{"id":122928,"date":"2020-04-01T07:04:38","date_gmt":"2020-04-21T01:06:29","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/122928\/"},"modified":"2020-04-21T09:06:31","modified_gmt":"2020-04-21T01:06:31","slug":"b13a1d2aab","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/122928\/","title":{"rendered":"\u6211\u56fd\u65b0\u836f\u521b\u5236\u7684\u53d1\u5c55\u73b0\u72b6\u53ca\u95ee\u9898\u6d45\u6790"},"content":{"rendered":"
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1\uff0e3 \u533b\u836f\u670d\u52a1\u4e1a\u5feb\u901f\u53d1\u5c55<\/span><\/strong><\/section>\n
\u533b\u836f\u670d\u52a1\u4e1a\u5305\u62ec\u59d4\u6258\u5408\u540c\u7814\u7a76\u673a\u6784( Contract Research Organization\uff0cCRO) \u3001\u59d4\u6258\u5408\u540c\u751f\u4ea7\u673a\u6784( Contract Manufacturing Organization\uff0cCMO) \u3001\u59d4\u6258\u5408\u540c\u8425\u9500\u673a\u6784( Contract Sales Organization\uff0cCSO) \u7b49\uff0c\u5176\u4e2dCRO \u662f\u65b0\u836f\u521b\u5236\u5173\u6ce8\u7684\u91cd\u70b9\u3002\u56fd\u5185CRO \u5e02\u573a\u8d77\u6b65\u665a\u3001\u5e02\u573a\u96c6\u4e2d\u5ea6\u4f4e\uff0c\u4f46\u6f5c\u529b\u5f88\u5927\uff0c\u76ee\u524d\u5df2\u8fdb\u5165\u5feb\u901f\u53d1\u5c55\u8f68\u9053\uff3b4 \uff0d 5\uff3d\u3002<\/section>\n
2017 \u5e74\uff0c\u56fd\u5185CRO \u5e02\u573a\u89c4\u6a21\u7ea642 \u4ebf\u7f8e\u5143\u3002\u5176\u4e2d\uff0c\u5316\u5b66\u836f\u726936 \u4ebf\u7f8e\u5143\uff0c\u751f\u7269\u5236\u52426 \u4ebf\u7f8e\u5143\u3002\u9884\u8ba1\u52302022 \u5e74\uff0c\u5316\u5b66\u836f\u7269\u548c\u751f\u7269\u5236\u5242\u7684CRO \u5e02\u573a\u5c06\u5206\u522b\u8fbe\u5230110 \u548c35 \u4ebf\u7f8e\u5143\u30022022 \u5e74\u56fd\u5185\u6574\u4e2aCRO \u5e02\u573a\u89c4\u6a21\u5c06\u8fd1150 \u4ebf\u7f8e\u5143\uff0c\u5e74\u5316\u589e\u901f28%\uff0c\u660e\u663e\u9ad8\u4e8e\u5168\u7403\u589e\u901f11%\u3002\u5176\u4e2d\uff0c\u56fd\u5185\u751f\u7269\u836f\u7269\u589e\u901f42%\uff0c\u5927\u5e45\u9886\u5148\u5316\u5b66\u836f\u7269\u589e\u901f25%\u3002<\/section>\n
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1\uff0e4 \u4f01\u4e1a\u7814\u53d1\u6295\u5165\u4e0d\u65ad\u589e\u957f<\/span><\/strong><\/section>\n
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1\uff0e6 \u793e\u4f1a\u8d44\u672c\u6295\u878d\u8d44\u6d3b\u8dc3<\/span><\/strong><\/section>\n
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2<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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2.1 \u65b0\u836f\u9776\u70b9\u7684\u6e90\u5934\u521b\u65b0\u4e0d\u8db3<\/span><\/strong><\/span><\/section>\n
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2\uff0e6\uff0e1 \u7814\u53d1\u6295\u5165\u4e0d\u8db3<\/strong><\/span><\/section>\n
