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\u8840\u6f3f\u7531\u6765\u88fd\u5264\u304a\u3088\u3073\u907a\u4f1d\u5b50\u7d44\u63db\u3048\u88fd\u5264\u306e\u53cc\u65b9\u306b\u3088\u308b\u88dc\u5145\u7642\u6cd5\u306f\u3001\u73fe\u5728\u3082\u8840\u53cb\u75c5\u6cbb\u7642\u306e\u4e2d\u5fc3\u7684\u306a\u9078\u629e\u80a2\u3067\u3042\u308a\u7d9a\u3051\u3066\u3044\u307e\u3059\u304c\u3001\u65b0\u898f\u6cbb\u7642\u85ac\u306e\u958b\u767a\u306b\u5411\u3051\u305f\u6709\u671b\u306a\u7814\u7a76\u3082\u7740\u5b9f\u306b\u9032\u3093\u3067\u3044\u308b\u3053\u3068\u304c\u660e\u3089\u304b\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u85ac\u5264\u306f\u3001\u51dd\u56fa\u30ab\u30b9\u30b1\u30fc\u30c9\u306b\u95a2\u4e0e\u3059\u308b\u3055\u307e\u3056\u307e\u306a\u5206\u5b50\u6a19\u7684\u3084\u907a\u4f1d\u5b50\u3001\u30bf\u30f3\u30d1\u30af\u8cea\u3092\u4f5c\u7528\u70b9\u3068\u3057\u3066\u3044\u308b\u70b9\u306b\u7279\u5fb4\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u3046\u3057\u305f\u7814\u7a76\u6210\u679c\u304b\u3089\u3001\u8fd1\u3044\u5c06\u6765\u3001\u8840\u53cb\u75c5\u3092\u6839\u6cbb\u306b\u5c0e\u304d\u5f97\u308b\u6cbb\u7642\u7d4c\u8def\u304c\u78ba\u7acb\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3068\u5408\u7406\u7684\u306b\u671f\u5f85\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059[6]\u3002<\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/em><\/p>\n

[1] \u7c73\u56fd\u75be\u75c5\u4e88\u9632\u7ba1\u7406\u30bb\u30f3\u30bf\u30fc\u3001\u8840\u53cb\u75c5\u30db\u30fc\u30e0\u30da\u30fc\u30b8 – \u30a4\u30f3\u30d2\u30d3\u30bf\u30fc\u3068\u8840\u53cb\u75c5<\/p>\n

[2]<\/a> Mannucci, P., 2020. \u8840\u53cb\u75c5\u6cbb\u7642\uff1a\u672a\u6765\u304c\u3059\u3067\u306b\u59cb\u307e\u3063\u3066\u3044\u307e\u3059\u3002Haematologica, 105(3), pp.545-553.<\/p>\n

[3]<\/a> FDA\u306f\u3001A\u578b\u8840\u53cb\u75c5\u60a3\u8005\u306b\u304a\u3051\u308b\u51fa\u8840\u306e\u4e88\u9632\u304a\u3088\u3073\u6e1b\u5c11\u3092\u76ee\u7684\u3068\u3057\u305f\u30a8\u30df\u30b7\u30ba\u30de\u30d6-kxwh\u3092\u627f\u8a8d\u3057\u3066\u3044\u307e\u3059\u3002\u8a73\u7d30\u306f\u3001\u6b21\u306e\u60c5\u5831\u6e90\u3067\u78ba\u8a8d\u3067\u304d\u307e\u3059\u3002 https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-emicizumab-kxwh-prevention-and-reduction-bleeding-patients-hemophilia-factor-viii<\/p>\n

[4]<\/a> CSL\u30d9\u30fc\u30ea\u30f3\u30b0\u306b\u3088\u308b\u907a\u4f1d\u5b50\u6cbb\u7642\u306f\u3001FDA\u306b\u3088\u308b\u512a\u5148\u5be9\u67fb\u306e\u4e00\u6642\u4e2d\u65ad\u3092\u7d4c\u3066\u5be9\u67fb\u304c\u518d\u958b\u3055\u308c\u3066\u304a\u308a\u3001\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u958b\u767a\u304c\u524d\u9032\u3057\u3066\u3044\u307e\u3059\u3002\u8a73\u7d30\u306f https:\/\/www.fiercebiotech.com\/biotech\/2020-trial-pause-isnt-holding-csl-behring-back-fda-oks-priority-review-application \u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n

[5]<\/a> \u30d0\u30a4\u30aa\u30de\u30ea\u30f3\u793e\u306e\u8840\u53cb\u75c5\u907a\u4f1d\u5b50\u6cbb\u7642\u85ac\u30ed\u30af\u30bf\u30d3\u30a2\u30f3\u3001FDA\u306e\u9045\u5ef6\u306e\u4e2d\u3001\u6761\u4ef6\u4ed8\u304d\u3067EU\u306e\u652f\u63f4\u3092\u7372\u5f97\u3057\u307e\u3059\u3002\u8a73\u7d30\u306fhttps:\/\/www.fiercepharma.com\/pharma\/biomarins-hemophilia-gene-therapy-roctavian-wins-conditional-eu-backing-fda-plan-delayed \u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n

[6]<\/a>\u4e16\u754c\u8840\u53cb\u75c5\u9023\u76df\u306b\u3088\u308b\u8840\u53cb\u75c5\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3059\u3002https:\/\/www1.wfh.org\/publications\/files\/pdf-1863.pdf \u304b\u3089\u95b2\u89a7\u3067\u304d\u307e\u3059\u3002<\/p>\n

