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class=\"wp-block-table\"><table><tbody><tr><td>\u5bf9\u4e8e\u836f\u7269\u7814\u53d1\u5173\u952e\u9636\u6bb5\u91cd\u5927\u95ee\u9898\u2014\u2014\u6c9f\u901a\u4ea4\u6d41\u4f1a\u8bae\u7533\u8bf7\uff08\u63a8\u8350\uff09<\/td><\/tr><tr><td>\u5bf9\u4e8e\u4e00\u822c\u6027\u6280\u672f\u95ee\u9898\u2014\u2014\u7f51\u7edc\u5e73\u53f0\u54a8\u8be2\uff08\u63a8\u8350\uff09<\/td><\/tr><tr><td>\u5bf9\u4e8e\u6ce8\u518c\u53d7\u7406\u548c\u5ba1\u8bc4\u4e1a\u52a1\u7684\u5b9e\u65f6\u54a8\u8be2\u2014\u2014\u7535\u8bdd\u54a8\u8be2<\/td><\/tr><tr><td>\u5bf9\u4e8e\u5728\u5ba1\u8bc4\u54c1\u79cd\u7ba1\u7406\u95ee\u9898\u7684\u54a8\u8be2\u2014\u2014\u7535\u8bdd\u6216\u90ae\u4ef6\u8054\u7cfb<\/td><\/tr><tr><td>\u5bf9\u4e8e\u5728\u5ba1\u54c1\u79cd\u2014\u2014\u95ee\u8be2\u5f0f\u6c9f\u901a\u4ea4\u6d41<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>2<\/strong><strong>\u3001\u6c9f\u901a\u4ea4\u6d41\u4f1a\u7684\u5ba1\u6838\u6d41\u7a0b\uff1a<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>\u6c9f\u901a\u4ea4\u6d41\u4f1a<\/strong><strong><\/strong><strong>\u7c7b\u578b<\/strong><strong><\/strong><\/td><td><strong>\u4f1a\u8bae\u5b89\u6392<\/strong><strong><\/strong><strong>\u65f6\u95f4<\/strong><strong><\/strong><\/td><td> <strong>\u8be5\u7c7b\u578b\u4f1a\u8bae\u7684\u60c5\u5f62<\/strong><\/td><\/tr><tr><td>I\u7c7b\u4f1a\u8bae<\/td><td>30\u65e5<\/td><td>\u4e3a\u89e3\u51b3\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u9047\u5230\u7684\u91cd\u5927\u5b89\u5168\u6027\u95ee\u9898\u548c\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269\u7814\u53d1\u8fc7\u7a0b\u4e2d\u7684\u91cd\u5927\u6280\u672f\u95ee\u9898\uff0c\u6216\u5176\u4ed6\u89c4\u5b9a\u60c5\u5f62\uff0c\u800c\u53ec\u5f00\u7684\u4f1a\u8bae<\/td><\/tr><tr><td>II\u7c7b\u4f1a\u8bae<\/td><td>60\u65e5<\/td><td>\u4e3a\u836f\u7269\u5728\u7814\u53d1\u5173\u952e\u9636\u6bb5\u800c\u53ec\u5f00\u7684\u4f1a\u8bae\uff0cPre-IND\u3001EOP2\/3\u3001Pre-NDA\uff0c\u2026\u2026<\/td><\/tr><tr><td>III\u7c7b\u4f1a\u8bae<\/td><td>75\u65e5<\/td><td>\u9664\u2160\u7c7b\u548c\u2161\u7c7b\u4f1a\u8bae\u4e4b\u5916\u7684\u5176\u4ed6\u4f1a\u8bae<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\uff081\uff09\u9879\u76ee\u7ba1\u7406\u4eba\u521d\u6b65\u5ba1\u6838\uff1a3\u65e5<\/p>\n\n\n\n