a\u6709\u6548\u6027[\u89c1\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879(5.6)]\u3002<\/p>\n\n\n\n

\u3000\u30007.3 CYP450\u5e95\u7269<\/p>\n\n\n\n

\u3000\u3000\u672a\u66fe\u62a5\u9053IL-17A\u5728CYP450\u9176\u8c03\u8282\u4e2d\u7684\u4f5c\u7528\u3002\u5728\u6162\u6027\u708e\u75c7\u671f\u95f4CYP450\u9176\u7684\u5f62\u6210\u53ef\u80fd\u88ab\u67d0\u4e9b\u7ec6\u80de\u56e0\u5b50\u6c34\u5e73\u589e\u52a0\u6539\u53d8(\u5982\uff0cIL-1\uff0cIL-6\uff0cIL-10\uff0cTNF\u03b1\uff0cIFN)\u3002\u56e0\u6b64\uff0cCOSENTYX\uff0cIL-17A\u7684\u4e00\u4e2a\u62ee\u6297\u5242\uff0c\u53ef\u80fd\u6b63\u5e38\u5316CYP450\u9176\u7684\u5f62\u6210\u3002\u63a5\u53d7\u540c\u65f6CYP450\u5e95\u7269\uff0c\u5c24\u5176\u662f\u6709\u72ed\u7a84\u6cbb\u7597\u6307\u6570\u836f\u7269\uff0c\u60a3\u8005\u5bf9COSENTYX\u7684\u5f00\u59cb\u6d3b\u7ec8\u6b62\u8003\u8651\u76d1\u89c6\u6cbb\u7597\u6548\u5e94(\u5982\uff0c\u5bf9\u534e\u6cd5\u6797[warfarin])\u6216\u836f\u7269\u6d53\u5ea6(\u5982\uff0c\u5bf9\u73af\u5b62\u7d20[cyclosporine])\u548c\u8003\u8651\u8c03\u6574CYP450\u5e95\u7269\u5242\u91cf\u3002<\/p>\n\n\n\n

\u3000\u30008 \u7279\u6b8a\u4eba\u7fa4\u4e2d\u4f7f\u7528<\/p>\n\n\n\n

\u3000\u30008.1 \u598a\u5a20<\/p>\n\n\n\n

\u3000\u3000\u598a\u5a20\u7c7b\u522bB<\/p>\n\n\n\n

\u3000\u3000\u5728\u598a\u5a20\u5987\u5973\u4e2d\u6ca1\u6709\u9002\u5f53\u548c\u5bf9\u7167\u826f\u597d\u7684COSENTYX\u8bd5\u9a8c\u3002\u7528\u7334\u8fdb\u884c\u53d1\u80b2\u6bd2\u6027\u7814\u7a76\u672a\u53d1\u73b0\u7531\u4e8e\u4f9d\u90a3\u897f\u666e\u5bf9\u80ce\u513f\u5371\u5bb3\u8bc1\u636e\u3002\u598a\u5a20\u671f\u95f4\u53ea\u6709\u6f5c\u5728\u83b7\u76ca\u80dc\u8fc7\u5bf9\u80ce\u513f\u6f5c\u5728\u98ce\u9669\u65f6\u624d\u5e94\u4f7f\u7528COSENTYX\u3002<\/p>\n\n\n\n

\u3000\u3000\u5728\u98df\u87f9\u7334\u7528\u4f9d\u90a3\u897f\u666e\u8fdb\u884c\u4e00\u9879\u80da\u80ce\u80ce\u513f\u53d1\u80b2\u7814\u7a76\u3002\u598a\u5a20\u7334\u5728\u5668\u5b98\u5f62\u6210\u671f\u6bcf\u5468\u76ae\u4e0b\u9014\u5f84\u7ed9\u4e88\u4f9d\u90a3\u897f\u666e\u81f3\u5242\u91cf\u81f3\u6700\u5927\u63a8\u8350\u4eba\u5242\u91cf(MRHD\uff1b\u5728mg\/kg\u57fa\u7840\u5728\u6bcd\u7334\u5242\u91cf150 mg\/kg)30\u500d\u6ca1\u6709\u89c2\u5bdf\u5230\u5728\u80ce\u513f\u4e2d\u7578\u5f62\u6216\u80da\u80ce\u80ce\u513f\u6bd2\u6027\u3002<\/p>\n\n\n\n

\u3000\u3000\u5728\u5c0f\u9f20\u4e2d\u7528\u9f20\u7c7b\u4f9d\u90a3\u897f\u666e\u7c7b\u4f3c\u7269\u8fdb\u884c\u4e00\u9879\u56f4\u4ea7\u671f\u53d1\u80b2\u6bd2\u6027\u7814\u7a76\u3002\u672a\u89c2\u5bdf\u5230\u5728\u80ce\u513f\u4e2d\u6765\u81ea\u598a\u5a20\u5c0f\u9f20\u5728\u598a\u5a20\u7b2c6\uff0c11\uff0c\u548c 17\u5929\u548c\u5728\u4ea7\u540e\u7b2c4\uff0c10\uff0c\u548c16\u5929\u7ed9\u4e88\u9f20\u7c7b\u4f9d\u90a3\u897f\u666e\u7c7b\u4f3c\u7269\u5728\u5242\u91cf\u76f4\u81f3150 mg\/kg\/dose\u5bf9\u53d1\u80b2\u529f\u80fd\u6027\uff0c\u5f62\u6001\u5b66\u6216\u514d\u75ab\u5b66\u6cbb\u7597\u76f8\u5173\u6548\u5e94\u3002<\/p>\n\n\n\n

\u3000\u30008.3 \u54fa\u4e73\u6bcd\u4eb2<\/p>\n\n\n\n

\u3000\u3000\u4e0d\u77e5\u9053\u82cf\u91d1\u5355\u6297\u662f\u5426\u6392\u6cc4\u5728\u4eba\u4e73\u6c41\u6216\u6444\u5165\u540e\u5168\u8eab\u5438\u6536\u3002\u56e0\u4e3a\u8bb8\u591a\u836f\u7269\u88ab\u6392\u6cc4\u5728\u4eba\u4e73\u6c41\uff0c\u5f53COSENTYX\u88ab\u7ed9\u4e88\u81f3\u54fa\u4e73\u5987\u5973\u5e94\u8c28\u614e\u4ece\u4e8b\u3002<\/p>\n\n\n\n

