{"id":56715,"date":"2021-12-16T08:16:00","date_gmt":"2021-12-16T01:16:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2021121608160056715"},"modified":"2021-12-16T17:54:05","modified_gmt":"2021-12-16T09:54:05","slug":"%e4%ba%91%e9%a1%b6%e6%96%b0%e8%80%80%e5%ae%a3%e5%b8%83%e5%85%b6%e5%90%88%e4%bd%9c%e4%bc%99%e4%bc%b4calliditas-therapeutics-%e7%9a%84tarpeyo%e5%b8%83%e5%9c%b0%e5%a5%88%e5%be%b7%e8%8e%b7","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2021121608160056715","title":{"rendered":"\u4e91\u9876\u65b0\u8000\u5ba3\u5e03\u5176\u5408\u4f5c\u4f19\u4f34Calliditas Therapeutics \u7684TARPEYO&#x2122;(\u5e03\u5730\u5948\u5fb7)\u83b7\u5f97\u7f8e\u56fdFDA\u52a0\u901f\u6279\u51c6\u4ee5\u964d\u4f4eIgA\u80be\u75c5\u60a3\u8005\u7684\u86cb\u767d\u5c3f"},"content":{"rendered":"<ul type=\"disc\">\n<li><i><i>TARPEYO(<\/i><i>\u5e03\u5730\u5948\u5fb7<\/i><i>)<\/i><i>\u8fdf\u91ca\u80f6\u56ca\u662f\u76ee\u524d\u7b2c\u4e00\u79cd\u4e5f\u662f\u552f\u4e00\u4e00\u79cd\u7528\u4e8e\u964d\u4f4e\u60a3\u6709\u5feb\u901f\u8fdb\u5c55\u98ce\u9669\u7684\u539f\u53d1\u6027<\/i><i>IgA<\/i><i>\u80be\u75c5\uff08\u901a\u5e38\u5c3f\u86cb\u767d\u4e0e\u808c\u9150\u6bd4<\/i><i>&nbsp;(UPCR) <\/i><i>\u2265<\/i><i>1.5g\/g<sup>1<\/sup><\/i><i>\uff09\u6210\u4eba\u60a3\u8005\u86cb\u767d\u5c3f\u7684\u6cbb\u7597\u65b9\u6cd5<\/i><\/i> <\/li>\n<li><i>TARPEYO(<\/i><i>\u9879\u76ee\u7814\u53d1\u540d\u79f0\u4e3a<\/i><i>NEFECON)<\/i><i>\u662f\u76ee\u524d\u7b2c\u4e00\u79cd\u4e5f\u662f\u552f\u4e00\u4e00\u79cd\u7ecf\u7f8e\u56fd<\/i><i>FDA<\/i><i>\u6279\u51c6\u4e13\u95e8\u6cbb\u7597\u6b64\u9002\u5e94\u75c7\u7684\u836f\u7269<\/i><i><sup>1,2<\/sup><\/i> <\/li>\n<li><i>IgA<\/i><i>\u80be\u75c5\u662f\u4e00\u79cd\u8fdb\u884c\u6027\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u6709\u8d85\u8fc7<\/i><i>50%<\/i><i>\u7684\u60a3\u8005\u53ef\u80fd\u8fdb\u5c55\u4e3a\u7ec8\u672b\u671f\u80be\u75c5<\/i><i>(ESRD)<\/i><i>\uff0c\u6b64\u7c7b\u60a3\u8005\u7684\u533b\u7597\u9700\u6c42\u4e9f\u5f85\u6ee1\u8db3<\/i><i><sup>3<\/sup><\/i> <\/li>\n<li><i>\u4e91\u9876\u65b0\u8000\u62e5\u6709\u5728\u4e2d\u56fd\uff08\u5927\u9646\u3001\u9999\u6e2f\u3001\u6fb3\u95e8\u4ee5\u53ca\u53f0\u6e7e\u5730\u533a\uff09\u548c\u65b0\u52a0\u5761\u5f00\u53d1\u548c\u5546\u4e1a\u5316<\/i><i>NEFECON<\/i><i>\u7684\u72ec\u5bb6\u6743\u5229<\/i><\/li>\n<\/ul>\n<p><p>\u4e0a\u6d772021\u5e7412\u670816\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; \u4e91\u9876\u65b0\u8000 (Everest Medicines, HKEX 1952.HK)\u4eca\u65e5\u516c\u5e03\uff0c\u5176\u5408\u4f5c\u4f19\u4f34Calliditas Therapeutics AB\uff08\u7eb3\u65af\u8fbe\u514b\u80a1\u7968\u4ee3\u7801\uff1aCALT\uff0c\u7eb3\u65af\u8fbe\u514b\u65af\u5fb7\u54e5\u5c14\u6469\u80a1\u7968\u4ee3\u7801\uff1aCALTX\uff09\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cCalliditas\u201d\uff09\u5ba3\u5e03\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40(FDA)\u5df2\u6279\u51c6TARPEYO<sup>TM<\/sup>(\u5e03\u5730\u5948\u5fb7)\u8fdf\u91ca\u80f6\u56ca\u7528\u4e8e\u964d\u4f4e\u60a3\u6709\u5feb\u901f\u8fdb\u5c55\u98ce\u9669\u7684\u539f\u53d1\u6027IgA\u80be\u75c5\uff08\u901a\u5e38\u5c3f\u86cb\u767d\u4e0e\u808c\u9150\u6bd4 (UPCR) \u22651.5g\/<span id=\"spanHghlt5847\">g<sup>1<\/sup><\/span>\uff09\u6210\u4eba\u60a3\u8005\u86cb\u767d\u5c3f\u7684\u6cbb\u7597\u65b9<span