{"id":4276,"date":"2025-03-04T06:15:55","date_gmt":"2025-03-04T06:15:55","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/fda-clearance-of-an-investigational-new-drug-ind-application-for-mesencure-phase-iii-clinical-study-in-respiratory-distress\/"},"modified":"2025-09-29T14:00:15","modified_gmt":"2025-09-29T07:00:15","slug":"san-pham-te-bao-duoc-fda-cap-phep-thu-nghiem-lam-sang-giai-doan-iii-dieu-tri-benh-suy-ho-hap","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/san-pham-te-bao-duoc-fda-cap-phep-thu-nghiem-lam-sang-giai-doan-iii-dieu-tri-benh-suy-ho-hap\/","title":{"rendered":"S\u1ea3n Ph\u1ea9m T\u1ebf B\u00e0o \u0110\u01b0\u1ee3c FDA C\u1ea5p Ph\u00e9p Th\u1eed Nghi\u1ec7m L\u00e2m S\u00e0ng Giai \u0110o\u1ea1n III \u0110i\u1ec1u Tr\u1ecb B\u1ec7nh Suy H\u00f4 H\u1ea5p"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">M\u1ee5c l\u1ee5c<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/san-pham-te-bao-duoc-fda-cap-phep-thu-nghiem-lam-sang-giai-doan-iii-dieu-tri-benh-suy-ho-hap\/#Bonus_Biogroup_thong_bao_Cuc_Quan_ly_Thuc_pham_va_Duoc_pham_Hoa_Ky_FDA_chap_thuan_don_xin_cap_phep_thuoc_moi_IND_cua_MesenCure%E2%84%A2_cho_nghien_cuu_lam_sang_giai_doan_III_ve_tinh_trang_suy_ho_hap\" >Bonus Biogroup th\u00f4ng b\u00e1o C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) ch\u1ea5p thu\u1eadn \u0111\u01a1n xin c\u1ea5p ph\u00e9p thu\u1ed1c m\u1edbi (IND) c\u1ee7a MesenCure\u2122 cho nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng giai \u0111o\u1ea1n III v\u1ec1 t\u00ecnh tr\u1ea1ng suy h\u00f4 h\u1ea5p.<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/san-pham-te-bao-duoc-fda-cap-phep-thu-nghiem-lam-sang-giai-doan-iii-dieu-tri-benh-suy-ho-hap\/#MesenCure%E2%84%A2_la_gi\" >MesenCure\u2122 l\u00e0 g\u00ec?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/san-pham-te-bao-duoc-fda-cap-phep-thu-nghiem-lam-sang-giai-doan-iii-dieu-tri-benh-suy-ho-hap\/#Nhung_diem_tao_nen_su_khac_biet_cua_MesenCure%E2%84%A2\" >Nh\u1eefng \u0111i\u1ec3m t\u1ea1o n\u00ean s\u1ef1 kh\u00e1c bi\u1ec7t c\u1ee7a MesenCure\u2122:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/san-pham-te-bao-duoc-fda-cap-phep-thu-nghiem-lam-sang-giai-doan-iii-dieu-tri-benh-suy-ho-hap\/#Gioi_thieu_ve_Bonus_Biogroup\" >Gi\u1edbi thi\u1ec7u v\u1ec1 Bonus Biogroup<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/san-pham-te-bao-duoc-fda-cap-phep-thu-nghiem-lam-sang-giai-doan-iii-dieu-tri-benh-suy-ho-hap\/#Tai_lieu_tham_khao\" >T\u00e0i li\u1ec7u tham kh\u1ea3o:<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"Bonus_Biogroup_thong_bao_Cuc_Quan_ly_Thuc_pham_va_Duoc_pham_Hoa_Ky_FDA_chap_thuan_don_xin_cap_phep_thuoc_moi_IND_cua_MesenCure%E2%84%A2_cho_nghien_cuu_lam_sang_giai_doan_III_ve_tinh_trang_suy_ho_hap\"><\/span><strong>Bonus Biogroup th\u00f4ng b\u00e1o C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) ch\u1ea5p thu\u1eadn \u0111\u01a1n xin c\u1ea5p ph\u00e9p thu\u1ed1c m\u1edbi (IND) c\u1ee7a MesenCure\u2122 cho nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng giai \u0111o\u1ea1n III v\u1ec1 t\u00ecnh tr\u1ea1ng suy h\u00f4 h\u1ea5p.