[7] \u5168\u7c73\u8840\u53cb\u75c5\u8ca1\u56e3\u306b\u3088\u308b\u3001\u3059\u3079\u3066\u306e\u51fa\u8840\u6027\u75be\u60a3\u306b\u5bfe\u3059\u308b\u73fe\u5728\u306e\u6cbb\u7642\u6cd5\u3092\u307e\u3068\u3081\u305f\u8cc7\u6599\u3067\u3059\u3002\u304b\u3089\u95b2\u89a7\u3067\u304d\u307e\u3059\u3002<\/p>\n

[8]<\/a> \u4e16\u754c\u8840\u53cb\u75c5\u9023\u76df\u306b\u3088\u308b\u8840\u53cb\u75c5\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3059\u3002https:\/\/www1.wfh.org\/publications\/files\/pdf-1863.pdf \u304b\u3089\u95b2\u89a7\u3067\u304d\u307e\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

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\u53c2\u8003\u6587\u732e\uff1a [1] \u7c73\u56fd\u75be\u75c5\u4e88\u9632\u7ba1\u7406\u30bb\u30f3\u30bf\u30fc\u3001\u8840\u53cb\u75c5\u30db\u30fc\u30e0\u30da\u30fc\u30b8 – \u30a4\u30f3\u30d2\u30d3\u30bf\u30fc\u3068\u8840\u53cb\u75c5 [2] Mannucci, P., 2020. \u8840\u53cb\u75c5\u6cbb\u7642\uff1a\u672a\u6765\u304c\u3059\u3067\u306b\u59cb\u307e\u3063\u3066\u3044\u307e\u3059\u3002Haematologica, 105(3), pp.545-553. [3] FDA\u306f\u3001A\u578b\u8840\u53cb\u75c5\u60a3\u8005\u306b\u304a\u3051\u308b\u51fa\u8840\u306e\u4e88\u9632\u304a\u3088\u3073\u6e1b\u5c11\u3092\u76ee\u7684\u3068\u3057\u305f\u30a8\u30df\u30b7\u30ba\u30de\u30d6-kxwh\u3092\u627f\u8a8d\u3057\u3066\u3044\u307e\u3059\u3002\u8a73\u7d30\u306f\u3001\u6b21\u306e\u60c5\u5831\u6e90\u3067\u78ba\u8a8d\u3067\u304d\u307e\u3059\u3002 https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-emicizumab-kxwh-prevention-and-reduction-bleeding-patients-hemophilia-factor-viii [4] CSL\u30d9\u30fc\u30ea\u30f3\u30b0\u306b\u3088\u308b\u907a\u4f1d\u5b50\u6cbb\u7642\u306f\u3001FDA\u306b\u3088\u308b\u512a\u5148\u5be9\u67fb\u306e\u4e00\u6642\u4e2d\u65ad\u3092\u7d4c\u3066\u5be9\u67fb\u304c\u518d\u958b\u3055\u308c\u3066\u304a\u308a\u3001\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u958b\u767a\u304c\u524d\u9032\u3057\u3066\u3044\u307e\u3059\u3002\u8a73\u7d30\u306f https:\/\/www.fiercebiotech.com\/biotech\/2020-trial-pause-isnt-holding-csl-behring-back-fda-oks-priority-review-application \u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002 [5] \u30d0\u30a4\u30aa\u30de\u30ea\u30f3\u793e\u306e\u8840\u53cb\u75c5\u907a\u4f1d\u5b50\u6cbb\u7642\u85ac\u30ed\u30af\u30bf\u30d3\u30a2\u30f3\u3001FDA\u306e\u9045\u5ef6\u306e\u4e2d\u3001\u6761\u4ef6\u4ed8\u304d\u3067EU\u306e\u652f\u63f4\u3092\u7372\u5f97\u3057\u307e\u3059\u3002\u8a73\u7d30\u306fhttps:\/\/www.fiercepharma.com\/pharma\/biomarins-hemophilia-gene-therapy-roctavian-wins-conditional-eu-backing-fda-plan-delayed \u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002 [6]\u4e16\u754c\u8840\u53cb\u75c5\u9023\u76df\u306b\u3088\u308b\u8840\u53cb\u75c5\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3059\u3002https:\/\/www1.wfh.org\/publications\/files\/pdf-1863.pdf \u304b\u3089\u95b2\u89a7\u3067\u304d\u307e\u3059\u3002 [7] \u5168\u7c73\u8840\u53cb\u75c5\u8ca1\u56e3\u306b\u3088\u308b\u3001\u3059\u3079\u3066\u306e\u51fa\u8840\u6027\u75be\u60a3\u306b\u5bfe\u3059\u308b\u73fe\u5728\u306e\u6cbb\u7642\u6cd5\u3092\u307e\u3068\u3081\u305f\u8cc7\u6599\u3067\u3059\u3002\u304b\u3089\u95b2\u89a7\u3067\u304d\u307e\u3059\u3002 [8] \u4e16\u754c\u8840\u53cb\u75c5\u9023\u76df\u306b\u3088\u308b\u8840\u53cb\u75c5\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3059\u3002https:\/\/www1.wfh.org\/publications\/files\/pdf-1863.pdf 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