id=\"spanHghlt5784\">\u6cd5\u3002<\/span>\u8be5\u9002\u5e94\u75c7\u83b7\u6279\u662f\u57fa\u4e8e\u5176\u52a0\u901f\u5ba1\u8bc4\u7a0b\u5e8f\u3002\u76ee\u524d\u5c1a\u672a\u660e\u786eTARPEYO\u662f\u5426\u80fd\u51cf\u7f13IgA\u80be\u75c5\u60a3\u8005\u7684\u80be\u529f\u80fd\u4e0b\u964d\u3002\u540e\u7eed\u6279\u51c6\u53ef\u80fd\u53d6\u51b3\u4e8e\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4e34\u5e8a\u83b7\u76ca\u7684\u9a8c\u8bc1\u548c\u63cf\u8ff0<sup>1<\/sup>\u3002<\/p>\n<p>Calliditas\u7684\u9996\u5e2d\u6267\u884c\u5b98Ren&eacute;e Aguiar-Lucander\u8868\u793a\uff0c\u201c\u6211\u4eec\u975e\u5e38\u9ad8\u5174\u80fd\u5c06\u76ee\u524d\u7b2c\u4e00\u79cd\uff0c\u4e5f\u662f\u552f\u4e00\u4e00\u79cd\u7ecf\u7f8e\u56fdFDA\u6279\u51c6\u7684\u7528\u4e8e\u964d\u4f4eIgA\u80be\u75c5\u86cb\u767d\u5c3f\u7684\u836f\u7269\u63a8\u5411\u5e02\u573a\u3002TARPEYO<span id=\"spanHghlt029f\">\u662f<\/span>\u7ecf\u7f8e\u56fdFDA\u6279\u51c6\u7684\u4ea7\u54c1\uff0c\u4ee5\u4e3a\u5904\u4e8e\u75be\u75c5\u5feb\u901f\u8fdb\u5c55\u98ce\u9669\u4e2d\u7684IgA\u80be\u75c5\u60a3\u8005\u63d0\u4f9b\u5e2e\u52a9\u3002\u201d<\/p>\n<p>\u4e91\u9876\u65b0\u8000\u9996\u5e2d\u6267\u884c\u5b98\u8584\u79d1\u745e\u535a\u58eb\u5f3a\u8c03\uff0c\u201c\u6b64\u6b21FDA\u6279\u51c6Calliditas\u7684\u521b\u65b0\u5e03\u5730\u5948\u5fb7\u5236\u5242\u6807\u5fd7\u7740IgA\u80be\u75c5\u6cbb\u7597\u5411\u524d\u8fc8\u51fa\u4e86\u91cd\u8981\u7684\u4e00\u6b65\uff0c\u6211\u4eec\u5c06\u4ee5\u201cNEFECON\u201d\u7684\u540d\u79f0\u5728\u6388\u6743\u8bb8\u53ef\u533a\u57df\u63a8\u8fdb\u8be5\u836f\u7684\u5f00\u53d1\u3002\u6211\u4eec\u5411\u5408\u4f5c\u4f19\u4f34Calliditas\u5728\u5168\u7403\u4e34\u5e8a\u548c\u76d1\u7ba1\u65b9\u9762\u53d6\u5f97\u7684\u5feb\u901f\u8fdb\u5c55\u8868\u793a\u795d\u8d3a\uff0c\u8fd9\u5c06\u4f7f\u90a3\u4e9b\u6709\u9700\u8981\u7684\u60a3\u8005\u80fd\u591f\u5c3d\u5feb\u83b7\u5f97\u6b64\u7c7b\u75be\u75c5\u7684\u9996\u6b3e\u6cbb\u7597\u836f\u7269\u3002\u4e91\u9876\u65b0\u8000\u671f\u5f85\u770b\u5230\u8fd9\u4e00\u91cd\u8981\u7597\u6cd5\u5728\u5927\u4e2d\u534e\u533a\u548cIgA\u80be\u75c5\u60a3\u75c5\u7387\u8f83\u9ad8\u7684\u5176\u4ed6\u4e9a\u6d32\u5730\u533a\u53d6\u5f97\u8fdb\u5c55\u3002\u201d<\/p>\n<p>TARPEYO\u5728NeflgArd\u5173\u952e\u60273\u671f\u7814\u7a76A\u90e8\u5206\u4e2d\u8fbe\u5230\u4e86\u964d\u4f4e\u86cb\u767d\u5c3f\u7684\u4e3b\u8981\u7ec8\u70b9\uff0c\u7531\u6b64\u901a\u8fc7\u52a0\u901f\u5ba1\u8bc4\u7a0b\u5e8f\u83b7\u6279\u3002\u4e0a\u8ff0\u7814\u7a76\u662f\u4e00\u9879\u6b63\u5728\u8fdb\u884c\u7684\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u539f\u53d1\u6027IgA\u80be\u75c5\u6210\u4eba\u60a3\u8005\u4e2d\u8bc4\u4ef7TARPEYO 16 mg\u6bcf\u65e5\u4e00\u6b21\u7ed9\u836f\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\u7684\u7597\u6548\u548c\u5b89\u5168\u6027<sup>1<\/sup>\u3002TARPEYO\u5728\u7ecf\u6d3b\u68c0\u786e\u8bca\u4e3aIgA\u80be\u75c5\u7684\u60a3\u8005\u4e2d\u8fdb\u884c\u4e86\u8bc4\u4f30\uff0c\u8fd9\u4e9b\u60a3\u8005eGFR \u2265 35 mL\/min\/1.73 m2 \uff0c\u86cb\u767d\u5c3f\u22651 g\/\u5929\u6216 UPCR \u22650.8 g\/g\uff0c\u4e14\u4f7f\u7528\u6700\u5927\u8010\u53d7\u7a33\u5b9a\u5242\u91cf\u7684 RAS \u6291\u5236\u5242\u6cbb\u7597\u3002<\/p>\n<p>\u5728\u7b2c9\u4e2a\u6708\u65f6\uff0cTARPEYO\u7ec4\u60a3\u8005(n=97)\u7684\u86cb\u767d\u5c3f\u8f83\u57fa\u7ebf\u4e0b\u964d34%\uff0c\u5177\u6709\u7edf\u8ba1\u5b66\u663e\u8457\u6027\uff0c\u800c\u5355\u72ec\u4f7f\u7528RASi\u7684\u60a3\u8005(n=102)\u7684\u86cb\u767d\u5c3f\u8f83\u57fa\u7ebf\u964d\u4f4e5%\u3002\u5728\u5173\u952e\u4e9a\u7ec4\u4e2d\uff0c\u7b2c9\u4e2a\u6708\u65f6UPCR \uff08\u5c3f\u86cb\u767d\u808c\u9150\u6bd4\u503c\uff09\u4e3b\u8981\u7ec8\u70b9\u7684\u6cbb\u7597\u6548\u679c\u4fdd\u6301\u4e00\u81f4\uff0c\u5305\u62ec\u5173\u952e\u7684\u4eba\u53e3\u7edf\u8ba1\u5b66\u548c\u57fa\u7ebf\u75be\u75c5\u7279\u5f81<sup>1<\/sup>\u3002\u672c\u7814\u7a76\u4e2d\u6700\u5e38\u89c1\u7684\u4e0d\u826f\u53cd\u5e94\uff08\u22655%\uff09\u662f\u9ad8\u8840\u538b\u3001\u5916\u5468\u6c34\u80bf\u3001\u808c\u8089\u75c9\u631b\u3001\u75e4\u75ae\u3001\u76ae\u708e\u3001\u4f53\u91cd\u589e\u52a0\u3001\u547c\u5438\u56f0\u96be\u3001\u9762\u90e8\u6c34\u80bf\u3001\u6d88\u5316\u4e0d\u826f\u3001\u75b2\u52b3\u548c\u591a\u6bdb\u75c7\u3002<\/p>\n<p>\u65af\u5766\u798f\u5927\u5b66\u533b\u5b66\u6559\u6388\u3001\u65af\u5766\u798f\u80be\u5c0f\u7403\u75be\u75c5\u7814\u7a76\u4e2d\u5fc3\u4e3b\u4efbRichard Lafayette\u535a\u58eb\u8bc4\u4ef7\u9053\uff0c\u201c\u5bf9\u8bb8\u591a\u60a3\u8005\u6765\u8bf4\uff0cIgA\u80be\u75c5\u5f88\u96be\u8bca\u65ad\uff0c\u800c\u4e14\u5b83\u53ef\u80fd\u9010\u6e10\u53d1\u5c55\u4e3a\u9700\u8981\u900f\u6790\u548c\/\u6216\u80be\u79fb\u690d\u7684\u75be\u75c5\u3002\u73b0\u5728TARPEYO\u5df2\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\uff0c\u4ece\u800c\u53ef\u4ee5\u4e3a\u60a3\u6709\u8fd9\u79cd\u590d\u6742\u75be\u75c5\u7684\u60a3\u8005\u63d0\u4f9b\u7279\u5b9a\u7684\u6cbb\u7597\u3002\u201d<\/p>\n<p>Calliditas\u9996\u5e2d\u533b\u5b66\u5b98Richard Philipson\u8865\u5145\u9053\uff1a\u201cTARPEYO\u662f\u9488\u5bf9IgA\u80be\u75c5\u7684\u75be\u75c5\u6839\u6e90\u5f00\u53d1\u7684\u6cbb\u7597\u836f\u7269\uff0c\u5176\u5728\u7f8e\u56fdFDA\u7684\u83b7\u6279\u663e\u793a\u4e86\u6211\u4eec\u5bf9IgA\u80be\u75c5\u60a3\u8005\u575a\u5b9a\u4e0d\u79fb\u7684\u5949\u732e\u7cbe\u795e\u3002\u6211\u4eec\u8981\u611f\u8c22\u53c2\u4e0eTARPEYO\u7814\u7a76\u7684\u60a3\u8005\u3001\u7814\u7a76\u8005\u548c\u4e34\u5e8a\u5de5\u4f5c\u8005\u3002\u201d<\/p>\n<p>\u7f8e\u56fdIGA\u80be\u75c5\u57fa\u91d1\u4f1a\u7406\u4e8b\u517c\u8054\u5408\u521b\u59cb\u4ebaBonnie Schneider\u8868\u793a\uff0c\u201c\u4e0d\u7ba1\u662f\u5bf9\u4e8e\u6211\u4eec\u6240\u6709\u4eba\uff0c\u8fd8\u662f\u6211\u4eec\u670d\u52a1\u7684\u6240\u6709IgA\u80be\u75c5\u60a3\u8005\uff0c\u4ece\u524d\u8fd9\u90fd\u662f\u4e00\u4e2a\u8270\u96be\u7684\u8fc7\u7a0b\u3002\u6211\u4eec\u4e3a\u62e5\u6709IgA\u80be\u75c5\u7279\u5b9a\u6cbb\u7597\u65b9\u6848\u611f\u5230\u975e\u5e38\u6b23\u6170\u3002\u201d<\/p>\n<p><i>\u5982\u9700\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u53c2\u9605<\/i><i>Calliditas<\/i><i>\u5173\u4e8e\u6b64\u516c\u544a\u7684<a target=\"_blank\" href=\"https:\/\/www.calliditas.se\/en\/fda-grants-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy-3927\/\" rel=\"nofollow noopener\"><span