{"id":9470,"date":"2018-06-08T01:00:00","date_gmt":"2018-07-27T09:38:52","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/roche%e8%a1%80%e5%8f%8b%e7%97%85%e6%96%b0%e8%8d%afhemlibra%e6%9c%80%e6%96%b0%e4%b8%b4%e5%ba%8a%e6%95%b0%e6%8d%ae%e5%85%ac%e5%b8%83%ef%bc%8c%e6%98%8e%e6%98%be%e9%99%8d%e4%bd%8e%e5%87%ba%e8%a1%80\/"},"modified":"2018-07-27T17:38:54","modified_gmt":"2018-07-27T09:38:54","slug":"roche%e8%a1%80%e5%8f%8b%e7%97%85%e6%96%b0%e8%8d%afhemlibra%e6%9c%80%e6%96%b0%e4%b8%b4%e5%ba%8a%e6%95%b0%e6%8d%ae%e5%85%ac%e5%b8%83%ef%bc%8c%e6%98%8e%e6%98%be%e9%99%8d%e4%bd%8e%e5%87%ba%e8%a1%80","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/9470\/","title":{"rendered":"Roche\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u6700\u65b0\u4e34\u5e8a\u6570\u636e\u516c\u5e03\uff0c\u660e\u663e\u964d\u4f4e\u51fa\u8840\u4e8b\u4ef6\uff01"},"content":{"rendered":"
\n

\"Roche\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u6700\u65b0\u4e34\u5e8a\u6570\u636e\u516c\u5e03\uff0c\u660e\u663e\u964d\u4f4e\u51fa\u8840\u4e8b\u4ef6\uff01\"<\/p>\n

\"Roche\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u6700\u65b0\u4e34\u5e8a\u6570\u636e\u516c\u5e03\uff0c\u660e\u663e\u964d\u4f4e\u51fa\u8840\u4e8b\u4ef6\uff01\"<\/p>\n


<\/p>\n

\uff08\u56fe\u7247\u6765\u6e90\u4e8e\u7f51\u7edc\uff09<\/span><\/p>\n


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

\u5173\u952e\u8bcd\uff1a<\/span><\/strong><\/span>Roche\uff1b<\/span>Hemlibra\uff1b\u8840\u53cb\u75c5<\/span><\/strong><\/span><\/p>\n

 <\/p>\n

2018\u5e745\u670821\u65e5\uff0c\u57282018\u5e74\u4e16\u754c\u8840\u53cb\u75c5\u8054\u76df(WFH)\u4e16\u754c\u5927\u4f1a\u4e0a\uff0cRoche\u516c\u5e03\u4e86\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u7684\u4e24\u9879III\u671f\u4e34\u5e8a\u7814\u7a76HAVEN 3\u548cHAVEN 4\u7684\u6700\u65b0\u7ed3\u679c\uff0c\u6570\u636e\u8868\u660e\u4f53\u5185\u4e0d\u542bVIII\u56e0\u5b50\u6291\u5236\u7269\u7684\u8840\u53cb\u75c5\u60a3\u8005\u63a5\u53d7Hemlibra\u6cbb\u7597\u540e\uff0c\u6700\u9ad8\u53ef\u4f7f\u51fa\u8840\u4e8b\u4ef6\u964d\u4f4e97%\uff01<\/span><\/p>\n

