{"id":4698,"date":"2020-12-09T15:50:23","date_gmt":"2020-12-09T07:50:23","guid":{"rendered":"https:\/\/www.957seo.com.tw\/wp\/?p=4698"},"modified":"2020-12-09T15:50:23","modified_gmt":"2020-12-09T07:50:23","slug":"%e4%b8%ad%e8%a3%95%e4%ba%8c%e9%a0%85%e6%96%b0%e8%97%a5%e9%96%8b%e7%99%bc%e6%9c%89%e6%96%ac%e7%8d%b2-%e6%96%b0%e5%86%a0%e6%96%b0%e8%97%a5%e5%b7%b2%e7%8d%b2%e7%be%8efda%e8%87%a8%e5%ba%8a%e5%89%8d","status":"publish","type":"post","link":"https:\/\/www.957seo.com.tw\/wp\/?p=4698","title":{"rendered":"\u4e2d\u88d5\u4e8c\u9805\u65b0\u85e5\u958b\u767c\u6709\u65ac\u7372 \u65b0\u51a0\u65b0\u85e5\u5df2\u7372\u7f8eFDA\u81e8\u5e8a\u524d\u8aee\u8a62"},"content":{"rendered":"\n

\u4e2d\u88d5 (4147-TW) \u4eca (9) \u65e5\u8868\u793a\uff0c\u6843\u5712\u8cc7\u6e90\u56de\u6536<\/a>\u65d7\u4e0b\u65b0\u85e5\u958b\u767c\u6709\u6240\u65ac\u7372\uff0c\u5305\u62ec\u5099\u53d7\u77da\u76ee\u7684\u65b0\u51a0\u65b0\u85e5\uff0c\u5df2\u7372\u5f97\u7f8e\u570b FDA \u81e8\u5e8a\u81ea\u52d5\u8cbc\u6a19\u6a5f<\/a>\u8a66\u9a57\u9001\u4ef6\u524d\u8aee\u8a62(Pre-IND)\uff0c\u800c\u611b\u6ecb\u975c\u8108\u63a8\u6ce8\u4e09\u671f\u8a66\u9a57\uff0c\u5713\u74f6\u8cbc\u6a19\u6a5f<\/a>\u5247\u9810\u8a08\u660e\u5e74\u590f\u5929\u53d6\u5f97\u4e0a\u5e02\u6838\u51c6\u3002<\/p>\n\n\n\n

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\u4e2d\u88d5\u898f\u5283\uff0c\u65b0\u51a0\u6297\u9ad4\u5c0f\u4e09\u901a\u7269\u6d41<\/a>\u65b0\u85e5\u9810\u8a08\u660e\u5e74\u521d\u518d\u5411 FDA \u63d0\u51fa\u65b0\u85e5\u81e8\u5e8a\u8a66\u9a57 (IND) \u7533\u8acb\uff0c\u6700\u5feb\u53ef\u671b\u660e\u5e74 3 \u6708\u5e95\u30014 \u6708\u521d\u555f\u52d5\u5169\u5cb8\u904b\u8f38<\/a>\u4e00\u671f\u81e8\u5e8a\uff0c\u4e3b\u8981\u6536\u521d\u671f\u611f\u67d3\u8005\uff0c\u529b\u62da 2022 \u5e74\u4e0a\u534a\u5e74\u53ef\u7533\u8acb\u7f8e\u570b\u7dca\u6025\u4f7f\u7528\u6388\u6b0a \u53f0\u7063\u5bc4\u5927\u9678<\/a>(EUA) \u4e14\u5c55\u958b\u92b7\u552e\u3002<\/p>\n\n\n\n

