{"id":78315,"date":"2019-01-10T00:00:50","date_gmt":"2019-02-01T06:15:54","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/78315\/"},"modified":"2019-02-01T14:15:55","modified_gmt":"2019-02-01T06:15:55","slug":"c2461c2ce3","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/78315\/","title":{"rendered":"2024\u5e74\u9884\u671f\u6700\u7545\u9500\u768410\u6b3e\u5728\u7814\u57fa\u56e0\u7597\u6cd5"},"content":{"rendered":"
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\"2024\u5e74\u9884\u671f\u6700\u7545\u9500\u768410\u6b3e\u5728\u7814\u57fa\u56e0\u7597\u6cd5\"<\/section>\n<\/section>\n
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\"2024\u5e74\u9884\u671f\u6700\u7545\u9500\u768410\u6b3e\u5728\u7814\u57fa\u56e0\u7597\u6cd5\"<\/p>\n


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\u4ece\u8868\u683c\u4e2d\u770b\u51fa\uff0c\u4e09\u6b3e\u70ed\u70b9\u57fa\u56e0\u7597\u6cd5\u5b9a\u4ef7\u5728100\u4e07\u7f8e\u5143\u5de6\u53f3\u3002Glybera\u4e0a\u5e02\u51e0\u5e74\u56e0\u9500\u552e\u989d\u60e8\u6de1\u800c\u4e8e2017\u5e74\u9000\u5e02\uff0c120\u4e07\u7f8e\u5143\u7684\u5b9a\u4ef7\u4f30\u8ba1\u6709\u592a\u591a\u60a3\u8005\u671b\u6d0b\u5174\u53f9\uff0c\u4e5f\u4e3a\u540e\u9762\u201c\u6709\u4ef7\u65e0\u5e02\u201c\u57cb\u4e0b\u4e86\u9690\u60a3\uff0c\u4f5c\u4e3a\u6b27\u76df\u9996\u6b3e\u83b7\u6279\u7684\u57fa\u56e0\u7597\u6cd5\uff0c\u8fd9\u6837\u7684\u8868\u7387\u8fd8\u771f\u8870\u3002Luxturna\u5b9a\u4ef788\u4e07\u7f8e\u5143\uff0c\u9884\u8ba12024\u5e74\u9500\u552e\u989d\u8fbe\u52301.49\u4ebf\u7f8e\u5143\uff0c2018\u5e74\u521d\u8bfa\u534e\u4ee51.7\u4ebf\u7f8e\u5143\u9ad8\u4ef7\u83b7\u5f97\u7f8e\u56fd\u4ee5\u5916\u7684\u5730\u533a\u5171\u540c\u7814\u53d1\u548c\u63a8\u5e7f\u6743\u76ca\u3002\u8bfa\u534e\u5728\u57fa\u56e0\u7597\u6cd5\u9886\u57df\u7684\u6295\u5165\u771f\u662f\u6177\u6168\uff0c2018\u5e744\u6708\u8fd8\u53c8\u4ee587\u4ebf\u7f8e\u5143\u6536\u8d2dAveXis\uff0c\u83b7\u5f97AAV9\u57fa\u56e0\u7597\u6cd5AVXS-101\uff0c\u4e0d\u4e8f\u662f\u9996\u6b3eCAR-T Kymriah\u7684\u63a8\u52a8\u8005\uff0c\u53efAVXS-101\u5b9a\u4ef7\u4e00\u516c\u5e03\uff0c\u77ac\u95f4\u5f15\u53d1\u7206\u70b9\uff0c\u8bfa\u534e\u62bc\u5b9d\u662f\u5426\u6b63\u786e\u6682\u4e14\u4e0d\u8bba\uff0c\u6e17\u900f\u7387\u5982\u4f55\u6211\u4eec\u4e5f\u62ed\u76ee\u4ee5\u5f85\uff0c400-500\u4e07\u7f8e\u5143\u771f\u625b\u4e0d\u4f4f\uff0c\u5c31\u7b97\u4ee5\u540e\u80fd\u5165\u533b\u4fdd\uff0c\u4ef7\u683c\u4e5f\u8fdc\u9ad8\u4e8eLentiGlobin\u7684\u7ea655\u4e07\u7f8e\u5143\u3002\u4e0e\u4ee5\u4e0a\u4e24\u6b3e\u76f8\u6bd4\uff0cStrimvelis\u5b9a\u4ef7\u5e76\u4e0d\u9ad8\uff0c\u4e0d\u8fc72018\u5e74\u4e5f\u505a\u5230\u4e86200\u4e07\u7f8e\u5143\u7684\u9500\u552e\u989d\u3002<\/span>
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\u8fd1\u671fEvaluate Pharma\u4e5f\u5c31\u201c\u9ad8\u5b9a\u4ef7\u3001\u5c0f\u5bb9\u91cf\u201d\u7b56\u7565\u5728\u591a\u4e2a\u65b9\u9762\u8fdb\u884c\u4e86\u8ba8\u8bba\uff0c\u4ece\u60a3\u8005\u6570\u91cf\u51fa\u53d1\uff0c\u9884\u6d4b\u4e86\u73b0\u5904\u4e8e\u7814\u53d1\u9636\u6bb5\uff0c\u5c06\u57282024\u5e74\u9500\u91cf\u4f4d\u5c45Top10\u7684\u57fa\u56e0\u7597\u6cd5\uff0c\u5177\u4f53\u89c1\u4e0b\u8868\u6240\u793a\u3002<\/span><\/p>\n