 <\/span><\/p>\n

Hemlibra (emicizumab-kxwh)<\/span><\/strong><\/span>\u662f\u7531Roche\u7814\u53d1\u7684\uff0c\u4e8e2017\u5e7411\u6708\u88abFDA\u6279\u51c6\u7684A\u578b\u8840\u53cb\u75c5\u65b0\u836f\uff0c\u4f5c\u4e3a\u5e38\u89c4\u9884\u9632\u3001\u9632\u6b62\u6216\u51cf\u5c11\u5177\u6709\u56e0\u5b50VIII\u6291\u5236\u5242\u7684A\u578b\u8840\u53cb\u75c5\u6210\u4eba\u548c\u513f\u7ae5\u60a3\u8005\u7684\u51fa\u8840\u4e8b\u4ef6\u3002A\u578b\u8840\u53cb\u75c5\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u9057\u4f20\u75c5\uff0c\u60a3\u8005\u7531\u4e8e\u7f3a\u4e4f\u4e00\u79cd\u53eb\u505a\u56e0\u5b50VIII\u7684\u51dd\u8840\u86cb\u767d\u56e0\u800c\u8840\u6db2\u4e0d\u80fd\u6b63\u5e38\u51dd\u56fa\uff0c\u5bfc\u81f4\u4e0d\u53d7\u63a7\u7684\u81ea\u53d1\u6027\u51fa\u8840\u3002Hemlibra\u662f\u8fd120\u5e74\u6765\u9996\u4e2a\u83b7FDA\u6279\u51c6\u7684\u7528\u4e8e\u6cbb\u7597\u4f53\u5185\u542b\u6709VIII\u56e0\u5b50\u6291\u5236\u7269\u7684A\u578b\u8840\u53cb\u75c5\u7684\u65b0\u836f\uff0c\u5176\u4e3a\u4e00\u79cd\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff0c\u53ef\u901a\u8fc7\u6865\u63a5\u51dd\u8840\u56e0\u5b50IXa\u548cX\u6765\u6062\u590d\u60a3\u8005\u7684\u51dd\u8840\u529f\u80fd\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2018\u5e745\u670821\u65e5\uff0c\u57282018\u5e74\u4e16\u754c\u8840\u53cb\u75c5\u8054\u76df(WFH)\u4e16\u754c\u5927\u4f1a\u4e0a\uff0cRoche\u516c\u5e03\u4e86\u5176\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u7684\u4e24\u9879III\u671f\u4e34\u5e8a\u7814\u7a76\u7684\u6700\u65b0\u7ed3\u679c\uff0cHAVEN 3\u4e34\u5e8a\u8bd5\u9a8c\u8868\u660e\u4f53\u5185\u4e0d\u542bVIII\u56e0\u5b50\u6291\u5236\u7269\u7684\u8840\u53cb\u75c5\u60a3\u8005\u63a5\u53d7Hemlibra\u6cbb\u7597\u540e\u8840\u4e8b\u4ef6\u6700\u9ad8\u964d\u4f4e97%\uff0cHAVEN 4\u4e34\u5e8a\u8bd5\u9a8c\u8868\u660e\u4f53\u5185\u542b\u6709\u6216\u4e0d\u542bVIII\u56e0\u5b50\u6291\u5236\u7269\u7684\u8840\u53cb\u75c5\u60a3\u8005\u63a5\u53d7Hemlibra\u6cbb\u7597\u540e\u672a\u53d1\u751f\u51fa\u8840\u4e8b\u4ef6\u7684\u6bd4\u7387\u4e3a56.1%\u3002<\/span><\/p>\n

 <\/span><\/p>\n

HAVEN3 (NCT02847637)<\/span><\/strong><\/span>\u662f\u4e00\u9879\u968f\u673a\u7684\u3001\u591a\u4e2d\u5fc3\u7684\u3001\u5f00\u653e\u6807\u7b7e\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u53c2\u4e0e\u8005\u4e3a\u5e74\u9f84\u4e0d\u5c0f\u4e8e12\u5c81\u7684\u4f53\u5185\u4e0d\u542b\u56e0\u5b50VIII\u6291\u5236\u5242\u4e14\u5148\u524d\u63a5\u53d7\u8fc7\u76f8\u5173\u6cbb\u7597\u7684\u60a3\u8005\u3002HAVEN 3\u662fRoche\u5f00\u5c55\u7684\u4e00\u9879\u5173\u952e\u6027\u4e34\u5e8aIII\u671f\u8bd5\u9a8c\uff0c2018\u5e744\u670817\u65e5FDA\u6839\u636eHAVEN 3\u7684\u90e8\u5206\u7ed3\u679c\u6388\u4e88Hemlibra\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff0c\u7528\u4e8e\u4f53\u5185\u4e0d\u542b\u56e0\u5b50VIII\u6291\u5236\u5242\u8840\u53cb\u75c5\u60a3\u8005\u7684\u9884\u9632\u6027\u6cbb\u7597\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u6839\u636eRoche\u57282018\u5e74\u4e16\u754c\u8840\u53cb\u75c5\u8054\u76df(WFH)\u4e16\u754c\u5927\u4f1a\u516c\u5e03\u7684\u8bd5\u9a8c\u6570\u636e\uff1a<\/span><\/p>\n

1)\u4e0e\u672a\u63a5\u53d7\u9884\u9632\u6027\u6cbb\u7597\u76f8\u6bd4\uff0c\u6bcf\u5468(3 mg\/kg\/wk)\u6216\u6bcf\u4e24\u5468(3 mg\/kg\/2 wks)\u63a5\u53d7Hemlibra\u9884\u9632\u6027\u6cbb\u7597\u540e\u60a3\u8005\u7684\u51fa\u8840\u4e8b\u4ef6\u5206\u522b\u964d\u4f4e\u4e8696% (P<0.0001)\u548c97%(P<0.0001)\uff1b<\/span><\/p>\n

