{"id":90117,"date":"2023-07-31T07:10:00","date_gmt":"2023-07-31T00:10:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2023073107100090117"},"modified":"2023-07-31T15:19:10","modified_gmt":"2023-07-31T07:19:10","slug":"%e5%88%9b%e8%83%9c%e9%9b%86%e5%9b%a2%e6%8a%97%e7%a1%ac%e9%aa%a8%e7%b4%a0%e5%8d%95%e6%8a%97tst002-blosozumab%e6%b2%bb%e7%96%97%e4%b8%ad%e5%9b%bd%e9%aa%a8%e5%af%86%e5%ba%a6%e9%99%8d%e4%bd%8e%e6%82%a3","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2023073107100090117","title":{"rendered":"\u521b\u80dc\u96c6\u56e2\u6297\u786c\u9aa8\u7d20\u5355\u6297TST002 (Blosozumab)\u6cbb\u7597\u4e2d\u56fd\u9aa8\u5bc6\u5ea6\u964d\u4f4e\u60a3\u8005II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u5f97\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u6279\u51c6"},"content":{"rendered":"<p><p><span class=\"legendSpanClass\">\u82cf\u5dde<\/span><span class=\"legendSpanClass\">2023\u5e747\u670831\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; 7\u670831\u65e5\uff0c\u521b\u80dc\u96c6\u56e2\uff0806628.HK\uff09\uff0c\u4e00\u5bb6\u5177\u5907\u751f\u7269\u836f\u54c1\u53d1\u73b0\u3001\u7814\u53d1\u3001\u5de5\u827a\u5f00\u53d1\u548c\u751f\u4ea7\u5168\u6d41\u7a0b\u6574\u5408\u80fd\u529b\u7684\u4e34\u5e8a\u9636\u6bb5\u7684\u751f\u7269\u5236\u836f\u516c\u53f8\uff0c\u5ba3\u5e03\u5df2\u83b7\u5f97\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3(CDE)\u6279\u51c6\uff0c\u5f00\u5c55TST002 (Blosozumab) II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u8be5\u7814\u7a76\u65e8\u5728\u8bc4\u4f30TST002 (Blosozumab)\u6ce8\u5c04\u6db2\u5355\u6b21\u53ca\u591a\u6b21\u9759\u8109\u6ef4\u6ce8\u7ed9\u836f\u5728\u9aa8\u5bc6\u5ea6\u964d\u4f4e\u60a3\u8005\u7684\u5b89\u5168\u6027\u3001\u8010\u53d7\u6027\u53ca\u836f\u4ee3\u52a8\u529b\u5b66\u3002<\/p>\n<p>\u9aa8\u8d28\u758f\u677e\u75c7\u662f\u6211\u56fd\u4e2d\u8001\u5e74\u4eba\u7fa4\u7684\u91cd\u8981\u5065\u5eb7\u95ee\u9898\uff0c\u9884\u8ba1\u52302050\u5e74\u6211\u56fd\u9aa8\u8d28\u758f\u677e\u75c7\u60a3\u8005\u5c06\u8fbe\u52301.2\u4ebf\u3002\u4e0e\u53ea\u80fd\u6291\u5236\u9aa8\u9abc\u5438\u6536\u7684\u6297RANKL\u5355\u514b\u9686\u6297\u4f53\u76f8\u6bd4\uff0c\u6297\u786c\u9aa8\u7d20\u5355\u514b\u9686\u6297\u4f53\u6210\u529f\u5b9e\u73b0\u4e86\u505c\u6b62\u9aa8\u4e22\u5931\u548c\u8fdb\u884c\u9aa8\u91cd\u5efa\u7684\u53cc\u91cd\u76ee\u6807\u3002\u5b89\u8fdb\u7684Eventity (Romosozumab)\u4e3a\u552f\u4e00\u4e00\u6b3e\u83b7\u7f8e\u56fdFDA\u6279\u51c6\u7684\u6297\u786c\u9aa8\u7d20\u6297\u4f53\u836f\u7269\u3002\u622a\u81f3\u76ee\u524d\uff0c\u4e2d\u56fd\u5c1a\u65e0\u83b7\u6279\u7684\u6297\u786c\u9aa8\u7d20\u6297\u4f53\u836f\u7269\u3002<\/p>\n<p>\u4e8e2023\u5e745\u6708\uff0c\u521b\u80dc\u96c6\u56e2\u516c\u5e03\u4e86I\u671f\u63ed\u76f2\u6570\u636e\uff0c\u7ed3\u679c\u663e\u793aTST002 (Blosozumab)\u5728\u6240\u6709\u5242\u91cf\u7ec4\u4e2d\u7684\u6574\u4f53\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u826f\u597d\u3002\u5728\u7597\u6548\u65b9\u9762\uff0c\u6240\u6709200-1200mg\u5242\u91cf\u7ec4\u5728\u63a5\u53d7\u5355\u5242\u91cfTST002 (Blosozumab)\u6cbb\u7597\u540e\u7b2c85\u5929\u5747\u663e\u793a\u51fa\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u8170\u690e\u9aa8\u5bc6\u5ea6\u589e\u52a0\uff0c\u4e0eBlosozumab\u76f8\u4f3c\u5242\u91cf\u6c34\u5e73\u7684\u5355\u5242\u91cf\u7814\u7a76\u7597\u6548\u76f8\u5f53\u3002\u6240\u6709\u5242\u91cf\u7ec4\u5728\u7b2c85\u5929\u8170\u690e\u9aa8\u5bc6\u5ea6\u8f83\u57fa\u7ebf\u5e73\u5747\u589e\u52a03.52% \u2013 6.20%\uff0c\u5747\u8d85\u8fc7\u6700\u5c0f\u663e\u8457\u5dee\u5f02(2.77%)\u3002\u5b89\u6170\u5242\u7ec4\u7684\u8170\u690e\u9aa8\u5bc6\u5ea6\u5219\u53ea\u589e\u52a0\u4e860.30%\uff0c\u5373\u4f7f\u91c7\u7528\u6700\u4f73\u7684\u9499\u548c\u7ef4\u751f\u7d20D\u8865\u5145\u6cbb\u7597\u3002\u6b64\u5916\uff0c\u5728\u5355\u5242\u91cf\u7ed9\u836fTST002 (Blosozumab)\u540e\uff0c\u89c2\u5bdf\u5230\u6574\u4e2a\u5242\u91cf\u7ec4\u7684BMD\u4ece1.30%\u589e\u81f32.24%\uff0c\u4ee4\u4eba\u9f13\u821e\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u63a5\u53d7\u5730\u8212\u5355\u6297\u6cbb\u7597\u4e00\u5e74\u540e\uff0c\u8170\u690e\u9aa8\u5bc6\u5ea6\u8f83\u57fa\u7ebf\u65f6\u5230\u7b2c12\u4e2a\u6708\u5e73\u5747\u53d8\u5316\u767e\u5206\u6bd4\u4e3a5.4%\u3002<sup>[1]<\/sup><\/p>\n<p>\u521b\u80dc\u96c6\u56e2\u5168\u7403\u836f\u7269\u5f00\u53d1\u6267\u884c\u526f\u603b\u88c1\uff0c\u9996\u5e2d\u533b\u5b66\u5b98Caroline Germa\u535a\u58eb\u8868\u793a\uff1a&quot;\u6211\u4eec\u5f88\u9ad8\u5174\u6536\u5230\u4e2d\u56fd\u836f\u76d1\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u7684\u6279\u51c6\u3002\u5728II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u6211\u4eec\u5c06\u8bc4\u4f30\u964d\u4f4eTST002(Blosozumab)\u7ed9\u836f\u9891\u7387\u7684\u51e0\u79cd\u6cbb\u7597\u65b9\u6848\uff0c\u4e3aIII\u671f\u4e34\u5e8a\u5960\u5b9a\u57fa\u7840\u3002\u6211\u4eec\u671f\u5f85\u672a\u6765\u80fd\u591f\u5145\u5206\u63a2\u7d22TST002\u7684\u5dee\u5f02\u6027\uff0c\u89e3\u51b3\u5927\u91cf\u9aa8\u8d28\u758f\u677e\u75c7\u60a3\u8005\u672a\u88ab\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002&quot;<\/p>\n<p>\u53c2\u8003\u6587\u732e\uff1a<\/p>\n<p><sup>[1] <a