{"id":32520,"date":"2021-06-01T12:53:00","date_gmt":"2021-06-01T05:53:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2021060112530032520"},"modified":"2021-06-01T21:41:12","modified_gmt":"2021-06-01T13:41:12","slug":"%e4%b8%87%e6%98%a5%e6%8d%b7%e6%8a%a5%ef%bc%81fda%e5%8f%97%e7%90%86%e6%99%ae%e9%82%a3%e5%b8%83%e6%9e%97nda%e5%b9%b6%e6%8e%88%e4%ba%88%e4%bc%98%e5%85%88%e5%ae%a1%e8%af%84%e8%b5%84","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2021060112530032520","title":{"rendered":"\u4e07\u6625\u6377\u62a5\uff01FDA\u53d7\u7406\u666e\u90a3\u5e03\u6797NDA\u5e76\u6388\u4e88\u201c\u4f18\u5148\u5ba1\u8bc4\u201d\u8d44\u683c"},"content":{"rendered":"<p><p>\u7ebd\u7ea62021\u5e746\u67081\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; <span id=\"spanHghltd1c2\">\u4e07\u6625<\/span>\u533b\u836f\uff08NASDAQ\uff1aBYSI\uff09\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u5f00\u53d1\u65b0\u578b\u514d\u75ab\u6297\u80bf\u7624\u7597\u6cd5\u7684\u5168\u7403\u6027\u5236\u836f\u516c\u53f8\uff0c<span id=\"spanHghlte4c0\">\u4eca\u65e5<\/span>\u5ba3\u5e03\u516c\u53f8\u6838\u5fc3\u4ea7\u54c1\u201c\u6ce8\u5c04\u7528\u666e\u90a3\u5e03\u6797\u6d53\u6eb6\u6db2\u201d\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\u5df2\u6b63\u5f0f\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d7\u7406\uff08NDA215340\uff09\uff0c\u672c\u6b21\u7533\u8bf7\u7684\u9002\u5e94\u75c7\u662f\u7528\u4e8e\u5316\u7597\u5bfc\u81f4\u7684\u91cd\u5ea6\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u75c7\uff08CIN\uff09\uff1b\u540c\u65f6\uff0c\u666e\u90a3\u5e03\u6797\u88abFDA\u7eb3\u5165\u201c\u4f18\u5148\u5ba1\u8bc4\u201d\uff08Priority <span id=\"spanHghlt9003\">review<\/span>\uff09\u3002<\/p>\n<p>\u4f18\u5148\u5ba1\u8bc4\u901a\u5e38\u9002\u7528\u4e8e\u80fd\u660e\u663e\u6539\u5584\u91cd\u5927\u75be\u75c5\u7684\u6cbb\u7597\u3001\u9884\u9632\u6216\u8bca\u65ad\u7684\u5728\u7814\u7597\u6cd5\u3002\u6b64\u524d\uff0c\u666e\u90a3\u5e03\u6797\u5df2\u4e8e2020\u5e749\u6708\u83b7\u5f97\u4e2d\u3001\u7f8e\u836f\u76d1\u673a\u6784\u6388\u4e88\u7684\u201c\u7a81\u7834\u6027\u6cbb\u7597\u54c1\u79cd\u201d\u201c\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u201d\uff08BTD\uff09\uff0c\u8be5\u8ba4\u5b9a\u65e8\u5728\u52a0\u5feb\u6f5c\u5728\u65b0\u836f\u7684\u5f00\u53d1\u548c\u5ba1\u8bc4\u3002\u4e00\u822c\u6765\u8bf4\uff0cFDA\u7684\u201c\u4f18\u5148\u5ba1\u8bc4\u201d\u5c06\u65b0\u836fNDA\u7684\u4e0a\u5e02\u6807\u51c6\u5ba1\u8bc4\u65f6\u95f4\u4ece\u53d7\u7406\u4e4b\u65e5\u8d77\u768410\u4e2a\u6708\u7f29\u77ed\u81f36\u4e2a\u6708\u3002\u6839\u636e\u5904\u65b9\u836f\u4f01\u4e1a\u4ed8\u8d39\u6cd5\u6848<span