{"id":9116,"date":"2025-08-25T17:18:16","date_gmt":"2025-08-25T09:18:16","guid":{"rendered":"https:\/\/chimebiologics.com\/?p=9116"},"modified":"2025-12-09T16:48:49","modified_gmt":"2025-12-09T08:48:49","slug":"chime-biologics-supports-the-bla-filing-of-polaris-group-in-u-s-fda-in-entering-the-substantive-review-stage","status":"publish","type":"post","link":"https:\/\/chimebiologics.com\/zh\/chime-biologics-supports-the-bla-filing-of-polaris-group-in-u-s-fda-in-entering-the-substantive-review-stage\/","title":{"rendered":"\u9f0e\u5eb7\u751f\u7269\u52a9\u529b\u5317\u6781\u661f\u836f\u4e1a\u96c6\u56e2\u5728\u7f8e\u56fdFDA\u83b7\u6279BLA\u7533\u8bf7\u5e76\u987a\u5229\u8fdb\u5165\u5b9e\u8d28\u6027\u5ba1\u8bc4\u9636\u6bb5"},"content":{"rendered":"<div class='flex_column av-mcn1nejp-0182da29d964c125ba238ee717c164b6 av_one_full  avia-builder-el-0  el_before_av_two_third  avia-builder-el-first  first no_margin flex_column_div '     ><section  class='av_textblock_section 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itemprop=\"text\" ><p><\/p>\n<h1><strong>\u9f0e\u5eb7\u751f\u7269\u52a9\u529b\u5317\u6781\u661f\u836f\u4e1a\u96c6\u56e2\u5728\u7f8e\u56fdFDA\u83b7\u6279BLA\u7533\u8bf7\u5e76\u987a\u5229\u8fdb\u5165\u5b9e\u8d28\u6027\u5ba1\u8bc4\u9636\u6bb5<\/strong><\/h1>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9120 aligncenter\" src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2025\/08\/\u82f1\u6587.jpg\" alt=\"\" width=\"750\" height=\"320\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2025\/08\/\u82f1\u6587.jpg 750w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2025\/08\/\u82f1\u6587-300x128.jpg 300w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2025\/08\/\u82f1\u6587-705x301.jpg 705w\" sizes=\"auto, (max-width: 750px) 100vw, 750px\" \/><\/p>\n<p><strong><b>2025\u5e748\u670825\u65e5<\/b><\/strong><strong><b>\uff0c<\/b><\/strong><strong><b>\u4e2d\u56fd\u6b66\u6c49 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href=\"https:\/\/polarispharma.com\/\"><u>https:\/\/polarispharma.com\/<\/u><\/a>\u3002<\/p>\n<p><strong><b>\u5173\u4e8e\u9f0e\u5eb7\u751f\u7269<\/b><\/strong><\/p>\n<p>\u9f0e\u5eb7\u751f\u7269\u662f\u4e00\u5bb6\u5168\u7403\u9886\u5148\u7684CDMO\u516c\u53f8\uff0c\u7387\u5148\u5f15\u8fdb\u4e86\u5168\u7403\u9996\u4e2a\u6a21\u5757\u5316\u751f\u7269\u5236\u836f\u5de5\u5382KUBio\u2122\uff0c\u8d4b\u80fd\u751f\u7269\u5236\u54c1\u4ece\u7ec6\u80de\u682a\u5f00\u53d1\u5230\u5546\u4e1a\u5316\u751f\u4ea7\u7684\u5168\u8fc7\u7a0b\u3002\u6211\u4eec\u4f4d\u4e8e\u4e0a\u6d77\u7684\u521b\u65b0\u4e2d\u5fc3\u805a\u7126\u9ad8\u6548\u7684\u7ec6\u80de\u682a\u5f00\u53d1\u548c\u5148\u8fdb\u7684\u6280\u672f\u5f00\u53d1\uff0c\u4e0e\u62e5\u6709\u591a\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u548c\u65b0\u836f\u4e0a\u5e02\u6210\u529f\u7ecf\u9a8c\u7684\u6b66\u6c49\u5236\u9020\u5de5\u5382\u76f8\u7ed3\u5408\uff0c\u9f0e\u5eb7\u751f\u7269\u6b63\u5728\u4e3a\u5168\u7403\u751f\u7269\u533b\u836f\u5ba2\u6237\u63d0\u4f9b\u4e00\u7ad9\u5f0f\u7684CMC\u89e3\u51b3\u65b9\u6848\u3002\u5728\u9f0e\u5eb7\u751f\u7269\uff0c\u6211\u4eec\u6709\u4e00\u4e2a\u5171\u540c\u7684\u76ee\u6807, \u81f4\u529b\u4e8e\u63d0\u9ad8\u524d\u6cbf\u751f\u7269\u533b\u836f\u5bf9\u5168\u7403\u60a3\u8005\u7684\u53ef\u53ca\u6027\uff0c\u5c65\u884c\u6211\u4eec\u5bf9\u4eba\u7c7b\u5065\u5eb7\u7684\u627f\u8bfa\u3002\u5982\u9700\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee\uff1a<a href=\"http:\/\/www.chimebiologics.com\/\"><u>www.chimebiologics.com<\/u><\/a>\u3002<\/p>\n<p><\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2d3l4o-9301d0cdc14489efa114080353995aa9\">\n.flex_column.av-2d3l4o-9301d0cdc14489efa114080353995aa9{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-2d3l4o-9301d0cdc14489efa114080353995aa9 av_one_third  avia-builder-el-4  el_after_av_two_third  avia-builder-el-last  no_margin flex_column_div av-zero-column-padding column-top-margin'     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