{"id":104987,"date":"2024-02-01T22:09:00","date_gmt":"2024-02-01T15:09:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/20240201220900104987"},"modified":"2024-02-02T02:27:19","modified_gmt":"2024-02-01T18:27:19","slug":"%e7%bb%bf%e5%8f%b6%e5%88%b6%e8%8d%af%e6%a3%95%e6%a6%88%e9%85%b8%e5%b8%95%e5%88%a9%e5%93%8c%e9%85%ae%e7%bc%93%e9%87%8a%e6%b7%b7%e6%82%ac%e6%b3%a8%e5%b0%84%e6%b6%b2%e5%9c%a8%e7%be%8efda%e5%ae%a1","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/20240201220900104987","title":{"rendered":"\u7eff\u53f6\u5236\u836f\u68d5\u6988\u9178\u5e15\u5229\u54cc\u916e\u7f13\u91ca\u6df7\u60ac\u6ce8\u5c04\u6db2\u5728\u7f8eFDA\u5ba1\u8bc4\u6392\u9664\u4e13\u5229\u969c\u788d"},"content":{"rendered":"

\u4e0a\u6d77<\/span>2024\u5e742\u67081\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u7eff\u53f6\u5236\u836f\u96c6\u56e2\uff082186.HK\uff09\u4e8e\u65e5\u524d\u66f4\u65b0\u5176\u68d5\u6988\u9178\u5e15\u5229\u54cc\u916e\u7f13\u91ca\u6df7\u60ac\u6ce8\u5c04\u6db2\uff08LY03010\uff09\u5728\u7f8e\u56fd\u7684\u65b0\u836f\u4e0a\u5e02\u5ba1\u8bc4\u6700\u65b0\u8fdb\u5c55\u3002\u76ee\u524d\uff0c\u8be5\u4ea7\u54c1\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u53d7\u7406\uff0c\u4e14\u5728\u300a\u7f8e\u56fd\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\u89c4\u5b9a\u7684\u8bc9\u8bbc\u65f6\u9650\u5185\u672a\u88ab\u63d0\u8d77\u4e13\u5229\u4fb5\u6743\u8bc9\u8bbc\uff0c\u610f\u5473\u7740LY03010\u9879\u76ee\u5728FDA\u5ba1\u6279\u8fdb\u7a0b\u4e2d\u7684\u4e13\u5229\u6311\u6218\u83b7\u5f97\u6210\u529f\u3002<\/p>\n

LY03010\u662f\u7eff\u53f6\u5236\u836f\u81ea\u4e3b\u7814\u53d1\u7684\u521b\u65b0\u5236\u5242\uff0c\u7528\u4e8e\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u548c\u5206\u88c2\u60c5\u611f\u6027\u969c\u788d\u3002\u8be5\u4ea7\u54c1\u4e8e2023\u5e74\u83b7\u5f97\u7f8e\u56fd\u53d1\u660e\u4e13\u5229\u6388\u6743\uff0c\u4e13\u5229\u5c06\u4e8e2039\u5e74\u5230\u671f\u3002\u7eff\u53f6\u5236\u836f\u5728\u7f8e\u56fd\u901a\u8fc7505\uff08b\uff09\uff082\uff09\u7684\u9014\u5f84\u5411FDA\u63d0\u4ea4\u4e86LY03010\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u540e\uff0c\u5411INVEGA SUSTENNA®<\/sup>\u7684\u65b0\u836f\u6301\u6709\u4eba\u548c\u4e13\u5229\u6743\u4eba\u53d1\u9001\u4e86\u7b2c\u56db\u6bb5\u4e13\u5229\u58f0\u660e\uff08Paragraph IV\uff09\uff0c\u6839\u636e\u300a\u7f8e\u56fd\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\u7684\u89c4\u5b9a\uff0c\u65b0\u836f\u6301\u6709\u4eba\u548c\u4e13\u5229\u6743\u4eba\u987b\u4e8e\u6536\u5230\u7b2c\u56db\u6bb5\u4e13\u5229\u58f0\u660e\u540e45\u5929\u5185\u8d77\u8bc9\u7eff\u53f6\uff0c\u624d\u4f1a\u89e6\u53d130\u4e2a\u6708\u7684\u505c\u6ede\u671f\u3002<\/p>\n

\u622a\u81f3\u672c\u516c\u544a\u53d1\u5e03\u65f6\uff0c\u89e6\u53d130\u4e2a\u6708\u505c\u6ede\u671f\u7684\u8d77\u8bc9\u671f\u9650\u5df2\u5c4a\u6ee1\uff0c\u7eff\u53f6\u5236\u836f\u5e76\u672a\u88ab\u63d0\u8d77\u8bc9\u8bbc\uff0c\u56e0\u6b64LY03010\u5728\u7f8e\u56fdFDA\u7684\u5ba1\u6279\u8fdb\u7a0b\u65e0\u4e13\u5229\u969c\u788d\u3002\u6839\u636e\u5904\u65b9\u836f\u7533\u62a5\u8005\u4ed8\u8d39\u6cd5\u6848\uff08PDUFA\uff09\uff0cFDA\u5bf9\u4e8eLY03010\u7684\u4e0a\u5e02\u7533\u8bf7\u505a\u51fa\u51b3\u8bae\u7684\u76ee\u6807\u65e5\u671f\u4e3a\u7f8e\u56fd\u65f6\u95f42024\u5e747\u670826\u65e5\u3002\u516c\u53f8\u9884\u8ba1\u5c06\u4e8e\u8be5\u4ea7\u54c1\u5728\u7f8e\u83b7\u6279\u4e0a\u5e02\u540e\u7b2c\u4e00\u65f6\u95f4\u5f00\u5c55\u5728\u7f8e\u56fd\u7684\u5546\u4e1a\u5316\u63a8\u5e7f\u3002\u4e0e\u6b64\u540c\u65f6\uff0cLY03010\u4e5f\u5728\u4e2d\u56fd\u8fdb\u5165\u4e0a\u5e02\u5ba1\u8bc4\u9636\u6bb5\uff0c\u5e76\u5728\u6b27\u6d32\u5f00\u5c55\u5173\u952e\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n