\u3000\u30008.4 \u513f\u7ae5\u4f7f\u7528<\/p>\n\n\n\n

\u3000\u3000\u5c1a\u672a\u786e\u5b9aCOSENTYX\u5728\u513f\u7ae5\u60a3\u8005\u4e2d\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n\n\n\n

\u3000\u30008.5 \u8001\u5e74\u4eba\u4f7f\u7528<\/p>\n\n\n\n

\u3000\u3000\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d3430\u4f8b\u6591\u5757\u6027\u94f6\u5c51\u75c5\u53d7\u8bd5\u8005\u66b4\u9732\u4e8eCOSENTYX\uff0c\u603b\u5171230\u4f8b\u4e3a65\u5c81\u6216\u4ee5\u4e0a\uff0c\u548c32\u4f8b\u53d7\u8bd5\u8005\u4e3a75\u5c81\u6216\u4ee5\u4e0a\u3002\u5c3d\u7ba1\u8001\u5e74\u548c\u8f83\u5e74\u8f7b\u53d7\u8bd5\u8005\u95f4\u672a\u89c2\u5bdf\u5230\u5b89\u5168\u6027\u548c\u7597\u6548\u4e2d\u5dee\u522b\uff0c\u5e74\u9f8465\u5c81\u548c\u4ee5\u4e0a\u53d7\u8bd5\u8005\u6570\u4e0d\u8db3\u4ee5\u786e\u5b9a\u4ed6\u4eec\u662f\u5426\u53cd\u5e94\u4e0d\u540c\u4e8e\u8f83\u5e74\u8f7b\u53d7\u8bd5\u8005\u3002<\/p>\n\n\n\n

\u3000\u30009 \u836f\u7269\u8fc7\u91cf<\/p>\n\n\n\n

\u3000\u3000\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u66fe\u7ed9\u4e88\u5242\u91cf\u81f330 mg\/kg\u9759\u8109(\u5373\uff0c\u7ea62000\u81f33000 mg)\u65e0\u5242\u91cf\u9650\u5236\u6bd2\u6027\u3002\u5728\u8fc7\u91cf\u4e8b\u4ef6\u4e2d\uff0c\u5efa\u8bae\u60a3\u8005\u88ab\u76d1\u89c6\u4efb\u4f55\u4e0d\u826f\u53cd\u5e94\u4f53\u5f81\u548c\u75c7\u72b6\u548c\u7acb\u5373\u5f00\u59cb\u9002\u5f53\u5bf9\u75c7\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u3000\u300010 \u4e00\u822c\u63cf\u8ff0<\/p>\n\n\n\n

\u3000\u3000\u4f9d\u90a3\u897f\u666e\u662f\u4e00\u79cd\u91cd\u7ec4\u4eba\u5355\u514b\u9686IgG1\/\u03ba\u6297\u4f53\u7279\u5f02\u6027\u5730\u7ed3\u5408\u81f3IL-17A\u3002\u5b83\u662f\u5728\u4e00\u4e2a\u91cd\u7ec4\u4e2d\u56fd\u4ed3\u9f20\u5375\u5de2(CHO)\u7ec6\u80de\u682a\u4e2d\u8868\u8fbe\u3002\u4f9d\u90a3\u897f\u666e\u6709\u5206\u5b50\u8d28\u91cf\u7ea6151 kDa\uff1b\u4f9d\u90a3\u897f\u666e\u7684\u4e24\u6761\u91cd\u94fe\u542b\u5728\u5be1\u7cd6\u94fe\u4e2d\u3002<\/p>\n\n\n\n

\u3000\u3000COSENTYX\u6ce8\u5c04\u6db2<\/p>\n\n\n\n

\u3000\u3000COSENTYX\u6ce8\u5c04\u6db2\u662f\u4e00\u79cd\u65e0\u83cc\uff0c\u65e0\u9632\u8150\u5242\uff0c\u6e05\u6f88\u81f3\u7565\u5fae\u4e73\u767d\uff0c\u65e0\u8272\u81f3\u7565\u5fae\u9ec4\u6eb6\u6db2\u3002\u5728\u4e00\u6b21\u6027Sensoready\u7b14\u4f9b\u5e94COSENTYX\u6709\u4e00\u4e2a27\u53f7\u56fa\u5b9a\u7684?\u82f1\u5bf8\u9488\uff0c\u6216\u4e00\u6b21\u6027\u9884\u88c5\u6ce8\u5c04\u5668\u6709\u4e00\u4e2a27\u53f7\u56fa\u5b9a\u7684?\u82f1\u5bf8\u9488\u3002COSENTYX Sensoready\u7b14\u6216\u9884\u88c5\u6ce8\u5c04\u5668\u7684\u53ef\u79fb\u53bb\u5e3d\u542b\u5929\u7136\u6a61\u80f6\u4e73\u80f6\u3002<\/p>\n\n\n\n

\u3000\u3000\u6bcf\u4e2aCOSENTYX Sensoready\u7b14\u6216\u9884\u88c5\u6ce8\u5c04\u5668\u542b150 mg\u7684\u82cf\u91d1\u5355\u6297\u5728\u4ee5\u4e0b\u4e2d\u5236\u5242\u5316\uff1aL-\u7ec4\u6c28\u9178\/\u7ec4\u6c28\u9178\u76d0\u9178\u76d0\u4e00\u6c34\u5408\u7269(3.103 mg)\uff0cL-\u7532\u786b\u6c28\u9178(0.746 mg)\uff0c\u805a\u5c71\u68a8\u918780(0.2 mg)\uff0c\u6d77\u85fb\u7cd6\u4e8c\u6c34(75.67 mg)\uff0c\u548c\u6ce8\u5c04\u7528\u65e0\u83cc\u6c34\uff0cUSP\uff0c\u5728pH 5.8\u3002<\/p>\n\n\n\n

