{"id":80856,"date":"2019-04-02T00:00:50","date_gmt":"2019-04-11T06:42:58","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/80856\/"},"modified":"2019-04-11T14:43:00","modified_gmt":"2019-04-11T06:43:00","slug":"b2a850f9bc","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/80856\/","title":{"rendered":"\u9038\u9054\u751f\u6280\u6b63\u5f0f\u5411FDA\u63d0\u51fa\u4eae\u4e19\u745e\u6797\u516d\u4e2a\u6708\u957f\u6548\u5242\u578b\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7"},"content":{"rendered":"
\n

\n

\u65e5\u524d\uff0c\u5b9d\u5c9b\u53f0\u6e7e\u4e0a\u5e02\u516c\u53f8<\/span>\u9038\u9054\u751f\u6280\u516c\u5f00\u5ba3\u5e03<\/span><\/p>\n

 <\/span><\/strong><\/p>\n

\u672c\u516c\u53f8\u65bc\u7f8e\u570b\u6642\u9593<\/span>108<\/span>\uff08\u516c\u5143<\/span>2019\u5e74\uff09<\/span><\/span>\u5e74<\/span>3\u6708<\/span>28<\/span>\u65e5\u6b63\u5f0f\u5b8c\u6210\u5411\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40<\/span>(FDA)<\/span>\u63d0\u9001\u67f3\u83e9\u6797\u524d\u5217\u817a\u764c\u65b0\u5291\u578b\u65b0\u85e5 <\/span>FP-001 50<\/span>\u6beb\u514b\uff08<\/span><\/span>\u516d\u500b\u6708\u5291\u578b<\/span>\uff09\u4e4b<\/span> 505(b)2 \u65b0\u85e5\u85e5\u8b49\u7533\u8acb<\/span><\/span>\uff08<\/span>NDA<\/span>\uff09\uff0c\u4ee5\u6838\u51c6\u8a72\u85e5\u54c1\u4f7f\u7528\u65bc\u665a\u671f\u524d\u5217\u817a\u764c\u7684\u7de9\u89e3\u6cbb\u7642\uff08<\/span>palliative treatment<\/span>\uff09\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4e09\u4e2a\u6708<\/span>\u7684\u957f\u6548\u5242\u578b\u4e5f\u4e8e\u8fd1\u671f\u516c\u5e03\u4e86\u4e34\u5e8a\u7ed3\u679c<\/span><\/p>\n