LY03010\u662f\u5e15\u5229\u54cc\u916e\u7684\u957f\u6548\u6ce8\u5c04\u5242\uff0c\u6bcf\u6708\u7ed9\u836f\u4e00\u6b21\uff0c\u5176\u5728\u7f8e\u56fd\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u57fa\u4e8e\u4e00\u9879\u968f\u673a\u3001\u591a\u6b21\u7ed9\u836f\u3001\u5f00\u653e\u3001\u4e0eINVEGA SUSTENNA®<\/sup>\u5e73\u884c\u5bf9\u7167\u7684\u5173\u952e\u4e34\u5e8a\u8bd5\u9a8c\u3002\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff1a\u4e0eINVEGA SUSTENNA®<\/sup>\u7684\u7ed9\u836f\u65b9\u6848\u76f8\u6bd4\uff0cLY03010\u51cf\u5c11\u8d77\u59cb\u7ed9\u836f\u9891\u7387, \u514d\u53bb\u60a3\u8005\u9996\u6b21\u6ce8\u5c04\u540e\u7b2c\u516b\u5929\u7684\u7ed9\u836f\uff0c\u4e14\u53ef\u5b9e\u73b0\u4e0eINVEGA SUSTENNA®<\/sup>\u76f8\u5f53\u7684\u66b4\u9732\u91cf\u3002\u5b89\u5168\u6027\u65b9\u9762\uff1aLY03010\u5177\u6709\u826f\u597d\u7684\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u3002\u8be5\u8bd5\u9a8c\u63d0\u793a\uff1aLY03010\u901a\u8fc7\u4f18\u5316\u7684\u8d77\u59cb\u7ed9\u836f\u65b9\u6848\uff0c\u5728\u786e\u4fdd\u7597\u6548\u548c\u5b89\u5168\u6027\u7684\u540c\u65f6\uff0c\u5c06\u8fdb\u4e00\u6b65\u65b9\u4fbf\u7ed9\u836f\u63d0\u9ad8\u987a\u5e94\u6027\u3002<\/p>\n

\u6bcf\u6708\u7ed9\u836f\u4e00\u6b21\u7684LY03010\uff0c\u6709\u671b\u4e0e\u7eff\u53f6\u5236\u836f\u5df2\u5728\u7f8e\u56fd\u4e0a\u5e02\u7684\u6bcf\u4e24\u5468\u7ed9\u836f\u4e00\u6b21\u7684Rykindo®<\/sup>\uff08\u5229\u57f9\u916e\u7f13\u91ca\u5fae\u7403\u6ce8\u5c04\u5242\uff09\u5f62\u6210\u5177\u6709\u660e\u663e\u4f18\u52bf\u7684\u4ea7\u54c1\u7ec4\u5408\u3002\u76ee\u524d\uff0c\u7eff\u53f6\u5236\u836f\u5df2\u5c31\u8be5\u4ea7\u54c1\u5728\u7f8e\u56fd\u7684\u5546\u4e1a\u5316\u63a8\u5e7f\uff0c\u4e0e\u6f5c\u5728\u7684\u8de8\u56fd\u516c\u53f8\u5408\u4f5c\u4f19\u4f34\u5728\u79ef\u6781\u63a8\u8fdb\u4e2d\u3002<\/p>\n