\u5176\u4ed6\u65b0\u85e5\u9032\u5c55\u65b9\u9762\uff0c\u4e2d\u88d5\u8868\u793a\uff0cTMB-355 \u611b\u6ecb\u975c\u8108\u63a8\u6ce8\u5305\u88dd\u8a2d\u8a08<\/a>\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u96d6\u4e00\u5ea6\u53d7\u65b0\u51a0\u80ba\u708e\u75ab\u60c5\u5f71\u97ff\u6536\u6848\uff0c\u4f46\u65e5\u524d\u5df2\u5b8c\u6210\u6700\u5f8c\u53d7\u8a66\u8005\u7be9\u6aa2\uff0c\u7a7a\u6c23\u6e05\u6de8\u6a5f<\/a>\u4e14\u63a5\u8fd1\u6536\u5c3e\uff0c\u9810\u8a08\u660e\u5e74\u590f\u5929\u53ef\u53d6\u5f97\u7f8e\u570b FDA \u4e0a\u5e02\u6838\u51c6\uff0c\u4e26\u555f\u52d5\u92b7\u552e\u3002<\/p>\n\n\n\n

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TMB-355 \u6539\u826f\u7684\u7b2c\u4e8c\u4ee3\u611b\u6ecb\u75c5\u9577\u6548\u85e5\u7269 TMB-365 \u65b9\u9762\uff0c\u4e2d\u88d5\u8868\u793a\u6276\u624b\u6b04\u6746<\/a>\u8a72\u85e5\u7269\u81e8\u5e8a\u8a66\u9a57\u6b63\u6301\u7e8c\u9032\u884c\u4e2d\uff0c\u81e8\u5e8a\u671f\u4e2d\u7d50\u679c\u986f\u793a\uff0c\u85e5\u6548\u53ca\u6301\u7e8c\u6027\u4e0a\u5747\u512a\u65bc\u9810\u671f\u3002\u64da\u4e86\u89e3\uff0cTMB-355 \u73bb\u7483\u96e8\u906e<\/a>\u9700\u5169\u5468\u6ce8\u5c04\u4e00\u6b21\uff0c\u800c TMB-365 \u53ef\u6bcf\u6708\u6ce8\u5c04\u4e00\u6b21\uff0c\u5e37\u5e55\u7246<\/a>\u5c07\u5927\u5e45\u63d0\u5347\u7528\u85e5\u65b9\u4fbf\u6027\u3002<\/p>\n\n\n\n

\u4e2d\u88d5\u5411\u570b\u969b\u611b\u6ecb\u75c5\u7814\u767c\u6a5f\u69cb ADARC \u6280\u8f49\u7684\u73bb\u7483\u5c4b<\/a>\u96d9\u6548\u578b\u6297\u9ad4 TMB-370\uff0c\u8207\u53bb\u5e74\u5f9e\u7f8e\u570b NIH \u6280\u8f49\u7684\u63a1\u5149\u7f69<\/a>\u55ae\u682a\u6297\u9ad4 TMB-380\uff0c\u4e2d\u88d5\u6307\u51fa\uff0c\u6b64\u5169\u9805\u65b0\u85e5\u7684\u4e8c\u671f\u81e8\u5e8a\u8a66\u9a57\u92c1\u683c\u67f5<\/a>\u9810\u8a08\u660e\u5e74\u79cb\u5929\u958b\u59cb\u57f7\u884c\uff0c\u7531\u7f8e\u570b\u7f8e\u570b\u653f\u5e9c\u55ae\u4f4d\u8ca0\u8cac\u8cbb\u7528\u8207\u57f7\u884c\uff0c\u92c1\u9580\u7a97<\/a>\u9810\u8a08\u516c\u53f8\u53ef\u7701\u4e0b 500 \u842c\u7f8e\u5143\u7d93\u8cbb\u3002\u6b64\u5916\uff0c\u4e2d\u88d5\u7af9\u5317\u7522\u7dda\u53f0\u4e2d\u5a5a\u7d17\u5de5\u4f5c\u5ba4<\/a>\u5df2\u5b8c\u6210 GMP \u78ba\u6548\uff0c\u4e0b\u500b\u6708\u53ef\u958b\u59cb\u751f\u7522 TMB-380\uff0c\u53f0\u4e2d\u5a5a\u7d17\u651d\u5f71<\/a>\u63d0\u4f9b\u4e8c\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u85e5\u7269\u9700\u6c42\u3002<\/p>\n\n\n\n

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