2)\u6bcf\u5468(3 mg\/kg\/wk)\u6216\u6bcf\u4e24\u5468(3 mg\/kg\/2wks)\u63a5\u53d7Hemlibra\u9884\u9632\u6027\u6cbb\u7597\u540e\uff0c\u672a\u53d1\u73b0\u51fa\u8840\u4e8b\u4ef6\u7684\u60a3\u8005\u6bd4\u7387\u5206\u522b\u4e3a55.6% (95% CI: 38.1; 72.1)\u548c60% (95% CI: 42.1; 76.1)\uff0c\u76f8\u6bd4\u672a\u63a5\u53d7Hemlibra\u9884\u9632\u6027\u6cbb\u7597\u76840% (95% CI: 0.0; 18.5)\uff1b<\/span><\/p>\n

3)\u60a3\u8005\u5185\u5bf9\u6bd4\u5206\u6790\u8868\u660e\uff0c\u4e0e\u5148\u524d\u63a5\u53d7\u8fc7\u7684\u6807\u51c6\u6cbb\u7597\u65b9\u6848\u76f8\u6bd4\uff0c\u63a5\u53d7\u6bcf\u5468\u4e00\u6b21Hemlibra\u9884\u9632\u6cbb\u7597\u540e\u60a3\u8005\u51fa\u8840\u4e8b\u4ef6\u964d\u4f4e68% (P<0.0001)\uff1b<\/span><\/p>\n

4)\u6ca1\u6709\u51fa\u73b0\u4e0d\u53ef\u9884\u6599\u6216\u4e25\u91cd\u7684\u4e0d\u826f\u4e8b\u4ef6\uff0c\u6700\u5e38\u89c1\u7684\u4e0d\u826f\u4e8b\u4ef6\u4e0e\u5148\u524d\u7684\u8bd5\u9a8c\u4e00\u81f4\u3002<\/span><\/p>\n

 <\/span><\/p>\n

HAVEN4 (NCT03020160)<\/span><\/strong><\/span>\u662f\u4e00\u9879\u5355\u81c2\u7684\u3001\u591a\u4e2d\u5fc3\u7684\u3001\u5f00\u53d1\u6807\u7b7e\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u53c2\u4e0e\u8005\u4e3a\u4f53\u5185\u542b\u6709\u6216\u4e0d\u542bVIII\u56e0\u5b50\u6291\u5236\u7269\u768448\u540d\u8840\u53cb\u75c5\u60a3\u8005\u3002\u6bcf\u56db\u5468\u63a5\u53d7Hemlibra\u9884\u9632\u6027\u6cbb\u7597\u540e\uff0c56.1% (95% CI: 39.7; 71.5)\u7684\u60a3\u8005\u5728\u4e00\u5e74\u5185\u672a\u51fa\u73b0\u51fa\u8840\u4e8b\u4ef6\uff0c90.2% (95% CI: 76.9; 97.3)\u7684\u60a3\u8005\u4e00\u5e74\u5185\u53d1\u73b03\u6b21\u6216\u66f4\u5c11\u7684\u51fa\u8840\u4e8b\u4ef6\u3002HAVEN 4\u7684\u4e34\u5e8a\u6570\u636e\u8868\u660e\uff0c\u5bf9\u4e8e\u4f53\u5185\u542b\u6216\u4e0d\u542bVIII\u56e0\u5b50\u6291\u5236\u7269\u7684\u8840\u53cb\u75c5\u60a3\u8005\uff0c\u6bcf\u56db\u5468\u4e00\u6b21\u7684Hemlibra\u9884\u9632\u6027\u6cbb\u7597\u53ef\u5728\u4e34\u5e8a\u610f\u4e49\u4e0a\u63a7\u5236\u51fa\u8840\u3002<\/span><\/p>\n

 <\/span><\/p>\n

Roche\u9996\u5e2d\u533b\u5b66\u5b98\u517c\u5168\u7403\u4ea7\u54c1\u5f00\u53d1\u8d1f\u8d23\u4ebaSandra Horning\u535a\u58eb\u5728\u58f0\u660e\u4e2d\u8868\u793a\uff0c\u201c\u8fd9\u4e9b\u65b0\u7684\u5173\u952e\u6570\u636e\u8868\u660e\uff0cHemlibra\u80fd\u591f\u63a7\u5236A\u578b\u8840\u53cb\u75c5\u60a3\u8005\u7684\u51fa\u8840\u4e8b\u4ef6\uff0c\u540c\u65f6\u60a3\u8005\u53ef\u4ee5\u9009\u62e9\u66f4\u4f4e\u9891\u7387\u7684\u76ae\u4e0b\u6ce8\u5c04\u6cbb\u7597\u65b9\u6848\u3002\u52a0\u4e0a\u8fd9\u6b21\u7684\u8bd5\u9a8c\u7ed3\u679c\uff0c\u6211\u4eec\u7684\u56db\u9879III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5168\u90e8\u53d6\u5f97\u79ef\u6781\u7ed3\u679c\uff0c\u8fdb\u4e00\u6b65\u8bc1\u660e\u4e86Hemlibra\u7684\u6574\u4f53\u7597\u6548\u548c\u5b89\u5168\u6027\uff0c\u4ee5\u53ca\u5176\u6709\u671b\u6539\u5584\u6240\u6709A\u578b\u8840\u53cb\u75c5\u60a3\u8005\u6cbb\u7597\u7684\u6f5c\u529b\u3002\u201d<\/span><\/p>\n