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3<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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3\uff0e1 \u56fd\u5bb6\u6218\u7565\u9ad8\u5ea6\u9876\u5c42\u8bbe\u8ba1<\/span><\/strong><\/span><\/section>\n
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\u300a\u56fd\u5bb6\u521b\u65b0\u9a71\u52a8\u53d1\u5c55\u6218\u7565\u7eb2\u8981\u300b\u63d0\u51fa: \u9762\u54112020 \u5e74\uff0c\u52a0\u5feb\u5b9e\u65bd\u5df2\u90e8\u7f72\u7684\u56fd\u5bb6\u79d1\u6280\u91cd\u5927\u4e13\u9879\uff0c\u5305\u62ec\u91cd\u5927\u65b0\u836f\u521b\u5236\uff0c\u5e76\u628a\u7814\u53d1\u521b\u65b0\u836f\u7269\u3001\u65b0\u578b\u75ab\u82d7\u3001\u5148\u8fdb\u533b\u7597\u88c5\u5907\u548c\u751f\u7269\u6cbb\u7597\u6280\u672f\u5217\u5165\u6218\u7565\u4efb\u52a1\u3002\u300a\u201c\u5065\u5eb7\u4e2d\u56fd2030\u201d\u89c4\u5212\u300b\u63d0\u51fa: \u5b8c\u5584\u653f\u4ea7\u5b66\u7814\u7528\u534f\u540c\u521b\u65b0\u4f53\u7cfb\uff0c\u63a8\u52a8\u751f\u7269\u533b\u836f\u521b\u65b0\u548c\u751f\u7269\u533b\u836f\u4ea7\u4e1a\u8f6c\u578b\u5347\u7ea7\u3002\u52a0\u5f3a\u4e13\u5229\u836f\u3001\u4e2d\u836f\u65b0\u836f\u3001\u65b0\u578b\u5236\u5242\u7b49\u521b\u65b0\u80fd\u529b\u5efa\u8bbe\uff0c\u63a8\u52a8\u6cbb\u7597\u91cd\u5927\u75be\u75c5\u7684\u4e13\u5229\u5230\u671f\u836f\u7269\u5b9e\u73b0\u4eff\u5236\u4e0a\u5e02\u3002<\/section>\n
\u300a\u4e2d\u56fd\u5236\u90202025\u300b\u5c06\u751f\u7269\u533b\u836f\u4f5c\u4e3a\u91cd\u70b9\u53d1\u5c55\u9886\u57df\u548c\u6218\u7565\u6027\u65b0\u5174\u4ea7\u4e1a\u52a0\u5feb\u57f9\u80b2\u3002\u300a\u201c\u5341\u4e09\u4e94\u201d\u56fd\u5bb6\u79d1\u6280\u521b\u65b0\u89c4\u5212\u300b\u63d0\u51fa\u6301\u7eed\u653b\u514b\u65b0\u836f\u521b\u5236\u5173\u952e\u6838\u5fc3\u6280\u672f\uff0c\u7814\u53d1\u5177\u6709\u56fd\u9645\u7ade\u4e89\u529b\u7684\u91cd\u5927\u6218\u7565\u4ea7\u54c1\u3002\u300a\u201c\u5341\u4e09\u4e94\u201d\u56fd\u5bb6\u793e\u4f1a\u53d1\u5c55\u79d1\u6280\u521b\u65b0\u89c4\u5212\u300b\u63d0\u51fa\u5728\u521b\u65b0\u836f\u7269\u3001\u9ad8\u7aef\u533b\u7597\u5668\u68b0\u7b49\u4ea7\u4e1a\u9886\u57df\u91cd\u70b9\u7a81\u7834\uff0c\u91cd\u70b9\u652f\u6301\u521b\u65b0\u836f\u7269\u3001\u9ad8\u7aef\u533b\u7597\u5668\u68b0\u9f99\u5934\u4f01\u4e1a\u53d1\u5c55\u3002<\/section>\n
3\uff0e2 \u6301\u7eed\u51fa\u53f0\u9f13\u52b1\u521b\u65b0\u653f\u7b56<\/span><\/strong><\/section>\n
2016 \u5e74\u4ee5\u6765\uff0c\u9f13\u52b1\u65b0\u836f\u521b\u5236\u7684\u653f\u7b56\u63aa\u65bd\u63a5\u8fde\u51fa\u53f0\u30022016 \u5e743 \u6708\uff0c\u300a\u5173\u4e8e\u5f00\u5c55\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u610f\u89c1\u300b\u6807\u5fd7\u7740\u4e00\u81f4\u6027\u8bc4\u4ef7\u5de5\u4f5c\u6b63\u5f0f\u542f\u52a8\u3002<\/section>\n
