{"id":814,"date":"2018-07-01T01:00:00","date_gmt":"2018-07-27T06:23:27","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e4%b8%80%e6%96%87%e8%af%86%e7%bb%bf%e5%8f%b6%e5%88%b6%e8%8d%afpipeline\/"},"modified":"2018-07-27T14:23:29","modified_gmt":"2018-07-27T06:23:29","slug":"%e4%b8%80%e6%96%87%e8%af%86%e7%bb%bf%e5%8f%b6%e5%88%b6%e8%8d%afpipeline","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/814\/","title":{"rendered":"\u4e00\u6587\u8bc6\u7eff\u53f6\u5236\u836fPipeline"},"content":{"rendered":"
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2017\u5e74\uff0c\u7eff\u53f6\u5236\u836f\u5b9e\u73b0\u9500\u552e\u6536\u516538.2\u4ebf\u5143\u4eba\u6c11\u5e01\uff0c\u540c\u6bd4\u589e\u957f30.7%<\/span>\uff1b\u5f52\u5c5e\u4e8e\u80a1\u4e1c\u7684\u6b63\u5e38\u5316\u51c0\u5229\u6da6\u8fbe\u5230<\/span>10.6<\/span>\u4ebf\u5143\u4eba\u6c11\u5e01\uff0c\u540c\u6bd4\u589e\u957f<\/span>19.0%<\/span>\u3002\u516c\u53f8\u4e3b\u8425\u4ea7\u54c1\uff0c\u5982\u529b\u6251\u7d20\u3001\u8d1d\u5e0c\u3001\u8840\u8102\u5eb7\u3001\u5e0c\u7f8e\u7eb3\u7b49\u3002<\/span><\/h2>\n
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\"\u4e00\u6587\u8bc6\u7eff\u53f6\u5236\u836fPipeline\"<\/p>\n

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2018\u5e746<\/span>\u670822<\/span>\u65e5\uff0c\u7eff\u53f6\u5236\u836f\u96c6\u56e2\u5728\u9999\u6e2f\u4e3e\u884c\u201c\u56fd\u9645\u5408\u4f5c\u6218\u7565\u53d1\u5e03\u4f1a\u201d\uff0c\u4f1a\u4e0a\u96c4\u5fc3\u52c3\u52c3\uff0c\u8868\u793a\uff1a2025<\/span>\u8dfb\u8eab\u5168\u7403\u5236\u836f\u516c\u53f8\u524d50<\/span>\u5f3a\u3002\u4e0b\u56fe\u6587\u8868\uff0c\u4e3a\u8bfb\u8005\u68b3\u7406\u7eff\u53f6\u5236\u836f\u7684\u4ea7\u54c1\u7ebf\u53ca\u5408\u4f5c\u3002  <\/span>  <\/span><\/p>\n<\/section>\n

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\u7eff\u53f6\u5236\u836fPipeline\u8fdb\u5ea6<\/span><\/strong><\/p>\n


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\"\u4e00\u6587\u8bc6\u7eff\u53f6\u5236\u836fPipeline\"<\/p>\n

\"\u4e00\u6587\u8bc6\u7eff\u53f6\u5236\u836fPipeline\"<\/p>\n

\u53c2\u8003\uff1aFDA\/CNDA\/CDE\/\u4e34\u5e8a\u8bd5\u9a8c\u767b\u8bb0\u4e2d\u5fc3\/Clinical trials<\/span>\uff0c\u836f\u878d\u6570\u636e\/Pharnex datamonitor<\/span>\uff1b<\/span><\/p>\n

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\u9644\uff1a<\/span><\/strong><\/span><\/p>\n

1.\u76d0\u9178\u5b89\u8212\u6cd5\u8f9b\u7f13\u91ca\u7247LY03005II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff1a<\/span><\/strong><\/span><\/p>\n


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II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u662f\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c\uff0c\u901a\u8fc710\u5bb6\u4e34\u5e8a\u7814\u7a76\u4e2d\u5fc3\u8fdb\u884c\u3002\u8be5\u9879\u8bd5\u9a8c\u4e2d\uff0c260\u4f8b\u6291\u90c1\u75c7\u60a3\u8005\u88ab\u968f\u673a\u5206\u914d\u81f3LY03005\u7ec4\u6216\u5b89\u6170\u5242\u7ec4\u3002<\/span><\/p>\n