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\u8fd9\u4e0e\u4e4b\u524d\u9884\u6d4b\u7684\u5168\u7403\u9500\u552e\u989dTop10\u5927\u540c\u5c0f\u5f02\u3002\u6700\u5927\u7684\u4eae\u70b9\u5728\u4e8eHMI-102\uff0c\u76ee\u524d\u8fd8\u5904\u4e8eIND\u9636\u6bb5\uff0c\u8ba1\u5212\u4e8e2019\u5e74\u542f\u52a8\u4e00\/\u4e8c\u671f\u4e34\u5e8a\u7814\u7a76\u30022018\u5e743\u6708Homology Medicines\u51ed\u501f\u201c\u540c\u6e90\u91cd\u7ec4\uff0c\u65e0\u9700CRISPR-Cas9\u7b49\u5916\u6e90\u7cfb\u7edf\u201c\u7684\u4f18\u52bf\u767b\u9646\u7eb3\u65af\u8fbe\u514b\uff0c\u5176\u4ea7\u54c1HMI-102\u7684\u8eab\u4ef7\u4e5f\u56e0\u6b64\u6c34\u6da8\u8239\u9ad8\uff0c\u8fdb\u5165Top10\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u8fd9\u4e9b\u9879\u76ee\u5927\u90e8\u5206\u5904\u4e8e\u4e2d\u665a\u671f\u9636\u6bb5\uff0c\u6709\u4e24\u6b3e\u5df2\u8fdb\u5165BLA\uff0c\u5206\u522b\u662f\u84dd\u9e1f\u751f\u7269\u7684LentiGlobin\u548c\u8bfa\u534e\u7684AVXS-001\uff0c\u4e24\u8005\u51c0\u73b0\u503c\uff08NPV\uff09\u6700\u9ad8\uff0cLentiGlobin\u643a\u4e24\u9002\u5e94\u75c7\u5165\u699c\u3002\u9488\u5bf9A\u578b\u8840\u53cb\u75c5\u6709\u4e24\u6b3e\uff0c\u5176\u4e2dSpark\u7684valoctocogene roxaparvovec\u4e0eSPK-8011\u76f8\u6bd4\uff0c\u5728\u9500\u552e\u989d\u548c\u51c0\u73b0\u503c\u4e0a\u90fd\u7565\u80dc\u4e00\u7b79\uff0c\u5176\u5b9e\u4e24\u79cd\u7597\u6cd5\u673a\u7406\u7c7b\u4f3c\uff0c\u5747\u662f\u4f7f\u7528AAV\u8f7d\u4f53\u5c06FVIII\uff08\u51dd\u8840\u56e0\u5b50VIII\uff09\u57fa\u56e0\u7684\u529f\u80fd\u6027\u62f7\u8d1d\u8f6c\u79fb\u5230\u60a3\u8005\u4f53\u5185\uff0c\u4f46\u6839\u636e\u76ee\u524d\u6570\u636e\u663e\u793a\uff0cvaloctocogene roxaparvovec\u53d1\u5c55\u8f83\u5feb\u5df2\u8fdb\u5165\u4e09\u671f\uff0c\u4e14\u4e34\u5e8a\u6570\u636e\u66f4\u52a0\u5177\u6709\u5438\u5f15\u6027\u3002\u9488\u5bf9B\u578b\u8840\u53cb\u75c5\u7684\u57fa\u56e0\u7597\u6cd5AMT-061\u4e0a\u699c\uff0c\u4f46\u540c\u662f\u8be5\u9886\u57df\u9886\u8dd1\u8005\u7684Spark\uff0c\u5176\u4e0e\u8f89\u745e\u5408\u4f5c\u5f00\u53d1\u7684SPK-9001\u5374\u843d\u699c\uff0c\u4e24\u8005\u73b0\u5747\u5904\u4e8e\u4e34\u5e8a\u4e09\u671f\uff0c\u4f46AMT-061\u4f7f\u7528FIX-Padua\u53d6\u4ee3\u91ce\u751f\u578bFIX\uff0cFIX\u6d3b\u6027\u6c34\u5e73\u53ef\u5927\u5927\u63d0\u9ad8\uff0c\u6709\u671b\u6210\u4e3a\u9996\u4e2a\u8fdb\u5165\u5e02\u573a\u7684B\u578b\u8840\u53cb\u75c5\u57fa\u56e0\u7597\u6cd5\uff0c\u62a2\u5f97\u5148\u673a\uff0c\u8eab\u4ef7\u81ea\u7136\u4e0d\u540c\u3002\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\uff08DMD\uff09\u7684\u6709\u4e24\u6b3e\uff0cSGT-001\u548cAAVrh74.MHCK7.Micro-Dystrophin\uff0c\u4e24\u8005\u9884\u6d4b\u76842024\u5e74\u9500\u552e\u989d\u5dee\u4e0d\u591a\uff0cNPV\u5374\u76f8\u5dee2.5\u500d\u591a\u3002\u57fa\u56e0\u7597\u6cd5\u7684\u5148\u950bSpark\u5360\u4e24\u6b3e\uff0c\u9488\u5bf9\u65e0\u8109\u7edc\u819c\u75c7\u548cA\u578b\u8840\u53cb\u75c5\u3002\u63a5\u4e0b\u6765\u5206\u522b\u4ecb\u7ecd\u8fd9\u5341\u6b3e\u5c06\u57282024\u5e74\u7545\u9500\u7684\u5728\u7814\u57fa\u56e0\u7597\u6cd5\u4ee5\u53ca\u76f8\u5e94\u7684\u9002\u5e94\u75c7\u3002<\/span><\/p>\n

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1<\/span>LentiGlobin<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n