\u3000\u3000\u6ce8\u5c04\u7528COSENTYX<\/p>\n\n\n\n

\u3000\u3000\u6ce8\u5c04\u7528COSENTYX\u662f\u4ee5\u65e0\u83cc\uff0c\u65e0\u9632\u8150\u5242\uff0c\u767d\u8272\u81f3\u7565\u5fae\u9ec4\uff0c\u51b0\u51bb\u5e72\u71e5\u7c89\u5728\u4e00\u6b21\u6027\u4f7f\u7528\u5c0f\u74f6\u5185\u4f9b\u5e94\u3002\u6bcf\u4e2aCOSENTYX \u5c0f\u74f6\u542b150 mg\u82cf\u91d1\u5355\u6297\u5728\u4ee5\u4e0b\u5236\u5242L-\u7ec4\u6c28\u9178e\/L-\u7ec4\u6c28\u9178\u76d0\u9178\u76d0\u4e00\u6c34\u5408\u7269(4.656 mg)\uff0c\u805a\u5c71\u68a8\u918780(0.6 mg)\uff0c\u548c\u8517\u7cd6(92.43 mg)\u3002\u75281 mL\u6ce8\u5c04\u7528\u65e0\u83cc\u6c34\uff0cUSP\uff0c\u91cd\u5efa\u540e\u5f97\u5230pH\u662f\u7ea65.8\u3002<\/p>\n\n\n\n

\u3000\u300011 \u4e34\u5e8a\u836f\u7406\u5b66<\/p>\n\n\n\n

\u3000\u300011.1 \u4f5c\u7528\u673a\u5236<\/p>\n\n\n\n

\u3000\u3000\u82cf\u91d1\u5355\u6297\u662f\u4ebaIgG1\u5355\u514b\u9686\u6297\u4f53\u9009\u62e9\u6027\u7ed3\u5408\u81f3\u767d\u4ecb\u7d20-17A(IL-17A)\u7ec6\u80de\u56e0\u5b50\u548c\u6291\u5236\u5b83\u4e0eIL-17\u53d7\u4f53\u76f8\u4e92\u4f5c\u7528\u3002IL-17A\u662f\u6d89\u53ca\u6b63\u5e38\u708e\u75c7\u548c\u514d\u75ab\u53cd\u5e94\u4e00\u79cd\u5929\u7136\u5730\u5b58\u5728\u7ec6\u80de\u56e0\u5b50\u3002\u82cf\u91d1\u5355\u6297\u6291\u5236\u4fc3\u708e\u6027\u7ec6\u80de\u56e0\u5b50\u548c\u8d8b\u5316\u56e0\u5b50\u5bf9\u91ca\u653e\u3002<\/p>\n\n\n\n

\u3000\u300011.2 \u836f\u6548\u52a8\u529b\u5b66<\/p>\n\n\n\n

\u3000\u3000\u5728\u94f6\u5c51\u75c5\u6591\u5757\u4e2d\u53d1\u73b0IL-17A\u5347\u9ad8\u6c34\u5e73\u3002\u7528COSENTYX\u6cbb\u7597\u53ef\u80fd\u51cf\u4f4e\u94f6\u5c51\u75c5\u6591\u5757\u4e2d\u8868\u76ae\u55dc\u4e2d\u6027\u548cIL-17A\u6c34\u5e73\u3002\u4f9d\u90a3\u897f\u666e\u6cbb\u7597\u540e\u5728\u54684\u548c\u546812\u6d4b\u5b9a\u603bIL-17A\u8840\u6e05\u6c34\u5e73(\u6e38\u79bb\u548c\u4f9d\u90a3\u897f\u666e-\u7ed3\u5408\u7684IL-17A)\u589e\u52a0\u3002\u8fd9\u4e9b\u836f\u6548\u52a8\u529b\u5b66\u6d3b\u6027\u662f\u6839\u636e\u5c0f\u63a2\u7d22\u6027\u7814\u7a76\u3002\u4e0d\u77e5\u9053\u8fd9\u4e9b\u836f\u6548\u52a8\u529b\u5b66\u6d3b\u6027\u548c\u4f9d\u90a3\u897f\u666e\u53d1\u6325\u5176\u4e34\u5e8a\u6548\u5e94\u673a\u5236\u76f8\u4e92\u5173\u7cfb\u3002<\/p>\n\n\n\n

\u3000\u300011.3 \u836f\u4ee3\u52a8\u529b\u5b66<\/p>\n\n\n\n

\u3000\u3000\u5438\u6536<\/p>\n\n\n\n

\u3000\u3000\u5728\u6591\u5757\u6027\u94f6\u5c51\u75c5\u60a3\u8005\u4e2d\u5355\u6b21\u90eb\u53bf\u5242\u91cf\u6216150 mg(\u63a8\u8350\u5242\u91cf\u4e00\u534a)\u6216300 mg\uff0c\u82cf\u91d1\u5355\u6297\u540e\u8fbe\u5230\u8840\u6e05\u5cf0\u6d53\u5ea6\u5747\u6570(\u00b1 SD (Cmax)\u5206\u522b\u4e3a13.7 \u00b1 4.8 \u03bcg\/mL\u548c27.3 \u00b1 9.5 \u03bcg\/mL\uff0c\u5728\u7ea6\u836f\u540e6\u5929\u3002<\/p>\n\n\n\n

\u3000\u3000\u591a\u6b21\u76ae\u4e0b\u5242\u91cf\u82cf\u91d1\u5355\u6297\u540e\uff0c\u572812\u5468\u65f6\u82cf\u91d1\u5355\u6297\u7684\u8840\u6e05\u8c37\u6d53\u5ea6\u5747\u6570(\u00b1SD)\u8303\u56f4\u4ece22.8 \u00b1 10.2 \u03bcg\/mL(150 mg)\u81f345.4 \u00b1 21.2 \u03bcg\/mL(300 mg)\u3002\u5728300 mg\u5242\u91cf\u5728\u54684\u548c\u546812\uff0c\u6839\u636e\u8de8-\u7814\u7a76\u6bd4\u8f83\u4eceSensoready\u7b14\u5f97\u5230\u5747\u6570\u8c37\u6d53\u5ea6\u8f83\u9ad823-30%\u51b0\u51bb\u5e72\u71e5\u7c89\u548c\u8f83\u9ad823-26%\u4e8e\u6765\u81ea\u9884\u88c5\u6ce8\u5c04\u5668\u7ed3\u679c\u3002<\/p>\n\n\n\n

