{"id":52318,"date":"2022-05-16T05:00:44","date_gmt":"2022-05-16T05:00:44","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=91769"},"modified":"2022-05-16T05:00:44","modified_gmt":"2022-05-16T05:00:44","slug":"zenas-biopharma-solicita-aprovacao-do-medicamento-investigacional-zb001-na-china-para-o-tratamento-de-doenca-ocular-da-tireoide","status":"publish","type":"post","link":"https:\/\/dailysouthafrica.com\/zenas-biopharma-solicita-aprovacao-do-medicamento-investigacional-zb001-na-china-para-o-tratamento-de-doenca-ocular-da-tireoide\/","title":{"rendered":"Zenas BioPharma solicita aprova\u00e7\u00e3o do medicamento investigacional ZB001 na China para o tratamento de Doen\u00e7a Ocular da Tireoide"},"content":{"rendered":"
\n

WALTHAM, Mass. e XANGAI, China, May 15, 2022 (GLOBE NEWSWIRE) — A Zenas BioPharma, uma empresa biofarmac\u00eautica global comprometida em se tornar l\u00edder no desenvolvimento e comercializa\u00e7\u00e3o de terapias imunol\u00f3gicas para pacientes necessitados em todo o mundo, anunciou hoje que solicitou a aprova\u00e7\u00e3o de um novo investigacional (IND) \u00e0 Administra\u00e7\u00e3o Nacional de Produtos M\u00e9dicos da China (NMPA) para o in\u00edcio de um estudo cl\u00ednico de Fase 1\/2 do ZB001 para o tratamento da Doen\u00e7a Ocular da Tireoide (TED). Este estudo foi projetado para avaliar a seguran\u00e7a, tolerabilidade, farmacocin\u00e9tica e efic\u00e1cia preliminar do ZB001.<\/p>\n

\u201cA solicita\u00e7\u00e3o de aprova\u00e7\u00e3o do ZB001 IND ao NMPA \u00e9 um marco significativo para a Zenas\u201d, disse Hua Mu, MD, PhD, Diretor Executivo da Zenas. \u201cNo momento n\u00e3o existe nenhuma terapia aprovada para pacientes com TED na China. As op\u00e7\u00f5es de tratamento s\u00e3o limitadas e muitas vezes envolvem altas doses de esteroides que resultam em efeitos colaterais graves ou interven\u00e7\u00e3o cir\u00fargica. O ZB001 tem o potencial de mudar o paradigma do tratamento para pacientes com TED na China.\u201d<\/p>\n

O ZB001 \u00e9 um anticorpo monoclonal humanizado diferenciado que direciona o receptor de fator de crescimento semelhante \u00e0 insulina 1 (IGF-1R) para o tratamento de TED. TED \u00e9 uma doen\u00e7a autoimune debilitante que causa inflama\u00e7\u00e3o e fibrose dentro da \u00f3rbita do olho, podendo causar vis\u00e3o dupla, dor e cegueira em potencial. Pacientes com doen\u00e7a grave muitas vezes requerem m\u00faltiplas cirurgias corretivas da \u00f3rbita, m\u00fasculos dos olhos e p\u00e1lpebras.<\/p>\n

A Zenas BioPharma licenciou os direitos exclusivos para desenvolver, fabricar e comercializar o ZB001 e outros compostos direcionados ao IGF-1R em indica\u00e7\u00f5es n\u00e3o oncol\u00f3gicas na Grande China da Viridian Therapeutics, Inc. (Viridian) em outubro de 2020. Em novembro de 2021, a Viridian solicitou um IND para o ZB001 (VRDN-001 na Viridian) \u00e0 Food and Drug Administration dos EUA e, em dezembro de 2021, deu in\u00edcio a um ensaio cl\u00ednico de Fase 1\/2 para avaliar a prova de conceito em pacientes com TED nos EUA.<\/p>\n

Sobre a Zenas BioPharma<\/strong><\/p>\n

A Zenas BioPharma \u00e9 uma empresa biofarmac\u00eautica mundial com sedes nos EUA e na China, comprometida em se tornar l\u00edder global no desenvolvimento e comercializa\u00e7\u00e3o de terapias imunol\u00f3gicas para pacientes nos EUA, China e em todo o mundo. A Zenas est\u00e1 avan\u00e7ando rapidamente um vasto pipeline de terap\u00eauticas inovadoras que continua a crescer por meio da nossa estrat\u00e9gia de desenvolvimento de neg\u00f3cios de sucesso. Nossa experiente equipe de lideran\u00e7a e rede de parceiros de neg\u00f3cios impulsionam a excel\u00eancia operacional para oferecer terapias potencialmente transformadoras para melhorar a vida das pessoas que enfrentam doen\u00e7as autoimunes e raras. Para mais informa\u00e7\u00e3o sobre a Zenas BioPharma, visite www.zenasbio.com<\/a> siga-nos no Twitter em @ZenasBioPharma<\/a> e LinkedIn<\/a>.<\/p>\n

Contato com Investidores e com a M\u00eddia:
\nJoe Farmer
\nZenas BioPharma
\nIR@zenasbio.com<\/a><\/p>\n

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

WALTHAM, Mass. e XANGAI, China, May 15, 2022 (GLOBE NEWSWIRE) \u2014 A Zenas BioPharma, uma empresa biofarmac\u00eautica global comprometida em se tornar l\u00edder no desenvolvimento e comercializa\u00e7\u00e3o de terapias imunol\u00f3gicas para pacientes necessitados em todo o mundo, anunciou hoje que solicitou a aprova\u00e7\u00e3o de um novo investigacional (IND) \u00e0 Administra\u00e7\u00e3o Nacional de Produtos M\u00e9dicos da [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[],"yoast_head":"\nZenas BioPharma solicita aprova\u00e7\u00e3o do medicamento investigacional ZB001 na China para o tratamento de Doen\u00e7a Ocular da Tireoide - Daily South Africa<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/dailysouthafrica.com\/zenas-biopharma-solicita-aprovacao-do-medicamento-investigacional-zb001-na-china-para-o-tratamento-de-doenca-ocular-da-tireoide\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zenas BioPharma solicita aprova\u00e7\u00e3o do medicamento investigacional ZB001 na China para o tratamento de Doen\u00e7a Ocular da Tireoide - 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