{"id":1338,"date":"2021-12-19T10:00:39","date_gmt":"2021-12-19T03:00:39","guid":{"rendered":"https:\/\/news.eloqasia.com\/?p=1338"},"modified":"2022-01-10T13:59:06","modified_gmt":"2022-01-10T06:59:06","slug":"lieu-phap-bo-doi-khang-the-don-dong-tac-dung-keo-dai-azd7442-duy-tri-kha-nang-trung-hoa-bien-the-omicron-trong-nghien-cuu-doc-lap-cua-co-quan-quan-ly-thuc-pham-va-duoc-pham-hoa-ky-fda","status":"publish","type":"post","link":"https:\/\/news.eloqasia.com\/?p=1338","title":{"rendered":"Li\u1ec7u ph\u00e1p b\u1ed9 \u0111\u00f4i kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i AZD7442 duy tr\u00ec kh\u1ea3 n\u0103ng trung h\u00f2a bi\u1ebfn th\u1ec3 Omicron trong nghi\u00ean c\u1ee9u \u0111\u1ed9c l\u1eadp c\u1ee7a C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA)"},"content":{"rendered":"

Li\u1ec7u ph\u00e1p kh\u00e1ng th\u1ec3 duy nh\u1ea5t \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t t\u1ea1i Hoa K\u1ef3 cho<\/em> d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i <\/em>nhi\u1ec5m COVID-19<\/em><\/p>\n

Li\u1ec7u ph\u00e1p b\u1ed9 \u0111\u00f4i kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i AZD7442 c\u1ee7a AstraZeneca (tixagevimab k\u1ebft h\u1ee3p c\u00f9ng cilgavimab) nh\u1eb1m ph\u00f2ng ng\u1eeba COVID-19 cho th\u1ea5y kh\u1ea3 n\u0103ng duy tr\u00ec ho\u1ea1t \u0111\u1ed9ng trung h\u00f2a \u0111\u1ed1i v\u1edbi bi\u1ebfn th\u1ec3 Omicron c\u1ee7a vi r\u00fat SARS-CoV-2 (B.1.1.529), theo d\u1eef li\u1ec7u ti\u1ec1n l\u00e2m s\u00e0ng m\u1edbi.<\/p>\n

Nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng n\u00e0y cho th\u1ea5y n\u1ed3ng \u0111\u1ed9 \u1ee9c ch\u1ebf t\u1ed1i thi\u1ec3u 50% ho\u1ea1t \u0111\u1ed9ng virus (IC50) c\u1ee7a AZD7442 – <\/em>th\u01b0\u1edbc \u0111o hi\u1ec7u l\u1ef1c trung h\u00f2a c\u1ee7a m\u1ed9t kh\u00e1ng th\u1ec3, l\u00e0 171 ng\/ml v\u00e0 277 ng\/ml trong hai x\u00e9t nghi\u1ec7m \u0111\u1ed1i chi\u1ebfu, v\u1eabn n\u1eb1m trong ph\u1ea1m vi hi\u1ec7u gi\u00e1 trung h\u00f2a \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh \u1edf ng\u01b0\u1eddi \u0111\u00e3 m\u1eafc COVID-19 tr\u01b0\u1edbc \u0111\u00f3. N\u1ed3ng \u0111\u1ed9 \u1ee9c ch\u1ebf t\u1ed1i thi\u1ec3u 50% ho\u1ea1t \u0111\u1ed9ng virus c\u1ee7a AZD7442 \u0111\u1ed1i v\u1edbi ch\u1ee7ng SARS-CoV-2 g\u1ed1c, tr\u01b0\u1edbc \u0111\u00e2y c\u00f2n g\u1ecdi l\u00e0 ch\u1ee7ng V\u0169 H\u00e1n, \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh l\u1ea7n l\u01b0\u1ee3t kho\u1ea3ng 1.3 ng\/ml v\u00e0 1.5 ng\/ml. 1<\/sup><\/p>\n

D\u1eef li\u1ec7u ban \u0111\u1ea7u thu \u0111\u01b0\u1ee3c t\u1eeb th\u00ed nghi\u1ec7m trung h\u00f2a b\u1eb1ng h\u1ed7n h\u1ee3p kh\u00e1ng th\u1ec3 tixagevimab k\u1ebft h\u1ee3p c\u00f9ng cilgavimab \u2013 b\u1ed9 \u0111\u00f4i kh\u00e1ng th\u1ec3 t\u1ea1o n\u00ean AZD7442 tr\u00ean virus gi\u1ea3 l\u1eadp (pseudovirus) mang to\u00e0n b\u1ed9 protein gai c\u1ee7a bi\u1ebfn th\u1ec3 Omicron \u2013 \u0111\u00e3 b\u1ed5 sung v\u00e0o b\u1ed9 d\u1eef li\u1ec7u b\u1eb1ng ch\u1ee9ng ti\u1ec1n l\u00e2m s\u00e0ng \u0111ang ng\u00e0y c\u00e0ng \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n c\u1ee7a AZD7442, \u0111\u00e3 ch\u1ee9ng minh AZD7442 c\u00f3 hi\u1ec7u qu\u1ea3 b\u1ea3o v\u1ec7 tr\u01b0\u1edbc t\u1ea5t c\u1ea3 c\u00e1c bi\u1ebfn th\u1ec3 \u0111\u00e1ng lo ng\u1ea1i \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o nghi\u00ean c\u1ee9u t\u1eeb tr\u01b0\u1edbc t\u1edbi nay.1 <\/sup><\/p>\n