id=\"spanHghlt6846\">\u65b0\u95fb\u7a3f<\/span><\/a>\u3002<\/i><\/p>\n<p><b><b>\u5173\u4e8eNEFECON<\/b><\/b><\/p>\n<p>NEFECON(\u5728\u7f8e\u56fd\u4ee5\u5546\u54c1\u540dTARPEYO<sup>&reg;<\/sup>\u83b7\u5f97\u52a0\u901f\u6279\u51c6) \u662f\u53e3\u670d\u9776\u5411\u5e03\u5730\u5948\u5fb7\u8fdf\u91ca\u80f6\u56ca\uff0c\u8be5\u76ae\u8d28\u7c7b\u56fa\u9187\u836f\u7269\u5177\u6709\u5f3a\u5927\u7684\u7cd6\u76ae\u8d28\u6fc0\u7d20\u6d3b\u6027\u548c\u5fae\u5f31\u7684\u77ff\u7269\u7c7b\u76ae\u8d28\u6fc0\u7d20\u6d3b\u6027\uff0c\u4f1a\u8fdb\u884c\u5927\u91cf\u7684\u9996\u8fc7\u4ee3\u8c22\u3002\u5b83\u88ab\u8bbe\u8ba1\u4e3a4mg\u7684\u8fdf\u91ca\u80f6\u56ca\uff0c\u5e76\u4ee5\u80a0\u6eb6\u8863\u5305\u8986\uff0c\u4ee5\u4fbf\u5728\u9012\u9001\u81f3\u56de\u80a0\u4e4b\u524d\u4fdd\u6301\u5b8c\u6574\u3002\u6bcf\u7c92\u80f6\u56ca\u5747\u542b\u6709\u5e03\u5730\u5948\u5fb7\u5305\u8863\u5fae\u4e38\uff0c\u9776\u5411\u56de\u80a0\u4e2d\u7684\u7c98\u819cB\u7ec6\u80de\uff0c\u5305\u62ec\u6d3e\u5c14\u96c6\u5408\u6dcb\u5df4\u7ed3\u5904\uff08\u8d1f\u8d23\u4ea7\u751f\u53ef\u5bfc\u81f4IgA\u80be\u75c5\u7684\u534a\u4e73\u7cd6\u7f3a\u9677\u7684IgA1\u6297\u4f53\uff08Gd-Ag1\uff09\uff09\u3002\u76ee\u524d\u5c1a\u4e0d\u660e\u786eNefecon\u7684\u7597\u6548\u5728\u591a\u5927\u7a0b\u5ea6\u4e0a\u662f\u901a\u8fc7\u56de\u80a0\u5c40\u90e8\u4f5c\u7528\u548c\u5168\u8eab\u4f5c\u7528\u4ecb\u5bfc\u7684\u30022019\u5e746\u6708\uff0c\u4e91\u9876\u65b0\u8000\u4e0eCalliditas\u7b7e\u8ba2\u4e86\u4e00\u4efd\u9644\u5e26\u7279\u8bb8\u6743\u4f7f\u7528\u8d39\u7684\u72ec\u5bb6\u8bb8\u53ef\u534f\u8bae\uff0c\u6388\u4e88\u4e91\u9876\u65b0\u8000\u5728\u4e2d\u56fd\uff08\u542b\u5927\u9646\u3001\u9999\u6e2f\u3001\u6fb3\u95e8\u4ee5\u53ca\u53f0\u6e7e\u5730\u533a\uff09\u548c\u65b0\u52a0\u5761\u5f00\u53d1\u548c\u5546\u4e1a\u5316NEFECON\u7684\u72ec\u5bb6\u6743\u5229\u3002<\/p>\n<p><b>\u5173\u4e8eNeflgArd\u7814\u7a76<\/b><\/p>\n<p>\u5168\u7403\u4e34\u5e8a\u7814\u7a76NeflgArd\u662f\u4e00\u9879\u6b63\u5728\u8fdb\u884c\u76843\u671f\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u539f\u53d1\u6027IgA\u80be\u75c5\u6210\u4eba\u60a3\u8005\uff08N=360\uff09\u4e2d\u8bc4\u4ef7\u5728\u4f18\u5316<span id=\"spanHghltc70f\">RASi<\/span>\u7597\u6cd5\u57fa\u7840\u4e0aNEFECON 16 mg\u6bcf\u65e5\u4e00\u6b21\u7ed9\u836f\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u3002<\/p>\n<p>\u8be5\u7814\u7a76\u7684A\u90e8\u5206\u5305\u62ec\u4e3a\u671f9\u4e2a\u6708\u7684\u8bbe\u76f2\u6cbb\u7597\u671f\u548c\u4e3a\u671f3\u4e2a\u6708\u7684\u968f\u8bbf\u671f\u3002\u4e3b\u8981\u7ec8\u70b9\u4e3aUPCR \uff08\u5c3f\u86cb\u767d\u808c\u9150\u6bd4\u503c\uff09\uff0c\u6b21\u8981\u7ec8\u70b9\u4e3aeGFR\uff08\u80be\u5c0f\u7403\u6ee4\u8fc7\u7387\uff09\u3002B\u90e8\u5206\u662f\u4e00\u9879\u786e\u8bc1\u6027\u9a8c\u8bc1\u7814\u7a76\uff0c\u671f\u95f4\u4e0d\u4f7f\u7528NEFECON\u8fdb\u884c\u6cbb\u7597\uff0c\u5c06\u5728\u4e24\u5e74\u5185\u8bc4\u4f30eGFR\u3002<\/p>\n<p>\u8be5\u7814\u7a76\u8fbe\u5230\u4e86A\u90e8\u5206\u7684\u4e3b\u8981\u76ee\u7684\uff0c\u5373\u8bc1\u660e\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0cNEFECON 16 mg\u6bcf\u65e5\u7ed9\u836f\u4e00\u6b21\u6cbb\u75979\u4e2a\u6708\u540e\u5c3f\u86cb\u767d\u808c\u9150\u6bd4\u7387\u3001\u5373UPCR\u6216\u86cb\u767d\u5c3f\u51fa\u73b0\u7edf\u8ba1\u5b66\u663e\u8457\u6027\u964d\u4f4e\u3002\u57289\u4e2a\u6708\u65f6\uff0c\u63a5\u53d7NEFECON\u52a0RASi\u6cbb\u7597\u7684\u60a3\u8005(n=97)\u8f83\u57fa\u7ebf\u964d\u4f4e34%\uff0c\u5177\u6709\u7edf\u8ba1\u5b66\u663e\u8457\u6027\uff0c\u800c\u5355\u72ec\u63a5\u53d7RASi\u6cbb\u7597\u7684\u60a3\u8005(n=102)\u964d\u4f4e5%\uff0c\u5bfc\u81f4UPCR\u964d\u4f4e31%(16%\u81f342%)\uff0cp=0.0001\u3002<\/p>\n<p><b>\u5173\u4e8e\u539f\u53d1\u6027\u514d\u75ab\u7403\u86cb\u767dA\u80be\u75c5\uff08IgA