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LentiGlobin\u662f\u84dd\u9e1f\u751f\u7269\u7814\u53d1\u7684\u4e00\u79cd\u03b2\u73e0\u86cb\u767d\u57fa\u56e0\u7597\u6cd5\uff0c\u66fe\u63d0\u4ea4\u4e0a\u5e02\u7533\u8bf7\uff0c\u7528\u4e8e\u6cbb\u7597\u03b2-\u5730\u4e2d\u6d77\u8d2b\u8840\u548c\u9570\u5200\u578b\u7ec6\u80de\u8d2b\u8840\u75c7\uff0c\u5df2\u83b7\u7f8e\u56fdFDA\u548c\u6b27\u76dfEMA\u8ba4\u8bc1\u7684\u6cbb\u7597\u9570\u5200\u72b6\u8d2b\u8840\u75c7\u5b64\u513f\u836f\u3002<\/span><\/p>\n


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\u03b2-\u5730\u4e2d\u6d77\u8d2b\u8840\u662f\u6211\u56fd\u5357\u65b9\u5404\u7701\u6700\u5e38\u89c1\u3001\u5371\u5bb3\u6700\u5927\u7684\u8840\u6db2\u9057\u4f20\u75c5\uff0c\u4eba\u7fa4\u53d1\u751f\u7387\u9ad8\u8fbe10%\u4ee5\u4e0a\uff0c\u4ee5\u5e7f\u4e1c\u3001\u5e7f\u897f\u4e3a\u4e3b\u3002\u56e0\u57fa\u56e0\u7a81\u53d8\u7a0b\u5ea6\u4e0d\u540c\uff0c\u5730\u4e2d\u6d77\u8d2b\u8840\u8868\u73b0\u591a\u6837\uff0c\u4e00\u822c\u5206\u4e3a\u8f7b\u578b\u3001\u4e2d\u95f4\u578b\u548c\u91cd\u578b\u3002\u636e\u7edf\u8ba1\uff0c\u4e2d\u56fd\u7684\u91cd\u75c7\u5730\u8d2b\u60a3\u8005\u7ea630\u4e07\uff0c\u800c\u5168\u7403\u7684\u60a3\u8005\u4ee56\u4e07\/\u5e74\u7684\u901f\u5ea6\u589e\u957f\u30022018\u5e7412\u6708\uff0cLentiGlobin\u7684\u4e34\u5e8a\u4e00\/\u4e8c\u671f\u7814\u7a76Northstar\uff08HGB-204\uff09\u7ed3\u679c\u4e8eASH\u4f1a\u8bae\u516c\u5e03\uff0c\u4f7f\u7528LentiGlobin\u6cbb\u7597\u768410\u540dTDT\u548c\u975e\u03b20\/\u03b20\u57fa\u56e0\u578b\u60a3\u8005\u4e2d\u67098\u540d\u5b9e\u73b0\u4e86\u8f93\u8840\u975e\u4f9d\u8d56\u6027\uff08transfusion independence\uff09\uff0c\u622a\u81f32018\u5e749\u670814\u65e5\uff0c\u8fd98\u540d\u60a3\u8005\u7ef4\u6301\u8f93\u8840\u975e\u4f9d\u8d56\u6027\uff0c\u4e2d\u4f4d\u6301\u7eed\u65f6\u95f4\u4e3a38\u4e2a\u6708\uff0821-44\u4e2a\u6708\uff09\uff0c\u603b\u8840\u7ea2\u86cb\u767d\u6c34\u5e73\u7a33\u5b9a\uff0c\u5728\u6700\u540e\u4e00\u6b21\u7814\u7a76\u968f\u8bbf\u65f6\u4e3a9.7-14.1g\/dL\u3002\u4f7f\u7528LentiGlobin\u6cbb\u7597TDT\u7684\u6210\u4eba\u548c\u9752\u5c11\u5e74\u60a3\u8005\u7684\u5b89\u5168\u6027\u901a\u5e38\u4e0e\u9aa8\u9ad3\u6e05\u9664\u6027\u9884\u5904\u7406\u4e00\u81f4\u3002\u8840\u5c0f\u677f\u79fb\u690d\u7684\u4e2d\u4f4d\u65f6\u95f4\u4e3a39.5\uff0819-191\uff09\u5929\u3002<\/span><\/p>\n

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2<\/span>AAVrh74.MHCK7.Micro-Dystrophin<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08DMD\uff09\u662f\u4e00\u79cd\u6bc1\u706d\u6027\u7684\u808c\u8089\u75be\u75c5\uff0c\u7531X\u67d3\u8272\u4f53\u4e0a\u7684\u6297\u808c\u840e\u7f29\u86cb\u767d\u57fa\u56e0\u7a81\u53d8\u5f15\u8d77\uff0c\u7279\u5f81\u662f\u8fdb\u884c\u6027\u808c\u8089\u9000\u5316\u548c\u840e\u7f29\uff0c\u5bfc\u81f4\u5fc3\u808c\u75c5\u548c\u547c\u5438\u8870\u7aed\u800c\u8fc7\u65e9\u6b7b\u4ea1\u3002\u636e\u4f30\u8ba1\uff0c\u5e73\u5747\u6bcf5000\u540d\u7537\u5a74\u5c31\u67091\u4eba\u53d7\u5230\u5f71\u54cd\uff0c\u7f8e\u56fd\u7ea6\u67091.5\u4e07\u540d\u7537\u5b69\u60a3\u6709DMD\uff0c\u5168\u4e16\u754c\u4f30\u8ba1\u670930\u4e07\u540d\u60a3\u8005\u3002<\/span><\/p>\n


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rAAVrh74.MCK.Micro-Dystrophin\u662fNationwide Children’s Hospital\u548cSarepta Therapeutics\u5408\u4f5c\u5f00\u53d1\u9488\u5bf9DMD\u7684\u4e00\u79cd\u57fa\u56e0\u7597\u6cd5\uff0c\u76ee\u524d\u5904\u4e8e\u6cbb\u7597DMD\u7684\u4e34\u5e8a\u4e00\/\u4e8c\u671f\u7814\u7a76\u3002\u7531\u4e8e\u8d28\u7c92\u5236\u9020\u95ee\u9898\uff0cFDA\u6b64\u524d\u66fe\u53eb\u505c\u8be5\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4f46\u73b0\u5728\u5df2\u7ecf\u653e\u884c\uff0c\u9884\u8ba1\u5f88\u5feb\u4f1a\u7ee7\u7eed\u5f00\u5c55\u3002<\/span><\/p>\n