id=\"spanHghlt6db0\">\u3010\u6ce81\u3011\uff0c<\/span>FDA\u5c06\u57282021\u5e7411\u670830\u65e5\u524d\u5b8c\u6210\u5bf9\u666e\u90a3\u5e03\u6797\u8be5NDA\u7684\u5ba1\u67e5\u3002<\/p>\n<p>\u6b64\u524d\u4e0d\u4e45\uff0c\u4e07\u6625\u533b\u836f\u57fa\u4e8e\u666e\u90a3\u5e03\u6797\u7684\u56fd\u9645\u591a\u4e2d\u5fc3III\u671f\u4e34\u5e8a\u8bd5\u9a8cPROTECTIVE-2\u7814\u7a76\u7ed3\u679c\uff0c\u540c\u6b65\u5411\u4e2d\u3001\u7f8e\u836f\u76d1\u673a\u6784\u63d0\u4ea4\u4e86NDA\uff0c\u7533\u8bf7\u5c06\u666e\u90a3\u5e03\u6797\u4e0e\u805a\u4e59\u4e8c\u9187\u5316\u91cd\u7ec4\u4eba\u7c92\u7ec6\u80de\u523a\u6fc0\u56e0\u5b50\u8054\u5408\u5e94\u7528\uff0c\u7528\u4e8e\u6210\u5e74\u975e\u9ad3\u6027\u6076\u6027\u80bf\u7624\u60a3\u8005\u5316\u7597\u5bfc\u81f4\u7684\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u75c7\uff08CIN\uff09\u3002\u6839\u636ePROTECTIVE-2\u7814\u7a76\u516c\u5e03\u7684\u7ed3\u679c\uff0c\u5728CIN\u7684\u9884\u9632\u65b9\u9762\uff0c\u666e\u90a3\u5e03\u6797\u4e0e\u57f9\u975e\u683c\u53f8\u4ead\u7684\u8054\u5408\u6cbb\u7597\u663e\u8457\u4f18\u4e8e\u5f53\u524d\u7684\u57f9\u975e\u683c\u53f8\u4ead\u5355\u836f\u6807\u51c6\u6cbb\u7597\uff0c\u8be5\u9879\u5173\u952e\u4e34\u5e8a\u7814\u7a76\u5728\u4e3b\u8981\u548c\u6240\u6709\u5173\u952e\u6b21\u8981\u7ec8\u70b9\u65b9\u9762\u5747\u90fd\u8fbe\u5230\u4f18\u6548\u6027\u3002<\/p>\n<p><b>\u8054\u5408\u6cbb\u7597\u5f00\u521b\u4e86<\/b><b>CIN\u9884\u9632\u7684\u65b0\u7eaa\u5143<\/b><\/p>\n<p>\u65e0\u8bba\u662f\u5728\u4e00\u7ebf\u8fd8\u662f\u540e\u7ebf\u6cbb\u7597\uff0c\u5316\u7597\u4f9d\u7136\u662f\u5f53\u524d\u7684\u764c\u75c7\u6807\u51c6\u6cbb\u7597\u65b9\u6848\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u7ec4\u6210\u90e8\u5206\u3002CIN\u662f\u5316\u7597\u6700\u5e38\u89c1\u7684\u526f\u4f5c\u7528\u4e4b\u4e00\uff0c\u5176\u53d1\u751f\u4e0e\u5316\u7597\u76f4\u63a5\u6740\u4f24\u4eba\u4f53\u7ec6\u80de\uff08\u80bf\u7624\u7ec6\u80de\u6216\u6b63\u5e38\u7ec6\u80de\uff09\u7684\u4f5c\u7528\u673a\u5236\u6709\u5173\uff0c\u662f\u5316\u7597\u635f\u5bb3\u9020\u8840\u7cfb\u7edf\u540e\u51fa\u73b0\u7684\u5171\u6027\u95ee\u9898\uff0c\u4e0e\u764c\u75c7\u7c7b\u578b\u65e0\u5173\u3002CIN\u4e0d\u4ec5\u80fd\u591f\u5f15\u53d1\u76f4\u63a5\u5a01\u80c1\u60a3\u8005\u751f\