 <\/span><\/p>\n

\u5c31\u5b89\u5168\u6027\u6765\u8bb2\uff0cHAVEN 3\u548cHAVEN 4\u7814\u7a76\u4e0e\u65e9\u671f\u7684\u4e34\u5e8a\u7814\u7a76\u5177\u6709\u4e00\u81f4\u6027\uff0c\u53e6\u5916\u6b64\u524dHemlibra\u66fe\u906d\u9047\u8fc7\u4e94\u4f8b\u60a3\u8005\u6b7b\u4ea1\u4e8b\u4ef6\uff0c\u800c\u5728\u90a3\u4e4b\u540eFDA\u8fd8\u662f\u6388\u4e88\u4e86Hemlibra\u6cbb\u7597\u4f53\u5185\u4e0d\u542b\u56e0\u5b50VIII\u6291\u5236\u5242\u7684\u8840\u53cb\u75c5\u60a3\u8005\u7684\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u3002<\/span><\/p>\n

 <\/span><\/p>\n

Hemlibra\u5177\u6709\u6210\u4e3a\u91cd\u78c5\u8840\u53cb\u75c5\u65b0\u836f\u7684\u6f5c\u529b\uff0c2018\u5e74\u521dClarivate Analytics\u5c31\u66fe\u9884\u6d4bHemlibra\u57282022\u5e74\u7684\u9500\u552e\u989d\u4f1a\u8fbe\u523040\u4ebf\u7f8e\u5143\uff0cRoche\u4e5f\u8868\u793a\u6709\u4fe1\u5fc3\u4f7fHemlibra\u8695\u98dfShire\u76ee\u524d\u7684\u8840\u53cb\u75c5\u5e02\u573a\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u53c2\u8003\u6765\u6e90\uff1a<\/span><\/p>\n

[1] Roche\u2019s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia Awithout factor VIII inhibitors\uff1b<\/span><\/p>\n

[2] Roche adds a stellar round of pivotal data on Hemlibra, looking to expand its market for a potential mega-blockbuster\u3002<\/span><\/p>\n


<\/p>\n

\u9644\u8868\uff1a<\/span><\/strong><\/span><\/p>\n

\u88681   HAVEN 3\u8bd5\u9a8c\u4e3b\u8981\u7814\u7a76\u7ed3\u679c<\/span><\/strong><\/p>\n

\"Roche\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u6700\u65b0\u4e34\u5e8a\u6570\u636e\u516c\u5e03\uff0c\u660e\u663e\u964d\u4f4e\u51fa\u8840\u4e8b\u4ef6\uff01\"<\/p>\n

\u88682   HAVEN 4\u8bd5\u9a8c\u4e3b\u8981\u7814\u7a76\u7ed3\u679c<\/span><\/strong><\/p>\n

\"Roche\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u6700\u65b0\u4e34\u5e8a\u6570\u636e\u516c\u5e03\uff0c\u660e\u663e\u964d\u4f4e\u51fa\u8840\u4e8b\u4ef6\uff01\"<\/p>\n

\"Roche\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u6700\u65b0\u4e34\u5e8a\u6570\u636e\u516c\u5e03\uff0c\u660e\u663e\u964d\u4f4e\u51fa\u8840\u4e8b\u4ef6\uff01\"<\/a><\/p>\n

\"Roche\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u6700\u65b0\u4e34\u5e8a\u6570\u636e\u516c\u5e03\uff0c\u660e\u663e\u964d\u4f4e\u51fa\u8840\u4e8b\u4ef6\uff01\"<\/p>\n

\"Roche\u8840\u53cb\u75c5\u65b0\u836fHemlibra\u6700\u65b0\u4e34\u5e8a\u6570\u636e\u516c\u5e03\uff0c\u660e\u663e\u964d\u4f4e\u51fa\u8840\u4e8b\u4ef6\uff01\"<\/p>\n

\n
\n
<\/section>\n<\/section>\n
\n

\u70b9\u51fb”\u9605\u8bfb\u539f\u6587”,\u968f\u65f6\u638c\u63e1\u884c\u4e1a\u52a8\u6001<\/p>\n<\/section>\n<\/section>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u6e21 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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