\u7cbe\u795e\u5206\u88c2\u75c7\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u7cbe\u795e\u7c7b\u75be\u75c5\uff0c\u5728\u5168\u7403\u8303\u56f4\u5185\u56f0\u6270\u7ea62400\u4e07\u4eba[i<\/span>]<\/sup>\u3002\u4f5c\u4e3a\u4e00\u79cd\u53cd\u590d\u53d1\u4f5c\u7684\u6162\u6027\u8fc1\u5ef6\u6027\u75be\u75c5\uff0c\u60a3\u8005\u6cbb\u7597\u4f9d\u4ece\u6027\u4f4e\u800c\u5bfc\u81f4\u7684\u590d\u53d1\u7387\u9ad8\u3001\u75c5\u60c5\u53cd\u590d\uff0c\u6210\u4e3a\u957f\u671f\u4ee5\u6765\u7cbe\u795e\u5206\u88c2\u75c7\u6cbb\u7597\u7684\u4e3b\u8981\u96be\u70b9\u3002\u800c\u957f\u6548\u5242\u578b\u53ef\u8fdb\u4e00\u6b65\u6ee1\u8db3\u4e34\u5e8a\u9700\u6c42\uff0c\u660e\u663e\u6539\u5584\u60a3\u8005\u7684\u6cbb\u7597\u4f9d\u4ece\u6027\u3001\u51cf\u5c11\u590d\u53d1\uff0c\u5df2\u6210\u4e3a\u6297\u7cbe\u795e\u75c5\u6cbb\u7597\u7684\u91cd\u8981\u624b\u6bb5\u3002LY03010\u4e0a\u5e02\u540e\u6709\u671b\u4e3a\u60a3\u8005\u63d0\u4f9b\u65b0\u7684\u6cbb\u7597\u9009\u62e9\u3002\u636e\u516c\u5f00\u4fe1\u606f\u663e\u793a\uff1a\u68d5\u6988\u9178\u5e15\u5229\u54cc\u916e\u957f\u6548\u6ce8\u5c04\u52422023\u5e74\u5728\u5168\u7403\u548c\u7f8e\u56fd\u5e02\u573a\u7684\u9500\u552e\u989d\u5206\u522b\u4e3a41.15\u4ebf\u7f8e\u5143\u548c28.97\u4ebf\u7f8e\u5143\u3002\u3002<\/p>\n

\u7eff\u53f6\u5236\u836f\u96c6\u56e2\u603b\u88c1\u6768\u8363\u5175\u5148\u751f\u8868\u793a\uff1a"LY03010\u6709\u671b\u6210\u4e3a\u9996\u4e2a\u5728\u7f8e\u56fd\u83b7\u6279\u7684\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u56fd\u4ea7\u68d5\u6988\u9178\u5e15\u5229\u54cc\u916e\u957f\u6548\u6ce8\u5c04\u5242\u3002\u5f53\u524d\u8be5\u4ea7\u54c1\u5728\u7f8e\u56fd\u7684\u4e0a\u5e02\u5ba1\u8bc4\u8fdb\u5c55\u7b26\u5408\u9884\u671f\uff0c\u76f8\u5173\u4e13\u5229\u95ee\u9898\u7684\u8fdb\u5c55\u8fdb\u4e00\u6b65\u589e\u5f3a\u4e86\u6211\u4eec\u5bf9\u4e8e\u5176\u80fd\u591f\u5982\u671f\u83b7\u6279\u7684\u4fe1\u5fc3\u3002\u6211\u4eec\u5c06\u79ef\u6781\u914d\u5408FDA\u7684\u5ba1\u8bc4\u8981\u6c42\uff0c\u5e76\u4e3a\u63a5\u4e0b\u6765\u7684\u4e0a\u5e02\u6279\u51c6\u524d\u68c0\u67e5\uff08PAI\uff0cPre-Approval Inspection\uff09\u505a\u597d\u5168\u9762\u51c6\u5907\u3002\u671f\u5f85\u8be5\u4ea7\u54c1\u80fd\u591f\u5c3d\u65e9\u60e0\u53ca\u5168\u7403\u60a3\u8005\uff0c\u670d\u52a1\u4e34\u5e8a\u6cbb\u7597\u6240\u9700\u3002"<\/p>\n

\u7cbe\u795e\u5206\u88c2\u75c7\u6240\u5728\u7684\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\uff08CNS\uff09\u6cbb\u7597\u9886\u57df\u662f\u7eff\u53f6\u5236\u836f\u6218\u7565\u5e03\u5c40\u7684\u6838\u5fc3\u6cbb\u7597\u9886\u57df\u4e4b\u4e00\u3002\u516c\u53f8\u5df2\u56f4\u7ed5\u8be5\u6cbb\u7597\u9886\u57df\u5f62\u6210\u4e00\u7cfb\u5217\u5177\u6709\u5dee\u5f02\u5316\u4f18\u52bf\u7684\u4ea7\u54c1\u7ec4\u5408\uff1a\u5728\u7f8e\u83b7\u6279\u7684Rykindo®<\/sup>\uff08\u5229\u57f9\u916e\u7f13\u91ca\u5fae\u7403\u6ce8\u5c04\u5242\uff09\u6210\u4e3a\u9996\u4e2a\u7531\u4e2d\u56fd\u836f\u4f01\u81ea\u4e3b\u7814\u53d1\u5e76\u5728\u7f8e\u83b7\u6279\u7684CNS\u65b0\u836f\uff1b\u5728\u534e\u83b7\u6279\u76841\u7c7b\u65b0\u836f\u82e5\u6b23\u6797®<\/sup>\uff08\u76d0\u9178\u6258\u9c81\u5730\u6587\u62c9\u6cd5\u8f9b\u7f13\u91ca\u7247\uff09\u4e3a\u4e2d\u56fd\u9996\u4e2a\u81ea\u4e3b\u7814\u53d1\u7684\u3001\u7528\u4e8e\u6cbb\u7597\u6291\u90c1\u75c7\u7684\u5316\u836f1\u7c7b\u521b\u65b0\u836f\u3002\u53e6\u6709\u601d\u745e\u5eb7®<\/sup>\uff08\u5bcc\u9a6c\u9178\u55b9\u786b\u5e73\uff09\u53ca\u5176\u7f13\u91ca\u7247\u3001\u6bcf\u65e5\u7ed9\u836f\u4e00\u6b21\u7684\u5229\u65af\u7684\u660e\u900f\u76ae\u8d34\u5242\u5728\u4e2d\u56fd\u53ca\u6d77\u5916\u5e02\u573a\u9500\u552e\uff0c\u6bcf\u5468\u7ed9\u836f\u4e24\u6b21\u7684\u5229\u65af\u7684\u660e\u900f\u76ae\u8d34\u5242\u5728\u4e2d\u56fd\u548c\u6b27\u6d32\u4e3b\u8981\u56fd\u5bb6\u4e0a\u5e02\u9500\u552e\u3002<\/p>\n