href=\"https:\/\/academic.oup.com\/jcem\/article\/105\/3\/e255\/5607536\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/academic.oup.com\/jcem\/article\/105\/3\/e255\/5607536<\/a><\/sup><\/p>\n<p><b>\u5173\u4e8eTST002(Blosozumab)<\/b><\/p>\n<p>TST002(Blosozumab)\u662f\u4e00\u79cd\u6cbb\u7597\u9aa8\u8d28\u758f\u677e\u548c\u5176\u4ed6\u9aa8\u8d28\u6d41\u5931\u75be\u75c5\u7684\u4eba\u6e90\u5316\u6297\u786c\u9aa8\u7d20\u5355\u514b\u9686\u6297\u4f53\u5019\u9009\u836f\u7269\uff0c\u5177\u6709\u589e\u5f3a\u9aa8\u5408\u6210\u4ee3\u8c22\u548c\u6297\u9aa8\u5438\u6536\u7684\u53cc\u91cd\u4f5c\u7528\uff0c\u53ef\u4fc3\u8fdb\u9aa8\u9abc\u5f62\u6210\u5e76\u6291\u5236\u9aa8\u5438\u6536\uff0c\u4ece\u800c\u80fd\u5feb\u901f\u63d0\u5347\u9aa8\u9abc\u5bc6\u5ea6\u548c\u589e\u52a0\u9aa8\u9abc\u5f3a\u5ea6\u3002\u5728\u63a5\u53d7\u6297\u786c\u9aa8\u7d20\u6297\u4f53\u6cbb\u7597\u6216\u81ea\u7136\u53d1\u751f\u7684\u57fa\u56e0\u7f3a\u5931\u7684\u4eba\u7fa4\u4e2d\uff0c\u963b\u65ad\u786c\u9aa8\u7d20\u6d3b\u6027\u5df2\u88ab\u8bc1\u5b9e\u662f\u63d0\u9ad8\u9aa8\u5bc6\u5ea6(BMD)\u53ca\u964d\u4f4e\u9aa8\u6298\u98ce\u9669\u7684\u6709\u6548\u65b9\u6cd5\u3002\u76ee\u524d\u53ea\u6709\u5b89\u8fdb\u7684Romosozumab\u5df2\u7ecf\u5728\u7f8e\u56fd\u3001\u6b27\u6d32\u548c\u65e5\u672c\u83b7\u5f97\u6279\u51c6\uff0c\u4f46\u4e2d\u56fd\u8fd8\u6ca1\u6709\u83b7\u6279\u51c6\u7684\u6297\u786c\u9aa8\u7d20\u6297\u4f53\u7597\u6cd5\u3002<\/p>\n<p><b>\u5173\u4e8e\u521b\u80dc\u96c6\u56e2<\/b><\/p>\n<p>\u521b\u80dc\u96c6\u56e2\u662f\u4e00\u5bb6\u4e34\u5e8a\u9636\u6bb5\u7684\u5728\u751f\u7269\u836f\u53d1\u73b0\u3001\u7814\u53d1\u3001\u5de5\u827a\u5f00\u53d1\u548c\u751f\u4ea7\u65b9\u9762\u5177\u6709\u5168\u9762\u7efc\u5408\u80fd\u529b\u7684\u751f\u7269\u5236\u836f\u516c\u53f8\u3002<\/p>\n<p>\u521b\u80dc\u96c6\u56e2\u603b\u90e8\u4f4d\u4e8e\u82cf\u5dde\uff0c\u5df2\u6210\u529f\u642d\u5efa\u4e86\u5168\u7403\u7684\u4e1a\u52a1\u5e03\u5c40\uff1a\u5728\u82cf\u5dde\u8bbe\u6709\u836f\u7269\u53d1\u73b0\u3001\u4e34\u5e8a\u548c\u8f6c\u5316\u7814\u7a76\u4e2d\u5fc3\uff0c\u521b\u80dc\u96