\u4e00\u81f4\u6027\u8bc4\u4ef7\u65e2\u53ef\u8282\u7ea6\u533b\u7597\u8d39\u7528\uff0c\u4e5f\u53ef\u63d0\u5347\u6211\u56fd\u4eff\u5236\u836f\u8d28\u91cf\u548c\u884c\u4e1a\u6574\u4f53\u6c34\u5e73; 2016 \u5e746 \u6708\u300a\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u5236\u5ea6\u8bd5\u70b9\u65b9\u6848\u300b\u6b63\u5f0f\u51fa\u53f0\uff0c\u5bf9\u8c03\u52a8\u79d1\u7814\u4eba\u5458\u7684\u7814\u53d1\u79ef\u6781\u6027\uff0c\u51cf\u5c11\u91cd\u590d\u6295\u8d44\u548c\u91cd\u590d\u5efa\u8bbe\uff0c\u63d0\u5347\u836f\u54c1\u8d28\u91cf\u5f71\u54cd\u6df1\u8fdc\u3002<\/section>\n
2017 \u5e7410 \u6708\uff0c\u300a\u5173\u4e8e\u6df1\u5316\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u9f13\u52b1\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u610f\u89c1\u300b\u5728\u4e94\u5927\u65b9\u9762\u9f13\u52b1\u521b\u65b0: \u6539\u9769\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u3001\u4f18\u5316\u5ba1\u8bc4\u5ba1\u6279\u3001\u52a0\u5f3a\u521b\u65b0\u6743\u76ca\u4fdd\u62a4\u3001\u660e\u786e\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u7684\u8d23\u4efb\u3001\u63d0\u5347\u6280\u672f\u652f\u6491\u7684\u80fd\u529b\u30022017 \u5e7412 \u6708\u300a\u5173\u4e8e\u9f13\u52b1\u836f\u54c1\u521b\u65b0\u5b9e\u884c\u4f18\u5148\u5ba1\u8bc4\u5ba1\u6279\u7684\u610f\u89c1\u300b\u660e\u786e: 7 \u79cd\u5177\u6709\u660e\u663e\u4e34\u5e8a\u4ef7\u503c\u7684\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u53ef\u5217\u5165\u4f18\u5148\u5ba1\u8bc4\u5ba1\u6279\u8303\u56f4\uff0c\u4ee5\u7f29\u77ed\u7279\u9700\u836f\u54c1\u4e0a\u5e02\u65f6\u95f4\uff0c\u63d0\u5347\u6211\u56fd\u533b\u836f\u521b\u65b0\u6c34\u5e73\uff3b6\uff3d\u3002<\/section>\n
2018 \u5e74\uff0c\u201c\u53e4\u4ee3\u7ecf\u5178\u540d\u65b9\u4e2d\u836f\u590d\u65b9\u5236\u5242\u7b80\u5316\u6ce8\u518c\u5ba1\u6279\u7ba1\u7406\u89c4\u5b9a\u201d\u53d1\u5e03\uff0c\u4ee5\u4fc3\u8fdb\u4e2d\u533b\u836f\u4e8b\u4e1a\u7684\u53d1\u5c55\u3002\u8fd9\u4e00\u7cfb\u5217\u653f\u7b56\u63a8\u52a8\u4e86\u836f\u54c1\u8d28\u91cf\u63d0\u9ad8\uff0c\u4fc3\u8fdb\u4e86\u4e0a\u5e02\u836f\u54c1\u7684\u5b89\u5168\u6709\u6548\u548c\u8d28\u91cf\u53ef\u63a7\uff0c\u63d0\u5347\u4e86\u6211\u56fd\u65b0\u836f\u4e0a\u5e02\u901f\u5ea6\uff0c\u5e76\u5c06\u52a0\u901f\u81ea\u52a8\u5316\u3001\u667a\u80fd\u5316\u5236\u9020\u6280\u672f\u5728\u65b0\u836f\u521b\u5236\u9886\u57df\u7684\u5e94\u7528\uff0c\u63a8\u52a8\u6211\u56fd\u5c3d\u5feb\u8fdb\u5165\u201c\u5236\u836f\u5de5\u4e1a4\uff0e0\u201d\u65f6\u4ee3\u3002<\/section>\n
3,3  \u5f15\u5bfc\u533b\u836f\u4f01\u4e1a\u79ef\u6781\u5e94\u5bf9\u548c\u53c2\u4e0e\u56fd\u9645\u7ade\u4e89<\/span><\/strong><\/span><\/section>\n
\u4f34\u968f\u7740\u6211\u56fd\u836f\u5ba1\u5236\u5ea6\u6539\u9769\u4ee5\u53ca\u52a0\u5165\u201c\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u8981\u6c42\u56fd\u9645\u534f\u8c03\u4f1a( ICH) \u201d\uff0c\u6211\u56fd\u533b\u836f\u4f01\u4e1a\u9762\u4e34\u7684\u56fd\u9645\u7ade\u4e89\u5f62\u5f0f\u4e5f\u65e5\u8d8b\u4e25\u5cfb\uff3b7 \uff0d 8\uff3d\u3002<\/section>\n