\u5728\u7814\u4ea7\u54c1\u4e2d\uff0c\u6ce8\u5c04\u7528\u7f57\u66ff\u9ad8\u6c40\u7f13\u91ca\u5fae\u7403\uff08LY03003\uff09\u4e5f\u5728\u4e2d\u56fd\u548c\u6d77\u5916\u5e02\u573a\u540c\u6b65\u5f00\u53d1\uff0c\u5176\u5728\u4e2d\u56fd\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u88ab\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u5ba1\u6279\u7a0b\u5e8f\uff1b\u53e6\u6709VMAT2\u6291\u5236\u5242LY03015\u7b49\u591a\u4e2a\u5728\u7814\u65b0\u836f\u5728\u4e2d\u56fd\u53ca\u6d77\u5916\u5904\u4e8e\u4e34\u5e8a\u9636\u6bb5\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u8d77\u8f83\u6709\u4f18\u52bf\u7684\u56fd\u9645\u5316\u7814\u53d1\u3001\u6ce8\u518c\u4e34\u5e8a\u3001\u4f9b\u5e94\u94fe\u4e0e\u5546\u4e1a\u5316\u80fd\u529b\uff0c\u4e3a\u672a\u6765\u65b0\u4ea7\u54c1\u7684\u5168\u7403\u5546\u4e1a\u5316\u5960\u5b9a\u575a\u5b9e\u57fa\u7840\u3002<\/p>\n

\u5173\u4e8e\u7eff\u53f6\u5236\u836f\u96c6\u56e2<\/u><\/b><\/p>\n

\u7eff\u53f6\u5236\u836f\u96c6\u56e2\u662f\u81f4\u529b\u4e8e\u521b\u65b0\u836f\u7269\u7684\u7814\u53d1\u3001\u751f\u4ea7\u548c\u9500\u552e\u7684\u56fd\u9645\u5316\u5236\u836f\u516c\u53f8\u3002\u7eff\u53f6\u5236\u836f\u5728\u4e2d\u56fd\u3001\u7f8e\u56fd\u548c\u6b27\u6d32\u8bbe\u6709\u7814\u53d1\u4e2d\u5fc3\uff0c\u62e5\u6709\u8d85\u8fc730\u4e2a\u4e2d\u56fd\u5728\u7814\u836f\u7269\u548c10\u591a\u4e2a\u6d77\u5916\u5728\u7814\u836f\u7269\u3002\u7eff\u53f6\u5236\u836f\u5728\u5fae\u7403\u3001\u8102\u8d28\u4f53\u3001\u900f\u76ae\u91ca\u836f\u7b49\u5148\u8fdb\u836f\u7269\u9012\u9001\u6280\u672f\u9886\u57df\u8fbe\u5230\u56fd\u9645\u5148\u8fdb\u6c34\u5e73\uff0c\u5728\u65b0\u5206\u5b50\u5b9e\u4f53\u3001\u751f\u7269\u6297\u4f53\u9886\u57df\u6536\u83b7\u591a\u9879\u521b\u65b0\u6210\u679c\uff0c\u5e76\u5728\u7ec6\u80de\u6cbb\u7597\u3001\u57fa\u56e0\u6cbb\u7597\u7b49\u9886\u57df\u8fdb\u884c\u4e86\u79ef\u6781\u5e03\u5c40\u548c\u5f00\u53d1\u3002<\/p>\n

\u7eff\u53f6\u5236\u836f\u6df1\u5ea6\u5e03\u5c40\u5168\u7403\u4f9b\u5e94\u94fe\u4f53\u7cfb\uff0c\u5df2\u5728\u5168\u7403\u5efa\u67098\u5927\u751f\u4ea7\u57fa\u5730\u5e76\u5efa\u7acb\u4e86\u4e0e\u56fd\u9645\u63a5\u8f68\u7684GMP\u8d28\u91cf\u7ba1\u7406\u548c\u63a7\u5236\u4f53\u7cfb\u3002\u516c\u53f8\u73b0\u670930\u4f59\u4e2a\u4e0a\u5e02\u4ea7\u54c1\uff0c\u4ea7\u54c1\u8986\u76d6\u80bf\u7624\u3001\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u3001\u5fc3\u8840\u7ba1\u3001\u6d88\u5316\u4e0e\u4ee3\u8c22\u7b49\u6cbb\u7597\u9886\u57df\uff1b\u4e1a\u52a1\u904d\u53ca\u5168\u740380\u591a\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\uff0c\u5176\u4e2d\u5305\u62ec\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u6b27\u6d32\u3001\u65e5\u672c\u7b49\u5168\u7403\u4e3b\u8981\u533b\u836f\u5e02\u573a\uff0c\u4ee5\u53ca\u9ad8\u901f\u589e\u957f\u7684\u5404\u5730\u65b0\u5174\u5e02\u573a\u3002<\/p>\n

