{"id":10045,"date":"2026-01-20T06:19:51","date_gmt":"2026-01-20T12:19:51","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=10045"},"modified":"2026-02-24T06:42:00","modified_gmt":"2026-02-24T12:42:00","slug":"nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/ja\/2026\/01\/20\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\/","title":{"rendered":"\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u793e\u3001\u907a\u4f1d\u6027\u7db2\u819c\u75be\u60a3\u306b\u304a\u3044\u3066\u539a\u751f\u52b4\u50cd\u7701\u306e\u5148\u99c6\u3051\u6307\u5b9a\u304a\u3088\u3073\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u3092\u53d6\u5f97 \u2015 \u7db2\u819c\u907a\u4f1d\u5b50\u6cbb\u7642\u3068\u3057\u3066\u306f\u521d\u306e\u5feb\u6319"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"10045\" class=\"elementor elementor-10045\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d5ad04f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6d5ad04f\" data-element_type=\"section\" data-e-type=\"section\">\r\n\t\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\r\n\t\t\t\t\r\n\t\t\t\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5bf9bdef\" data-id=\"5bf9bdef\" data-element_type=\"column\" data-e-type=\"column\">\r\n\r\n\t\t\t\t\r\n\t\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\r\n\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e3a8c93 elementor-widget elementor-widget-text-editor\" data-id=\"e3a8c93\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3 style=\"text-align: center;\"><em><strong>Japan&#8217;s Ministry of Health, Labor and Welfare (MHLW) grants MCO-010 Pioneering Regenerative Medical Product (Sakigake) and Orphan Drug designations,<\/strong>\u00a0\u907a\u4f1d\u6027\u7db2\u819c\u75be\u60a3\u306b\u3088\u308b\u91cd\u5ea6\u306e\u8996\u529b\u55aa\u5931\u60a3\u8005\u3092\u6cbb\u7642\u3059\u308b\u305f\u3081\u306e\u3001\u8fc5\u901f\u306a\u898f\u5236\u7d4c\u8def\u3092\u53ef\u80fd\u306b\u3059\u308b<\/em><\/h3><h3 style=\"text-align: center;\"><em><strong>\u5f37\u529b\u306a\u4e16\u754c\u7684\u306a\u898f\u5236\u306e\u52e2\u3044\u3092\u57fa\u76e4\u3068\u3057\u3066\u3001,<\/strong> \u3053\u308c\u306b\u306f\u3001EMA\u306e\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a5\u4ef6\u3068\u3001\u7db2\u819c\u75be\u60a3\u306b\u5bfe\u3059\u308bFDA\u306e\u8fc5\u901f\u627f\u8a8d\u30d7\u30ed\u30b0\u30e9\u30e0\u8907\u6570\u4ef6\u304c\u542b\u307e\u308c\u308b\u3002<\/em><\/h3><h3 style=\"text-align: center;\"><em><strong>FDA\u3001EMA\u3001PMDA\u304cMOGENRY\u2122\u30d6\u30e9\u30f3\u30c9\u540d\u3092\u6761\u4ef6\u4ed8\u304d\u3067\u627f\u8a8d\u00a0<\/strong>for MCO-010 as Nanoscope&#8217;s rolling BLA\u00a0with the FDA\u00a0for retinitis pigmentosa advances<\/em><\/h3><h3 style=\"text-align: center;\"><em><strong>MCO-010\u306f\u4e3b\u8981\u5e02\u5834\u306b\u304a\u3051\u308b\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u5546\u696d\u5316\u6e96\u5099\u306b\u5411\u3051\u3066\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u3001,<\/strong> reinforcing Nanoscope&#8217;s leadership in optogenetic therapy<\/em><\/h3><p><span class=\"legendSpanClass\">\u30c0\u30e9\u30b9<\/span>,\u00a0<span class=\"legendSpanClass\">2026\u5e741\u670820\u65e5<\/span>\u00a0 &#8212; <a href=\"http:\/\/nanostherapeutics.com\/ja\/\" target=\"_blank\" rel=\"nofollow noopener\">\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u793e<\/a>, a biotechnology company committed to developing and commercializing novel, disease-agnostic therapies for patients with photoreceptor loss and vision impairment due to retinal degeneration,\u00a0today announced that Japan&#8217;s Ministry of Health, Labour and Welfare\u00a0(MHLW) has granted\u00a0<b>\u5148\u99c6\u3051\u3068\u5b64\u5150\u00a0<\/b><b>\u85ac\u00a0<\/b><b>MCO-010\u3078\u306e\u6307\u5b9a<\/b>, Nanoscope&#8217;s lead asset to treat patients with severe vision loss from inherited retinal diseases (IRDs).