<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><i>Ng\u00e0y 20 th\u00e1ng 2 n\u0103m 2025<\/i><\/p>\n<p>TEL AVIV, Israel, ng\u00e0y 20 th\u00e1ng 2 n\u0103m 2025 (GLOBE NEWSWIRE) &#8211; Bonus Biogroup (TASE: BONS), m\u1ed9t c\u00f4ng ty c\u00f4ng ngh\u1ec7 sinh h\u1ecdc giai \u0111o\u1ea1n cu\u1ed1i \u0111ang nghi\u00ean c\u1ee9u t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 t\u00e1i t\u1ea1o v\u00e0 \u0111i\u1ec1u h\u00f2a mi\u1ec5n d\u1ecbch (MSC) \u0111\u1ec3 ph\u00e1t tri\u1ec3n c\u00e1c gi\u1ea3i ph\u00e1p k\u1ef9 thu\u1eadt m\u00f4 v\u00e0 li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o m\u1edbi. H\u1ecd th\u00f4ng b\u00e1o r\u1eb1ng c\u00f4ng ty \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c s\u1ef1 ch\u1ea5p thu\u1eadn c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) \u0111\u1ec3 ti\u1ebfn h\u00e0nh nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng Giai \u0111o\u1ea1n III t\u1ea1i Hoa K\u1ef3 nh\u1eb1m \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ed9 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m <strong>MesenCure\u2122<\/strong> (li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o \u0111\u1ed3ng lo\u1ea1i bao g\u1ed3m MSC c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb m\u00f4 m\u1ee1 t\u0103ng c\u01b0\u1eddng) \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb t\u00ecnh tr\u1ea1ng suy h\u00f4 h\u1ea5p \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n nh\u1eadp vi\u1ec7n, b\u1ec7nh n\u1eb7ng do vi\u00eam ph\u1ed5i li\u00ean quan \u0111\u1ebfn COVID-19.&nbsp;<\/p>\n<h4><span class=\"ez-toc-section\" id=\"MesenCure%E2%84%A2_la_gi\"><\/span><strong>MesenCure\u2122 l\u00e0 g\u00ec?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><strong>MesenCure<\/strong> <strong>l\u00e0 m\u1ed9t lo\u1ea1i thu\u1ed1c \u0111i\u1ec1u tr\u1ecb t\u1ebf b\u00e0o \u0111\u1ed3ng lo\u1ea1i bao g\u1ed3m MSC c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb m\u00f4 m\u1ee1 \u0111\u01b0\u1ee3c t\u0103ng c\u01b0\u1eddng \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb t\u00ecnh tr\u1ea1ng vi\u00eam v\u00e0 t\u1ed5n th\u01b0\u01a1ng m\u00f4, bao g\u1ed3m vi\u00eam ph\u1ed5i v\u00e0 suy h\u00f4 h\u1ea5p.