{"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 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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>. 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\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\u2019s 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\u2019s rolling BLA\u00a0with the FDA\u00a0for retinitis pigmentosa advances Positions MCO-010 for global pre-commercialization readiness across major markets, reinforcing Nanoscope\u2019s leadership in optogenetic therapy DALLAS,\u00a0Jan. 20, 2026\u00a0 \u2014 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,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"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 v27.6 - 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. Nanoscope has developed MCO-010, the first and only broad spectrum, fast response and ultra-sensitive optogenetic technology for vision restoration that is gene-agnostic.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"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\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Secures Japan MHLW Sakigake and Orphan Drug Designations Across Inherited Retinal Diseases - A First for a Retinal Gene Therapy - Nanoscope Therapeutics\" \/>\n<meta property=\"og: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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