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3<\/span>SGT-001<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


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SGT-001\u662fSolid Biosciences\u7814\u53d1\u7684\u4e00\u79cd\u5c06\u8f6c\u67d3\u4e86\u542b\u6709\u529f\u80fd\u6027\u808c\u8425\u517b\u4e0d\u826f\u86cb\u767d\u57fa\u56e0\uff08\u5408\u6210\u7684dystrophin\u57fa\u56e0\uff0c\u4ea6\u79f0\u4e3amicrodystrophin\uff09\u7684\u817a\u76f8\u5173\u75c5\u6bd2AAV9\u8f7d\u4f53\uff0c\u9012\u9001\u5230\u60a3\u8005\u808c\u8089\u7ec6\u80de\u4e2d\u7684\u57fa\u56e0\u7597\u6cd5\uff0c\u6cbb\u7597DMD\u5df2\u83b7FDA\u548cEMA\u6388\u4e88\u7684\u5b64\u513f\u836f\u8d44\u683c\uff0c\u53ca\u7f8e\u56fd\u7684\u5feb\u901f\u901a\u9053\u8d44\u683c\uff0c\u76ee\u524d\u5904\u4e8e\u4e34\u5e8a\u4e00\/\u4e8c\u671f\u7814\u7a76\u8bd5\u9a8c\u9636\u6bb5\u3002<\/span><\/p>\n


<\/p>\n

2018\u5e742\u670814\u65e5\uff0c\u5728\u5176\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u60a3\u8005\u5f00\u59cb\u4f7f\u7528SGT-001\uff0c\u53ef\u51e0\u5929\u540e\uff0c\u60a3\u8005\u56e0\u8840\u5c0f\u677f\u8ba1\u6570\u51cf\u5c11\uff0c\u968f\u540e\u7ea2\u7ec6\u80de\u8ba1\u6570\u51cf\u5c11\u548c\u8865\u4f53\u6fc0\u6d3b\u4f4f\u9662\u3002Solid Biosciences\u5c06\u8fd9\u4e00\u610f\u5916\u4e8b\u4ef6\u5f52\u7c7b\u4e3a\u7591\u4f3c\u610f\u5916\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94( SUSAR)\uff0c\u5e76\u5c06\u5176\u62a5\u544a\u7ed9FDA\uff0c\u800c\u540e\u8bd5\u9a8c\u88ab\u6682\u505c\u30022018\u5e746\u6708\uff0c\u5728Solid\u516c\u53f8\u6ee1\u610f\u5730\u89e3\u7b54\u4e86\u6240\u6709\u4e34\u5e8a\u95ee\u9898\u4e4b\u540e\uff0cFDA\u53d6\u6d88\u4e86\u5bf9IGNITE DMD\u9879\u76ee\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6682\u505c\u63a7\u5236\u3002\u76ee\u524dSolid\u5df2\u7ecf\u5f00\u59cb\u6062\u590d\u5176\u4e34\u5e8a\u8bd5\u9a8c\u6d3b\u52a8\uff0c\u5e76\u6709\u671b\u57282019\u5e74\u4e0b\u534a\u5e74\u63d0\u4f9b\u4e2d\u671f\u5206\u6790\u6570\u636e\u3002<\/span><\/p>\n

 <\/span><\/p>\n

SGT-001\u6700\u521d\u7531\u5bc6\u82cf\u91cc\u5927\u5b66\u54e5\u4f26\u6bd4\u4e9a\u5206\u6821\u5f00\u53d1\uff0c\u7136\u540e\u6388\u6743\u7ed9Solid GT\uff08Solid Biosciences\u7684\u5b50\u516c\u53f8\uff09\u3002<\/span><\/p>\n


<\/p>\n

2016\u5e746\u6708\uff0cSolid Biosciences\u4e0e\u4e09\u5bb6\u6148\u5584\u673a\u6784Duchenne Now\uff0cFight DMD\u548cSave Our Sons\u8fbe\u6210\u5408\u4f5c\u534f\u8bae\uff0c\u652f\u6301\u8be5\u516c\u53f8\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u8ba1\u5212\u30022016\u5e7410\u6708\uff0cSolid Biosciences\u83b7\u5f97Alex’s Wish\u548cDuchenne Now\u6148\u5584\u673a\u6784\u7684\u8d44\u52a9\uff0c\u4ee5\u652f\u6301\u516c\u53f8\u7684\u57fa\u56e0\u6cbb\u7597\u8ba1\u5212\uff0c\u4e0e\u4f5b\u7f57\u91cc\u8fbe\u5927\u5b66\u5408\u4f5c\u5f00\u53d1\u548c\u6539\u8fdb\u57fa\u56e0\u7597\u6cd5\u7684\u751f\u4ea7\u6280\u672f\u30022017\u5e749\u6708\uff0cSolid Biosciences\u4e0eSynpromics\u7b7e\u7f72\u7814\u7a76\u548c\u5f00\u53d1\u534f\u8bae\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\n
\n
\n

4<\/span>AVXS-101<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/span><\/p>\n