<\/p><p>The\u00a0Sakigake designation, Japan&#8217;s premier fast-track regulatory program for innovative therapies addressing serious unmet medical needs, is designed to accelerate patient access to breakthrough treatments. Sakigake status enables prioritized regulatory consultation and review\u2014often targeting a\u00a0six-month review timeline\u2014through close collaboration with the Pharmaceuticals and Medical Devices Agency (PMDA) and may support\u00a0premium pricing\u00a0following approval. Combined with Orphan Drug designation (for use in less than 50,000 patients with high medical need), the decision establishes a strong\u00a0regulatory pathway for MCO-010 in Japan.<b>\u00a0MCO-010\u306f\u00a0<\/b><b>\u7db2\u819c\u907a\u4f1d\u5b50\u6cbb\u7642\u85ac\u3068\u3057\u3066\u521d\u3081\u3066\u3001\u5148\u99c6\u3051\u6307\u5b9a\u3068\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u306e\u4e21\u65b9\u3092\u53d7\u3051\u305f\u3002.<\/b><\/p><p>&#8220;These designations from Japan&#8217;s MHLW mark another\u00a0pivotal milestone for Nanoscope,&#8221; said\u00a0<a href=\"https:\/\/nanostherapeutics.com\/ja\/who-we-are\/samarendra-mohanty\/\" target=\"_blank\" rel=\"nofollow noopener\">\u30b5\u30de\u30ec\u30f3\u30c9\u30e9\u30fb\u30e2\u30cf\u30f3\u30c6\u30a3\u535a\u58eb\u3001\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u793e\u9577\u517c\u6700\u9ad8\u79d1\u5b66\u8cac\u4efb\u8005<\/a>. &#8220;Sakigake recognition underscores the novelty of MCO-010 as a one-time, in-office intravitreal optogenetic therapy and its potential to address profound vision loss where no approved treatments exist. Together with our progress in the U.S. and Europe, we are advancing one of the most comprehensive global regulatory strategies in optogenetic retinal gene therapy for patients living with inherited retinal diseases.&#8221;<\/p><p><b>\u5f37\u529b\u306a\u4e3b\u8981\u5e02\u5834\u898f\u5236\u306e\u52e2\u3044<\/b><\/p><p>The MHLW&#8217;s decision builds on accelerated regulatory pathways across other major markets:<\/p><ul type=\"disc\"><li><b>\u6b27\u5dde\u9023\u5408\uff08EMA\uff09\uff1a<\/b>\u00a0\u975e\u75c7\u5019\u6027\u304a\u3088\u3073\u75c7\u5019\u6027\u306e\u687f\u4f53\u30fb\u9310\u4f53\u512a\u4f4d\u6027\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3001\u306a\u3089\u3073\u306b\u9ec4\u6591\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3092\u542b\u30805\u3064\u306e\u5e0c\u5c11\u75be\u60a3\u6307\u5b9a<\/li><li><b>\u7c73\u56fd\uff08FDA\uff09\uff1a<\/b><br \/><ul type=\"circle\"><li>\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u306b\u5bfe\u3059\u308b\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u304a\u3088\u3073\u8fc5\u901f\u627f\u8a8d\u6307\u5b9a<\/li><li>\u30b9\u30bf\u30fc\u30ac\u30eb\u30c8\u75c5\uff08SD\uff09\u306b\u5bfe\u3059\u308b\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u3001\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u3001\u304a\u3088\u3073\u518d\u751f\u533b\u7642\u5148\u9032\u6cbb\u7642\uff08RMAT\uff09\u306e\u6307\u5b9a<\/li><\/ul><\/li><\/ul><p>\u3055\u3089\u306b\u3001\u00a0<b>FDA\u3001EMA\u3001PMDA\u306f\u00a0<\/b><b>\u6761\u4ef6\u4ed8\u304d\u00a0<\/b><b>MCO-010\u306e\u30d6\u30e9\u30f3\u30c9\u540dMOGENRY\u2122\u3092\u627f\u8a8d\u3057\u307e\u3057\u305f\u3002<\/b>, \u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u306f\u5f15\u304d\u7d9a\u304d\u305d\u306e\u9032\u6b69\u3092\u9042\u3052\u3066\u3044\u308b\u3002\u00a0<b>\u30ed\u30fc\u30ea\u30f3\u30b0\u65b9\u5f0f\u306e\u751f\u7269\u88fd\u5264\u627f\u8a8d\u7533\u8acb\uff08BLA\uff09\u00a0<\/b><b>\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u627f\u8a8d\u306e\u305f\u3081\u00a0<\/b><b>RP\u7528<\/b><b>\u00a0\u60a3\u8005<\/b>\u00a0\u30a2\u30e1\u30ea\u30ab\u5408\u8846\u56fd\u306b\u304a\u3044\u3066\u3002.