\u80be\u75c5\uff09<\/b><\/p>\n<p>\u539f\u53d1\u6027\u514d\u75ab\u7403\u86cb\u767dA\u80be\u75c5(IgA\u80be\u75c5\uff0cIgAN\u6216\u4f2f\u683c\u6c0f\u75c5)\u662f\u4e00\u79cd\u4fb5\u88ad\u80be\u810f\u7684\u8fdb\u884c\u6027\u6162\u6027\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u5f53\u81ea\u8eab\u6297\u4f53\u8bc6\u522b\u51fa\u534a\u4e73\u7cd6\u7f3a\u9677\u7684IgA1\u5206\u5b50\u65f6\u51fa\u73b0\uff0c\u53ef\u4ea7\u751fIgA1\u514d\u75ab\u590d\u5408\u7269\uff0c\u5e76\u6c89\u79ef\u5728\u80be\u5c0f\u7403\u7cfb\u819c\u4e2d<sup>4,5<\/sup>\u3002\u8fd9\u79cd\u80be\u810f\u6c89\u79ef\u53ef\u5bfc\u81f4\u8fdb\u884c\u6027\u80be\u810f\u635f\u5bb3\uff0c\u5e76\u53ef\u80fd\u5bfc\u81f4\u7ec8\u672b\u671f\u80be\u810f\u75be\u75c5\u3002IgA\u80be\u75c5\u6700\u5e38\u5728\u9752\u5c11\u5e74\u665a\u671f\u81f3\u8fd140\u5c81\u65f6\u53d1\u75c5<sup>5,6<\/sup>\u3002<\/p>\n<p>&nbsp;<b>\u5173\u4e8e\u4e91\u9876\u65b0\u8000<\/b><\/p>\n<p>\u4e91\u9876\u65b0\u8000\u662f\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u521b\u65b0\u836f\u5f00\u53d1\u53ca\u5546\u4e1a\u5316\u7684\u751f\u7269\u5236\u836f\u516c\u53f8\uff0c\u81f4\u529b\u4e8e\u6ee1\u8db3\u4e9a\u6d32\u5e02\u573a\u5c1a\u672a\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002\u4e91\u9876\u65b0\u8000\u7684\u7ba1\u7406\u56e2\u961f\u5728\u4e9a\u6d32\u53ca\u5168\u7403\u5236\u836f\u4f01\u4e1a\u4ece\u4e8b\u8fc7\u9ad8\u8d28\u91cf\u4e34\u5e8a\u5f00\u53d1\u3001\u836f\u653f\u4e8b\u52a1\u3001\u5316\u5b66\u5236\u9020\u4e0e\u63a7\u5236(CMC)\u3001\u4e1a\u52a1\u53d1\u5c55\u548c\u8fd0\u8425\uff0c\u62e5\u6709\u6df1\u539a\u7684\u4e13\u957f\u548c\u4e30\u5bcc\u7684\u7ecf\u9a8c\u3002\u4e91\u9876\u65b0\u8000\u5df2\u6253\u902010\u6b3e\u6709\u6f5c\u529b\u6210\u4e3a\u5168\u7403\u540c\u7c7b\u9996\u521b\u6216\u8005\u540c\u7c7b\u6700\u4f73\u7684\u836f\u7269\u7ec4\u5408\uff0c\u5176\u4e2d\u5927\u90e8\u5206\u5df2\u7ecf\u5904\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u540e\u671f\u9636\u6bb5\u3002\u516c\u53f8\u7684\u6cbb\u7597\u9886\u57df\u5305\u62ec\u80bf\u7624\u3001\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u3001\u5fc3\u80be\u75be\u75c5\u3001\u611f\u67d3\u6027\u548c\u4f20\u67d3\u6027\u75be\u75c5\u3002\u6709\u5173\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee\u516c\u53f8\u7f51\u7ad9\uff1a&nbsp;<a target=\"_blank\" href=\"http:\/\/www.everestmedicines.com\/\" rel=\"nofollow noopener\">www.everestmedicines.com<\/a>\u3002<\/p>\n<p><b>\u5173\u4e8eCalliditas<\/b><\/p>\n<p>Calliditas Therapeutics\u662f\u4e00\u5bb6\u603b\u90e8\u4f4d\u4e8e\u745e\u5178\u65af\u5fb7\u54e5\u5c14\u6469\u7684\u751f\u7269\u5236\u836f\u516c\u53f8\uff0c\u4e13\u6ce8\u4e8e\u8bc6\u522b\u3001\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u5b64\u513f\u75c5\u9002\u5e94\u75c7\u7684\u521b\u65b0\u7597\u6cd5\uff0c\u6700\u521d\u4e13\u6ce8\u4e8e\u5177\u6709\u91cd\u5927\u672a\u6ee1\u8db3\u533b\u7597\u9700\u6c42\u7684\u80be\u810f\u548c\u809d\u810f\u75be\u75c5\u3002<\/p>\n<p>Calliditas\u5df2\u5728\u7eb3\u65af\u8fbe\u514b\u65af\u5fb7\u54e5\u5c14\u6469(\u80a1\u7968\u4ee3\u7801: CALTX)\u548c\u7eb3\u65af\u8fbe\u514b\u5168\u7403\u7cbe\u9009\u5e02\u573a(\u80a1\u7968\u4ee3\u7801: CALT)\u4e0a\u5e02\u3002\u8bbf\u95ee<u><a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3144682-1&amp;h=883637062&amp;u=http:\/\/www.calliditas.com\/&amp;a=www.calliditas.com\" rel=\"nofollow noopener\">www.calliditas.com<u>&nbsp;<\/u><\/a><\/u>\u4ee5\u83b7\u53d6\u66f4\u591a\u4fe1\u606f\u3002<\/p>\n<p><b>1. <\/b>TARPEYOTM (budesonide) [prescribing information].Stockholm, SE: Calliditas Therapeutics AB; 2021<\/p>\n<p><b>2. <\/b>Fellstrom BC, Barratt J, Cook H, et al.Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase <span class=\"xn-money\">2b<\/span> trial.Lancet.<span class=\"xn-chron\">May 27, 2017<\/span>;389(10084):2117-2127. https:\/\/doi:10.1016\/S0140-6736(17)30550-0<\/p>\n<p><b>3. <\/b>Hastings, M. C., Bursac, Z., Julian, B. A., Villa Baca, E., Featherston, J., Woodford, S. Y., Bailey, L., &amp; Wyatt, R. J. (2018).Life Expectancy for Patients From the Southeastern United States With IgA Nephropathy.Kidney Int Rep, 3(1), 99-104. <a href=\"https:\/\/doi.org\/10.1016\/j\" rel=\"nofollow\">https:\/\/doi.org\/10.1016\/j<\/a>. ekir.2017.08.008<\/p>\n<p><b>4. <\/b>Barratt, J., &amp; Feehally, J. (2005).IgA nephropathy.J Am Soc Nephrol, 16(7), 2088-2097. <a href=\"https:\/\/doi.org\/10.1681\/ASN.2005020134\" rel=\"nofollow\">https:\/\/doi.org\/10.1681\/ASN.2005020134<\/a><\/p>\n<p><b>5. <\/b>Barratt, J., Rovin, B. H., Cattran, D., et al.(2020).Why Target the Gut to Treat IgA Nephropathy? Kidney Int Rep, 5(10), 1620-1624. <a href=\"https:\/\/doi.org\/10.1016\/j.ekir.2020.08.009\" rel=\"nofollow\">https:\/\/doi.org\/10.1016\/j.ekir.2020.08.009<\/a><\/p>\n<p><b>6.<\/b>&nbsp;Jarrick, S., Lundberg, S., Welander, A., et al.(2019).Mortality in IgA Nephropathy: A Nationwide Population-Based Cohort Study.J Am Soc Nephrol, 30(5), 866-876. <a href=\"https:\/\/doi.org\/10.1681\/ASN.2018101017\" rel=\"nofollow\">https:\/\/doi.org\/10.1681\/ASN.2018101017<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>TARPEYO(\u5e03\u5730\u5948\u5fb7)\u8fdf\u91ca\u80f6\u56ca\u662f\u76ee\u524d\u7b2c\u4e00\u79cd\u4e5f\u662f\u552f\u4e00\u4e00\u79cd\u7528\u4e8e\u964d\u4f4e\u60a3\u6709\u5feb\u901f\u8fdb\u5c55\u98ce\u9669\u7684\u539f\u53d1\u6027IgA\u80be\u75c5\uff08\u901a\u5e38\u5c3f\u86cb\u767d\u4e0e\u808c\u9150\u6bd4&nbsp;(UPCR) \u22651.5g\/g1\uff09\u6210\u4eba\u60a3\u8005\u86cb\u767d\u5c3f\u7684\u6cbb\u7597\u65b9\u6cd5 TARPEYO(\u9879\u76ee\u7814\u53d1\u540d\u79f0\u4e3aNEFECON)\u662f\u76ee\u524d\u7b2c\u4e00\u79cd\u4e5f\u662f\u552f\u4e00\u4e00\u79cd\u7ecf\u7f8e\u56fdFDA\u6279\u51c6\u4e13\u95e8\u6cbb\u7597\u6b64\u9002\u5e94\u75c7\u7684\u836f\u72691,2 IgA\u80be\u75c5\u662f\u4e00\u79cd\u8fdb\u884c\u6027\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u6709\u8d85\u8fc750%\u7684\u60a3\u8005\u53ef\u80fd\u8fdb\u5c55\u4e3a\u7ec8\u672b\u671f\u80be\u75c5(ESRD)\uff0c\u6b64\u7c7b\u60a3\u8005\u7684\u533b\u7597\u9700\u6c42\u4e9f\u5f85\u6ee1\u8db33 \u4e91\u9876\u65b0\u8000\u62e5\u6709\u5728\u4e2d\u56fd\uff08\u5927\u9646\u3001\u9999\u6e2f\u3001\u6fb3\u95e8\u4ee5\u53ca\u53f0\u6e7e\u5730\u533a\uff09\u548c\u65b0\u52a0\u5761\u5f00\u53d1\u548c\u5546\u4e1a\u5316NEFECON\u7684\u72ec\u5bb6\u6743\u5229 \u4e0a\u6d772021\u5e7412\u670816\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; \u4e91\u9876\u65b0\u8000 (Everest Medicines, HKEX 1952.HK)\u4eca\u65e5\u516c\u5e03\uff0c\u5176\u5408\u4f5c\u4f19\u4f34Calliditas Therapeutics