c6\u56e2\u603b\u90e8\u53ca\u4ee5\u8fde\u7eed\u704c\u6d41\u751f\u4ea7\u5de5\u827a\u4e3a\u6838\u5fc3\u6280\u672f\u7684\u751f\u4ea7\u57fa\u5730\u4e5f\u6b63\u5728\u5efa\u8bbe\u4e2d\u3002\u5728\u676d\u5dde\u62e5\u6709\u5de5\u827a\u4e0e\u4ea7\u54c1\u5f00\u53d1\u4e2d\u5fc3\u4ee5\u53ca\u836f\u7269\u751f\u4ea7\u57fa\u5730\uff0c\u5728\u7f8e\u56fd\u666e\u6797\u65af\u987f\u3001\u5317\u4eac\u3001\u4e0a\u6d77\u3001\u5e7f\u5dde\u5206\u522b\u8bbe\u6709\u4e34\u5e8a\u5f00\u53d1\u4e2d\u5fc3\uff0c\u5e76\u5728\u7f8e\u56fd\u6ce2\u58eb\u987f\u3001\u6d1b\u6749\u77f6\u8bbe\u7acb\u4e86\u4e1a\u52a1\u62d3\u5c55\u4e2d\u5fc3\u3002\u521b\u80dc\u96c6\u56e2\u7684\u5f00\u53d1\u7ba1\u7ebf\u5df2\u6709\u5341\u4e09\u4e2a\u6cbb\u7597\u7528\u6297\u4f53\u65b0\u836f\u5206\u5b50\uff0c\u6db5\u76d6\u80bf\u7624\u3001\u9aa8\u79d1\u548c\u80be\u75c5\u7b49\u9886\u57df\u3002<\/p>\n<p>\u5982\u9700\u4e86\u89e3\u5173\u4e8e\u521b\u80dc\u96c6\u56e2\u7684\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee\u516c\u53f8\u7f51\u7ad9\uff1awww.transcenta.com\u6216\u9886\u82f1\u8d26\u53f7\uff1aTranscenta\u3002<\/p>\n<p><b>\u524d\u77bb\u6027\u58f0\u660e<\/b><\/p>\n<p>\u672c\u65b0\u95fb\u7a3f\u6240\u53d1\u5e03\u7684\u4fe1\u606f\u4e2d\u53ef\u80fd\u4f1a\u5305\u542b\u67d0\u4e9b\u524d\u77bb\u6027\u8868\u8ff0\u3002\u8fd9\u4e9b\u8868\u8ff0\u672c\u8d28\u4e0a\u5177\u6709\u76f8\u5f53\u98ce\u9669\u548c\u4e0d\u786e\u5b9a\u6027\u3002\u5728\u4f7f\u7528&quot;\u9884\u671f&quot;\u3001&quot;\u76f8\u4fe1&quot;\u3001&quot;\u9884\u6d4b&quot;\u3001&quot;\u671f\u671b&quot;\u3001&quot;\u6253\u7b97&quot;\u53ca\u5176\u4ed6\u7c7b\u4f3c\u8bcd\u8bed\u8fdb\u884c\u8868\u8ff0\u65f6\uff0c\u51e1\u4e0e\u672c\u516c\u53f8\u6709\u5173\u7684\uff0c\u76ee\u7684\u5747\u662f\u8981\u6307\u660e\u5176\u5c5e\u524d\u77bb\u6027\u8868\u8ff0\u3002\u672c\u516c\u53f8\u5e76\u65e0\u4e49\u52a1\u4e0d\u65ad\u5730\u66f4\u65b0\u8fd9\u4e9b\u9884\u6d4b\u6027\u9648\u8ff0\u3002<\/p>\n<p>\u8fd9\u4e9b\u524d\u77bb\u6027\u8868\u8ff0\u4e43\u57fa\u4e8e\u672c\u516c\u53f8\u7ba1\u7406\u5c42\u5728\u505a\u51fa\u8868\u8ff0\u65f6\u5bf9\u672a\u6765\u4e8b\u52a1\u7684\u73b0\u6709\u770b\u6cd5\u3001\u5047\u8bbe\u3001\u671f\u671b\u3001\u4f30\u8ba1\u3001\u9884\u6d4b\u548c\u7406\u89e3\u3002\u8fd9\u4e9b\u8868\u8ff0\u5e76\u975e\u5bf9\u672a\u6765\u53d1\u5c55\u7684\u4fdd\u8bc1\uff0c\u4f1a\u53d7\u5230\u98ce\u9669\u3001\u4e0d\u786e\u6027\u53ca\u5176\u4ed6\u56e0\u7d20\u7684\u5f71\u54cd\uff