 <\/span><\/p>\n

\u67f3\u83e9\u6797\u524d\u5217\u817a\u764c\u65b0\u5291\u578b\u65b0\u85e5<\/span>FP-001 25 \u6beb\u514b\uff08\u4e09\u500b\u6708\u5291\u578b\uff09\u7684\u591a\u570b\u591a\u4e2d\u5fc3\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\uff0c\u8a66\u9a57\u6578\u64da\u5206\u6790\u986f\u793a\uff0c\u9ad8\u9054<\/span>97.9%\u7684\u53d7\u8a66\u8005\u9054\u5230\u4e3b\u8981\u7642\u6548\u6307\u6a19\uff08<\/span>primary efficacy end point\uff09\u3002\u6b64\u958b\u653e\u6027\u3001\u7121\u5c0d\u7167\u7d44\u7684\u8a66\u9a57\u65bc\u516d\u500b\u6708\u671f\u9593\u9023\u7e8c\u70ba\u53d7\u8a66\u75c5\u60a3\u65bd\u6253\u5169\u91dd<\/span>FP-001 25\u6beb\u514b\uff08\u4e09\u500b\u6708\u5291\u578b\uff09\uff0c\u4ee5\u89c0\u5bdf\u5176\u6291\u5236\u8840\u6e05\u4e2d\u776a\u56fa\u916e\u6fc3\u5ea6\u7684\u6548\u679c\u3002\u8a66\u9a57\u4e3b\u8981\u7642\u6548\u6307\u6a19\u662f\u5728\u521d\u6b21\u7528\u85e5\u5f8c\u7684<\/span>28\u5929\u5167\u8840\u6e05\u776a\u916e\u542b\u91cf\u4e0b\u964d\u81f3\u672a\u8d85\u904e<\/span>50 ng\/dL\u3001\u4e26\u5728\u7528\u85e5\u7684<\/span>28\u5929\u81f3<\/span>168\u5929\u671f\u9593\u776a\u56fa\u916e\u542b\u91cf\u7dad\u6301\u672a\u8d85\u904e <\/span>50 ng\/dL\u7684\u53d7\u8a66\u8005\u4f54\u7e3d\u610f\u5716\u6cbb\u7642\uff08<\/span>intent-to-treat, ITT\uff09\u7fa4\u9ad4\u7684\u767e\u5206\u6bd4\u3002\u8a66\u9a57\u7e3d\u8a08\u6536\u9304<\/span>144\u540d\u75c5\u60a3\uff08<\/span>ITT\u7fa4\u9ad4\uff09\uff0c\u5176\u4e2d\u5171<\/span>132\u4f4d\u6210\u529f\u5b8c\u6210\u7642\u7a0b\u4e26\u4e14\u672a\u51fa\u73fe\u5f71\u97ff\u4e3b\u8981\u7642\u6548\u6307\u6a19\u7684\u91cd\u5927\u8a66\u9a57\u9055\u898f\uff08<\/span>major protocol violation\uff09\uff0c\u5176\u6cbb\u7642\u6709\u6548\u6027\u6309<\/span>Kaplan-Meier\u5206\u6790\u6cd5\u8a08\u7b97\u4e4b<\/span>95%\u96d9\u5c3e\u4fe1\u8cf4\u5340\u9593\u4e0a\u3001\u4e0b\u9650\u5404\u70ba<\/span>99.3%\u53ca<\/span>93.5%\uff0c\u8d85\u904e\u7f8e\u570b<\/span>FDA\u5c0d\u65bc<\/span>95%\u96d9\u4fe1\u8cf4\u5340\u9593\u4e0b\u9650\u9700\u8d85\u904e<\/span>90%\u7684\u8981\u6c42\u3002\u53d7\u8a66\u75c5\u60a3\u65bc\u7528\u85e5\u7684\u7b2c<\/span>28\u5929\u5167\u5e73\u5747\u8840\u6e05\u777e\u56fa\u916e\u542b\u91cf\u964d\u81f3<\/span>17.6ng\/dL\uff0c\u9060\u4f4e\u65bc\u85e5\u7269\u53bb\u52e2\u76ee\u6a19\uff08<\/span>50 ng\/dL\uff09\uff0c\u6291\u5236\u6bd4\u7387\u9ad8\u9054<\/span>98.6%\u3002\u4e09\u4f4d\u53d7\u8a66\u8005\u672a\u65bc\u5be6\u9a57\u671f\u9593\u9054\u5230\u4e3b\u8981\u7642\u6548\u6307\u6a19\uff0c\u5176\u4e2d\u5169\u4f4d\u53d7\u8a66\u8005\u65bc\u7528\u85e5\u5f8c<\/span>28\u5929\u5167\u776a\u56fa\u916e\u6291\u5236\u672a\u9054\u53bb\u52e2\u76ee\u6a19\uff08<\/span>50 ng\/dL\uff09\uff0c\u4e00\u4f4d\u5728\u7b2c\u4e8c\u5291\u85e5\u7269\u6ce8\u5c04\u5f8c\u51fa\u73fe\u77ed\u66ab\u776a\u56fa\u916e\u6fc3\u5ea6\u589e\u52a0\u3002\u7e3d\u9ad4\u800c\u8a00\uff0c\u75c5\u60a3\u6bcf\u4e09\u500b\u6708\u6ce8\u5c04<\/span>FP-001 25\u6beb\u514b\u91dd\u5291\u5177\u6709\u826f\u597d\u5b89\u5168\u6027\u8207\u8010\u53d7\u6027\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u4e0d\u826f\u53cd\u5e94\u65b9\u9762<\/span><\/p>\n