<p>\uff082\uff09\u5ba1\u8bc4\u56e2\u961f\u5ba1\u6838<\/p>\n\n\n\n<p>\uff083\uff09\u786e\u5b9a\u53ec\u5f00\u6c9f\u901a\u4ea4\u6d41\u4f1a\u8bae\u7684\uff0c\u9879\u76ee\u7ba1\u7406\u4eba\u5458\u9700\u5728\u786e\u5b9a\u4f1a\u8bae\u65e5\u671f\u540e5\u65e5\u5185\u901a\u8fc7\u201c\u7533\u8bf7\u4eba\u4e4b\u7a97\u201d\u544a\u77e5\u7533\u8bf7\u4eba\u3002<\/p>\n\n\n\n<p>\uff084\uff09\u4f1a\u8bae\u7eaa\u8981\u6700\u8fdf\u4e8e\u4f1a\u8bae\u7ed3\u675f\u540e30\u65e5\u5185\u5b9a\u7a3f\uff0c\u9879\u76ee\u7ba1\u7406\u4eba\u5458\u5728\u5b9a\u7a3f\u540e2\u65e5\u5185\u4e0a\u4f20\u81f3\u6c9f\u901a\u4ea4\u6d41\u7cfb\u7edf\u3002<\/p>\n\n\n\n<p>\u5ba3\u8bb2\u4f1a\u4e0a\u5f3a\u8c03\uff0c\u4e0d\u5e94\u56e0\u4e3a\u4f1a\u8bae\u5b89\u6392\u65f6\u95f4\u77ed\u5c31\u9009\u62e9I\u7c7b\u4f1a\u8bae\uff0c\u540e\u9762\u5ba1\u6838\u7684\u65f6\u5019\u53d1\u73b0\u7c7b\u522b\u4e0d\u5408\u9002\u8fd8\u662f\u4f1a\u8fdb\u884c\u8c03\u6574\uff0c\u53ea\u4f1a\u66f4\u52a0\u6d6a\u8d39\u7b49\u5f85\u7684\u65f6\u95f4\u3002<\/p>\n\n\n\n<p><strong>3<\/strong><strong>\u3001\u62df\u6c9f\u901a\u4ea4\u6d41\u7684\u5b66\u79d1<\/strong><\/p>\n\n\n\n<p>\u5b66\u79d1\u7684\u52fe\u9009\u8981\u4e0e\u8ba8\u8bba\u95ee\u9898\u6e05\u5355\u5339\u914d\uff0c\u5e38\u89c1\u7684\u95ee\u9898\u5305\u62ec\uff1aPK\u8bd5\u9a8c\u8bbe\u8ba1\u3001BE\u8c41\u514d\u7b49\u95ee\u9898\u672a\u52fe\u9009\u4e34\u5e8a\u836f\u7406\u4e13\u4e1a\uff1b\u6837\u672c\u91cf\u8ba1\u7b97\u3001\u5173\u952e\u7814\u7a76\u8bbe\u8ba1\u7b49\u95ee\u9898\u672a\u52fe\u9009\u7edf\u8ba1\u4e13\u4e1a\uff1b\u8d77\u59cb\u5242\u91cf\u95ee\u9898\u672a\u52fe\u9009\u836f\u7406\u6bd2\u7406\u4e13\u4e1a\uff1b2\u7c7b\u6539\u826f\u578b\u65b0\u836f\u7acb\u9898\u4f9d\u636e\u3001\u89c4\u683c\u5408\u7406\u6027\u3001\u7533\u8bf7\u52a0\u5feb\u7a0b\u5e8f\u672a\u52fe\u9009\u4e34\u5e8a\u4e13\u4e1a\u3002<\/p>\n\n\n\n<p><strong>4<\/strong><strong>\u3001\u5ba1\u8bc4\u56e2\u961f\u5ba1\u6838\u7684\u5173\u952e\u70b9<\/strong><\/p>\n\n\n\n<p><strong>4<\/strong><strong>\u3001\u5ba1\u8bc4\u56e2\u961f\u5ba1\u6838\u7684\u5173\u952e\u70b9<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>\u6c9f\u901a\u4ea4\u6d41\u7684\u5fc5\u8981\u6027\uff1f\uff08\u6307\u5357\u672a\u8986\u76d6\uff09<\/td><\/tr><tr><td>\u6c9f\u901a\u4ea4\u6d41\u7684\u7b54\u590d\u65b9\u5f0f\u3002\uff08\u57fa\u4e8e\u95ee\u9898\uff