<\/p><p>\u3053\u308c\u3089\u306e\u898f\u5236\u7d4c\u8def\u304c\u78ba\u7acb\u3055\u308c\u305f\u3053\u3068\u3067\u3001\u00a0<b>\u65e5\u672c\u3001\u7c73\u56fd\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u306b\u304a\u3044\u3066\u3001MCO-010\u306f<\/b>\u00a0<b>\u4e16\u754c\u3067\u6700\u3082\u5148\u9032\u7684\u306a\u5149\u907a\u4f1d\u5b66\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u7642\u6cd5\u304c\u958b\u767a\u4e2d<\/b>. \u3053\u308c\u3089\u306e\u9023\u643a\u3057\u305f\u6307\u5b9a\u306f\u3001\u958b\u767a\u671f\u9593\u306e\u77ed\u7e2e\u3001\u898f\u5236\u5f53\u5c40\u3068\u306e\u9023\u643a\u5f37\u5316\u3001\u305d\u3057\u3066\u4e3b\u8981\u5e02\u5834\u5168\u4f53\u3067\u627f\u8a8d\u3055\u308c\u308b\u6700\u521d\u306e\u5149\u907a\u4f1d\u5b66\u7642\u6cd5\u3068\u306a\u308b\u6a5f\u4f1a\u3092\u652f\u63f4\u3057\u307e\u3059\u3002.<\/p><p><b>MCO\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306b\u3064\u3044\u3066<br class=\"dnr\" \/><\/b>MCO\u306f\u3001\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u3001\u30b9\u30bf\u30fc\u30ac\u30eb\u30c8\u75c5\uff08SD\uff09\u3001\u5730\u56f3\u72b6\u840e\u7e2e\u75c7\uff08GA\uff09\u306a\u3069\u306e\u5149\u53d7\u5bb9\u4f53\u5909\u6027\u75c7\u60a3\u8005\u306e\u8996\u529b\u56de\u5fa9\u3092\u76ee\u7684\u3068\u3057\u305f\u3001\u75be\u60a3\u3092\u554f\u308f\u306a\u3044\u5358\u56de\u6295\u4e0e\u306e\u785d\u5b50\u4f53\u5185\u6cbb\u7642\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002MCO\u306f\u3001\u9ad8\u5bc6\u5ea6\u306e\u53cc\u6975\u7db2\u819c\u7d30\u80de\u3092\u6d3b\u6027\u5316\u3057\u3066\u5149\u611f\u53d7\u6027\u3092\u6301\u305f\u305b\u308b\u3053\u3068\u3067\u3001\u5149\u53d7\u5bb9\u4f53\u6b7b\u5f8c\u306b\u6b8b\u5b58\u3059\u308b\u8996\u899a\u56de\u8def\u3092\u6d3b\u7528\u3057\u307e\u3059\u3002MCO\u6cbb\u7642\u306f\u3001\u907a\u4f1d\u5b50\u691c\u67fb\u3001\u4fb5\u8972\u7684\u306a\u624b\u8853\u3001\u307e\u305f\u306f\u7e70\u308a\u8fd4\u3057\u6295\u4e0e\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u305f\u3081\u3001\u65e2\u5b58\u306e\u7db2\u819c\u8a3a\u7642\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u5185\u3067\u5e45\u5e83\u3044\u60a3\u8005\u306b\u9069\u7528\u53ef\u80fd\u3067\u3059\u3002.<\/p><p><b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u306b\u3064\u3044\u3066<br class=\"dnr\" \/><\/b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u306f\u3001\u7db2\u819c\u5909\u6027\u75be\u60a3\u306b\u3088\u308a\u5931\u660e\u3057\u305f\u6570\u767e\u4e07\u4eba\u306e\u60a3\u8005\u306e\u305f\u3081\u306b\u3001\u75be\u60a3\u3092\u554f\u308f\u306a\u3044\u8996\u529b\u56de\u5fa9\u306e\u305f\u3081\u306e\u5149\u907a\u4f1d\u5b66\u7684\u6cbb\u7642\u6cd5\u3092\u958b\u767a\u3057\u3066\u3044\u307e\u3059\u3002\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\uff08<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>\uff09\u3001FDA\u3078\u306eBLA\u7533\u8acb\u304c\u9806\u6b21\u958b\u59cb\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001MCO-010\u306f\u907a\u4f1d\u5b50\u691c\u67fb\u3092\u5fc5\u8981\u3068\u305b\u305a\u3001\u8a3a\u7642\u6240\u30671\u56de\u6ce8\u5c04\u3059\u308b\u3060\u3051\u3067\u6295\u4e0e\u3067\u304d\u308b\u305f\u3081\u3001RP\u60a3\u8005\u306e\u6a19\u6e96\u6cbb\u7642\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u540c\u793e\u306f\u307e\u305f\u3001\u30b9\u30bf\u30fc\u30ac\u30eb\u30c8\u75c5\uff08SD\uff09\uff08<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>\uff09\u3092\u958b\u59cb\u3057\u3001\u00a0<a href=\"https:\/\/nanostherapeutics.com\/ja\/2024\/09\/12\/nanoscope-therapeutics-announces-end-of-phase-2-meeting-with-u-s-fda-and-plan-to-initiate-a-phase-3-clinical-trial-of-mco-010-to-treat-stargardt-macular-degeneration\/\" target=\"_blank\" rel=\"nofollow