2015 \u5e74\u4ee5\u6765\uff0c\u6211\u56fd\u7b80\u5316\u4e86\u5883\u5916\u4e0a\u5e02\u65b0\u836f\u5ba1\u6279\u7a0b\u5e8f\uff0c\u7b26\u5408\u6761\u4ef6\u7684\u836f\u54c1\u53ef\u4ee5\u76f4\u63a5\u4ee5\u5883\u5916\u8bd5\u9a8c\u6570\u636e\u7533\u62a5\u4e0a\u5e02\uff0c\u4f7f\u836f\u54c1\u4e0a\u5e02\u65f6\u95f4\u52a0\u5feb1 \uff5e 2 \u5e74\u3002\u963f\u65af\u5229\u5eb7\u516c\u53f8\u4e09\u4ee3EGFR \u6291\u5236\u5242\u5965\u5e0c\u66ff\u5c3c\u548c\u9ed8\u6c99\u4e1c\u516c\u53f8\u7684keytruda\u5206\u522b\u53ea\u7528\u4e867 \u4e2a\u6708\u548c6 \u4e2a\u6708\uff0c\u5c31\u5b8c\u6210\u4e86\u56fd\u5185\u7533\u62a5\u4e0a\u5e02\u6d41\u7a0b\u3002\u5bf9\u4e8e\u8fd9\u4e9b\u70ed\u95e8\u9776\u70b9\uff0c\u6211\u56fd\u65b0\u836f\u521b\u5236\u9762\u4e34\u7740\u8fdb\u53e3\u65b0\u836f\u52a0\u5feb\u4e0a\u5e02\u5e26\u6765\u7684\u51b2\u51fb\u3002<\/section>\n
\u6211\u56fd\u4e8e2017 \u5e74\u52a0\u5165ICH\u3002ICH \u7684\u57fa\u672c\u5b97\u65e8\u662f\u901a\u8fc7\u5efa\u7acb\u56fd\u9645\u6807\u51c6\u548c\u89c4\u8303\uff0c\u51cf\u5c11\u836f\u54c1\u7814\u53d1\u548c\u4e0a\u5e02\u7684\u6210\u672c\u3002\u8fd9\u65e2\u6709\u5229\u4e8e\u52a0\u5feb\u56fd\u5916\u65b0\u836f\u548c\u4e34\u5e8a\u6025\u9700\u4eff\u5236\u836f\u7684\u56fd\u5185\u4e0a\u5e02\uff0c\u6ee1\u8db3\u516c\u4f17\u7528\u836f\u9700\u6c42\uff0c\u4e5f\u6709\u5229\u4e8e\u56fd\u4ea7\u836f\u54c1\u8d70\u5411\u56fd\u9645\u3002<\/section>\n
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\u5e94\u901a\u8fc7\u9f13\u52b1\u4f18\u80dc\u52a3\u6c70\u3001\u6276\u5927\u6276\u5f3a\u7b49\u653f\u7b56\u63aa\u65bd\u63d0\u9ad8\u4ea7\u4e1a\u7684\u89c4\u6a21\u96c6\u4e2d\u5ea6; \u901a\u8fc7\u7a0e\u6536\u51cf\u514d\u3001\u77e5\u8bc6\u4ea7\u6743\u4fdd\u62a4\u7b49\u7ecf\u6d4e\u548c\u793e\u4f1a\u653f\u7b56\u6fc0\u52b1\u4f18\u52bf\u4f01\u4e1a\u52a0\u5927\u7814\u53d1\u6295\u5165\uff0c\u5f15\u5bfc\u4f01\u4e1a\u4e3b\u52a8\u53c2\u4e0e\u65b0\u836f\u521b\u5236\uff0c\u63d0\u9ad8\u7814\u53d1\u7684\u79ef\u6781\u6027\u3002<\/section>\n
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\u672c\u516c\u4f17\u53f7\u53d1\u5e03\u7684\u6587\u7ae0\u5747\u4e3a\u4fc3\u8fdb\u5236\u836f\u754c\u540c\u884c\u7684\u4ea4\u6d41\u4e0e\u5b66\u4e60\uff1b\u672a\u7528\u4e8e\u4efb\u4f55\u5546\u4e1a\u7528\u9014\u3002\u6211\u4eec\u5c0a\u91cd\u539f\u521b\u4f5c\u54c1\u3002\u9009\u53d6\u7684\u6587\u7ae0\u5df2\u660e\u786e\u6ce8\u660e\u6765\u6e90\u548c\u4f5c\u8005\uff0c\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\uff0c\u5982\u6d89\u53ca\u4fb5\u6743\u6216\u5176\u4ed6\u95ee\u9898\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\u8fdb\u884c\u5220\u9664\u3002<\/strong><\/p>\n

\u5185\u5bb9\u7531\u5c0f\u7f16\u67e5\u9605\u6587\u732e\u9009\u53d6\uff0c\u6392\u7248\u4e0e\u7f16\u8f91\u4e3a\u539f\u521b\u3002\u5982\u8f6c\u8f7d\uff0c\u8bf7\u5c0a\u91cd\u52b3\u52a8\u6210\u679c\uff0c\u6ce8\u660e\u6765\u6e90\u4e8e\u516c\u4f17\u53f7\u3002<\/p>\n

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