AVXS-101\uff08Onasemnogene abeparvovec\uff09\u662f\u4e00\u79cd\u57fa\u4e8eREGENXBIO\u516c\u53f8NAV\u00ae<\/span><\/sup>\u57fa\u56e0\u8f93\u9001\u6280\u672f\u5e73\u53f0\u5f00\u53d1\u7684\u57fa\u56e0\u7597\u6cd5\uff0c\u542b\u9012\u9001\u4eba\u8fd0\u52a8\u795e\u7ecf\u5143\u751f\u5b58\u86cb\u767d\uff08SMN\uff09\u57fa\u56e0\u7684\u817a\u76f8\u5173\u75c5\u6bd29\u578b\uff08AAV9\uff09\u8f7d\u4f53\uff0c\u53ef\u8de8\u8d8a\u8840\u8111\u5c4f\u969c\u76f4\u63a5\u9012\u9001\u81f3\u7ec6\u80de\uff0c\u76ee\u524d\u5904\u4e8e\u6cbb\u7597\u810a\u9ad3\u6027\u808c\u840e\u7f29\u75c7\u7684BLA\u9636\u6bb5\u3002<\/span><\/p>\n


<\/p>\n

AVXS-101\u7531AveXis\u539f\u7814\uff0c2016\u5e74\u5168\u56fd\u513f\u7ae5\u533b\u9662\uff08Nationwide Children’s Hospital\uff09\u83b7\u5f97\u4e86\u8be5\u4ea7\u54c1\u7684\u5408\u4f5c\u7814\u53d1\u6388\u6743\u30022018\u5e74\u8bfa\u534e\u6536\u8d2dAveXis\u83b7\u5f97\u5176\u6743\u76ca\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
\n

5<\/span>Valoctocogene roxaparvovec<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/span><\/p>\n

A\u578b\u8840\u53cb\u75c5\u662fFVIII\u7f3a\u4e4f\u6240\u5bfc\u81f4\u7684\u51fa\u8840\u6027\u75be\u75c5\uff0c\u7ea6\u5360\u5148\u5929\u6027\u51fa\u8840\u6027\u75be\u75c5\u768485%\uff0c\u53d1\u75c5\u7387\u5927\u7ea6\u662fB\u578b\u8840\u53cb\u75c5\u76844\u500d\uff0c\u662f\u7f55\u89c1\u75c5\u91cc\u4e00\u4e2a\u76f8\u5bf9\u6709\u5229\u53ef\u56fe\u7684\u5e02\u573a\u3002\u76ee\u524d\u5168\u7403\u60a3\u8005\u8d85\u8fc715\u4e07\u540d\uff0c\u4e2d\u56fd\u7684\u53d1\u75c5\u7387\u7ea6\u4e3a10\u4e07\u5206\u4e4b3-4\u3002<\/span><\/p>\n


<\/p>\n

BMN-270\uff08Valoctocogene roxaparvovec\uff09\u662f\u4e00\u79cd\u9488\u5bf9A\u578b\u8840\u53cb\u75c5\u7684\u57fa\u56e0\u7597\u6cd5\uff0c\u5c06\u542b\u8f6c\u67d3\u4e86\u51dd\u8840\u56e0\u5b50VIII\u57fa\u56e0\u7684\u817a\u76f8\u5173\u75c5\u6bd2\u8f7d\u4f53\u9001\u5f80\u60a3\u8005\u7684\u809d\u810f\u7ec6\u80de\uff0c\u4e0e\u76ee\u524d\u7684\u51dd\u8840\u56e0\u5b50VIII\u66ff\u4ee3\u7597\u6cd5\u76f8\u6bd4\uff0c\u76f8\u5bf9\u4f4e\u6c34\u5e73\u7684\u51dd\u8840\u56e0\u5b50VIII\u5c31\u5177\u6709\u4e34\u5e8a\u7597\u6548\uff0c\u5fae\u521b\u6027\u66f4\u5f3a\uff0c\u4e0d\u9700\u8981\u6bcf\u5468\u591a\u6b21\u9759\u8109\u5185\u6ce8\u5c04\u3002<\/span><\/p>\n


<\/p>\n

BMN-270\u6700\u521d\u7531\u4f26\u6566\u5927\u5b66\u5b66\u9662\uff08UCL\uff09\u548cSt Jude\u513f\u7ae5\u7814\u7a76\u533b\u9662\u7814\u53d1\uff0cBioMarin\u4e8e2013\u5e74\u83b7\u5f97\u7814\u53d1\u6743\u76ca\uff0c\u6210\u4e3a\u7b2c\u4e00\u5bb6\u4e3aA\u578b\u8840\u53cb\u75c5\u5f00\u53d1\u57fa\u56e0\u6cbb\u7597\u7684\u516c\u53f8\u3002\u8be5\u836f\u7528\u4e8e\u6cbb\u7597A\u578b\u8840\u53cb\u75c5\uff0c\u5df2\u5728\u7f8e\u56fd\u83b7\u5f97\u5b64\u513f\u836f\u548c\u7a81\u7834\u6027\u7597\u6cd5\u8d44\u683c\uff0c\u4e5f\u5df2\u83b7\u5f97\u800c\u6b27\u76dfPRIME\u8d44\u683c\uff0c\u76ee\u524d\u6700\u9ad8\u5904\u4e8e\u4e34\u5e8a\u4e09\u671f\u8bd5\u9a8c\u9636\u6bb5\u3002<\/span><\/p>\n