u547d\u7684\u611f\u67d3\uff0c\u8fd8\u80fd\u591f\u5bfc\u81f4\u5316\u7597\u76f8\u5bf9\u5242\u91cf\u5f3a\u5ea6\uff08RDI\uff09\u7684\u964d\u4f4e\uff0c\u8fdb\u800c\u5f71\u54cd\u5316\u7597\u83b7\u76ca\u5bfc\u81f4\u751f\u5b58\u671f\u7f29\u77ed\u3002\u4e34\u5e8a\u4e0d\u826f\u7ed3\u5c40\u7684\u53d1\u751f\u7387\u4e0eCIN\u7684\u4e25\u91cd\u7a0b\u5ea6\uff08\u91cd\u5ea6\uff09\u548c\u6301\u7eed\u65f6\u95f4\u5bc6\u5207\u76f8\u5173\u3002<\/p>\n<p><b>1.&nbsp;<\/b><b>\u7a81\u7834\u6027\uff1a<\/b>\u666e\u90a3\u5e03\u6797\u4e0e\u57f9\u975e\u683c\u53f8\u4ead\u8054\u5408\u6cbb\u7597\u4ee5\u5b8c\u5168\u907f\u514d\u91cd\u5ea6CIN\u53d1\u751f\u4e3a\u6cbb\u7597\u76ee\u6807\uff0c\u4e0e\u4ee5\u7f29\u77ed\u91cd\u5ea6\u4e2d\u6027\u7c92\u7ec6\u80de\u6301\u7eed\u65f6\u95f4\uff08DSN\uff09\u4e3a\u76ee\u6807\u7684G-SCF\u6807\u51c6\u6cbb\u7597\u76f8\u6bd4\uff0c\u662f\u4e00\u79cd\u8d28\u7684\u7a81\u7834\uff0c\u662fCIN\u9002\u5e94\u75c7\u6cbb\u7597\u4e0a\u81ea1991\u5e74Neupogen\u83b7\u6279\u4ee5\u6765\u53c8\u4e00\u4e2a\u91cd\u8981\u7684\u91cc\u7a0b\u7891\u4e8b\u4ef6\u3002\u800cDSN=0\u5219\u4ee3\u8868\u4e86\u8be5\u7c7bCIN\u6cbb\u7597\u7684\u6700\u7ec8\u6781\u76ee\u6807\uff0c\u6807\u5fd7\u7740\u6cbb\u7597\u83b7\u76ca\u6700\u5927\u5316\uff0c\u4e5f\u540c\u65f6\u4ee3\u8868\u5f7b\u5e95\u6d88\u9664\u4e0e\u91cd\u5ea6CIN\u76f8\u5173\u7684\u4e34\u5e8a\u4e0d\u826f\u7ed3\u5c40\u53d1\u751f\u7684\u53ef\u80fd\u6027\u3002\u76d1\u7ba1\u90e8\u95e8\u548c\u884c\u4e1a\u4e13\u5bb6\u8ba4\u4e3a\uff1a\u4e0eCIN\u6cbb\u7597\u4f20\u7edf\u7684DSN\u7ec8\u70b9\u76f8\u6bd4\uff0cDSN=0\u7684\u767e\u5206\u6bd4\u6539\u5584\u5177\u6709\u66f4\u9ad8\u7684\u4e34\u5e8a\u4ef7\u503c\uff0c\u5e76\u4e14\u5728\u73b0\u6709\u6cbb\u7597\u80cc\u666f\u4e0b\u4e5f\u66f4\u4e3a\u654f\u611f\u3002<\/p>\n<p><b>2.&nbsp;<\/b><b>\u4f18\u6548\u6027\uff1a<\/b>\u4f5c\u4e3aCIN\u9002\u5e94\u75c7\u73b0\u6709\u7684\u6807\u51c6\u6cbb\u7597\uff0c\u57f9\u975e\u683c\u53f8\u4ead\u5e76\u672a\u5b8c\u5168\u6ee1\u8db3\u4e34\u5e8a\u9700\u6c42\uff0cProtective 2\u7684\u7814\u7a76\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u6807\u51c6\u6cbb\u7597\u76f8\u6bd4\uff0c\u666e\u90a3\u5e03\u6797\u4e0e\u57f9\u975e\u683c\u53f8\u4ead\u8054\u5408\u6cbb\u7597\u5728\u4e3b\u8981\u7ec8\u70b9\u548c\u6240\u6709\u7684\u5173\u952e\u6b21\u8981\u7ec8\u70b9\u90fd\u8fbe\u5230\u4e86\u4f18\u6548\u6027\uff0c\u663e\u8457\u586b\u8865\u4e86\u4e34\u5e8a\u9700\u6c42\u7684\u7a7a\u767d\u3002<\/p>\n<p><b>\u4e3b\u8981\u7ec8\u70b9\uff08\u7b2c\u4e00\u5468\u671f\u4e2d\u672a\u53d1\u751f<\/b><b>4\u7ea7\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u75c7\u7684\u60a3\u8005\u767e\u5206\u6bd4\uff09\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li><b>\u8054\u5408\u6cbb\u7597\u7ec4<\/b><b>31.5%Vs\u5355\u836f\u6cbb\u7597\u7ec413.6%\uff0cCI\uff1a17.90 [7.13\uff0c28.66]\uff0cp=0.0015\u3002 <\/b><\/li>\n<\/ul>\n<p><b>\u5173\u952e\u6b21\u8981\u7ec8\u70b9\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li><b>\u7b2c<\/b><b>1\u5468\u671f\u7b2c1-8\u5929\u7684DSN\uff08ANC\uff1c0.5&times;10<sup>9<\/sup>\/L\uff09\uff1a\u8054\u5408\u6cbb\u7597\u7ec4\uff081.1\u5929\uff09\u6bd4\u5355\u836f\u6cbb\u7597\u7ec4\uff081.8\u5929\uff09\u66f4\u77ed\uff0cp=0.0065 (\u8bc1\u660e\u666e\u90a3\u5e03\u6797\u5728\u5316\u7597\u540e\u524d8\u5929\u65e9\u671f\u8d77\u6548)\uff1b<\/b> <\/li>\n<li><b>\u7b2c<\/b><b>1\u5468\u671f\u5e73\u5747ANC\u6700\u5c0f\u503c\uff08&times;10<sup>9<\/sup>\/L\uff09\uff1a\u8054\u5408\u6cbb\u7597\u7ec4\uff080.538\uff09\u6bd4\u5355\u836f\u6cbb\u7597\u7ec4\uff080.308\uff09\u66f4\u9ad8\uff0cp=0.0002\uff1b <\/b><\/li>\n<li><b>\u7b2c<\/b><b>1\u5468\u671f\u672a\u53d1\u751f3\u7ea7\u548c4\u7ea7\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u75c7\u7684\u60a3\u8005\u767e\u5206\u6bd4\uff1a\u8054\u5408\u6cbb\u7597\u7ec4\uff0820.7%\uff09\u6bd4\u5355\u836f\u6cbb\u7597\u7ec4\uff084.6%\uff09\u66f4\u9ad8\uff0cp=0.0003\uff1b<\/b> <\/li>\n<li><b>\u7b2c<\/b><b>1\u5468\u671f\u7684DSN\uff1a\u8054\u5408\u6cbb\u7597\u7ec4\u6bd4\u5355\u836f\u6cbb\u7597\u7ec4\u66f4\u77ed\uff0cp=0.03\u3002<\/b><\/li>\n<\/ul>\n<p><b>\u63a2\u7d22\u6027\u7ec8\u70b9 <\/b><b>&#8211; \u7b2c1\u5468\u671f\u4e25\u91cd\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u75c7\u7684\u6301\u7eed\u65f6\u95f4\uff08PN, ANC&lt;0.1&times;109\/L\uff09\uff1a<\/b><\/p>\n<ul type=\"disc\">\n<li><b>\u53d1\u751f<\/b><b>PN\u7684\u60a3\u8005\u6bd4\u4f8b\uff1a\u8054\u5408\u6cbb\u7597\u7ec4\uff0821.6%\uff09\u6bd4\u5355\u836f\u6cbb\u7597\u7ec4\uff0846.4%\uff09\u66f4\u4f4e\uff0cp=0.0001\uff1b<\/b> <\/li>\n<li><b>PN\u7684\u6301\u7eed\u65f6\u95f4\uff1a\u8054\u5408\u6cbb\u7597\u7ec4\uff080.34\u5929\uff09\u6bd4\u5355\u836f\u6cbb\u7597\u7ec4\uff080.63\u5929\uff09\u66f4\u4f4e\uff0cp=0.0004\uff1b<\/b><\/li>\n<\/ul>\n<p><b>3. <\/b><b>\u5b89\u5168\u6027\uff1a<\/b>\u4e0e\u5355\u836f\u6cbb\u7597\u76f8\u6bd4\uff0c\u8054\u5408\u6cbb\u7597\u4e0d\u4ec5\u6ca1\u6709\u