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\n

\u8fd1\u65e5\uff0c\u5b89\u65af\u6cf0\u6765\u516c\u544a\u79f0\u5176\u5728\u7814\u65b0\u836fRoxadustat\uff08\u7f57\u6c99\u53f8\u4ed6\uff09\u5728\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u8fbe\u5230\u4e3b\u8981\u7ec8\u70b9\uff0c\u524d24\u5468\u300128\u5468\u548c52\u5468\u7684\u8840\u7ea2\u86cb\u767d\u5e94\u7b54\u7387\u76f8\u6bd4\u57fa\u7ebf\u6709\u663e\u8457\u6027\u5dee\u5f02\u3002\u867d\u7136\u5b89\u65af\u6cf0\u6765\u6ca1\u6709\u516c\u5e03\u5177\u4f53\u6570\u636e\uff0c\u4f46\u4ece\u4e8c\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6765\u770b\uff0c\u8fd9\u4e2a\u836f\u7269\u662f\u975e\u5e38\u6709\u6f5c\u529b\u7684\u3002\u56e0\u4e3a\u6162\u6027\u80be\u75c5\u7efc\u5408\u5f81\u5f15\u8d77\u7684\u8d2b\u8840\u6cbb\u7597\u65b9\u6848\u7f3a\u4e4f\uff0c\u76ee\u524d\u53ea\u80fd\u4f7f\u7528\u4fc3\u7ea2\u7d20\u6cbb\u7597\uff0c\u5982\u672c\u54c1\u83b7\u6279\uff0c\u6709\u671b\u8ba9\u80be\u75c5\u7efc\u5408\u5f81\u60a3\u8005\u964d\u4f4e\u5bf9\u4fc3\u7ea2\u7d20\u7684\u4f9d\u8d56\u3002<\/span><\/p>\n

Roxadustat \u662f\u4e00\u79cd\u65b0\u578b\u7684\u53e3\u670d\u4f4e\u6c27\u8bf1\u5bfc\u56e0\u5b50\u812f\u6c28\u9170\u7f9f\u5316\u9176\u6291\u5236\u5242\uff0c\u53ef\u8bf1\u5bfc\u5185\u6e90\u6027\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\u5347\u9ad8\uff0c\u4fc3\u8fdb\u7ea2\u7ec6\u80de\u751f\u6210\uff0c\u56e0\u6b64\u53ef\u4ee5\u7528\u4f5c\u6162\u6027\u80be\u810f\u75be\u75c5\u60a3\u8005\u8d2b\u8840\u6cbb\u7597\u30022017 \u5e74 10 \u6708 31 \u65e5\uff0c\u5b89\u65af\u6cf0\u6765\u548c FibroGen \u516c\u5f00\u4e00\u9879\u8bc4\u4f30 Roxadustat \u6cbb\u7597\u6162\u6027\u80be\u810f\u75be\u75c5\uff08CKD\uff09\u8d2b\u8840\u60a3\u8005\u7684 III \u671f\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u300243 \u540d\u66fe\u63a5\u53d7\u6216\u672a\u63a5\u53d7\u7ea2\u7ec6\u80de\u751f\u6210\u4fc3\u8fdb\u5242\u6cbb\u7597\u7684\u65e5\u672c\u8179\u819c\u900f\u6790\u60a3\u8005\uff0c\u5728 18 \u81f3 24 \u5468\u90fd\u8868\u73b0\u51fa\u79ef\u6781\u7684\u7597\u6548\u6570\u636e\u3002\u7ed3\u679c\u663e\u793a\uff0cRoxadustat \u8010\u53d7\u6027\u826f\u597d\uff0c\u63a5\u53d7\u8fc7\u548c\u672a\u63a5\u53d7\u5148\u524d\u4fc3\u7ea2\u7ec6\u80de\u751f\u6210\u5242\u6cbb\u7597\u7684\u60a3\u8005\u5747\u5b9e\u73b0\u7ef4\u6301\u8840\u7ea2\u86cb\u767d\u5728\u76ee\u6807\u6c34\u5e73\u8303\u56f4\u5185\uff0c\u5176\u4e2d\u672a\u63a5\u53d7\u8fc7\u4fc3\u7ea2\u7ec6\u80de\u751f\u6210\u5242\u6cbb\u7597\u60a3\u4e3a\u8fbe\u6807\u6bd4\u4f8b 92.3%\uff0c\u800c\u63a5\u53d7\u8fc7\u7684\u60a3\u8005\u4e3a 74.4%\u3002\u53e6\u4e00\u9879Clin J Am Soc Nephrol\u671f\u520a\u53d1\u8868\u7684\u4e00\u7bc7 2b \u671f\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\u7ed3\u679c\u663e\u793a 145 \u4f8b\u8840\u7ea2\u86cb\u767d \u2264 10.5 g\/dl \u7684\u975e\u900f\u6790 CKD \u60a3\u8005\uff0c\u7ecf\u8fc7\u4e0d\u540c\u7ed9\u836f\u65b9\u6848\u7684 Roxadustat \u6cbb\u7597 16 \u5468\u6216 24 \u5468\uff0c92%\u7684\u60a3\u8005\u83b7\u5f97\u8840\u7ea2\u86cb\u767d\u5e94\u7b54\u3002\u6cbb\u7597 16 \u5468\u540e\uff0c\u94c1\u8c03\u7d20\u6c34\u5e73\u663e\u8457\u964d\u4f4e 16.9%\uff0c\u7f51\u7ec7\u7ea2\u7ec6\u80de\u8840\u7ea2\u86cb\u767d\u542b\u91cf\u65e0\u53d8\u5316\uff0c\u8840\u7ea2\u86cb\u767d\u5e73\u5747\u589e\u52a01.83g\/dl\uff0c\u8bd5\u9a8c\u8fbe\u5230\u9884\u8bbe\u7684\u6cbb\u7597\u7ec8\u70b9\u3002<\/span><\/p>\n