<\/p>\n

\u5728\u5176GENEr8-1\u4e34\u5e8a\u4e00\/\u4e8c\u671f\u8bd5\u9a8c\u4e2d\uff0c\u517140\u540dA\u578b\u8840\u53cb\u75c5\u60a3\u8005\uff0c\u57286×10^13 vg\/kg(\u8f7d\u4f53\u57fa\u56e0\u7ec4\/\u516c\u65a4\u4f53\u91cd\uff0cvector genome\/kg)\u7ec4\u4e2d\uff0c\u5e73\u5747\u5e74\u51fa\u8840\u7387(ABR)\u964d\u4f4e\u4e8697%\uff0c\u5728\u63a5\u53d7\u6cbb\u7597\u540e\u7b2c\u4e8c\u5e74\u60a3\u8005\u6ca1\u6709\u81ea\u53d1\u6027\u51fa\u8840\u4e8b\u4ef6\uff0c\u622a\u6b62\u6cbb\u7597104\u5468\uff0c\u60a3\u8005\u51dd\u8840\u56e0\u5b50VIII\u7684\u7528\u91cf\u5e73\u5747\u51cf\u5c11\u4e8696%\uff0cFVIII\u6d3b\u6027\u6c34\u5e73\u572859\uff05\u7684\u6b63\u5e38\u8303\u56f4\u5185\uff0c\u5e76\u4e14\u4e2d\u503c\u63a5\u8fd1\u6b63\u5e38\u6c34\u5e73\u4e3a46\uff05\uff1b\u622a\u6b62\u6cbb\u759752\u5468\uff0c4×10^13 vg\/kg \u7ec4\u7ed3\u679c\u663e\u793a\uff0cABR\u964d\u4f4e\u4e8692%\uff0cFVIII\u7528\u91cf\u5e73\u5747\u51cf\u5c11\u4e8698%\uff0cFVIII\u6d3b\u6027\u6c34\u5e73\u4e3a32\uff05\u3002\u8bd5\u9a8c\u671f\u95f4\u836f\u7269\u8010\u53d7\u6027\u826f\u597d\uff0c\u6ca1\u6709\u60a3\u8005\u4ea7\u751f\u5bf9\u5916\u6765\u51dd\u8840\u56e0\u5b50VIII\u7684\u6291\u5236\uff0c\u4e5f\u6ca1\u6709\u60a3\u8005\u9000\u51fa\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span><\/p>\n


<\/p>\n

BMN-270\u7684\u4e24\u9879\u4e34\u5e8a\u4e09\u671f\u8bd5\u9a8c\u4e5f\u6b63\u5728\u8fdb\u884c\u4e2d\uff0cGENER8-2\uff08NCT03392974\uff09\u7814\u7a76\u5c06\u8bc4\u4f30\u786e\u8ba44×10^13 vg\/kg\u5242\u91cf\u7814\u7a76\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u4e3b\u8981\u7ec8\u70b9\u4e3a52\u5468\u4e2d\u4f4dFVIII\u6d3b\u6027\u6c34\u5e73\u7684\u53d8\u5316\uff0c\u5b89\u5168\u6027\u65b9\u9762\u5c06\u7814\u7a76\u8eab\u4f53\u5bf9\u836f\u7269\u4f5c\u51fa\u7684\u53cd\u5e94\uff0c\u5b8c\u6210\u65e5\u671f\u9884\u8ba1\u57282022\u5e7412\u67081\u65e5\u3002GENER8-1\uff08NCT03370913\uff09\u7814\u7a76\u5c06\u8bc4\u4f30\u786e\u8ba46×10^13 vg\/kg\u5242\u91cf\u7684BMN-270\u5728\u7f8e\u56fd\u548c\u82f1\u56fd\u7ea6130\u540d\u91cd\u75c7A\u578b\u8840\u53cb\u75c5\u60a3\u8005\u4e2d\u7814\u7a76\u836f\u7269\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u4ee5\u53ca\u5bf9\u5f53\u524d\u62a4\u7406\u6807\u51c6\u7684\u4f18\u8d8a\u6027\uff0c\u9884\u8ba1\u5c06\u4e8e2019\u5e74\u7b2c\u4e00\u5b63\u5ea6\u5b8c\u6210\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\n
\n
\n

6<\/span>AMT-061<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/span><\/p>\n

B\u578b\u8840\u53cb\u75c5\u662f\u7531\u4e8e\u7f3a\u4e4f\u5fc5\u8981\u7684\u51dd\u8840\u56e0\u5b50IX\uff08FIX\uff09\u800c\u9020\u6210\u7684\u51dd\u8840\u529f\u80fd\u969c\u788d\uff0c\u53d1\u75c5\u7387\u5927\u7ea6\u4e3a3.5\u4e07\u5206\u4e4b\u4e00\uff0c\u4f4e\u4e8eA\u578b\u8840\u53cb\u75c5\u3002AAV5-hFIXco-Padua\uff08AMT-061\uff09\u662f\u7531uniQure\u5f00\u53d1\u7684\u4e00\u79cd\u9488\u5bf9B\u578b\u8840\u53cb\u75c5\u7684\u57fa\u56e0\u7597\u6cd5\u3002\u8fd9\u662f\u4e00\u79cd\u8840\u6e05\u578b5\u7684\u91cd\u7ec4\u817a\u76f8\u5173\u75c5\u6bd2\u8f7d\u4f53\uff08AAV5\uff09\uff0c\u7531\u643a\u5e26\u5177\u6709\u51dd\u8840\u56e0\u5b50IX\u7684\u5e15\u591a\u74e6\u57fa\u56e0\u53d8\u4f53\uff08FIX-Padua\uff09\u7684\u57fa\u56e0\u76d2\u7ec4\u6210\uff0c\u66fe\u7ecf\u88abEMA\u6388\u4e88PRIME\u8d44\u683c\u548c\u5b64\u513f\u836f\u8d44\u683c\uff0c\u88abFDA\u6388\u4e88\u7a81\u7834\u7597\u6cd5\u8d44\u683c\uff0c\u6b63\u5728\u8fdb\u884c\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u7528\u4e8e\u6cbb\u7597\u91cd\u5ea6\u6216\u4e2d\u5ea6\u91cd\u5ea6B\u578b\u8840\u53cb\u75c5\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
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7<\/span>SPK-8011<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/span><\/p>\n