II\u671f\u8bd5\u9a8c\u521d\u6b65\u7ed3\u679c\u663e\u793a\uff0c\u8bd5\u9a8c\u6210\u529f\u8fbe\u5230\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u76ee\u6807\uff0c6\u5468\u672b\u4e3b\u8981\u7597\u6548\u6307\u6807\u6c49\u5bc6\u5c14\u987f17\u9879\u6291\u90c1\u91cf\u8868\uff08HAM-D17\uff09\u603b\u5206\u8f83\u57fa\u7ebf\u51cf\u5206\u503c\uff0cLY03005\u7684\u4e09\u4e2a\u5242\u91cf\u7ec4\uff0840mg\u300180mg\u3001160mg\uff09\u5747\u663e\u8457\u4f18\u4e8e\u5b89\u6170\u5242\uff08P<0.05\uff09\u3002\u5173\u952e\u6b21\u8981\u7597\u6548\u7ec8\u70b9\u8499\u54e5\u9a6c\u5229\u2014\u827e\u65af\u4f2f\u683c\u6291\u90c1\u91cf\u8868(MADRS)\u603b\u52066\u5468\u672b\u8f83\u57fa\u7ebf\u53d8\u5316\uff0cLY03005\u5404\u7ec4\u5747\u663e\u8457\u4f18\u4e8e\u5b89\u6170\u5242\uff08p\uff1c0.05\uff09\u3002<\/span><\/p>\n

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\u7eff\u53f6\u8868\u793a\u5927\u90e8\u5206\u5176\u4ed6\u6297\u6291\u90c1\u836f\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6837\u672c\u91cf\u666e\u904d\u504f\u5c0f\uff0c\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u8fbe\u5230\u7edf\u8ba1\u5b66\u5dee\u5f02\u7684\u96be\u5ea6\u8f83\u5927\u3002<\/span><\/p>\n


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2.<\/span><\/strong><\/span> <\/span><\/span>2017\u5e748\u6708\uff0c\u7eff\u53f6\u5236\u836f\u5ba3\u5e03\u6536\u8d2d\u5c71\u4e1c\u535a\u5b89\u751f\u7269\u7684\u4e24\u79cd\u5728\u7814\u4ea7\u54c1\uff08LY01008\u53caLY06006\uff09\u4ee5\u53ca\u5176\u5404\u81ea\u7684\u6280\u672f\u3001\u6570\u636e\u8fde\u540c\u8be5\u7b49\u4ea7\u54c1\u9644\u5e26\u7684\u4e00\u5207\u6743\u5229\uff0c\u6536\u8d2d\u603b\u4ef74.5\u4ebf\u5143\u3002\uff08\u535a\u5b89\u662f\u7eff\u53f6\u96c6\u56e2\u4e0b\u5c5e\u516c\u53f8\uff09<\/span><\/p>\n


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LY01008-\u8d1d\u4f10\u73e0\u5355\u6297biosimilar\uff0c\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u91c7\u7528\u968f\u673a\u3001\u53cc\u76f2\u3001\u5e73\u884c\u7ec4\u522b\u3001\u9633\u6027\u5bf9\u7167\u8bbe\u8ba1\u3002100\u540d\u5065\u5eb7\u7537\u6027\u53d7\u8bd5\u8005\u63091 : 1\u6bd4\u4f8b\u968f\u673a\u5206\u914d\u81f3LY 01008\u7ec4\u6216\u5b89\u7ef4\u6c40\u00ae\u7ec4\uff0c\u63a5\u53d7\u5355\u6b21\u9759\u8109\u7ed9\u836f\u3002\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff1a\u4e3b\u8981\u836f\u4ee3\u52a8\u529b\u5b66(PK)\u53c2\u6570\u3001\u65f6\u95f4-\u6d53\u5ea6\u66f2\u7ebf\u4e0b\u9762\u79ef\uff08AUC 0 -t\uff09\u3001\u8840\u836f\u5cf0\u6d53\u5ea6\uff08Cmax\uff09\u8fd9\u4e09\u4e2a\u9884\u8bbe\u6307\u6807\u5747\u8fbe\u5230\u9884\u8bbe\u7b49\u6548\u6807\u51c6\uff08\u51e0\u4f55\u5747\u503c\u6bd4\u503c\u768490%\uff0c\u7f6e\u4fe1\u533a\u95f4\u4ecb\u4e8e80.00%\u2013 125.00%\uff09\u3002\u5065\u5eb7\u53d7\u8bd5\u8005\u4f7f\u7528\u4e24\u836f\u5747\u5b89\u5168\u8010\u53d7\uff0c\u5b89\u5168\u6027\u548c\u514d\u75ab\u539f\u6027\u8868\u73b0\u76f8\u4f3c\u3002\u8d1d\u4f10\u73e0\u5355\u6297biosimilar\u3002<\/span><\/p>\n


