{"id":71294,"date":"2018-10-11T01:00:00","date_gmt":"2018-12-07T04:54:19","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/3b79580793\/"},"modified":"2018-12-07T12:54:20","modified_gmt":"2018-12-07T04:54:20","slug":"3b79580793","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/71294\/","title":{"rendered":"\u7f8e\u56fd\u9996\u6b3eRituximab\u751f\u7269\u7c7b\u4f3c\u7269\u83b7ODAC\u5168\u7968\u652f\u6301\uff0c\u6765\u81eaCelltrion"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section class=\"xmteditor\" style=\"display:none;\"  ><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);font-size: 16px;white-space: normal;background-color: rgb(255, 255, 255);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding-right: 10px;padding-left: 10px;max-width: 100%;box-sizing: border-box;line-height: 1.6;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 0.8em;margin-bottom: 0.5em;max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);font-size: 16px;white-space: normal;background-color: rgb(255, 255, 255);border-width: 0px;border-style: initial;border-color: initial;text-align: center;word-wrap: break-word !important;\"><\/section>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 16px;white-space: normal;background-color: rgb(255, 255, 255);text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"color: rgb(52, 168, 83);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">#biosimilars<\/strong><br  \/><\/p>\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding-right: 22px;padding-left: 22px;max-width: 100%;box-sizing: border-box;line-height: 1.6;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><br  \/><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u6628\u5929\u665a\u4e9b\u65f6\u95f4<br  \/><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u65b0\u53ec\u5f00\u7684ODAC\u4f1a\u8bae<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u7ed9\u51fa\u4e86\u5168\u7968\u901a\u8fc7\u7684\u7ed3\u679c<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">16\u7968\u5168\u90e8\u652f\u6301\u6279\u51c6CT-P10<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u7f8e\u9996\u6b3eRituximab\u7c7b\u4f3c\u7269\u5373\u5c06\u83b7\u6279\u4e0a\u5e02<br  \/><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><br  \/><\/p>\n<p style=\"text-align: center;\"><img class=\"\"     style=\"width: 241px;height: 62px;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/2-1544158460.png\" alt=\"\u7f8e\u56fd\u9996\u6b3eRituximab\u751f\u7269\u7c7b\u4f3c\u7269\u83b7ODAC\u5168\u7968\u652f\u6301\uff0c\u6765\u81eatrion\" title=\"\u7f8e\u56fd\u9996\u6b3eRituximab\u751f\u7269\u7c7b\u4f3c\u7269\u83b7ODAC\u5168\u7968\u652f\u6301\uff0c\u6765\u81eatrion\"><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\"><br  \/><\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">\u8be5\u4ea7\u54c1\u6765\u81eatrion<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">\u6b64\u524d\u8be5\u4ea7\u54c1\u5df2\u7ecf\u4e8e\u53bb\u5e74\u521d<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">\u83b7EC\u6279\u51c6\u5728\u6b27\u6d32\u4e0a\u5e02<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">\u5728\u82f1\u8377\u4ee5\u516d\u5230\u4e03\u6298\u7684\u4ef7\u683c\u9500\u552e<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">\u534a\u5e74\u65f6\u95f4\u62ff\u4e0b30%\u5e02\u573a\u4efd\u989d<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">\u5230\u4e86\u56db\u5b63\u5ea6<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">\u5df2\u7ecf\u62ff\u4e0b\u82f143%\u837758%\u4efd\u989d<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u6b27\u6d32\u5e02\u573a\u8fd8\u6709Sandoz\u4ea7\u54c1<span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">Riximyo<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u4e24\u6b3e\u4ea7\u54c1\u7684\u4e0a\u5e02\u9500\u552e<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u4f7f\u5f97Roche\u539f\u7814\u4ea7\u54c1\u7f8e\u7f57\u534e<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u6b27\u6d32\u9500\u552e\u989d\u57282017\u5e74\u4e0b\u6ed111%<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u800c\u5230\u4e862018\u4e0a\u534a\u5e74<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u6b27\u6d32\u9500\u552e\u989d\u5df2\u7ecf\u4e0b\u8dcc47%<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><br  \/><\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/2-1544158460.jpg\" alt=\"\u7f8e\u56fd\u9996\u6b3eRituximab\u751f\u7269\u7c7b\u4f3c\u7269\u83b7ODAC\u5168\u7968\u652f\u6301\uff0c\u6765\u81eatrion\" title=\"\u7f8e\u56fd\u9996\u6b3eRituximab\u751f\u7269\u7c7b\u4f3c\u7269\u83b7ODAC\u5168\u7968\u652f\u6301\uff0c\u6765\u81eatrion\"><\/p>\n<p