\n\n\n\n
\n

[i] \u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u5b98\u7f51: https:\/\/www.who.int\/zh\/news-room\/fact-sheets\/detail\/schizophrenia<\/a><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

\u4e0a\u6d772024\u5e742\u67081\u65e5 \/\u7f8e\u901a\u793e\/ — \u7eff\u53f6\u5236\u836f\u96c6\u56e2\uff082186.HK\uff09\u4e8e\u65e5\u524d\u66f4\u65b0\u5176\u68d5\u6988\u9178\u5e15\u5229\u54cc\u916e\u7f13\u91ca\u6df7\u60ac\u6ce8\u5c04\u6db2\uff08LY03010\uff09\u5728\u7f8e\u56fd\u7684\u65b0\u836f\u4e0a\u5e02\u5ba1\u8bc4\u6700\u65b0\u8fdb\u5c55\u3002\u76ee\u524d\uff0c\u8be5\u4ea7\u54c1\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u53d7\u7406\uff0c\u4e14\u5728\u300a\u7f8e\u56fd\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\u89c4\u5b9a\u7684\u8bc9\u8bbc\u65f6\u9650\u5185\u672a\u88ab\u63d0\u8d77\u4e13\u5229\u4fb5\u6743\u8bc9\u8bbc\uff0c\u610f\u5473\u7740LY03010\u9879\u76ee\u5728FDA\u5ba1\u6279\u8fdb\u7a0b\u4e2d\u7684\u4e13\u5229\u6311\u6218\u83b7\u5f97\u6210\u529f\u3002 LY03010\u662f\u7eff\u53f6\u5236\u836f\u81ea\u4e3b\u7814\u53d1\u7684\u521b\u65b0\u5236\u5242\uff0c\u7528\u4e8e\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u548c\u5206\u88c2\u60c5\u611f\u6027\u969c\u788d\u3002\u8be5\u4ea7\u54c1\u4e8e2023\u5e74\u83b7\u5f97\u7f8e\u56fd\u53d1\u660e\u4e13\u5229\u6388\u6743\uff0c\u4e13\u5229\u5c06\u4e8e2039\u5e74\u5230\u671f\u3002\u7eff\u53f6\u5236\u836f\u5728\u7f8e\u56fd\u901a\u8fc7505\uff08b\uff09\uff082\uff09\u7684\u9014\u5f84\u5411FDA\u63d0\u4ea4\u4e86LY03010\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u540e\uff0c\u5411INVEGA SUSTENNA®\u7684\u65b0\u836f\u6301\u6709\u4eba\u548c\u4e13\u5229\u6743\u4eba\u53d1\u9001\u4e86\u7b2c\u56db\u6bb5\u4e13\u5229\u58f0\u660e\uff08Paragraph IV\uff09\uff0c\u6839\u636e\u300a\u7f8e\u56fd\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\u7684\u89c4\u5b9a\uff0c\u65b0\u836f\u6301\u6709\u4eba\u548c\u4e13\u5229\u6743\u4eba\u987b\u4e8e\u6536\u5230\u7b2c\u56db\u6bb5\u4e13\u5229\u58f0\u660e\u540e45\u5929\u5185\u8d77\u8bc9\u7eff\u53f6\uff0c\u624d\u4f1a\u89e6\u53d130\u4e2a\u6708\u7684\u505c\u6ede\u671f\u3002 \u622a\u81f3\u672c\u516c\u544a\u53d1\u5e03\u65f6\uff0c\u89e6\u53d130\u4e2a\u6708\u505c\u6ede\u671f\u7684\u8d77\u8bc9\u671f\u9650\u5df2\u5c4a\u6ee1\uff0c\u7eff\u53f6\u5236\u836f\u5e76\u672a\u88ab\u63d0\u8d77\u8bc9\u8bbc\uff0c\u56e0\u6b64LY03010\u5728\u7f8e\u56fdFDA\u7684\u5ba1\u6279\u8fdb\u7a0b\u65e0\u4e13\u5229\u969c\u788d\u3002\u6839\u636e\u5904\u65b9\u836f\u7533\u62a5\u8005\u4ed8\u8d39\u6cd5\u6848\uff08PDUFA\uff09\uff0cFDA\u5bf9\u4e8eLY03010\u7684\u4e0a\u5e02\u7533\u8bf7\u505a\u51fa\u51b3\u8bae\u7684\u76ee\u6807\u65e5\u671f\u4e3a\u7f8e\u56fd\u65f6\u95f42024\u5e747\u670826\u65e5\u3002\u516c\u53f8\u9884\u8ba1\u5c06\u4e8e\u8be5\u4ea7\u54c1\u5728\u7f8e\u83b7\u6279\u4e0a\u5e02\u540e\u7b2c\u4e00\u65f6\u95f4\u5f00\u5c55\u5728\u7f8e\u56fd\u7684\u5546\u4e1a\u5316\u63a8\u5e7f\u3002\u4e0e\u6b64\u540c\u65f6\uff0cLY03010\u4e5f\u5728\u4e2d\u56fd\u8fdb\u5165\u4e0a\u5e02\u5ba1\u8bc4\u9636\u6bb5\uff0c\u5e76\u5728\u6b27\u6d32\u5f00\u5c55\u5173\u952e\u4e34\u5e8a\u8bd5\u9a8c\u3002 