<\/strong> M\u1ed9t l\u1ee3i th\u1ebf ti\u1ec1m n\u0103ng c\u1ee7a MesenCure trong \u0111i\u1ec1u tr\u1ecb suy h\u00f4 h\u1ea5p, bao g\u1ed3m ARDS, n\u1eb1m \u1edf vi\u1ec7c t\u1eadp trung v\u00e0o \u0111i\u1ec1u tr\u1ecb t\u00ecnh tr\u1ea1ng vi\u00eam v\u00e0 ph\u1ee5c h\u1ed3i m\u00f4 ph\u1ed5i thay v\u00ec nh\u1eafm v\u00e0o c\u00e1c nguy\u00ean nh\u00e2n c\u01a1 b\u1ea3n g\u00e2y vi\u00eam, ch\u1eb3ng h\u1ea1n nh\u01b0 nhi\u1ec5m tr\u00f9ng do vi-r\u00fat ho\u1eb7c vi khu\u1ea9n ho\u1eb7c c\u00e1c t\u1ed5n th\u01b0\u01a1ng kh\u00e1c c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn t\u1ed5n th\u01b0\u01a1ng ph\u1ed5i c\u1ea5p t\u00ednh. Do \u0111\u00f3, MesenCure d\u1ef1 ki\u1ebfn \u200b\u200bs\u1ebd duy tr\u00ec ho\u1ea1t \u0111\u1ed9ng \u0111i\u1ec1u tr\u1ecb c\u1ee7a m\u00ecnh b\u1ea5t k\u1ec3 t\u00e1c nh\u00e2n g\u00e2y b\u1ec7nh l\u00e0 g\u00ec v\u00e0 c\u00f3 th\u1ec3 cung c\u1ea5p ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb hi\u1ec7u qu\u1ea3 h\u01a1n cho nhi\u1ec1u nh\u00f3m b\u1ec7nh nh\u00e2n kh\u00e1c nhau.<\/p>\n<h4><span class=\"ez-toc-section\" id=\"Nhung_diem_tao_nen_su_khac_biet_cua_MesenCure%E2%84%A2\"><\/span><strong>Nh\u1eefng \u0111i\u1ec3m t\u1ea1o n\u00ean s\u1ef1 kh\u00e1c bi\u1ec7t c\u1ee7a MesenCure\u2122:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<ul>\n<li>Ph\u1ea3n \u1ee9ng cao v\u1edbi t\u00ecnh tr\u1ea1ng vi\u00eam v\u00e0 t\u1ed5n th\u01b0\u01a1ng m\u00f4<\/li>\n<li>Kh\u1ea3 n\u0103ng \u0111i\u1ec1u h\u00f2a mi\u1ec5n d\u1ecbch v\u00e0 t\u00e1i t\u1ea1o v\u01b0\u1ee3t tr\u1ed9i<\/li>\n<li>S\u1ea3n xu\u1ea5t trong \u0111i\u1ec7u ki\u1ec7n GMP n\u0103ng su\u1ea5t cao c\u00f3 th\u1ec3 m\u1edf r\u1ed9ng<\/li>\n<li>Ti\u1ec1m n\u0103ng \u0111i\u1ec1u tr\u1ecb t\u1edbi 100.000 b\u1ec7nh nh\u00e2n t\u1eeb m\u1ed9t ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o hi\u1ebfn t\u1eb7ng duy nh\u1ea5t<\/li>\n<\/ul>\n<h4><span class=\"ez-toc-section\" id=\"Gioi_thieu_ve_Bonus_Biogroup\"><\/span><strong>Gi\u1edbi thi\u1ec7u v\u1ec1 Bonus Biogroup<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><strong>Bonus Biogroup (TASE: BONS) l\u00e0 m\u1ed9t c\u00f4ng ty c\u00f4ng ngh\u1ec7 sinh h\u1ecdc ti\u00ean ti\u1ebfn \u0111ang trong giai \u0111o\u1ea1n l\u00e2m s\u00e0ng, ph\u00e1t tri\u1ec3n c\u00e1c li\u1ec7u ph\u00e1p &#8216;th\u1ebf h\u1ec7 ti\u1ebfp theo&#8217; cho nhi\u1ec1u ch\u1ec9 \u0111\u1ecbnh trong l\u0129nh v\u1ef1c y h\u1ecdc t\u00e1i t\u1ea1o.&nbsp;<\/strong>C\u00f4ng ty n\u00e0y \u0111\u1eb7t m\u1ee5c ti\u00eau ph\u00e1t tri\u1ec3n v\u00e0 cung c\u1ea5p c\u00e1c s\u1ea3n ph\u1ea9m k\u1ef9 thu\u1eadt m\u00f4 v\u00e0 li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 gi\u00e1 c\u1ea3 ph\u1ea3i ch\u0103ng \u0111\u1ec3 gi\u1ea3i quy\u1ebft c\u00e1c t\u00ecnh tr\u1ea1ng b\u1ec7nh nghi\u00eam tr\u1ecdng, \u0111\u1ea1i di\u1ec7n cho th\u1ecb tr\u01b0\u1eddng tr\u1ecb gi\u00e1 nhi\u1ec1u t\u1ef7 \u0111\u00f4 la v\u1edbi c\u00e1c l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb h\u1ea1n ch\u1ebf.