589e\u52a0\u989d\u5916\u7684\u6bd2\u6027\uff0c\u53cd\u800c\u5c064\u7ea7\u5b89\u5168\u6027\u4e8b\u4ef6\u53d1\u751f\u7387\u964d\u4f4e\u4e86\u8bb8\u591a\uff0c\u771f\u6b63\u8d77\u5230\u4e86\u589e\u6548\u51cf\u6bd2\u7684\u4f5c\u7528\u3002\u8054\u5408\u6cbb\u7597\u5b89\u5168\u6027\u4e8b\u4ef6\u7684\u4e25\u91cd\u7a0b\u5ea6\u5728\u6574\u4f53\u4e0a\u4e5f\u5448\u73b0\u51fa\u4ece\u9ad8\u7ea7\u522b\u5411\u4f4e\u7ea7\u522b\u8f6c\u6362\u7684\u8d8b\u52bf\u3002\u5728\u8010\u53d7\u6027\u65b9\u9762\uff0c\u8054\u5408\u6cbb\u7597\u6574\u4f53\u8010\u53d7\u6027\u826f\u597d\uff0c\u5728\u9aa8\u75db\u3001\u8840\u5c0f\u677f\u51cf\u5c11\u548c\u751f\u6d3b\u8d28\u91cf\u7b49\u591a\u4e2a\u65b9\u9762\u663e\u793a\u51fa\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u6539\u5584\u7684\u8d8b\u52bf\u3002<\/p>\n<p><b>4\u7ea7AE\u53d1\u751f\u7387\uff1a\u8054\u5408\u6cbb\u7597\u7ec4\uff0858.6%\uff09\u6bd4\u5355\u836f\u6cbb\u7597\u7ec4\uff0880.0%\uff09\u66f4\u4f4e\uff0cp=0.0006\uff1b<\/b><\/p>\n<p>\u66f4\u503c\u5f97\u5173\u6ce8\u7684\u662f\uff0c\u666e\u90a3\u5e03\u6797\u4f5c\u4e3a\u5168\u7403\u9996\u4e2a\u80fd\u591f\u523a\u6fc0\u6811\u7a81\u72b6\u7ec6\u80de\u6210\u719f\uff0c\u589e\u5f3a\u6297\u539f\u9012\u5448\uff0cT\u7ec6\u80de\u6d3b\u5316\u7684\u514d\u75ab\u5c0f\u5206\u5b50\u836f\u7269\uff0c\u6709\u671b\u6210\u4e3a\u7ee7PD-1\/L1\u4e4b\u540e\u53c8\u4e00\u91cd\u78c5\u7ea7\u514d\u75ab\u6297\u80bf\u7624\u57fa\u77f3\u6027\u836f\u7269\u3002\u666e\u90a3\u5e03\u6797\u4e0ePD-1\/L1+CTLA-4\/\u4f20\u7edf\u7684\u653e\u5316\u7597\u8054\u7528\uff0c\u53ef\u4ee5\u589e\u5f3a\u6297\u539f\u751f\u6210\u5e76\u5c06\u6297\u539f\u9012\u5448\u7ed9T\u7ec6\u80de\uff0c\u5171\u540c\u6784\u6210\u5168\u5468\u671f\u8c03\u63a7\u80bf\u7624\u514d\u75ab\u7684\u201c\u8d85\u7ea7\u9e21\u5c3e\u9152\u7597\u6cd5\u201d\u3002\u8be5\u6cbb\u7597\u65b9\u6848\u7684\u591a\u9879\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\u6b63\u5728\u7b79\u5212\u548c\u8fdb\u884c\u4e2d\uff0c\u6700\u65b0\u7684\u6570\u636e\u5c06\u4e8e\u8fd1\u671f\u5728ASCO\u5e74\u4f1a\u4e0a\u516c\u5e03\u3002<\/p>\n<p>\u666e\u90a3\u5e03\u6797\u5728\u4f5c\u7528\u673a\u5236\u3001\u65f6\u95f4\u3001\u7279\u70b9\u4ee5\u53ca\u6fc0\u6d3b\u514d\u75ab\u65b9\u9762\u7684\u72ec\u7279\u6027\uff0c\u4f7f\u5176\u540c\u65f6\u88ab\u4e2d\u56fd\u548c\u7f8e\u56fd\u8ba4\u5b9a\u4e3a\u5177\u6709\u201c\u7a81\u7834\u6027\u201d\u7684CIN\u6cbb\u7597\u836f\u7269\u3002\u6709\u7406\u7531\u76f8\u4fe1\uff0c\u666e\u90