LY03010\u662f\u5e15\u5229\u54cc\u916e\u7684\u957f\u6548\u6ce8\u5c04\u5242\uff0c\u6bcf\u6708\u7ed9\u836f\u4e00\u6b21\uff0c\u5176\u5728\u7f8e\u56fd\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u57fa\u4e8e\u4e00\u9879\u968f\u673a\u3001\u591a\u6b21\u7ed9\u836f\u3001\u5f00\u653e\u3001\u4e0eINVEGA SUSTENNA®\u5e73\u884c\u5bf9\u7167\u7684\u5173\u952e\u4e34\u5e8a\u8bd5\u9a8c\u3002\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff1a\u4e0eINVEGA SUSTENNA®\u7684\u7ed9\u836f\u65b9\u6848\u76f8\u6bd4\uff0cLY03010\u51cf\u5c11\u8d77\u59cb\u7ed9\u836f\u9891\u7387, \u514d\u53bb\u60a3\u8005\u9996\u6b21\u6ce8\u5c04\u540e\u7b2c\u516b\u5929\u7684\u7ed9\u836f\uff0c\u4e14\u53ef\u5b9e\u73b0\u4e0eINVEGA SUSTENNA®\u76f8\u5f53\u7684\u66b4\u9732\u91cf\u3002\u5b89\u5168\u6027\u65b9\u9762\uff1aLY03010\u5177\u6709\u826f\u597d\u7684\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u3002\u8be5\u8bd5\u9a8c\u63d0\u793a\uff1aLY03010\u901a\u8fc7\u4f18\u5316\u7684\u8d77\u59cb\u7ed9\u836f\u65b9\u6848\uff0c\u5728\u786e\u4fdd\u7597\u6548\u548c\u5b89\u5168\u6027\u7684\u540c\u65f6\uff0c\u5c06\u8fdb\u4e00\u6b65\u65b9\u4fbf\u7ed9\u836f\u63d0\u9ad8\u987a\u5e94\u6027\u3002 \u6bcf\u6708\u7ed9\u836f\u4e00\u6b21\u7684LY03010\uff0c\u6709\u671b\u4e0e\u7eff\u53f6\u5236\u836f\u5df2\u5728\u7f8e\u56fd\u4e0a\u5e02\u7684\u6bcf\u4e24\u5468\u7ed9\u836f\u4e00\u6b21\u7684Rykindo®\uff08\u5229\u57f9\u916e\u7f13\u91ca\u5fae\u7403\u6ce8\u5c04\u5242\uff09\u5f62\u6210\u5177\u6709\u660e\u663e\u4f18\u52bf\u7684\u4ea7\u54c1\u7ec4\u5408\u3002\u76ee\u524d\uff0c\u7eff\u53f6\u5236\u836f\u5df2\u5c31\u8be5\u4ea7\u54c1\u5728\u7f8e\u56fd\u7684\u5546\u4e1a\u5316\u63a8\u5e7f\uff0c\u4e0e\u6f5c\u5728\u7684\u8de8\u56fd\u516c\u53f8\u5408\u4f5c\u4f19\u4f34\u5728\u79ef\u6781\u63a8\u8fdb\u4e2d\u3002 \u7cbe\u795e\u5206\u88c2\u75c7\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u7cbe\u795e\u7c7b\u75be\u75c5\uff0c\u5728\u5168\u7403\u8303\u56f4\u5185\u56f0\u6270\u7ea62400\u4e07\u4eba[i]\u3002\u4f5c\u4e3a\u4e00\u79cd\u53cd\u590d\u53d1\u4f5c\u7684\u6162\u6027\u8fc1\u5ef6\u6027\u75be\u75c5\uff0c\u60a3\u8005\u6cbb\u7597\u4f9d\u4ece\u6027\u4f4e\u800c\u5bfc\u81f4\u7684\u590d\u53d1\u7387\u9ad8\u3001\u75c5\u60c5\u53cd\u590d\uff0c\u6210\u4e3a\u957f\u671f\u4ee5\u6765\u7cbe\u795e\u5206\u88c2\u75c7\u6cbb\u7597\u7684\u4e3b\u8981\u96be\u70b9\u3002\u800c\u957f\u6548\u5242\u578b\u53ef\u8fdb\u4e00\u6b65\u6ee1\u8db3\u4e34\u5e8a\u9700\u6c42\uff0c\u660e\u663e\u6539\u5584\u60a3\u8005\u7684\u6cbb\u7597\u4f9d\u4ece\u6027\u3001\u51cf\u5c11\u590d\u53d1\uff0c\u5df2\u6210\u4e3a\u6297\u7cbe\u795e\u75c5\u6cbb\u7597\u7684\u91cd\u8981\u624b\u6bb5\u3002LY03010\u4e0a\u5e02\u540e\u6709\u671b\u4e3a\u60a3\u8005\u63d0\u4f9b\u65b0\u7684\u6cbb\u7597\u9009\u62e9\u3002\u636e\u516c\u5f00\u4fe1\u606f\u663e\u793a\uff1a\u68d5\u6988\u9178\u5e15\u5229\u54cc\u916e\u957f\u6548\u6ce8\u5c04\u52422023\u5e74\u5728\u5168\u7403\u548c\u7f8e\u56fd\u5e02\u573a\u7684\u9500\u552e\u989d\u5206\u522b\u4e3a41.15\u4ebf\u7f8e\u5143\u548c28.97\u4ebf\u7f8e\u5143\u3002\u3002 \u7eff\u53f6\u5236\u836f\u96c6\u56e2\u603b\u88c1\u6768\u8363\u5175\u5148\u751f\u8868\u793a\uff1a"LY03010\u6709\u671b\u6210\u4e3a\u9996\u4e2a\u5728\u7f8e\u56fd\u83b7\u6279\u7684\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u56fd\u4ea7\u68d5\u6988\u9178\u5e15\u5229\u54cc\u916e\u957f\u6548\u6ce8\u5c04\u5242\u3002\u5f53\u524d\u8be5\u4ea7\u54c1\u5728\u7f8e\u56fd\u7684\u4e0a\u5e02\u5ba1\u8bc4\u8fdb\u5c55\u7b26\u5408\u9884\u671f\uff0c\u76f8\u5173\u4e13\u5229\u95ee\u9898\u7684\u8fdb\u5c55\u8fdb\u4e00\u6b65\u589e\u5f3a\u4e86\u6211\u4eec\u5bf9\u4e8e\u5176\u80fd\u591f\u5982\u671f\u83b7\u6279\u7684\u4fe1\u5fc3\u3002\u6211\u4eec\u5c06\u79ef\u6781\u914d\u5408FDA\u7684\u5ba1\u8bc4\u8981\u6c42\uff0c\u5e76\u4e3a\u63a5\u4e0b\u6765\u7684\u4e0a\u5e02\u6279\u51c6\u524d\u68c0\u67e5\uff08PAI\uff0cPre-Approval Inspection\uff09\u505a\u597d\u5168\u9762\u51c6\u5907\u3002\u671f\u5f85\u8be5\u4ea7\u54c1\u80fd\u591f\u5c3d\u65e9\u60e0\u53ca\u5168\u7403\u60a3\u8005\uff0c\u670d\u52a1\u4e34\u5e8a\u6cbb\u7597\u6240\u9700\u3002" \u7cbe\u795e\u5206\u88c2\u75c7\u6240\u5728\u7684\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\uff08CNS\uff09\u6cbb\u7597\u9886\u57df\u662f\u7eff\u53f6\u5236\u836f\u6218\u7565\u5e03\u5c40\u7684\u6838\u5fc3\u6cbb\u7597\u9886\u57df\u4e4b\u4e00\u3002\u516c\u53f8\u5df2\u56f4\u7ed5\u8be5\u6cbb\u7597\u9886\u57df\u5f62\u6210\u4e00\u7cfb\u5217\u5177\u6709\u5dee\u5f02\u5316\u4f18\u52bf\u7684\u4ea7\u54c1\u7ec4\u5408\uff1a\u5728\u7f8e\u83b7\u6279\u7684Rykindo®\uff08\u5229\u57f9\u916e\u7f13\u91ca\u5fae\u7403\u6ce8\u5c04\u5242\uff09\u6210\u4e3a\u9996\u4e2a\u7531\u4e2d\u56fd\u836f\u4f01\u81ea\u4e3b\u7814\u53d1\u5e76\u5728\u7f8e\u83b7\u6279\u7684CNS\u65b0\u836f\uff1b\u5728\u534e\u83b7\u6279\u76841\u7c7b\u65b0\u836f\u82e5\u6b23\u6797®\uff08\u76d0\u9178\u6258\u9c81\u5730\u6587\u62c9\u6cd5\u8f9b\u7f13\u91ca\u7247\uff09\u4e3a\u4e2d\u56fd\u9996\u4e2a\u81ea\u4e3b\u7814\u53d1\u7684\u3001\u7528\u4e8e\u6cbb\u7597\u6291\u90c1\u75c7\u7684\u5316\u836f1\u7c7b\u521b\u65b0\u836f\u3002\u53e6\u6709\u601d\u745e\u5eb7®\uff08\u5bcc\u9a6c\u9178\u55b9\u786b\u5e73\uff09\u53ca\u5176\u7f13\u91ca\u7247\u3001\u6bcf\u65e5\u7ed9\u836f\u4e00\u6b21\u7684\u5229\u65af\u7684\u660e\u900f\u76ae\u8d34\u5242\u5728\u4e2d\u56fd\u53ca\u6d77\u5916\u5e02\u573a\u9500\u552e\uff0c\u6bcf\u5468\u7ed9\u836f\u4e24\u6b21\u7684\u5229\u65af\u7684\u660e\u900f\u76ae\u8d34\u5242\u5728\u4e2d\u56fd\u548c\u6b27\u6d32\u4e3b\u8981\u56fd\u5bb6\u4e0a\u5e02\u9500\u552e\u3002 \u5728\u7814\u4ea7\u54c1\u4e2d\uff0c\u6ce8\u5c04\u7528\u7f57\u66ff\u9ad8\u6c40\u7f13\u91ca\u5fae\u7403\uff08LY03003\uff09\u4e5f\u5728\u4e2d\u56fd\u548c\u6d77\u5916\u5e02\u573a\u540c\u6b65\u5f00\u53d1\uff0c\u5176\u5728\u4e2d\u56fd\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u88ab\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u5ba1\u6279\u7a0b\u5e8f\uff1b\u53e6\u6709VMAT2\u6291\u5236\u5242LY03015\u7b49\u591a\u4e2a\u5728\u7814\u65b0\u836f\u5728\u4e2d\u56fd\u53ca\u6d77\u5916\u5904\u4e8e\u4e34\u5e8a\u9636\u6bb5\u3002\u516c\u53f8\u5df2\u5efa\u7acb\u8d77\u8f83\u6709\u4f18\u52bf\u7684\u56fd\u9645\u5316\u7814\u53d1\u3001\u6ce8\u518c\u4e34\u5e8a\u3001\u4f9b\u5e94\u94fe\u4e0e\u5546\u4e1a\u5316\u80fd\u529b\uff0c\u4e3a\u672a\u6765\u65b0\u4ea7\u54c1\u7684\u5168\u7403\u5546\u4e1a\u5316\u5960\u5b9a\u575a\u5b9e\u57fa\u7840\u3002 \u5173\u4e8e\u7eff\u53f6\u5236\u836f\u96c6\u56e2 \u7eff\u53f6\u5236\u836f\u96c6\u56e2\u662f\u81f4\u529b\u4e8e\u521b\u65b0\u836f\u7269\u7684\u7814\u53d1\u3001\u751f\u4ea7\u548c\u9500\u552e\u7684\u56fd\u9645\u5316\u5236\u836f\u516c\u53f8\u3002\u7eff\u53f6\u5236\u836f\u5728\u4e2d\u56fd\u3001\u7f8e\u56fd\u548c\u6b27\u6d32\u8bbe\u6709\u7814\u53d1\u4e2d\u5fc3\uff0c\u62e5\u6709\u8d85\u8fc730\u4e2a\u4e2d\u56fd\u5728\u7814\u836f\u7269\u548c10\u591a\u4e2a\u6d77\u5916\u5728\u7814\u836f\u7269\u3002\u7eff\u53f6\u5236\u836f\u5728\u5fae\u7403\u3001\u8102\u8d28\u4f53\u3001\u900f\u76ae\u91ca\u836f\u7b49\u5148\u8fdb\u836f\u7269\u9012\u9001\u6280\u672f\u9886\u57df\u8fbe\u5230\u56fd\u9645\u5148\u8fdb\u6c34\u5e73\uff0c\u5728\u65b0\u5206\u5b50\u5b9e\u4f53\u3001\u751f\u7269\u6297\u4f53\u9886\u57df\u6536\u83b7\u591a\u9879\u521b\u65b0\u6210\u679c\uff0c\u5e76\u5728\u7ec6\u80de\u6cbb\u7597\u3001\u57fa\u56e0\u6cbb\u7597\u7b49\u9886\u57df\u8fdb\u884c\u4e86\u79ef\u6781\u5e03\u5c40\u548c\u5f00\u53d1\u3002 \u7eff\u53f6\u5236\u836f\u6df1\u5ea6\u5e03\u5c40\u5168\u7403\u4f9b\u5e94\u94fe\u4f53\u7cfb\uff0c\u5df2\u5728\u5168\u7403\u5efa\u67098\u5927\u751f\u4ea7\u57fa\u5730\u5e76\u5efa\u7acb\u4e86\u4e0e\u56fd\u9645\u63a5\u8f68\u7684GMP\u8d28\u91cf\u7ba1\u7406\u548c\u63a7\u5236\u4f53\u7cfb\u3002\u516c\u53f8\u73b0\u670930\u4f59\u4e2a\u4e0a\u5e02\u4ea7\u54c1\uff0c\u4ea7\u54c1\u8986\u76d6\u80bf\u7624\u3001\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u3001\u5fc3\u8840\u7ba1\u3001\u6d88\u5316\u4e0e\u4ee3\u8c22\u7b49\u6cbb\u7597\u9886\u57df\uff1b\u4e1a\u52a1\u904d\u53ca\u5168\u740380\u591a\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\uff0c\u5176\u4e2d\u5305\u62ec\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u6b27\u6d32\u3001\u65e5\u672c\u7b49\u5168\u7403\u4e3b\u8981\u533b\u836f\u5e02\u573a\uff0c\u4ee5\u53ca\u9ad8\u901f\u589e\u957f\u7684\u5404\u5730\u65b0\u5174\u5e02\u573a\u3002 [i] \u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u5b98\u7f51: https:\/\/www.who.int\/zh\/news-room\/fact-sheets\/detail\/schizophrenia  … Read More<\/a><\/p>\n","protected":false},"author":556,"featured_media":0,"comment_status":"close","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1965],"tags":[],"class_list":["post-104987","post","type-post","status-publish","format-standard","hentry","category-partnerships"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/104987","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/users\/556"}],"replies":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/comments?post=104987"}],"version-history":[{"count":1,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/104987\/revisions"}],"predecessor-version":[{"id":104988,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/104987\/revisions\/104988"}],"wp:attachment":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/media?parent=104987"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/categories?post=104987"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/tags?post=104987"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}