\u3000\u3000\u6bcf4\u5468\u7ed9\u836f\u65b9\u6848\u540e24\u5468\u540e\u5b9e\u73b0\u82cf\u91d1\u5355\u6297\u7684\u7a33\u6001\u6d53\u5ea6\u3002\u5747\u6570(\u00b1SD)\u7a33\u6001\u8c37\u6d53\u5ea6\u8303\u56f4\u4ece16.7 \u00b1 8.2 \u03bcg\/mL(150 mg)\u81f334.4 \u00b1 16.6 \u03bcg\/mL(300 mg)\u3002<\/p>\n\n\n\n

\u3000\u3000\u5728\u5065\u5eb7\u53d7\u8bd5\u8005\u548c\u6709\u6591\u5757\u6027\u94f6\u5c51\u75c5\u53d7\u8bd5\u8005\u4e2d\uff0c\u76ae\u4e0b\u5242\u91cf150 mg(\u63a8\u8350\u5242\u91cf\u4e00\u534a)\u6216300 mg\u540e\u82cf\u91d1\u5355\u6297\u751f\u7269\u5229\u7528\u5ea6\u8303\u56f4\u4ece55%\u81f377%\u3002<\/p>\n\n\n\n

\u3000\u3000\u5206\u5e03<\/p>\n\n\n\n

\u3000\u3000\u6591\u5757\u6027\u94f6\u5c51\u75c5\u60a3\u8005\u4e2d\u5728\u672b\u7aef\u76f8\u671f\u95f4\u5747\u6570\u5206\u5e03\u5bb9\u79ef(Vz)\u5355\u6b21\u9759\u8109\u7ed9\u4e88\u540e\u8303\u56f4\u4ece7.10\u81f38.60 L\u3002\u63a8\u8350\u4e0d\u4f7f\u7528\u9759\u8109[\u89c1\u5242\u91cf\u548c\u7ed9\u836f\u65b9\u6cd5(2)]\uff0c<\/p>\n\n\n\n

\u3000\u3000\u5728\u6591\u5757\u6027\u94f6\u5c51\u75c5\u60a3\u8005\u5355\u6b21\u76ae\u4e0b\u5242\u91cf\u82cf\u91d1\u5355\u6297300 mg\u57281\u548c2\u5468\u540e\uff0c\u5728\u75c5\u53d8\u548c\u975e-\u75c5\u53d8\u76ae\u80a4\u95f4\u8d28\u6db2\u4e2d\u82cf\u91d1\u5355\u6297\u6d53\u5ea6\u8303\u56f4\u4ece\u4e3a\u8840\u6e05\u6d53\u5ea627%\u81f340%\u3002<\/p>\n\n\n\n

\u3000\u3000\u6d88\u9664<\/p>\n\n\n\n

\u3000\u3000\u5c1a\u672a\u786e\u5b9a\u82cf\u91d1\u5355\u6297\u7684\u4ee3\u8c22\u9014\u5f84\u7279\u70b9\u3002\u4f5c\u4e3a\u4ebaIgG1\u03ba\u5355\u514b\u9686\u6297\u4f53\u82cf\u91d1\u5355\u6297\u9884\u671f\u4e0e\u5185\u6e90\u6027IgG\u76f8\u540c\u65b9\u5f0f\u901a\u8fc7\u964d\u89e3\u4ee3\u8c22\u88ab\u964d\u89e3\u81f3\u5c0f\u80bd\u548c\u6c28\u57fa\u9178\u3002<\/p>\n\n\n\n

\u3000\u3000\u8de8\u8d8a\u6240\u6709\u94f6\u5c51\u75c5\u8bd5\u9a8c\uff0c\u5728\u6591\u5757\u6027\u94f6\u5c51\u75c5\u53d7\u8bd5\u8005\u9759\u8109\u548c\u76ae\u4e0b\u7ed9\u4e88\u540e\u5747\u6570\u5168\u8eab\u6e05\u9664\u7387(CL)\u8303\u56f4\u4ece0.14 L\/day\u81f30.22 L\/day\u548c\u5747\u6570\u534a\u8870\u671f\u8303\u56f4\u4ece22\u81f331\u5929\u3002\u4e0d\u63a8\u8350\u9759\u8109\u4f7f\u7528[\u89c1\u5242\u91cf\u548c\u7ed9\u836f\u65b9\u6cd5(2)]\u3002<\/p>\n\n\n\n

\u3000\u3000\u5242\u91cf\u7ebf\u6027<\/p>\n\n\n\n

\u3000\u3000\u5728\u6709\u94f6\u5c51\u75c5\u53d7\u8bd5\u8005\u4e2d\u8de8\u8d8a\u5242\u91cf\u8303\u56f4\u4ece25 mg(\u7ea6\u63a8\u8350\u5242\u91cf0.083\u500d)\u81f3300 mg\u76ae\u4e0b\u7ed9\u4e88\u540e\u82cf\u91d1\u5355\u6297\u8868\u73b0\u5242\u91cf-\u6b63\u6bd4\u4f8b\u836f\u4ee3\u52a8\u529b\u5b66\u3002<\/p>\n\n\n\n

\u3000\u3000\u4f53\u91cd<\/p>\n\n\n\n

\u3000\u3000\u5f53\u4f53\u91cd\u589e\u52a0\u65f6\u82cf\u91d1\u5355\u6297\u6e05\u9664\u7387\u548c\u5206\u5e03\u5bb9\u79ef\u589e\u52a0\u3002<\/p>\n\n\n\n

\u3000\u3000\u7279\u6b8a\u4eba\u7fa4<\/p>\n\n\n\n

\u3000\u3000\u809d\u6216\u80be\u53d7\u635f\uff1a<\/p>\n\n\n\n

\u3000\u3000\u809d\u6216\u80be\u53d7\u635f\u5bf9\u82cf\u91d1\u5355\u6297\u836f\u4ee3\u52a8\u529b\u5b66\u5f71\u54cd\u672a\u8fdb\u884c\u6b63\u5f0f\u8bd5\u9a8c\u3002<\/p>\n\n\n\n