SPK-8011\u7531Spark\u57fa\u56e0\u7597\u6cd5\u516c\u53f8\u5f00\u53d1\uff0c\u662f\u4e00\u79cd\u65b0\u578b\u751f\u7269\u5de5\u7a0b\u817a\u75c5\u6bd2\uff08AAV\uff09\u8f7d\u4f53\uff0c\u5305\u542b\u88ab\u809d\u810f\u7279\u5f02\u6027\u542f\u52a8\u5b50\u63a7\u5236\u3001\u7ecf\u8fc7\u5bc6\u7801\u5b50\u4f18\u5316\u5904\u7406\u7684\u4eba\u51dd\u8840\u56e0\u5b50VIII\u57fa\u56e0\u7684AAV-LK03\u8863\u58f3\uff0c\u7528\u4e8e\u6cbb\u7597A\u578b\u8840\u53cb\u75c5\uff0c\u5df2\u83b7\u7f8e\u56fd\u5b64\u513f\u836f\u548c\u7a81\u7834\u6027\u7597\u6cd5\u8d44\u683c\uff0c\u76ee\u524d\u5904\u4e8e\u4e34\u5e8a\u4e00\/\u4e8c\u671f\u8bd5\u9a8c\u9636\u6bb5\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\n
\n
\n

8<\/span>HMI-102<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/span><\/p>\n

\u82ef\u4e19\u916e\u5c3f\u75c7\uff08Phenylketonuria\uff0cPKU\uff09\u662f\u4e00\u79cd\u9020\u6210\u82ef\u4e19\u6c28\u9178\uff08phenylalanine\uff09\u5728\u4f53\u5185\u79ef\u7d2f\u7684\u7f55\u89c1\u9057\u4f20\u75c5\u3002\u7531\u4e8e\u6709\u52a9\u4e8e\u4ea7\u751f\u5206\u89e3\u82ef\u4e19\u6c28\u9178\u6240\u9700\u7684\u9176\u7684\u57fa\u56e0\u7f3a\u9677\u6240\u81f4\u3002PKU\u60a3\u8005\u8840\u6db2\u4e2d\u9ad8\u6d53\u5ea6\u82ef\u4e19\u6c28\u9178\u4f1a\u5bf9\u5176\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u9020\u6210\u4e0d\u53ef\u9006\u635f\u4f24\uff0c\u4f7f\u60a3\u8005\u4ea7\u751f\u667a\u529b\u4f4e\u4e0b\u3001\u81ea\u95ed\u75c7\u3001\u766b\u75eb\u3001\u8fd0\u52a8\u969c\u788d\u7b49\u4e34\u5e8a\u75c7\u72b6\u3002<\/span><\/p>\n


<\/p>\n

HMI-102\u662fHomology Medicines\u516c\u53f8\u7814\u53d1\u7684\u4e00\u9879\u9488\u5bf9\u82ef\u4e19\u916e\u5c3f\u75c7(PKU)\u7684\u57fa\u56e0\u6cbb\u7597\uff0c\u65e8\u5728\u6062\u590dPKU\u7684\u6b63\u5e38\u4ee3\u8c22\u9014\u5f84\uff0c2018\u5e745\u670818\u65e5\u516c\u5e03\u7684\u65b0\u6570\u636e\u663e\u793a\u5176\u5177\u6709\u7684\u6cbb\u7597\u6f5c\u529b\uff0c\u8ba1\u5212\u5728\u6210\u4ebaPKU\u60a3\u8005\u4e2d\u542f\u52a81\/2\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5df2\u83b7\u7f8e\u56fdFDA\u6388\u4e88\u7684\u5b64\u513f\u836f\u8d44\u683c\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
\n

9<\/span>SPK-7001<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n

\n


<\/p>\n<\/section>\n<\/section>\n

\u65e0\u8109\u7edc\u819c\u75c7\uff08Choroideremia\u3001CHM\uff09\u662f\u4e00\u79cdX\u67d3\u8272\u4f53\u76f8\u5173\u7684IRDs\uff0c\u5728\u9752\u5c11\u5e74\u4e2d\u8868\u73b0\u4e3a\u591c\u76f2\u75c7\u548c\u89c6\u91ce\u51cf\u5c11\uff0c\u5e76\u8fdb\u884c\u6027\u7684\u89c6\u91ce\u7f29\u7a84\uff0cCHM\u7684\u7279\u70b9\u662fCHM\u57fa\u56e0\u7684\u7f3a\u5931\u6216\u8005\u7a81\u53d8\uff0c\u5bfc\u81f4Rab escort \u86cb\u767d1\u7684\u7f3a\u5931\uff0c\u4f30\u8ba1\u7f8e\u56fd\u53ca\u6b27\u6d325\u56fd\u6709\u5927\u7ea612500\u540d\u7537\u6027\u60a3\u6709\u6b64\u75c5\u3002\u7528\u4e8e\u6cbb\u7597CHM\u7684SPK-7001\u5df2\u83b7\u5f97\u7f8e\u56fdFDA\u548c\u6b27\u76dfEMA\u8ba4\u8bc1\u5b64\u513f\u836f\u8d44\u683c\u3002\u8be5\u836f\u6700\u521d\u7531\u5bbe\u5915\u6cd5\u5c3c\u4e9a\u5927\u5b66\u4e0e\u8d39\u57ce\u513f\u7ae5\u533b\u9662\u5408\u4f5c\u5f00\u53d1\uff0c\u4e4b\u540e\u6388\u6743\u4e8eSpark Therapeutics\u3002\u76ee\u524dSPK-7001\u5df2\u88ab\u63a8\u8fdb\u5230\u5f00\u653e\u6807\u7b7e\uff0c\u5242\u91cf\u9012\u589e\u7684\u4e34\u5e8a\u4e00\/\u4e8c\u671f\u8bd5\u9a8c\u4e2d\uff0c\u4ee5\u8bc4\u4f30\u89c6\u7f51\u819c\u4e0b\u7ed9\u836f\u6cbb\u7597\u65e0\u8109\u7edc\u819c\u75c7\u7684\u5b89\u5168\u6027\u548c\u521d\u6b65\u7597\u6548\uff0c\u73b0\u6709\u4e34\u5e8a\u6570\u636e\u8868\u660e\uff0cSPK-7001\u8010\u53d7\u6027\u8f83\u597d\uff0c\u672a\u89c1\u836f\u7269\u76f8\u5173\u6027\u526f\u53cd\u5e94\u6216\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u3002<\/span><\/p>\n


