{"id":5121,"date":"2025-11-06T18:15:03","date_gmt":"2025-11-06T15:15:03","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=5121"},"modified":"2025-11-06T20:03:41","modified_gmt":"2025-11-06T17:03:41","slug":"solid-biosciences-sgt-003-innovation-passport-designation-licensing","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/solid-biosciences-sgt-003-innovation-passport-designation-licensing\/","title":{"rendered":"Solid Biosciences, Duchenne Musk\u00fcler Distrofisi i\u00e7in Ara\u015ft\u0131rma A\u015famas\u0131ndaki Gen Terapisi SGT-003 i\u00e7in Birle\u015fik Krall\u0131k Yenilik\u00e7i Lisanslama ve Eri\u015fim Yolu kapsam\u0131nda \u0130novasyon Pasaportu Tan\u0131m\u0131 ile \u00d6d\u00fcllendirildi"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Solid Biosciences, Duchenne kas distrofisi (Duchenne) i\u00e7in \u015eirketin ara\u015ft\u0131rma a\u015famas\u0131ndaki gen tedavisi SGT-003&#039;e yeni ILAP kapsam\u0131nda bir \u0130novasyon Pasaportu verildi\u011fini duyurdu. \u0130novasyon Pasaportu, Birle\u015fik Krall\u0131k&#039;ta piyasaya s\u00fcr\u00fclme s\u00fcresini k\u0131saltmay\u0131 ve hastalar\u0131n yeni ila\u00e7lara eri\u015fimini kolayla\u015ft\u0131rmay\u0131 ama\u00e7layan ILAP&#039;\u0131n giri\u015f noktas\u0131d\u0131r. \u0130novasyon Pasaportu, MHRA ve ILAP ortak kurulu\u015flar\u0131n\u0131n, d\u00fczenleyici ve geli\u015ftirme a\u015famalar\u0131 i\u00e7in \u00fcr\u00fcne \u00f6zel bir yol haritas\u0131 geli\u015ftirmelerini sa\u011flar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SGT-003, kar\u015f\u0131lanmam\u0131\u015f klinik ihtiya\u00e7lar\u0131 ele alan d\u00f6n\u00fc\u015ft\u00fcr\u00fcc\u00fc \u00fcr\u00fcnlere daha se\u00e7ici bir \u015fekilde odaklanan yeni ILAP&#039;a kat\u0131lan ilk \u00fc\u00e7 ara\u015ft\u0131rma ama\u00e7l\u0131 t\u0131bbi \u00fcr\u00fcnden biridir. <strong>Devam\u0131n\u0131 oku<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/tr\/faq-solid-biosciences-sgt-003-gene-therapy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Solid Biosciences SGT-003 Gen Terapisi Hakk\u0131nda S\u0131k\u00e7a Sorulan Sorular<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u0130novasyon pasaportu ne anlama geliyor?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0130novasyon Pasaportu \u00f6d\u00fcl\u00fc, pazara sunma s\u00fcresini h\u0131zland\u0131r\u0131yor ve hastalar\u0131n d\u00f6n\u00fc\u015ft\u00fcr\u00fcc\u00fc yeni ila\u00e7lara eri\u015fimini h\u0131zland\u0131rmaya yard\u0131mc\u0131 oluyor.<\/li>\n\n\n\n<li>Yeni Yenilik\u00e7i Lisanslama ve Eri\u015fim Yolu (ILAP) tan\u0131m\u0131, Solid&#039;in Birle\u015fik Krall\u0131k Ulusal Sa\u011fl\u0131k Sistemi (NHS), Birle\u015fik Krall\u0131k \u0130la\u00e7 ve Sa\u011fl\u0131k \u00dcr\u00fcnleri D\u00fczenleme Ajans\u0131 (MHRA) ve sa\u011fl\u0131k teknolojisi de\u011ferlendirme (HTA) kurulu\u015flar\u0131yla do\u011frudan \u00e7al\u0131\u015fmas\u0131 i\u00e7in benzersiz, u\u00e7tan uca d\u00fczenleyici eri\u015fim yolu sa\u011fl\u0131yor: Ulusal Sa\u011fl\u0131k ve Bak\u0131m M\u00fckemmelli\u011fi Enstit\u00fcs\u00fc (NICE), \u0130sko\u00e7 \u0130la\u00e7 Konsorsiyumu (SMC) ve T\u00fcm Galler Terap\u00f6tik ve Toksikoloji Merkezi (AWTTC).<\/li>\n\n\n\n<li>Innovation Passport, SGT-003&#039;\u00fcn Duchenne kas distrofisi i\u00e7in \u0130ngiltere&#039;de piyasaya s\u00fcr\u00fclen ilk gen tedavisi olma potansiyelini destekliyor.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Daha fazla bilgi edin<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/tr\/solid-biosciences-provides-update-on-inspire-duchenne-clinical-trial-progress-and-planned-regulatory-discussions\/\" target=\"_blank\" rel=\"noreferrer noopener\">Solid Biosciences, INSPIRE DUCHENNE Klinik Ara\u015ft\u0131rma \u0130lerlemesi ve Planlanan D\u00fczenleyici Tart\u0131\u015fmalar Hakk\u0131nda G\u00fcncelleme Sa\u011fl\u0131yor<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SGT-003, \u015fu anda ABD, \u0130ngiltere, \u0130talya ve Kanada genelinde 15 aktif klinik ara\u015ft\u0131rma merkezinde kat\u0131l\u0131mc\u0131lar\u0131 kaydeden devam eden Faz 1\/2 INSPIRE DUCHENNE klinik ara\u015ft\u0131rmas\u0131nda de\u011ferlendirilmektedir. Ayr\u0131ca, Solid ilk klinik ara\u015ft\u0131rma merkezini aktif hale getirmi\u015f olup, SGT-003&#039;\u00fcn ABD d\u0131\u015f\u0131nda y\u00fcr\u00fct\u00fclen, Faz 3, randomize, \u00e7ift k\u00f6r, plasebo kontroll\u00fc bir klinik ara\u015ft\u0131rmas\u0131 olan IMPACT DUCHENNE i\u00e7in kat\u0131l\u0131mc\u0131lar\u0131 taramaktad\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Bu Sayfay\u0131 Takip Edin<\/strong>&nbsp;&gt;&gt;&gt;&nbsp;<a href=\"https:\/\/dmdwarrior.com\/tr\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Duchenne i\u00e7in T\u00fcm Klinik Ara\u015ft\u0131rmalar<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Solid Biosciences announced that SGT-003, the Company\u2019s investigational gene therapy for Duchenne muscular dystrophy (Duchenne), has been granted an Innovation Passport under the new ILAP. The Innovation Passport is the entry point for the ILAP, which aims to accelerate time to market and facilitate patient access to new medicines in the UK. The Innovation Passport [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5122,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[454,110,170,109],"class_list":["post-5121","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-innovation-passport","tag-sgt-003","tag-sgt-003-gene-therapy","tag-solid-biosciences"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/5121","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=5121"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/5121\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/5122"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=5121"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=5121"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=5121"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}