noopener\">\u30d5\u30a7\u30fc\u30ba3\u767b\u9332\u8a66\u9a13<\/a>\u00a02026\u5e74\u521d\u982d\u306b\u958b\u59cb\u4e88\u5b9a\u3067\u3059\u3002MCO-010\u306f\u3001\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u3068\u30b9\u30bf\u30d5\u30a3\u30f3\u30fb\u30c7\u30a3\u30d5\u30a3\u30b7\u30eb\uff08SD\uff09\u306e\u4e21\u65b9\u3067FDA\u306e\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u304a\u3088\u3073\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u3092\u53d7\u3051\u3066\u304a\u308a\u3001SD\u306b\u3064\u3044\u3066\u306fRMAT\u6307\u5b9a\u3082\u53d7\u3051\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u975e\u75c7\u5019\u6027\u304a\u3088\u3073\u75c7\u5019\u6027\u306e\u687f\u4f53\u30fb\u9310\u4f53\u512a\u4f4d\u6027\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3001\u9ec4\u6591\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3092\u5bfe\u8c61\u3068\u3059\u308bEMA\u306e\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u3082\u53d7\u3051\u3066\u3044\u307e\u3059\u3002\u5730\u7406\u7684\u840e\u7e2e\uff08GA\uff09\u306b\u5bfe\u3059\u308bMCO\u306e\u7b2c2\u76f8\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u30012026\u5e74\u521d\u982d\u306b\u958b\u59cb\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3059\u3002IND\u7533\u8acb\u6e96\u5099\u4e2d\u306e\u305d\u306e\u4ed6\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u306f\u3001\u30ec\u30fc\u30d0\u30fc\u5148\u5929\u6027\u9ed2\u5185\u969c\uff08LCA\uff09\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><p><b>\u63a5\u89e6\uff1a<br class=\"dnr\" \/><\/b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u793e<br class=\"dnr\" \/>(817) 857-1186<br class=\"dnr\" \/><a href=\"mailto:PR@nanostherapeutics.com\" target=\"_blank\" rel=\"nofollow noopener\">PR@nanostherapeutics.com<\/a><\/p><p>\u51fa\u5178 \u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t<\/section>\r\n\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Japan&#8217;s Ministry of Health, Labor and Welfare (MHLW) grants MCO-010 Pioneering Regenerative Medical Product (Sakigake) and Orphan Drug designations,\u00a0enabling an accelerated regulatory pathway to treat patients with severe vision loss from inherited retinal diseases Builds on strong global regulatory momentum, including five EMA Orphan designations and multiple FDA expedited programs across retinal indications FDA, EMA and PMDA\u00a0conditionally\u00a0approve MOGENRY\u2122 brand name\u00a0for MCO-010 as Nanoscope&#8217;s rolling BLA\u00a0with the FDA\u00a0for retinitis pigmentosa advances Positions MCO-010 for global pre-commercialization readiness across major markets, reinforcing Nanoscope&#8217;s leadership in optogenetic therapy DALLAS,\u00a0Jan. 20, 2026\u00a0 &#8212; Nanoscope Therapeutics, Inc., a biotechnology company committed to developing and commercializing novel, disease-agnostic therapies for patients with photoreceptor loss and vision [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":10046,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[13,8],"tags":[],"class_list":["post-10045","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-page","category-nanoscope-press-release"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nanoscope Secures Japan MHLW Sakigake and Orphan Drug Designations Across Inherited Retinal Diseases - A First for a Retinal Gene Therapy - Nanoscope Therapeutics<\/title>\n<meta name=\"description\" content=\"Our multi-characteristic opsin (MCO) platform is the first to demonstrate an ability to restore vision to retinal disease patients with severe vision loss in clincial trials. 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