\u3000\u3000\u5e74\u9f84\uff1a\u8001\u5e74\u4eba\u7fa4\uff1a<\/p>\n\n\n\n

\u3000\u3000\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u5206\u6790\u8868\u660e\u5728\u6210\u5e74\u6709\u6591\u5757\u6027\u94f6\u5c51\u75c5\u53d7\u8bd5\u8005\u82cf\u91d1\u5355\u6297\u7684\u6e05\u9664\u7387\u4e0d\u53d7\u5e74\u9f84\u663e\u8457\u5f71\u54cd\u3002 65\u5c81\u6216\u4ee5\u4e0a\u53d7\u8bd5\u8005\u6709\u82cf\u91d1\u5355\u6297\u8868\u89c2\u6e05\u9664\u7387\u4e0e\u5c0f\u4e8e65\u5c81\u53d7\u8bd5\u8005\u76f8\u4f3c\u3002<\/p>\n\n\n\n

\u3000\u300012 \u975e\u4e34\u5e8a\u6bd2\u7406\u5b66<\/p>\n\n\n\n

\u3000\u300012.1 \u764c\u53d1\u751f\uff0c\u7a81\u53d8\u53d1\u751f\uff0c\u751f\u80b2\u529b\u53d7\u635f<\/p>\n\n\n\n

\u3000\u3000\u672a\u66fe\u8fdb\u884c\u52a8\u7269\u7814\u7a76\u8bc4\u4ef7COSENTYX\u7684\u81f4\u764c\u6027\u6216\u81f4\u7a81\u53d8\u6027\u6f5c\u529b\u3002\u6709\u4e9b\u53d1\u8868\u6587\u732e\u63d0\u793aIL-17A \u5728\u4f53\u5916\u76f4\u63a5\u5730\u4fc3\u8fdb\u764c\u7ec6\u80de\u4fb5\u88ad\uff0c\u800c\u5176\u4ed6\u62a5\u9053\u8868\u660eIL17A\u4fc3\u8fdbT-\u7ec6\u80de\u9636\u6bb5\u80bf\u7624\u6392\u65a5\u3002\u5728\u5c0f\u9f20\u4e2d\u7528\u4e00\u79cd\u4e2d\u548c\u6297\u4f53\u8017\u7aedIL-17A\u6291\u5236\u80bf\u7624\u53d1\u5c55\u3002\u4e0d\u77e5\u9053\u5728\u5c0f\u9f20\u6a21\u578b\u4e2d\u5b9e\u9a8c\u53d1\u73b0\u5bf9\u4eba\u4e2d\u6076\u6027\u98ce\u9669\u7684\u76f8\u5173\u3002<\/p>\n\n\n\n

\u3000\u3000\u5728\u96c4\u6027\u548c\u96cc\u6027\u5c0f\u9f20\u5728\u4ea4\u914d\u9636\u6bb5\u524d\u548c\u671f\u95f4\u7ed9\u4e88\u82cf\u91d1\u5355\u6297\u7684\u9f20\u7c7b\u7c7b\u4f3c\u7269\u5728\u76ae\u4e0b\u5242\u91cf\u81f3150 mg\/kg\u6bcf\u5468\u4e00\u6b21\u672a\u89c2\u5bdf\u5230\u5bf9\u751f\u80b2\u529b\u5f71\u54cd\u3002<\/p>\n\n\n\n

\u3000\u300013 \u4e34\u5e8a\u7814\u7a76<\/p>\n\n\n\n

\u3000\u3000\u56db\u9879\u591a\u4e2d\u5fc3\uff0c\u968f\u673a\u5316\uff0c\u53cc\u76f2\uff0c\u5b89\u6170\u5242-\u5bf9\u7167\u8bd5\u9a8c(\u8bd5\u9a8c1\uff0c2\uff0c3\uff0c\u548c4)\u7eb3\u51652403\u4f8b\u53d7\u8bd5\u8005(691\u4f8b\u968f\u673a\u5316\u81f3COSENTYX 300 mg\uff0c692\u4f8b\u81f3COSENTYX 150 mg\uff0c694\u81f3\u5b89\u6170\u5242\uff0c\u548c323\u4f8b\u81f3\u4e00\u4e2a\u751f\u7269\u6d3b\u6027\u5bf9\u7167)18\u5c81\u548c\u4ee5\u4e0a\u6709\u6591\u5757\u6027\u94f6\u5c51\u75c5\u6709\u6700\u5c0f\u4f53\u8868\u9762\u79ef\u6d89\u53ca10%\uff0c\u548c\u94f6\u5c51\u75c5\u9762\u79ef\u548c\u4e25\u91cd\u7a0b\u5ea6\u6307\u6570(PASI)\u8bc4\u5206\u5927\u4e8e\u6216\u7b49\u4e8e12\uff0c\u548c\u662f\u5bf9\u5149\u6cbb\u7597\u6216\u5168\u8eab\u6cbb\u7597\u88ab\u9009\u8005\u3002<\/p>\n\n\n\n

\u3000\u3000\u8bd5\u9a8c1\u7eb3\u5165738\u4f8b\u53d7\u8bd5\u8005(245\u968f\u673a\u5316\u81f3COSENTYX 300 mg\uff0c245\u4f8b\u81f3COSENTYX 150 mg\uff0c\u548c248\u4f8b\u81f3\u5b89\u6170\u5242)\u3002\u53d7\u8bd5\u8005\u63a5\u53d7\u76ae\u4e0b\u6cbb\u7597\u5728\u54680\uff0c1\uff0c2\uff0c3\u548c4\u63a5\u7740\u6bcf4\u5468\u7ed9\u836f\u3002\u53d7\u8bd5\u8005\u968f\u673a\u5316\u81f3COSENTYX\u63a5\u53d7300 mg\u6216150 mg\u5242\u91cf\u5728\u54680\uff0c1\uff0c2\uff0c3\uff0c\u548c4\u63a5\u7740\u6bcf4\u5468\u76f8\u540c\u7ed9\u836f\u3002\u53d7\u8bd5\u8005\u968f\u673a\u5316\u81f3\u63a5\u53d7\u5b89\u6170\u5242\u662f\u5728\u572812\u5468\u65f6\u975e-\u53cd\u5e94\u8005\u7136\u540e\u88ab\u4ea4\u53c9\u81f3\u63a5\u53d7COSENTYX(\u6d3b300 mg\u6216150 mg) \u5728\u546812\uff0c13\uff0c14\uff0c15\uff0c\u548c16\u63a5\u7740\u6bcf4\u5468\u76f8\u540c\u7ed9\u836f\u3002\u6240\u6709\u53d7\u8bd5\u8005\u5728\u7814\u7a76\u7684\u9996\u6b21\u7ed9\u7814\u7a76\u6cbb\u7597\u540e\u88ab\u968f\u8bbf\u81f352\u5468\u3002<\/p>\n\n\n\n