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3. <\/span><\/strong><\/span>\u6ce8\u5c04\u7528\u7f57\u66ff\u6208\u6c40\u7f13\u91ca\u5fae\u7403\uff08LY03003\uff09\u6709\u610f\u601d\u3002\u6309\u7167\u4e0eFDA\u6c9f\u901a\u7684\u65b9\u6848\uff0cLY03003\u5c06\u540c\u76ee\u524d\u552f\u4e00\u4e0a\u5e02\u7684\u7f57\u66ff\u6208\u6c40\u5236\u5242Neupro\u00ae\u900f\u76ae\u8d34\u5242\u8fdb\u884c\u76f8\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u8bd5\u9a8c\uff0c\u5982\u53ef\u8bc1\u660eLY03003\u4e0e Neupro\u00ae \u751f\u7269\u7b49\u6548\uff0c\u5219\u53ef\u8fdb\u4e00\u6b65\u514d\u9664\u5f00\u5c55III\u671f\u7597\u6548\u786e\u8bc1\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span><\/p>\n


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4.<\/span><\/strong><\/span> <\/span><\/span>\u529b\u6251\u7d20\u73b0\u5728\u7684\u5b9a\u4ef7\u5df2\u7ecf\u4e0d\u7b97\u8d35\uff0c\u672a\u6765\u4e0d\u6392\u9664\u4f1a\u5728\u9002\u5f53\u65f6\u673a\u4f5c\u51fa\u9002\u5f53\u7684\u8ba9\u6b65\uff08\u964d\u4ef7\uff09\uff0c\u6765\u6362\u53d6\u5e02\u573a\u66f4\u5927\u7684\u673a\u4f1a\u30022017\u5e74\u770b\u5230\u533b\u9662\u8986\u76d6\u7684\u6bd4\u8f83\u591a\uff0c\u672a\u6765\u9762\u5bf9\u7ade\u4e89\u5bf9\u624b\uff08\u51e0\u5bb6\u767d\u86cb\u767d\u7d2b\u6749\u9187\uff1f\uff09\uff0c\u4e5f\u662f\u63d0\u524d\u505a\u4e86\u51c6\u5907\uff0c\u5305\u62ec\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4e5f\u662f\u4e3a\u4e86\u8fce\u63a5\u4ee5\u540e\u7684\u66f4\u5927\u7684\u5e02\u573a\u8986\u76d6\u3002\u4eca\u5e74\u4f1a\u5728\u57fa\u5c42\u4e0a\u4ed8\u51fa\u66f4\u591a\u7684\u6295\u5165\u3002<\/span><\/p>\n


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5. <\/span><\/strong><\/span>\u601d\u745e\u5eb7\u548c\u601d\u745e\u5eb7\u7f13\u91ca\u7247\u5728\u4e0e<\/span>AZ\u4ea4\u6613\u8986\u76d6\u7684<\/span>51\u4e2a\u5e02\u573a\u7684<\/span>2017\u5e74\u603b\u9500\u552e\u989d\u5206\u522b\u8fbe\u5230<\/span>8500\u4e07\u7f8e\u5143\u548c<\/span>6300\u4e07\u7f8e\u5143\u3002\u5bcc\u9a6c\u9178\u55b9\u786b\u5e73\u7f13\u91ca\u7247\u7684\u5236\u5242\u4e13\u5229\u4e5f\u5728\u5927\u591a\u6570\u5e02\u573a\u8fc7\u671f\u3002<\/span>LY03004\uff08\u5373\u5229\u57f9\u916e\u7f13\u91ca\u5fae\u7403\uff0c\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u548c\u53cc\u76f8\u60c5\u611f\u969c\u788d\u7684\u836f\u7269\uff09\u5728\u4e0a\u5e02\u4e4b\u524d\u505a\u597d\u5728\u5f53\u5730\u5e02\u573a\u7684\u54c1\u724c\u548c\u9500\u552e\u7f51\u7edc\u5efa\u8bbe\u5de5\u4f5c\u3002<\/span><\/span><\/p>\n


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6.\u5176\u4ed6\u5408\u4f5c\u6295\u8d44\uff1a<\/span><\/strong><\/span><\/p>\n

2016\u5e74<\/span>7\u6708<\/span><\/span>,<\/span>\u4e0e\u745e\u58eb<\/span>Acino\u516c\u53f8\u7b7e\u7ea6\uff0c\u4ee5<\/span>2.45\u4ebf\u6b27\u5143\u8d2d\u4e70\u65d7\u4e0b\u900f\u76ae\u91ca\u836f\u7269\u4e1a\u52a1\uff0c\u5373<\/span>Acino AG\u548c<\/span>Acino Supply AG<\/span>\uff1b<\/span><\/span><\/p>\n