style=\"text-align: center;\"><span style=\"font-size: 12px;color: rgb(178, 178, 178);\">MabThera\/Rituxan sales in Europe<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><br  \/><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u56fd\u5185\u590d\u661f\u533b\u836f\u65d7\u4e0b\u590d\u5b8f\u6c49\u9716<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u5df2\u7ecf\u5728\u53bb\u5e74\u63d0\u4ea4\u8be5\u7c7b\u4f3c\u7269\u4e0a\u5e02\u7533\u8bf7<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u5e76\u4e8e\u5e74\u521d\u83b7\u5f97\u56fd\u5185\u6709\u9650\u5ba1\u8bc4\u8d44\u683c<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u7531\u4e8e\u4e2d\u4fe1\u56fd\u5065\u64a4\u56de\u6ce8\u518c\u7533\u8bf7<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">HLX-01\u4e5f\u5c31\u6709\u5e0c\u671b\u6210\u4e3a\u9996\u6b3e\u4e0a\u5e02\u836f\u7269<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u76ee\u524d\u56fd\u5185\u8fdb\u5165III\u671f\u7684\u4f01\u4e1a<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u8fd8\u5305\u62ec<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\">\u6d77\u6b63\u3001<span style=\"color: rgb(62, 62, 62);font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);\">\u4fe1\u8fbe<\/span>\u548c\u795e\u5dde\u7ec6\u80de<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;text-align: center;\"><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);font-size: 16px;white-space: normal;background-color: rgb(255, 255, 255);overflow-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding-right: 10px;padding-left: 10px;max-width: 100%;box-sizing: border-box;line-height: 1.6;word-wrap: break-word !important;\">\n<p style=\"text-align: center;\">\n<p style=\"text-align: center;\"><br  \/><\/p>\n<hr  \/>\n<p style=\"text-align: center;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: right;text-indent: 88px;background-color: rgb(255, 255, 255);\"><br  \/><\/span><\/p>\n<p style=\"text-align: left;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: right;text-indent: 88px;background-color: rgb(255, 255, 255);\">trion, Inc. (Applicant) has submitted a biologics license application (BLA) under section 351(k) of the Public Health Service Act (PHS Act) for CT-P10, a proposed biosimilar to US- licensed Rituxan (rituximab) (BLA# 103705).<\/span><\/p>\n<p style=\"text-align: center;\"><br  \/><\/p>\n<p class=\"\" style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;white-space: normal;text-indent: 7pt;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Treatment of adult patients with<\/span><\/p>\n<ol class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"margin-top: 0pt;margin-bottom: 0pt;max-width: 100%;min-height: 1em;text-align: left;text-indent: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 12pt;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Relapsed or refractory, low grade or follicular, CD20-positive, B-cell Non-Hodgkin\u2019s Lymphoma (NHL) as a single agent.<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-top: 0pt;margin-bottom: 0pt;max-width: 100%;min-height: 1em;text-align: left;text-indent: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 12pt;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-top: 0pt;margin-bottom: 0pt;max-width: 100%;min-height: 1em;text-align: left;text-indent: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 12pt;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.<\/span><\/p>\n<\/li>\n<\/ol>\n<p style=\"text-align: center;\"><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"<p>#biosimilars \u6628\u5929\u665a\u4e9b\u65f6\u95f4 \u65b0\u53ec\u5f00\u7684ODAC\u4f1a\u8bae \u7ed9\u51fa\u4e86\u5168\u7968\u901a\u8fc7\u7684\u7ed3\u679c 16\u7968\u5168\u90e8\u652f\u6301\u6279\u51c6CT-P [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":71295,"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\/71294"}],"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=71294"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/71294\/revisions"}],"predecessor-version":[{"id":71298,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/71294\/revisions\/71298"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/71295"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=71294"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=71294"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=71294"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}