 <\/span><\/p>\n

\u5728\u75c5\u60a3\u4e0d\u9069\u53cd\u61c9\u65b9\u9762\uff0c<\/span>90\u4f4d\u53d7\u8a66\u8005\u65bc\u63a5\u53d7\u6cbb\u7642\u5f8c\u767c\u751f\u5171<\/span>217\u8d77\u4e0d\u826f\u53cd\u61c9\u4e8b\u4ef6\uff08<\/span>treatment-emergentadverse events, TEAEs\uff09\uff0c\u5305\u542b\u81c9\u6f6e\u7d05\uff08<\/span>24.31%\uff09\u3001\u9ad8\u8840\u58d3\uff08<\/span>11.11%\uff09\u3001\u9ad4\u91cd\u589e\u52a0\uff08<\/span>7.64%\uff09\u3001\u6ce8\u5c04\u8655\u51fa\u8840\uff08<\/span>5.56%\uff09\u7b49\uff0c\u56b4\u91cd\u7a0b\u5ea6\u591a\u70ba\u8f15\u5ea6\u81f3\u4e2d\u5ea6\uff1a<\/span>79\u4f4d\u53d7\u8a66\u8005\uff08<\/span>87.8%\uff09<\/span><\/span>\u5171\u767c\u751f<\/span>165<\/span>\u8d77\u4e00\u7d1a<\/span>TEAE<\/span>\u3001<\/span>28<\/span>\u4f4d\uff08<\/span>31.1%<\/span>\uff09\u5171\u767c\u751f<\/span>43<\/span>\u8d77\u4e8c\u7d1a<\/span>TEAE<\/span>\uff0c\u50c5\u6709<\/span>7<\/span>\u4f4d\u53d7\u8a66\u8005\uff08<\/span>7.77%<\/span>\uff09\u767c\u751f\u5171<\/span>9<\/span>\u8d77\u7684\u4e0d\u826f\u53cd\u61c9\u4e8b\u4ef6\u70ba\u56b4\u91cd\u7b49\u7d1a\uff0c\u5176\u5b89\u5168\u6027\u6578\u64da\u4ea6\u8207<\/span>FP-001 50<\/span>\u6beb\u514b\uff08\u516d\u500b\u6708\u5291\u578b\uff09\u4ee5\u53ca\u5176\u4ed6\u5e02\u552e\u540c\u578b\u85e5\u54c1\u985e\u4f3c\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u6388\u6743\u5408\u4f5c<\/span><\/p>\n

 <\/span><\/p>\n

\u76ee\u524d\u9038\u9054\u6b63\u7a4d\u6975\u9810\u5099\u5728\u7f8e\u570b\u3001\u6b50\u76df\u3001\u53f0\u7063\u53ca\u5176\u4ed6\u91cd\u9ede\u570b\u5bb6\u9032\u884c<\/span>FP-001 50\u6beb\u514b\u53ca<\/span>25<\/span>\u6beb\u514b\u7684<\/span><\/span>\u85e5\u8b49\u7533\u8acb\u3002\u672a\u4f86\uff0c\u6709\u4e86\u4e09\u500b\u6708\u53ca\u516d\u500b\u6708\u5169\u7a2e\u5291\u578b\uff0c\u75c5\u4eba\u5c07\u64c1\u6709\u66f4\u5b8c\u6574\u7684\u9078\u64c7\uff0c\u800c<\/span>FP-001<\/span>\u9810\u5145\u586b\u5f0f\u91dd\u5291\u66f4\u514b\u670d\u4e86\u5e02\u552e\u54c1\u724c\u9700\u4eba\u5de5\u6df7\u5408\u7684\u4e0d\u4fbf\uff0c\u518d\u901a\u904e\u7d93\u92b7\u5925\u4f34\u7684\u5546\u696d\u5316\u5be6\u529b\uff0c\u5982<\/span>\u672c\u6708\u4efd\u5ba3\u5e03\u6388\u6b0a\u7d93\u92b7\u5408\u4f5c\u7684<\/span>Accord Healthcare\uff0c\u76f8\u4fe1\u5c07\u80fd\u5920\u6975\u5927\u5316<\/span>FP-001\u7522\u54c1\u7684\u50f9\u503c\u3002<\/span><\/span>\u672a\u4f86\uff0c\u9664\u4e86\u5728\u4e0d\u540c\u5e02\u5834\u7684\u85e5\u8b49\u7533\u8acb\uff0c\u9038\u9054\u4e5f\u898f\u5283\u5728\u8fd1\u671f\u65bc\u7f8e\u570b\u5e02\u5834\u6388\u6b0a\u7d93\u92b7\u5408\u4f5c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u53e6\u5916\u4e5f\u5c07\u9678\u7e8c\u5728\u4e2d\u570b\u3001\u53f0\u7063\u3001\u65e5\u672c\u7b49\u5e02\u5834\u6d3d\u8ac7\u6388\u6b0a\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u516c\u53f8<\/span>SIF\u957f\u6548\u6280\u672f\u5e73\u53f0\u53ef\u9002\u5e94\u591a\u79cd<\/span>API<\/span>\u7684\u5242\u578b\u5f00\u53d1\uff0c\u51fa\u4e86\u5df2\u7ecf\u5ba3\u5e03<\/span>NDA<\/span>\u7684\u4eae\u4e19\u745e\u6797\u4e4b\u5916\uff0c\u548c\u5176\u4ed6\u957f\u6548\u6280\u672f\u5e73\u53f0\u4e00\u6837\uff0cpipeline\u4e3b\u8981\u9488\u5bf9\u4e00\u4e9b\u534a\u8870\u671f\u77ed\u7684\u3001\u9700\u8981\u9891\u7e41\u7ed9\u836f\u7684\u3001\u6162\u6027\u75c5\u7b49\u9886\u57df\u3002<\/span><\/span><\/p>\n