2017\u5e74\u8ba4\u8d2d<\/span><\/span>Exicure Inc.<\/span><\/strong><\/span>\u7684\u80a1\u4efd\uff0c\u7528\u4e8e\u63a8\u8fdb<\/span><\/span>\u65b0\u578b\u6838\u9178\u836f\u7269<\/span><\/strong><\/span>\u7684\u7814\u7a76\u5f00\u53d1\uff1b<\/span><\/span><\/p>\n

2018\u5e743<\/span>\u6708\u5ba3\u5e03\u4e0e\u7f8e\u56fd\u52a0\u5dde\u7684<\/span><\/span>Excel Biopharm LLC<\/span><\/strong><\/span>\u7b7e\u7f72\u5408\u4f5c\u534f\u8bae\uff0c\u5408\u4f5c\u5f00\u53d1\u7528\u4e8e<\/span><\/span>\u4e0b\u4e00\u4ee3\u80bf\u7624\u514d\u75ab\u7597\u6cd5\u7684\u6cbb\u7597\u578b\u6297\u4f53\uff1b<\/span><\/strong><\/span><\/p>\n

2018\u5e745<\/span>\u6708\uff0c\u5e03\u5c40\u80bf\u7624\u514d\u75ab\u6cbb\u7597\uff0c\u4e0e<\/span><\/span>ELPIS BIOPHARM\u5408\u4f5c\u5f00\u53d1CAR-T<\/span><\/strong><\/span>\u7597\u6cd5\uff1b<\/span><\/span><\/p>\n

\u5411\u8036\u9c81\u5927\u5b66\u5e72\u7ec6\u80de\u7814\u7a76\u4e2d\u5fc3\u63d0\u4f9b100\u4e07\u7f8e\u5143\u8d44\u52a9\uff0c\u7528\u4e8e\u6797\u6d77\u5e06\u535a\u58eb\u8bfe\u9898\u7ec4\u57fa\u7840\u5e72\u7ec6\u80de\u7814\u7a76\u652f\u6301\u7b49\u3002<\/span><\/p>\n


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\u53c2\u8003\uff1a<\/span><\/strong><\/span><\/p>\n

FDA\/CNDA\/CDE\/\u4e34\u5e8a\u8bd5\u9a8c\u767b\u8bb0\u4e2d\u5fc3<\/span>\/Clinical trials<\/span>\uff0c\u836f\u878d\u6570\u636e<\/span>\/Pharnex datamonitor<\/span>\uff1b<\/span><\/span><\/span><\/span><\/p>\n

http:\/\/data.eastmoney.com\/notices\/detail\/02186\/AN201806201157149516,JWU3JWJiJWJmJWU1JThmJWI2JWU1JTg4JWI2JWU4JThkJWFm.html<\/span><\/span>\uff1b<\/span><\/span><\/p>\n

<\/span>http:\/\/www.luye.cn\/lvye\/newsshow.php?id=1174<\/span><\/span>\uff1b<\/span><\/span><\/p>\n

http:\/\/skl.luye.cn\/index.php<\/span><\/span>\u7b49\u3002<\/span><\/span><\/p>\n


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<\/span><\/strong>
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\u6b22\u8fce\u5173\u6ce8\u836f\u878d\u5708\u5b98\u7f51<\/span><\/p>\n

\u770b\u8fd9\u91cc\uff1a<\/span>www.pharnex.com<\/span><\/span><\/p>\n

\u70b9\u51fb\u6587\u672b \u9605<\/span>\u8bfb\u539f\u6587 <\/span>\u53ef\u76f4\u63a5\u8fdb\u5165<\/span><\/p>\n<\/section>\n<\/section>\n


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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u7269\u7b80\u8baf <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

2017\u5e74\uff0c\u7eff\u53f6\u5236\u836f\u5b9e\u73b0\u9500\u552e\u6536\u516538.2\u4ebf\u5143\u4eba\u6c11\u5e01\uff0c\u540c\u6bd4\u589e\u957f30.7%\uff1b\u5f52\u5c5e\u4e8e\u80a1\u4e1c\u7684\u6b63\u5e38\u5316\u51c0\u5229\u6da6\u8fbe\u523010.6\u4ebf […]<\/p>\n","protected":false},"author":1,"featured_media":815,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/814"}],"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=814"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/814\/revisions"}],"predecessor-version":[{"id":820,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/814\/revisions\/820"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/815"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=814"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=814"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=814"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}