a3\u5e03\u6797\u5c06\u4e0d\u4ec5\u5728CIN\u6cbb\u7597\u65b9\u9762\u5e26\u6765\u4e86\u201c0\u201d\u7684\u7a81\u7834\uff0c\u8fd8\u5c06\u901a\u8fc7\u4e0e\u5316\u7597\u548c\/\u6216\u80bf\u7624\u514d\u75ab\u6cbb\u7597\u8054\u5408\u5e94\u7528\u5e26\u6765\u66f4\u5927\u7684\u7a81\u7834\u3002<\/p>\n<p>\u4e07\u6625\u533b\u836fCEO\u517c\u9996\u5e2d\u79d1\u5b66\u5bb6\u9ec4\u5c9a\u535a\u58eb\u8868\u793a\uff1a\u201c\u6211\u4eec\u5f88\u9ad8\u5174FDA\u63a5\u53d7\u4e86\u666e\u90a3\u5e03\u6797\u7684\u9996\u4e2a\u9002\u5e94\u75c7NDA\uff0c\u5e76\u4e14\u6388\u4e88\u4e86\u2018\u4f18\u5148\u5ba1\u8bc4\u2019\u8d44\u683c\uff0c\u8fd9\u662f\u6211\u4eec\u57282021\u5e74\u7684\u5173\u952e\u91cc\u7a0b\u724c\u4e4b\u4e00\u3002\u672c\u6b21NDA\u63d0\u4ea4\u662f\u4e07\u6625\u533b\u836f\u591a\u5e74\u521b\u65b0\u548c\u52aa\u529b\u7684\u7ed3\u679c\uff0c\u7814\u7a76\u8bc1\u5b9e\u666e\u90a3\u5e03\u6797\u8054\u5408G-CSF\u5c06\u4e3a\u6cbf\u7528\u591a\u5e74\u7684\u6807\u51c6\u6cbb\u7597\u5e26\u6765\u5168\u65b0\u7684\u6539\u5584\uff0c\u6781\u5927\u6ee1\u8db3\u73b0\u6709\u533b\u7597\u9700\u6c42\uff0c\u8fdb\u4e00\u6b65\u51cf\u8f7b\u5316\u7597\u60a3\u8005\u7684CIN\u8d1f\u62c5\uff0c\u8fd9\u662f\u81eaG-CSF\u6279\u51c6\u8fd130\u5e74\u6765\u7684CIN\u7597\u6548\u63d0\u9ad8\u7684\u9996\u6b21\u521b\u4e3e\u3002\u7531\u4e8eCIN\u53ef\u80fd\u5bfc\u81f4RDI\u964d\u4f4e\u5e76\u5f15\u53d1\u5371\u53ca\u751f\u547d\u7684\u611f\u67d3\uff0c\u56e0\u6b64\u6211\u4eec\u5e0c\u671b\u666e\u90a3\u5e03\u6797\u80fd\u591f\u63d0\u9ad8\u60a3\u8005\u5bf9\u5316\u7597\u7684\u8010\u53d7\u6027\uff0c\u8fdb\u800c\u63d0\u9ad8\u764c\u75c7\u6cbb\u7597\u7684\u6210\u529f\u7387\u3002\u201d<\/p>\n<p>\u3010\u6ce81\u3011\u300a\u5904\u65b9\u836f\u4f01\u4e1a\u4ed8\u8d39\u6cd5\u6848\u300b\uff08Prescription Drug User Fee Act\uff0cPDUFA\uff09\u7531\u7f8e\u56fd\u56fd\u4f1a\u4e8e1992\u5e74\u5236\u5b9a\u3002FDA\u5c06\u5c31\u6bcf\u4e00\u9879\u7533\u8bf7\u8bbe\u7f6e\u4e00\u4e2a\u5ba1\u6279\u622a\u6b62\u65e5\u671f\uff0c\u5373PDUFA \u65e5\u671f\uff0c\u5728\u6b64\u65f6\u95f4\u4e4b\u524dFDA\u5fc5\u987b\u505a\u51fa\u5176\u5ba1\u8bc4\u51b3\u5b9a\u3002\u8be5\u6cd5\u6848\u5728\u52a0\u5feb\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u65b9\u9762\u53d1\u6325\u4e86\u91cd\u8981\u7684\u4f5c\u7528\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7ebd\u7ea62021\u5e746\u67081\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; 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