09<\/td><\/tr><tr><td>\u6c9f\u901a\u95ee\u9898\u662f\u5426\u660e\u786e\uff1f\uff08\u53ea\u9648\u8ff0\u4e86\u7814\u7a76\u8bbe\u8ba1\u6216\u6570\u636e\uff0c\u6ca1\u6709\u95ee\u9898\uff1b\u53ea\u6709\u95ee\u9898\uff0c\u6ca1\u6709\u4f01\u4e1a\u521d\u6b65\u7684\u610f\u89c1\uff1b\u62df\u6c9f\u901a\u7684\u4e13\u4e1a\u6b65\u660e\u786e\uff09<\/td><\/tr><tr><td>\u6c9f\u901a\u7684\u95ee\u9898\u662f\u5426\u5177\u4f53\uff1f\uff08\u95ee\u9898\u8fc7\u5927\uff1a\u73b0\u6709\u6570\u636e\u80fd\u5426\u652f\u6301\u4e0a\u5e02\/\u5f00\u5c55\u4e34\u5e8a\uff0c\u8fd9\u51e0\u4e4e\u662f\u5b8c\u6574\u7684\u6ce8\u518c\u7533\u8bf7\u5ba1\u8bc4\u624d\u80fd\u56de\u7b54\u7684\u95ee\u9898\uff09<\/td><\/tr><tr><td>\u6c9f\u901a\u65f6\u673a\u662f\u5426\u5408\u9002\uff1f\uff08\u6570\u636e\u662f\u5426\u5145\u5206\uff1f\u95ee\u9898\u662f\u5426\u5408\u9002\uff1f\uff09<\/td><\/tr><tr><td>\u95ee\u9898\u65e0\u6cd5\u901a\u8fc7\u6c9f\u901a\u4ea4\u6d41\u89e3\u51b3\u3002\uff08BTD\u7533\u8bf7\u3001\u65b0\u589e\u9002\u5e94\u75c7\u3001\u8054\u5408\uff09<\/td><\/tr><tr><td>\u6570\u636e\u4e0d\u5145\u5206\uff08EOP2\uff1a\u5242\u91cf\u4e0d\u786e\u5b9a\uff0c\u65e0\u7597\u6548\u6570\u636e\uff1bpre-NDA\uff1a\u5c1a\u672a\u5b8c\u6210\u5165\u7ec4\u548c\u8ba1\u5212\u8bbf\u89c6\u8981\u6c42\uff09<\/td><\/tr><tr><td>\u5206\u6790\u4e0d\u5145\u5206\uff08pre-NDA\uff1a\u4ec5\u63d0\u4f9b\u4e3b\u8981\u7597\u6548\u6570\u636e\uff0c\u5b89\u5168\u6027\u65e0\u6cd5\u8bc4\u4f30\uff09<\/td><\/tr><tr><td>\u5e7b\u706f\u8d28\u91cf\u91cd\u89c6\u7a0b\u5ea6\u4e0d\u591f\uff085\u9875PPT\uff0c15\u4e2a\u9644\u4ef6\uff09<\/td><\/tr><tr><td>\u5148\u9012\u4ea4\u7533\u8bf7\uff0c\u518d\u51c6\u5907\u8d44\u6599\uff08\u62a2\u5751\u5360\u4f4d\uff09<\/td><\/tr><tr><td>\u91cd\u8981\u95ee\u9898\u672a\u53ca\u65f6\u6c9f\u901a\uff08\u4f8b\u59822\u7c7b\u6539\u826f\u578b\u65b0\u836f\u7acb\u9898\u5408\u7406\u6027\uff0c\u5173\u952e\u7814\u7a76\u524d\u53d1\u751f\u91cd\u5927\u53d8\u66f4\uff0c\u62a5\u4ea7\u524d\u624d\u6c9f\u901a\uff09<\/td><\/tr><tr><td>\u5bf9\u4e8e\u6c9f\u901a\u4ea4\u6d41\u672a\u8fbe\u6210\u5171\u8bc6\u7684\u90e8\u5206\u9009\u62e9\u6027\u5ffd\u7565\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>&nbsp;<\/p>\n\n\n\n<p>\u4ee5\u4e0a\u5185\u5bb9\u6765\u836f\u95fb\u8d44\u8baf\uff08<a 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