\u3000\u3000\u8bd5\u9a8c2\u7eb3\u51651306\u4f8b\u53d7\u8bd5\u8005(327\u968f\u673a\u5316\u81f3COSENTYX 300 mg\uff0c327\u4f8b\u81f3COSENTYX 150 mg\uff0c326 \u4f8b\u81f3\u5b89\u6170\u5242\u548c323\u4f8b\u81f3\u67d0\u79cd\u751f\u7269\u6d3b\u6027\u5bf9\u7167)\u3002COSENTYX\u548c\u5b89\u6170\u5242\u6570\u636e\u88ab\u63cf\u8ff0\u3002\u53d7\u8bd5\u8005\u63a5\u53d7\u76ae\u4e0b\u6cbb\u7597\u5728\u54680\uff0c1\uff0c2\uff0c3\u548c4\u63a5\u7740\u6bcf4\u5468\u7ed9\u836f\u3002\u53d7\u8bd5\u8005\u968f\u673a\u5316\u81f3COSENTYX\u63a5\u53d7300 mg\u6216150 mg \u5242\u91cf\u5728\u54680\uff0c1\uff0c2\uff0c3\uff0c\u548c4\u63a5\u7740\u6bcf4\u5468\u76f8\u540c\u7ed9\u836f\u3002\u53d7\u8bd5\u8005\u968f\u673a\u5316\u81f3\u63a5\u53d7\u5b89\u6170\u5242\u662f\u975e-\u53cd\u5e94\u8005\u572812\u5468\u65f6\u7136\u540e\u88ab\u4ea4\u53c9\u81f3\u63a5\u53d7COSENTYX(\u6d3b300 mg\u6216150 mg)\u5728\u546812\uff0c13\uff0c14\uff0c15\uff0c\u548c16\u63a5\u7740\u6bcf4\u5468\u76f8\u540c\u7ed9\u836f\u3002\u6240\u6709\u53d7\u8bd5\u8005\u5728\u9996\u6b21\u7ed9\u4e88\u7814\u7a76\u6cbb\u7597\u540e\u88ab\u968f\u8bbf\u81f352\u5468\u3002<\/p>\n\n\n\n

\u3000\u3000\u8bd5\u9a8c3\u7eb3\u5165177\u4f8b\u53d7\u8bd5\u8005(59\u968f\u673a\u5316\u81f3COSENTYX 300 mg\uff0c59\u4f8b\u81f3COSENTYX 150 mg\uff0c\u548c59\u4f8b\u81f3\u5b89\u6170\u5242)\u548c\u8bc4\u4f30\u5b89\u5168\u6027\uff0c\u8010\u53d7\u6027\uff0c\u548cCOSENTYX\u901a\u8fc7\u9884\u88c5\u6ce8\u5c04\u5668\u81ea\u8eab\u7ed9\u4e88\u517112\u5468\u7684\u53ef\u7528\u6027\u3002\u53d7\u8bd5\u8005\u63a5\u53d7\u76ae\u4e0b\u6cbb\u7597\u5728\u54680\uff0c1\uff0c2\uff0c3\u548c4\uff0c\u63a5\u7740\u6bcf4\u5468\u76f8\u540c\u7ed9\u836f\u5171\u81f3\u7ed9\u836f\u81f3\u603b\u517112\u5468\u3002<\/p>\n\n\n\n

\u3000\u3000\u8bd5\u9a8c4\u7eb3\u5165182\u4f8b\u53d7\u8bd5\u8005(60\u4f8b\u968f\u673a\u5316\u81f3COSENTYX 300 mg\uff0c61\u4f8b\u81f3COSENTYX 150 mg\uff0c\u548c61\u4f8b\u81f3\u5b89\u6170\u5242)\u548c\u8bc4\u4f30\u5b89\u5168\u6027\uff0c\u8010\u53d7\u6027\uff0c\u548cCOSENTYX\u901a\u8fc7Sensoready\u7b14\u81ea\u8eab\u7ed9\u836f\u517112\u5468\u7684\u53ef\u7528\u6027\u3002\u53d7\u8bd5\u8005\u63a5\u53d7\u76ae\u4e0b\u6cbb\u7597\u5728\u54680\uff0c1\uff0c2\uff0c3\u548c4\uff0c\u63a5\u7740\u6bcf4\u5468\u76f8\u540c\u7ed9\u836f\u603b\u5171\u81f312\u5468\u3002<\/p>\n\n\n\n

\u3000\u3000\u7ec8\u70b9<\/p>\n\n\n\n

\u3000\u3000\u5728\u6240\u6709\u8bd5\u9a8c\u4e2d\uff0c\u7ec8\u70b9\u662f\u4ece\u57fa\u7ebf\u81f3\u546812\u548c\u6cbb\u7597\u6210\u529f(\u6e05\u9664\u6216\u51e0\u4e4e\u6e05\u9664)\u5728\u4fee\u8ba2\u7684\u7814\u7a76\u8005\u5168\u9762\u8bc4\u4f302011(IGA)\u5b9e\u73b0\u51cf\u4f4ePASI\u8bc4\u5206\u81f3\u5c1175%(PASI 75)\u53d7\u8bd5\u8005\u7684\u6bd4\u4f8b\u3002\u5176\u4ed6\u8bc4\u4ef7\u7ed3\u5c40\u5305\u62ec\u4ece\u57fa\u7ebf\u81f312\u5468\u65f6\u5b9e\u73b0PASI\u8bc4\u5206\u51cf\u4f4e\u81f3\u5c1190%(PASI 90)\u53d7\u8bd5\u8005\u6bd4\u4f8b\uff0c\u7ef4\u6301\u7597\u6548\u81f3\u546852\uff0c\u548c\u572812\u5468\u65f6\u6839\u636e\u94f6\u5c51\u75c5\u75c7\u72b6\u65e5\u8bb0?\u7619\u75d2\uff0c\u75bc\u75db\u548c\u8131\u76ae\u4e2d\u6539\u5584\u3002<\/p>\n\n\n\n