<\/p>\n<p><i><strong>C\u00f4ng ty \u0111ang n\u1ed7 l\u1ef1c m\u1edf r\u1ed9ng ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 bao g\u1ed3m nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb suy h\u00f4 h\u1ea5p do b\u1ea5t k\u1ef3 nguy\u00ean nh\u00e2n n\u00e0o, bao g\u1ed3m h\u1ed9i ch\u1ee9ng suy h\u00f4 h\u1ea5p c\u1ea5p t\u00ednh (ARDS)<\/strong><\/i><\/p>\n<p><i><strong>Theo \u01b0\u1edbc t\u00ednh c\u1ee7a C\u00f4ng ty, ti\u1ec1m n\u0103ng th\u1ecb tr\u01b0\u1eddng c\u1ee7a MesenCure trong ARDS do m\u1ecdi nguy\u00ean nh\u00e2n ch\u1ec9 ri\u00eang t\u1ea1i Hoa K\u1ef3 c\u00f3 th\u1ec3 \u0111\u1ea1t kho\u1ea3ng 9,6 t\u1ef7 \u0111\u00f4 la v\u00e0o n\u0103m 2030.<\/strong><\/i><\/p>\n<h4><span class=\"ez-toc-section\" id=\"Tai_lieu_tham_khao\"><\/span><strong>T\u00e0i li\u1ec7u tham kh\u1ea3o:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<ol>\n<li><a href=\"https:\/\/www.stemcellsciencenews.com\/newsletter\/236060\/\">https:\/\/www.stemcellsciencenews.com\/newsletter\/236060\/<\/a><\/li>\n<li><a href=\"https:\/\/bonus-bio.com\/index.php\/science-and-medicine\/mesencure\">https:\/\/bonus-bio.com\/index.php\/science-and-medicine\/mesencure<\/a><\/li>\n<li><a href=\"https:\/\/www.globenewswire.com\/news-release\/2025\/02\/20\/3029598\/0\/en\/Bonus-Biogroup-Announces-U-S-Food-and-Drug-Administration-FDA-Clearance-of-an-Investigational-New-Drug-IND-Application-for-MesenCure-Phase-III-Clinical-Study-in-Respiratory-Distres.html\">https:\/\/www.globenewswire.com\/news-release\/2025\/02\/20\/3029598\/0\/en\/Bonus-Biogroup-Announces-U-S-Food-and-Drug-Administration-FDA-Clearance-of-an-Investigational-New-Drug-IND-Application-for-MesenCure-Phase-III-Clinical-Study-in-Respiratory-Distres.html<\/a><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bonus Biogroup th\u00f4ng b\u00e1o C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) ch\u1ea5p thu\u1eadn \u0111\u01a1n xin c\u1ea5p ph\u00e9p thu\u1ed1c m\u1edbi (IND) c\u1ee7a MesenCure\u2122 cho nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng giai \u0111o\u1ea1n III v\u1ec1 t\u00ecnh tr\u1ea1ng suy h\u00f4 h\u1ea5p. Ng\u00e0y 20 th\u00e1ng 2 n\u0103m 2025 TEL AVIV, Israel, ng\u00e0y 20 th\u00e1ng 2 n\u0103m 2025<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/san-pham-te-bao-duoc-fda-cap-phep-thu-nghiem-lam-sang-giai-doan-iii-dieu-tri-benh-suy-ho-hap\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":5743,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-4276","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>S\u1ea3n Ph\u1ea9m T\u1ebf B\u00e0o \u0110\u01b0\u1ee3c FDA C\u1ea5p Ph\u00e9p Th\u1eed Nghi\u1ec7m 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