AB\uff08\u7eb3\u65af\u8fbe\u514b\u80a1\u7968\u4ee3\u7801\uff1aCALT\uff0c\u7eb3\u65af\u8fbe\u514b\u65af\u5fb7\u54e5\u5c14\u6469\u80a1\u7968\u4ee3\u7801\uff1aCALTX\uff09\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cCalliditas\u201d\uff09\u5ba3\u5e03\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40(FDA)\u5df2\u6279\u51c6TARPEYOTM(\u5e03\u5730\u5948\u5fb7)\u8fdf\u91ca\u80f6\u56ca\u7528\u4e8e\u964d\u4f4e\u60a3\u6709\u5feb\u901f\u8fdb\u5c55\u98ce\u9669\u7684\u539f\u53d1\u6027IgA\u80be\u75c5\uff08\u901a\u5e38\u5c3f\u86cb\u767d\u4e0e\u808c\u9150\u6bd4 (UPCR) \u22651.5g\/g1\uff09\u6210\u4eba\u60a3\u8005\u86cb\u767d\u5c3f\u7684\u6cbb\u7597\u65b9\u6cd5\u3002\u8be5\u9002\u5e94\u75c7\u83b7\u6279\u662f\u57fa\u4e8e\u5176\u52a0\u901f\u5ba1\u8bc4\u7a0b\u5e8f\u3002\u76ee\u524d\u5c1a\u672a\u660e\u786eTARPEYO\u662f\u5426\u80fd\u51cf\u7f13IgA\u80be\u75c5\u60a3\u8005\u7684\u80be\u529f\u80fd\u4e0b\u964d\u3002\u540e\u7eed\u6279\u51c6\u53ef\u80fd\u53d6\u51b3\u4e8e\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4e34\u5e8a\u83b7\u76ca\u7684\u9a8c\u8bc1\u548c\u63cf\u8ff01\u3002 Calliditas\u7684\u9996\u5e2d\u6267\u884c\u5b98Ren&eacute;e Aguiar-Lucander\u8868\u793a\uff0c\u201c\u6211\u4eec\u975e\u5e38\u9ad8\u5174\u80fd\u5c06\u76ee\u524d\u7b2c\u4e00\u79cd\uff0c\u4e5f\u662f\u552f\u4e00\u4e00\u79cd\u7ecf\u7f8e\u56fdFDA\u6279\u51c6\u7684\u7528\u4e8e\u964d\u4f4eIgA\u80be\u75c5\u86cb\u767d\u5c3f\u7684\u836f\u7269\u63a8\u5411\u5e02\u573a\u3002TARPEYO\u662f\u7ecf\u7f8e\u56fdFDA\u6279\u51c6\u7684\u4ea7\u54c1\uff0c\u4ee5\u4e3a\u5904\u4e8e\u75be\u75c5\u5feb\u901f\u8fdb\u5c55\u98ce\u9669\u4e2d\u7684IgA\u80be\u75c5\u60a3\u8005\u63d0\u4f9b\u5e2e\u52a9\u3002\u201d \u4e91\u9876\u65b0\u8000\u9996\u5e2d\u6267\u884c\u5b98\u8584\u79d1\u745e\u535a\u58eb\u5f3a\u8c03\uff0c\u201c\u6b64\u6b21FDA\u6279\u51c6Calliditas\u7684\u521b\u65b0\u5e03\u5730\u5948\u5fb7\u5236\u5242\u6807\u5fd7\u7740IgA\u80be\u75c5\u6cbb\u7597\u5411\u524d\u8fc8\u51fa\u4e86\u91cd\u8981\u7684\u4e00\u6b65\uff0c\u6211\u4eec\u5c06\u4ee5\u201cNEFECON\u201d\u7684\u540d\u79f0\u5728\u6388\u6743\u8bb8\u53ef\u533a\u57df\u63a8\u8fdb\u8be5\u836f\u7684\u5f00\u53d1\u3002\u6211\u4eec\u5411\u5408\u4f5c\u4f19\u4f34Calliditas\u5728\u5168\u7403\u4e34\u5e8a\u548c\u76d1\u7ba1\u65b9\u9762\u53d6\u5f97\u7684\u5feb\u901f\u8fdb\u5c55\u8868\u793a\u795d\u8d3a\uff0c\u8fd9\u5c06\u4f7f\u90a3\u4e9b\u6709\u9700\u8981\u7684\u60a3\u8005\u80fd\u591f\u5c3d\u5feb\u83b7\u5f97\u6b64\u7c7b\u75be\u75c5\u7684\u9996\u6b3e\u6cbb\u7597\u836f\u7269\u3002\u4e91\u9876\u65b0\u8000\u671f\u5f85\u770b\u5230\u8fd9\u4e00\u91cd\u8981\u7597\u6cd5\u5728\u5927\u4e2d\u534e\u533a\u548cIgA\u80be\u75c5\u60a3\u75c5\u7387\u8f83\u9ad8\u7684\u5176\u4ed6\u4e9a\u6d32\u5730\u533a\u53d6\u5f97\u8fdb\u5c55\u3002\u201d TARPEYO\u5728NeflgArd\u5173\u952e\u60273\u671f\u7814\u7a76A\u90e8\u5206\u4e2d\u8fbe\u5230\u4e86\u964d\u4f4e\u86cb\u767d\u5c3f\u7684\u4e3b\u8981\u7ec8\u70b9\uff0c\u7531\u6b64\u901a\u8fc7\u52a0\u901f\u5ba1\u8bc4\u7a0b\u5e8f\u83b7\u6279\u3002\u4e0a\u8ff0\u7814\u7a76\u662f\u4e00\u9879\u6b63\u5728\u8fdb\u884c\u7684\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u65e8\u5728\u539f\u53d1\u6027IgA\u80be\u75c5\u6210\u4eba\u60a3\u8005\u4e2d\u8bc4\u4ef7TARPEYO 16 mg\u6bcf\u65e5\u4e00\u6b21\u7ed9\u836f\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\u7684\u7597\u6548\u548c\u5b89\u5168\u60271\u3002TARPEYO\u5728\u7ecf\u6d3b\u68c0\u786e\u8bca\u4e3aIgA\u80be\u75c5\u7684\u60a3\u8005\u4e2d\u8fdb\u884c\u4e86\u8bc4\u4f30\uff0c\u8fd9\u4e9b\u60a3\u8005eGFR \u2265 35 mL\/min\/1.73 m2 \uff0c\u86cb\u767d\u5c3f\u22651 g\/\u5929\u6216 UPCR \u22650.8 g\/g\uff0c\u4e14\u4f7f\u7528\u6700\u5927\u8010\u53d7\u7a33\u5b9a\u5242\u91cf\u7684 RAS \u6291\u5236\u5242\u6cbb\u7597\u3002 \u5728\u7b2c9\u4e2a\u6708\u65f6\uff0cTARPEYO\u7ec4\u60a3\u8005(n=97)\u7684\u86cb\u767d\u5c3f\u8f83\u57fa\u7ebf\u4e0b\u964d34%\uff0c\u5177\u6709\u7edf\u8ba1\u5b66\u663e\u8457\u6027\uff0c\u800c\u5355\u72ec\u4f7f\u7528RASi\u7684\u60a3\u8005(n=102)\u7684\u86cb\u767d\u5c3f\u8f83\u57fa\u7ebf\u964d\u4f4e5%\u3002\u5728\u5173\u952e\u4e9a\u7ec4\u4e2d\uff0c\u7b2c9\u4e2a\u6708\u65f6UPCR \uff08\u5c3f\u86cb\u767d\u808c\u9150\u6bd4\u503c\uff09\u4e3b\u8981\u7ec8\u70b9\u7684\u6cbb\u7597\u6548\u679c\u4fdd\u6301\u4e00\u81f4\uff0c\u5305\u62ec\u5173\u952e\u7684\u4eba\u53e3\u7edf\u8ba1\u5b66\u548c\u57fa\u7ebf\u75be\u75c5\u7279\u5f811\u3002\u672c\u7814\u7a76\u4e2d\u6700\u5e38\u89c1\u7684\u4e0d\u826f\u53cd\u5e94\uff08\u22655%\uff09\u662f\u9ad8\u8840\u538b\u3001\u5916\u5468\u6c34\u80bf\u3001\u808c\u8089\u75c9\u631b\u3001\u75e4\u75ae\u3001\u76ae\u708e\u3001\u4f53\u91cd\u589e\u52a0\u3001\u547c\u5438\u56f0\u96be\u3001\u9762\u90e8\u6c34\u80bf\u3001\u6d88\u5316\u4e0d\u826f\u3001\u75b2\u52b3\u548c\u591a\u6bdb\u75c7\u3002 \u65af\u5766\u798f\u5927\u5b66\u533b\u5b66\u6559\u6388\u3001\u65af\u5766\u798f\u80be\u5c0f\u7403\u75be\u75c5\u7814\u7a76\u4e2d\u5fc3\u4e3b\u4efbRichard Lafayette\u535a\u58eb\u8bc4\u4ef7\u9053\uff0c\u201c\u5bf9\u8bb8\u591a\u60a3\u8005\u6765\u8bf4\uff0cIgA\u80be\u75c5\u5f88\u96be\u8bca\u65ad\uff0c\u800c\u4e14\u5b83\u53ef\u80fd\u9010\u6e10\u53d1\u5c55\u4e3a\u9700\u8981\u900f\u6790\u548c\/\u6216\u80be\u79fb\u690d\u7684\u75be\u75c5\u3002\u73b0\u5728TARPEYO\u5df2\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\uff0c\u4ece\u800c\u53ef\u4ee5\u4e3a\u60a3\u6709\u8fd9\u79cd\u590d\u6742\u75be\u75c5\u7684\u60a3\u8005\u63d0\u4f9b\u7279\u5b9a\u7684\u6cbb\u7597\u3002\u201d Calliditas\u9996\u5e2d\u533b\u5b66\u5b98Richard Philipson\u8865\u5145\u9053\uff1a\u201cTARPEYO\u662f\u9488\u5bf9IgA\u80be\u75c5\u7684\u75be\u75c5\u6839\u6e90\u5f00\u53d1\u7684\u6cbb\u7597\u836f\u7269\uff0c\u5176\u5728\u7f8e\u56fdFDA\u7684\u83b7\u6279\u663e\u793a\u4e86\u6211\u4eec\u5bf9IgA\u80be\u75c5\u60a3\u8005\u575a\u5b9a\u4e0d\u79fb\u7684\u5949\u732e\u7cbe\u795e\u3002\u6211\u4eec\u8981\u611f\u8c22\u53c2\u4e0eTARPEYO\u7814\u7a76\u7684\u60a3\u8005\u3001\u7814\u7a76\u8005\u548c\u4e34\u5e8a\u5de5\u4f5c\u8005\u3002\u201d \u7f8e\u56fdIGA\u80be\u75c5\u57fa\u91d1\u4f1a\u7406\u4e8b\u517c\u8054\u5408\u521b\u59cb\u4ebaBonnie Schneider\u8868\u793a\uff0c\u201c\u4e0d\u7ba1\u662f\u5bf9\u4e8e\u6211\u4eec\u6240\u6709\u4eba\uff0c\u8fd8\u662f\u6211\u4eec\u670d\u52a1\u7684\u6240\u6709IgA\u80be\u75c5\u60a3\u8005\uff0c\u4ece\u524d\u8fd9\u90fd\u662f\u4e00\u4e2a\u8270\u96be\u7684\u8fc7\u7a0b\u3002\u6211\u4eec\u4e3a\u62e5\u6709IgA\u80be\u75c5\u7279\u5b9a\u6cbb\u7597\u65b9\u6848\u611f\u5230\u975e\u5e38\u6b23\u6170\u3002\u201d \u5982\u9700\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u53c2\u9605Calliditas\u5173\u4e8e\u6b64\u516c\u544a\u7684\u65b0\u95fb\u7a3f\u3002 \u5173\u4e8eNEFECON NEFECON(\u5728\u7f8e\u56fd\u4ee5\u5546\u54c1\u540dTARPEYO&reg;\u83b7\u5f97\u52a0\u901f\u6279\u51c6) 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