\u3000\u3000PASI\u662f\u4e00\u4e2a\u590d\u5408\u8bc4\u5206\u8003\u8651\u53d7\u4fb5\u72af\u4f53\u8868\u9762\u79ef\u548c\u6027\u8d28\u548c\u5728\u53d7\u4fb5\u72af\u533a\u57df(\u786c\u7ed3\uff0c\u7ea2\u6591\u548c\u8131\u76ae)\u94f6\u5c51\u75c5\u53d8\u5316\u4e25\u91cd\u7a0b\u5ea6\u4e24\u65b9\u9762\u3002IGA\u662f\u4e00\u4e2a5\u7c7b\u522b\u8bc4\u5206\u5305\u62ec\u201c0 = \u6e05\u9664\u201d \u201c1 = \u51e0\u4e4e\u6e05\u9664\u201d\uff0c\u201c2 = \u8f7b\u201d\uff0c\u201c3 = \u4e2d\u201d\u6216\u201c4 = \u4e25\u91cd\u201d \u8868\u660e\u533b\u751f\u7684\u94f6\u5c51\u75c5\u4e25\u91cd\u7a0b\u5ea6\u603b\u4f53\u8bc4\u4f30\u96c6\u4e2d\u5728\u786c\u7ed3\uff0c\u7ea2\u6591\u548c\u8131\u76ae\u3002\u201c\u6e05\u9664\u201d\u6216\u201c\u51e0\u4e4e\u6e05\u9664\u201d\u7684\u6cbb\u7597\u6210\u529f\u7ec4\u6210\u94f6\u5c51\u75c5\u7684\u65e0\u5f81\u8c61\u6216\u6b63\u5e38\u81f3\u75c5\u53d8\u7684\u7c89\u7ea2\u989c\u8272\uff0c\u6591\u5757\u7684\u65e0\u539a\u5ea6\u548c\u65e0\u81f3\u5c0f\u75c5\u7076\u8131\u76ae\u3002<\/p>\n\n\n\n

\u3000\u3000\u57fa\u7ebf\u7279\u5f81<\/p>\n\n\n\n

\u3000\u3000\u8de8\u57df\u6240\u6709\u6cbb\u7597\u7ec4\u57fa\u7ebfPASI\u8bc4\u5206\u8303\u56f4\u4ece11\u81f372\u6709\u4e2d\u4f4d\u657020\u548c\u57fa\u7ebfIGA\u8bc4\u5206\u8303\u56f4\u4ece\u201c\u4e2d\u5ea6\u201d(62%) \u81f3\u201c\u4e25\u91cd\u201d(38%)\u30022077\u4f8b\u6591\u5757\u6027\u94f6\u5c51\u75c5\u53d7\u8bd5\u8005\u88ab\u5305\u62ec\u5728\u5b89\u6170\u5242-\u5bf9\u7167\u8bd5\u9a8c\u4e2d\uff0c79%\u4e3a\u751f\u7269\u5236\u54c1-\u672a\u6cbb\u7597\u8fc7(\u4ee5\u524d\u4ece\u672a\u63a5\u53d7\u7528\u751f\u7269\u5236\u54c1\u6cbb\u7597)\u548c45%\u662f\u975e-\u751f\u7269\u5236\u54c1\u5931\u8d25(\u5bf9\u67d0\u79cd\u4ee5\u524d\u6cbb\u7597\u7528\u975e-\u751f\u7269\u5236\u54c1\u6cbb\u7597\u6ca1\u6709\u53cd\u5e94)\u3002\u60a3\u8005\u63a5\u53d7\u67d0\u79cd\u7528\u751f\u7269\u5236\u54c1\u6cbb\u7597\uff0c\u8d85\u8fc7\u4e09\u5206\u4e4b\u4e00\u662f\u751f\u7269\u5236\u54c1\u5931\u8d25\u3002\u8bd5\u9a8c\u53d7\u8bd5\u8005\u7ea615%\u81f325%\u6709\u94f6\u5c51\u75c5\u5173\u8282\u708e\u75c5\u53f2\u3002<\/p>\n\n\n\n

\u3000\u3000\u4e34\u5e8a\u53cd\u5e94<\/p>\n\n\n\n

\u3000\u3000\u8fd9\u4e9b\u4e9a\u7ec4\u4e2d\u5bf9COSENTYX\u53cd\u5e94\u4e2d\u5e74\u9f84\uff0c\u6027\u522b\u548c\u79cd\u65cf\u4e9a\u7ec4\u5bf9\u68c0\u67e5\u6ca1\u6709\u9274\u5b9a\u51fa\u5dee\u522b\u3002\u6839\u636e\u5728\u6709\u4e2d\u5ea6\u81f3\u4e25\u91cd\u94f6\u5c51\u75c5\u60a3\u8005\u4e2d\u4e8b\u540e\u4e9a\u7ec4\u5206\u6790\uff0c\u60a3\u8005\u6709\u8f83\u4f4e\u4f53\u91cd\u548c\u75be\u75c5\u4e25\u91cd\u7a0b\u5ea6\u8f83\u4f4e\u53ef\u80fd\u5b9e\u73b0\u7528COSENTYX 150 mg\u4e00\u4e2a\u53ef\u63a5\u53d7\u53cd\u5e94\u3002<\/p>\n\n\n\n