0c\u6709\u4e9b\u4e43\u8d85\u51fa\u672c\u516c\u53f8\u7684\u63a7\u5236\u8303\u56f4\uff0c\u96be\u4ee5\u9884\u8ba1\u3002\u56e0\u6b64\uff0c\u53d7\u6211\u4eec\u7684\u4e1a\u52a1\u3001\u7ade\u4e89\u73af\u5883\u3001\u653f\u6cbb\u3001\u7ecf\u6d4e\u3001\u6cd5\u5f8b\u548c\u793e\u4f1a\u60c5\u51b5\u7684\u672a\u6765\u53d8\u5316\u53ca\u53d1\u5c55\u7684\u5f71\u54cd\uff0c\u5b9e\u9645\u7ed3\u679c\u53ef\u80fd\u4f1a\u4e0e\u524d\u77bb\u6027\u8868\u8ff0\u6240\u542b\u8d44\u6599\u6709\u8f83\u5927\u5dee\u522b\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u82cf\u5dde2023\u5e747\u670831\u65e5 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6.20%\uff0c\u5747\u8d85\u8fc7\u6700\u5c0f\u663e\u8457\u5dee\u5f02(2.77%)\u3002\u5b89\u6170\u5242\u7ec4\u7684\u8170\u690e\u9aa8\u5bc6\u5ea6\u5219\u53ea\u589e\u52a0\u4e860.30%\uff0c\u5373\u4f7f\u91c7\u7528\u6700\u4f73\u7684\u9499\u548c\u7ef4\u751f\u7d20D\u8865\u5145\u6cbb\u7597\u3002\u6b64\u5916\uff0c\u5728\u5355\u5242\u91cf\u7ed9\u836fTST002 (Blosozumab)\u540e\uff0c\u89c2\u5bdf\u5230\u6574\u4e2a\u5242\u91cf\u7ec4\u7684BMD\u4ece1.30%\u589e\u81f32.24%\uff0c\u4ee4\u4eba\u9f13\u821e\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u63a5\u53d7\u5730\u8212\u5355\u6297\u6cbb\u7597\u4e00\u5e74\u540e\uff0c\u8170\u690e\u9aa8\u5bc6\u5ea6\u8f83\u57fa\u7ebf\u65f6\u5230\u7b2c12\u4e2a\u6708\u5e73\u5747\u53d8\u5316\u767e\u5206\u6bd4\u4e3a5.4%\u3002[1] \u521b\u80dc\u96c6\u56e2\u5168\u7403\u836f\u7269\u5f00\u53d1\u6267\u884c\u526f\u603b\u88c1\uff0c\u9996\u5e2d\u533b\u5b66\u5b98Caroline Germa\u535a\u58eb\u8868\u793a\uff1a&quot;\u6211\u4eec\u5f88\u9ad8\u5174\u6536\u5230\u4e2d\u56fd\u836f\u76d1\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u7684\u6279\u51c6\u3002\u5728II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u6211\u4eec\u5c06\u8bc4\u4f30\u964d\u4f4eTST002(Blosozumab)\u7ed9\u836f\u9891\u7387\u7684\u51e0\u79cd\u6cbb\u7597\u65b9\u6848\uff0c\u4e3aIII\u671f\u4e34\u5e8a\u5960\u5b9a\u57fa\u7840\u3002\u6211\u4eec\u671f\u5f85\u672a\u6765\u80fd\u591f\u5145\u5206\u63a2\u7d22TST002\u7684\u5dee\u5f02\u6027\uff0c\u89e3\u51b3\u5927\u91cf\u9aa8\u8d28\u758f\u677e\u75c7\u60a3\u8005\u672a\u88ab\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002&quot; \u53c2\u8003\u6587\u732e\uff1a [1] https:\/\/academic.oup.com\/jcem\/article\/105\/3\/e255\/5607536 \u5173\u4e8eTST002(Blosozumab) 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