<\/p>\n

\n
\n
\n

10<\/span>ABO-102<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/span><\/p>\n

A\u578b\u5723\u83f2\u5229\u6ce2\u7efc\u5408\u75c7\uff08Sanfilippo Syndrome Type A\uff09\uff0c\u5373\u9ecf\u591a\u7cd6\u8d2e\u79ef\u75c7IIIA\u578b\uff08MPS IIIA\uff09\u662f\u4e00\u79cd\u7f55\u89c1\u7684\u5e38\u67d3\u8272\u4f53\u9690\u6027\u9057\u4f20\u75be\u75c5\uff0c\u5f71\u54cd\u4f53\u5185\u6240\u6709\u7ec6\u80de\u548c\u5668\u5b98\uff0c\u53ef\u5bfc\u81f4\u513f\u7ae5\u7684\u795e\u7ecf\u8ba4\u77e5\u80fd\u529b\u8870\u9000\u3001\u5931\u8bed\u3001\u6d3b\u52a8\u80fd\u529b\u4e27\u5931\u53ca\u592d\u6298\u3002ABO-102\u662f\u4e00\u79cd\u9488\u5bf9\u8be5\u75be\u75c5\u7684\u4ee5\u817a\u75c5\u6bd2\u76f8\u5173\u7684\u57fa\u56e0\u7597\u6cd5\u3002\u8be5\u54c1\u6700\u521d\u662f\u7531Nationwide Children’s Hospital\u7814\u53d1\u7684\uff0c\u540e\u6765\u6388\u6743\u7ed9Abeona Therapeutics\uff0c\u5df2\u83b7EMA\u7684\u5b64\u513f\u836f\u548cFDA\u7684\u5feb\u901f\u5ba1\u6279\u8d44\u683c\uff0c\u76ee\u524d\u5904\u4e8e\u4e34\u5e8a\u4e00\/\u4e8c\u671f\u7814\u7a76\u4e2d\u3002Abeona Therapeutics\u57282017\u5e74\u7b2c13\u5c4aWORLDSymposium\u2122\u6eb6\u9176\u4f53\u8d2e\u79ef\u75be\u75c5\u4e16\u754c\u63a2\u8ba8\u4f1a\u4e0a\u516c\u5e03\u7684\u4e34\u5e8a\u4e00\/\u4e8c\u671f\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff0cABO-102\u6210\u529f\u5230\u8fbe\u60a3\u8005\u5168\u8eab\u7684\u76ee\u6807\u7ec4\u7ec7\uff0c\u5305\u62ec\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\uff0c\u5b89\u5168\u6027\u3001\u8010\u53d7\u6027\u826f\u597d\uff0c\u53ef\u51cf\u5c11\u60a3\u8005\u5c3f\u6db2\u4e2d\u786b\u9178\u4e59\u9170\u809d\u7d20\u548c\u5c3f\u6db2\u4e2d\u603bGAG\u91cf\uff0c\u6b64\u5916\u809d\u813e\u80bf\u5927\u4ee5\u53ca\u8ba4\u77e5\u529f\u80fd\u7684\u6539\u5584\u8f83\u597d\u3002<\/span><\/p>\n

 <\/p>\n

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

1.Tiny populations up the ante for gene therapy pricing\uff1b<\/span><\/p>\n

2. Gene therapy deal-making shows no signs of stopping\uff1b<\/span><\/p>\n

3.Bluebird bio Presents Updated Data from Clinical Studies of LentiGlobin Gene Therapy in Transfusion-Dependent \u03b2-Thalassemia and Sickle Disease at 60th Annual Meeting of the American Society of Hematology\u2018<\/span><\/p>\n

4.Solid Bio\u5ba3\u5e03FDA\u89e3\u9664SGT-001\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6682\u505c\u72b6\u6001\uff1b<\/span><\/p>\n

5. Amy Brown.Vantage_2019_Preview\uff1b<\/span><\/p>\n

6.BioMarin Provides 2 Years of Clinical Data in 6e13 vg\/kg Dose from Ongoing Phase 1\/2 Study in Valoctocogene Roxaparvovec Gene Therapyfor Severe Hemophilia A at World Federation of Hemophilia 2018 World Congress\uff1b<\/span><\/p>\n

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\n
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<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

\u8f6c\u8f7d\u81ea\uff1a \u57fa\u56e0\u7597\u6cd5\u5b9a\u4ef7\u9ad8\u4e00\u76f4\u88ab\u8bdf\u75c5\uff0c\u968f\u77402018\u5e7411\u6708Luxturna\u5728\u6b27\u76df\u83b7\u6279\uff0c\u4ee5\u53ca\u8bfa\u534e\u5c06AVXS-101 […]<\/p>\n","protected":false},"author":1,"featured_media":78316,"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\/78315"}],"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=78315"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/78315\/revisions"}],"predecessor-version":[{"id":78319,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/78315\/revisions\/78319"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/78316"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=78315"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=78315"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=78315"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}