\u3000\u3000\u7528COSENTYX 300 mg\u548c150 mg\u4e0e\u5b89\u6170\u5242\u6bd4\u8f83\u572812\u5468\u65f6\u5b9e\u73b0PASI 90\u53cd\u5e94\u5206\u522b\u4e3a59%(145\/245)\u548c39%(95\/245)\u76f8\u6bd4\u8f831%(3\/248)\u53d7\u8bd5\u8005(\u8bd5\u9a8c1)\u548c\u5206\u522b\u4e3a54%(175\/327)\u548c42%(137\/327)\u76f8\u6bd4\u8f832%(5\/326)\u53d7\u8bd5\u8005(\u8bd5\u9a8c2)\u3002\u5728\u8bd5\u9a8c3\u548c4\u4e2d\u89c1\u5230\u76f8\u4f3c\u7ed3\u679c\u3002<\/p>\n\n\n\n

\u3000\u3000\u7ee7\u7eed\u6cbb\u7597\u5386\u65f652\u5468\uff0c\u5728\u8bd5\u9a8c1\u4e2d\u7528COSENTYX 300 mg\u6cbb\u7597\u53d7\u8bd5\u8005\u572812\u5468\u65f6\u662fPASI 75\u53cd\u5e94\u8005\u53d7\u8bd5\u8005\u7ef4\u6301\u5176\u53cd\u5e94\u572881%(161\/200)\u548c\u7528COSENTYX 150 mg\u6cbb\u7597\u53d7\u8bd5\u8005\u572872%(126\/174)\u3002\u8bd5\u9a8c1\u7528COSENTYX 300 mg\u6cbb\u7597\u53d7\u8bd5\u8005\u572812\u5468\u65f6\u5bf9IGA\u662f\u6e05\u9664\u6216\u51e0\u4e4e\u6e05\u9664\u5bf9\u53d7\u8bd5\u8005\u4e5f\u7ef4\u6301\u5176\u53cd\u5e94\u572874%(119\/160)\u548c\u7528COSENTYX 150 mg\u6cbb\u7597\u53d7\u8bd5\u8005\u572859%(74\/125)\u3002\u76f8\u4f3c\u5730\u5728\u8bd5\u9a8c2\u4e2d\uff0c\u7528COSENTYX 300mg\u6cbb\u7597\u53d7\u8bd5\u8005PASI 75\u53cd\u5e94\u8005\u7ef4\u6301\u5176\u53cd\u5e94\u572884%(210\/249)\u548c\u7528COSENTYX 150mg\u6cbb\u7597\u53d7\u8bd5\u8005\u572882%(180\/219)\u3002\u8bd5\u9a8c2\u7528COSENTYX 300mg\u6cbb\u7597\u53d7\u8bd5\u8005\u5bf9IGA\u662f\u6e05\u9664\u6216\u51e0\u4e4e\u6e05\u9664\u53d7\u8bd5\u8005\u4e5f\u7ef4\u6301\u5176\u53cd\u5e94\u572880%(161\/202)\u548c\u7528COSENTYX 150mg\u6cbb\u7597\u53d7\u8bd5\u8005\u572868%(113\/167)\u3002<\/p>\n\n\n\n

\u3000\u3000\u9009\u62e9\u53c2\u52a0(39%)\u5728\u88ab\u62a5\u544a\u7ed3\u5c40\u8bc4\u4f30\u60a3\u8005\u53d7\u8bd5\u8005\u4e2d\uff0c\u7528\u94f6\u5c51\u75c5\u75c7\u72b6\u65e5\u8bb0?\u572812\u5468\u65f6(\u8bd5\u9a8c1\u548c2)\u89c2\u5bdf\u5230\u4e0e\u5b89\u6170\u5242\u6bd4\u8f83\u7619\u75d2\uff0c\u75bc\u75db\u548c\u8131\u76ae(scaling)\u76f8\u5173\u4f53\u5f81\u548c\u75c7\u72b6\u5bf9\u6539\u5584\u3002<\/p>\n\n\n\n

\u3000\u300014 \u5982\u4f55\u4f9b\u5e94\/\u8d2e\u5b58\u548c\u5904\u7f6e<\/p>\n\n\n\n

\u3000\u300014.1 \u5982\u4f55\u4f9b\u5e94<\/p>\n\n\n\n

\u3000\u3000COSENTYX Sensoready\u7b14\uff1a<\/p>\n\n\n\n

\u3000\u3000NDC 0078-0639-41\uff1a\u4e24\u4e2a150mg\/mL(300 mg\u5242\u91cf)Sensoready\u7b14(\u6ce8\u5c04\u6db2)\u7684\u7eb8\u76d2<\/p>\n\n\n\n

\u3000\u3000NDC 0078-0639-68\uff1a\u4e00\u4e2a150mg\/mL\u4e00\u6b21\u6027\u4f7f\u7528Sensoready\u7b14(\u6ce8\u5c04\u6db2)\u7684\u7eb8\u76d2<\/p>\n\n\n\n

\u3000\u3000COSENTYX\u9884\u88c5\u6ce8\u5c04\u5668\uff1a<\/p>\n\n\n\n

\u3000\u3000NDC 0078-0639-98\uff1a\u4e24\u4e2a150mg\/mL(300 mg\u5242\u91cf)\u4e00\u6b21\u6027\u4f7f\u7528\u9884\u88c5\u6ce8\u5c04\u5668(\u6ce8\u5c04\u6db2)\u7eb8\u76d2<\/p>\n\n\n\n

\u3000\u3000NDC 0078-0639-97\uff1a\u4e00\u4e2a150mg\/mL\u4e00\u6b21\u7528\u9884\u88c5\u6ce8\u5c04\u5668(\u6ce8\u5c04\u6db2)\u7eb8\u76d2<\/p>\n\n\n\n

\u3000\u3000COSENTYX Sensoready\u7b14\u548c\u9884\u88c5\u6ce8\u5c04\u5668\u53ef\u79fb\u53bb\u5e3d\u542b\u5929\u7136\u6a61\u80f6\u4e73\u80f6\u3002\u6bcf\u652fSensoready\u7b14\u548c\u9884\u88c5\u6ce8\u5c04\u5668\u88c5\u914d\u6709\u9488\u5b89\u5168\u9632\u8303\u3002<\/p>\n\n\n\n

\u3000\u3000COSENTYX\u5c0f\u74f6(\u53ea\u4e3a\u536b\u751f\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u4f7f\u7528)\uff1a<\/p>\n\n\n\n

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