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\"HIF-\u4e8c\u6c27\u9176\u6291\u5236\u5242\u6709\u671b\u8ba9\u80be\u75c5\u7efc\u5408\u5f81\u60a3\u8005\u964d\u4f4e\u5bf9\u4fc3\u7ea2\u7d20\u7684\u4f9d\u8d56\"<\/p>\n

\u6d41\u884c\u75c5\u5b66\u6570\u636e\u663e\u793a\u4e2d\u56fd\u6162\u6027\u80be\u810f\u75c5\uff08CKD\uff09\u60a3\u8005\u4eba\u6570\u8d85\u8fc7 1 \u4ebf\uff0c\u5176\u4e2d\u8d85\u8fc7 100\u4e07\u60a3\u8005\u662f\u7ec8\u672b\u671f\uff0c\u9700\u8981\u63a5\u53d7\u900f\u6790\u6216\u80be\u79fb\u690d\u6cbb\u7597\uff0c98.2%\u7684\u900f\u6790\u60a3\u8005\u4e3a\u5408\u5e76\u8d2b\u8840\uff0c52.1%\u4e3a\u975e\u900f\u6790\u60a3\u8005\u5408\u5e76\u8d2b\u8840\uff0c\u6cbb\u7597\u836f\u7269\u4e3b\u8981\u662f\u94c1\u5242\u548c\u4fc3\u7ea2\u7d20\uff0c\u4e3b\u8981\u7684\u7ed9\u836f\u65b9\u5f0f\u5747\u4e3a\u6ce8\u5c04\uff0c\u56e0\u6b64\u6709\u53e3\u670d\u7684\u4f18\u52bf\u3002FibroGen \u5df2\u7ecf\u5728 2017 \u5e74 10 \u6708\u5411\u4e2d\u56fd\u63d0\u4ea4\u4e0a\u5e02\u7533\u8bf7\uff0c2018 \u5e74\u6709\u671b\u5728\u7f8e\u56fd\u63d0\u4ea4 NDA\uff0c\u662f 2018 \u5e74\u6700\u503c\u5f97\u5173\u6ce8\u7684\u91cd\u78c5\u4ea7\u54c1\u4e4b\u4e00\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u5728 2022 \u5e74\u7684\u9500\u552e\u989d\u53ef\u8fbe 20 \u4ebf\u7f8e\u5143\uff0c\u800cEvalutePharma\u5206\u6790\u5e08\u5219\u9884\u6d4b\u672c\u54c1\u7684\u9500\u552e\u989d\u5cf0\u503c\u53ef\u8fbe58-81\u4ebf\u7f8e\u5143\u3002\u672c\u54c1\u80fd\u5426\u5728 2018 \u5e74\u4e0a\u5e02\uff0c\u8fd9\u5c31\u5f97\u770b CFDA \u7684\u5ba1\u8bc4\u901f\u5ea6\u4e86\u3002<\/span><\/p>\n

\u9664\u4e86\u7f57\u6c99\u53f8\u4ed6\uff0c\u4e5f\u6709\u591a\u4e2a\u540c\u9776\u70b9\u836f\u7269\u7d27\u8ddf\u800c\u6765\uff0c\u5904\u5728\u4e09\u671f\u4e34\u5e8a\u7684\u836f\u7269\u5305\u62ecAkebia\u516c\u53f8\u7684Vadadustat\u3001\u548cGSK\u7684Daprodustat\u3002\u4e0d\u96be\u60f3\u8c61\u7684\u662f\uff0c\u672a\u6765\u4fc3\u7ea2\u7d20\u768475\u4ebf\u7f8e\u5143\u5e02\u573a\uff0c\u5373\u5c06\u9762\u4e34\u4f4e\u6c27\u8bf1\u5bfc\u56e0\u5b50\u812f\u6c28\u9170\u7f9f\u5316\u9176\u6291\u5236\u5242\u7684\u6311\u6218\u3002<\/span><\/span><\/p>\n

\"HIF-\u4e8c\u6c27\u9176\u6291\u5236\u5242\u6709\u671b\u8ba9\u80be\u75c5\u7efc\u5408\u5f81\u60a3\u8005\u964d\u4f4e\u5bf9\u4fc3\u7ea2\u7d20\u7684\u4f9d\u8d56\"<\/p>\n

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\u53c2\u8003\u6587\u732e<\/span><\/p>\n


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Astellas pharma. Astellas and FibroGen Announce Positive Topline Results from First Japan Phase 3 Trial for Roxadustat in Chronic Kidney Disease Patients with Anemia. (2017-10-31), [2018-01-05]: https:\/\/www.astellas.com\/en\/news\/9871<\/span><\/p>\n

Astellas pharma. Astellas Announces Positive Topline Results for Global Phase 3 Trial of Roxadustat in Chronic Kidney Disease (CKD) Patients with Anemia not on Dialysis\uff1ahttps:\/\/www.astellas.com\/en\/news\/14261<\/span><\/p>\n

Provenzano R, Besarab A, Sun CH, Diamond SA et al. Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592) for the Treatment of Anemia in Patients with CKD. Clinical Journal of the American Society of Nephrology. 2016, 11(6): 982-91.
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EvaluatePharma. Roxadustat passes Alps test but has bigger mountains to climb\uff1ahttp:\/\/www.evaluate.com\/vantage\/articles\/news\/trial-results\/roxadustat-passes-alps-test-has-bigger-mountains-climb<\/span><\/p>\n


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