\"\u9038\u9054\u751f\u6280\u6b63\u5f0f\u5411FDA\u63d0\u51fa\u4eae\u4e19\u745e\u6797\u516d\u4e2a\u6708\u957f\u6548\u5242\u578b\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\"<\/p>\n

\"\u9038\u9054\u751f\u6280\u6b63\u5f0f\u5411FDA\u63d0\u51fa\u4eae\u4e19\u745e\u6797\u516d\u4e2a\u6708\u957f\u6548\u5242\u578b\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\"<\/p>\n

\u4e0e\u918b\u9178\u4eae\u4e19\u745e\u6797\u5fae\u7403\u5242\u578b\u53ca\u51dd\u80f6\u5242\u578b\u7684\u5bf9\u6bd4\u7814\u7a76\uff0c\u5c0f\u7f16\u4ee5\u4e3a\u5bf9\u4e8e\u5927\u4e8e<\/span>45mg\u5242\u578b\u6ce8\u5c04\u4f53\u79ef\u8f83\u5c0f\u5bf9\u4e8e\u4e34\u5e8a\u75c5\u4eba\u6765\u8bf4\u53ef\u80fd\u75db\u82e6\u5c0f\u4e00\u70b9\uff0c\u5bf9\u6bd4\u4e0b\u5242\u91cf\u4e0a<\/span>lupron<\/span>\u4e0e<\/span>eligard<\/span>\u90fd\u662f<\/span>45mg<\/span>\uff0c\u800c<\/span>LMIS<\/span>\u662f<\/span>50mg\u3002<\/span><\/span><\/p>\n

\"\u9038\u9054\u751f\u6280\u6b63\u5f0f\u5411FDA\u63d0\u51fa\u4eae\u4e19\u745e\u6797\u516d\u4e2a\u6708\u957f\u6548\u5242\u578b\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\"<\/p>\n

\u516c\u53f8\u91c7\u53d6\u7684\u4e34\u5e8a\u7b56\u7565<\/span><\/span><\/p>\n

\"\u9038\u9054\u751f\u6280\u6b63\u5f0f\u5411FDA\u63d0\u51fa\u4eae\u4e19\u745e\u6797\u516d\u4e2a\u6708\u957f\u6548\u5242\u578b\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\"<\/p>\n

\"\u9038\u9054\u751f\u6280\u6b63\u5f0f\u5411FDA\u63d0\u51fa\u4eae\u4e19\u745e\u6797\u516d\u4e2a\u6708\u957f\u6548\u5242\u578b\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\"<\/p>\n

\u4e13\u5229\u5e03\u5c40<\/span><\/span><\/p>\n

\"\u9038\u9054\u751f\u6280\u6b63\u5f0f\u5411FDA\u63d0\u51fa\u4eae\u4e19\u745e\u6797\u516d\u4e2a\u6708\u957f\u6548\u5242\u578b\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\"<\/p>\n

\u795d\u597d\u9038\u9054\u751f\u6280\uff0c\u5c3d\u65e9\u4ea7\u54c1\u4e0a\u5e02\uff01\u4ee5\u4e0a\u5185\u5bb9\u6e90\u4e8e\u516c\u5f00\u8d44\u6599\uff0c\u5982\u679c\u4e0d\u5e0c\u671b\u520a\u6587\u3001\u8054\u7cfb\u5c0f\u7f16\u5220\u9664\uff01<\/span><\/span><\/p>\n


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

\u65e5\u524d\uff0c\u5b9d\u5c9b\u53f0\u6e7e\u4e0a\u5e02\u516c\u53f8\u9038\u9054\u751f\u6280\u516c\u5f00\u5ba3\u5e03   \u672c\u516c\u53f8\u65bc\u7f8e\u570b\u6642\u9593108\uff08\u516c\u51432019\u5e74\uff09\u5e743\u670828\u65e5\u6b63\u5f0f […]<\/p>\n","protected":false},"author":1,"featured_media":80857,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80856"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=80856"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80856\/revisions"}],"predecessor-version":[{"id":80864,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80856\/revisions\/80864"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/80857"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=80856"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=80856"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=80856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}