Th\u1eed nghi\u1ec7m n\u00e0y \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ed9c l\u1eadp b\u1edfi c\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u t\u1ea1i Trung t\u00e2m \u0110\u00e1nh gi\u00e1 v\u00e0 Nghi\u00ean c\u1ee9u Thu\u1ed1c sinh h\u1ecdc (CBER), thu\u1ed9c C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA), \u0111\u01b0\u1ee3c h\u1ed7 tr\u1ee3 b\u1edfi c\u00e1c qu\u1ef9 nghi\u00ean c\u1ee9u c\u1ee7a Ch\u00ednh ph\u1ee7 Hoa K\u1ef3.<\/p>\n

Mene Pangalos, Ph\u00f3 Ch\u1ee7 t\u1ecbch \u0110i\u1ec1u h\u00e0nh BioPharmaceuticals R&D thu\u1ed9c AstraZeneca, cho bi\u1ebft: \u201cNghi\u00ean c\u1ee9u tr\u00ean cho th\u1ea5y AZD7442 duy tr\u00ec kh\u1ea3 n\u0103ng trung h\u00f2a bi\u1ebfn th\u1ec3 Omicron. B\u1eb1ng c\u00e1ch k\u1ebft h\u1ee3p hai kh\u00e1ng th\u1ec3 c\u00f3 hi\u1ec7u l\u1ef1c m\u1ea1nh v\u1edbi ho\u1ea1t \u0111\u1ed9ng ri\u00eang bi\u1ec7t v\u00e0 b\u1ed5 tr\u1ee3 nhau \u0111\u1ec3 ch\u1ed1ng l\u1ea1i vi r\u00fat, AZD7442 \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 tr\u00e1nh kh\u1ea3 n\u0103ng kh\u00e1ng thu\u1ed1c c\u1ee7a c\u00e1c bi\u1ebfn th\u1ec3 SARS-CoV-2 m\u1edbi. AZD7442 l\u00e0 li\u1ec7u ph\u00e1p kh\u00e1ng th\u1ec3 c\u00f3 t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p t\u1ea1i Hoa K\u1ef3 cho d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m COVID-19, c\u0169ng nh\u01b0 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p t\u1ea1i c\u00e1c qu\u1ed1c gia kh\u00e1c, v\u00e0 ch\u00fang t\u00f4i \u0111ang l\u00e0m vi\u1ec7c ch\u1eb7t ch\u1ebd v\u1edbi c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd \u0111\u1ec3 \u0111\u1ec7 tr\u00ecnh h\u1ed3 s\u01a1 c\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng AZD7442 trong \u0111i\u1ec1u tr\u1ecb COVID-19.\u201d<\/p>\n

T\u1ea1i th\u1eddi \u0111i\u1ec3m di\u1ec5n ra c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u1ee7a AZD7442, bi\u1ebfn th\u1ec3 Omicron ch\u01b0a b\u1eaft \u0111\u1ea7u l\u01b0u h\u00e0nh. <\/em>V\u00ec v\u1eady, t\u1eadp \u0111o\u00e0n v\u1eabn \u0111ang ti\u1ebfp t\u1ee5c thu th\u1eadp d\u1eef li\u1ec7u \u0111\u1ec3 hi\u1ec3u r\u00f5 h\u01a1n \u00fd ngh\u0129a c\u1ee7a c\u00e1c k\u1ebft qu\u1ea3 n\u00e0y trong th\u1ef1c h\u00e0nh l\u00e2m s\u00e0ng. Nh\u1eefng ph\u00e2n t\u00edch b\u1ed5 sung \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 ho\u1ea1t \u0111\u1ed9ng c\u1ee7a AZD7442 \u0111\u1ed1i v\u1edbi bi\u1ebfn th\u1ec3 Omicron hi\u1ec7n \u0111ang \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh b\u1edfi AstraZeneca v\u00e0 c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m b\u00ean th\u1ee9 ba, v\u00e0 s\u1ebd s\u1edbm c\u00f3 th\u00eam d\u1eef li\u1ec7u.<\/p>\n

AZD7442 nh\u1eadn \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p (EUA) t\u1ea1i Hoa K\u1ef3 v\u00e0o th\u00e1ng 12 n\u0103m 2021 cho d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m (ph\u00f2ng ng\u1eeba) COVID-19 cho nh\u1eefng ng\u01b0\u1eddi b\u1ecb suy gi\u1ea3m mi\u1ec5n d\u1ecbch t\u1eeb trung b\u00ecnh \u0111\u1ebfn n\u1eb7ng do t\u00ecnh tr\u1ea1ng b\u1ec7nh l\u00fd ho\u1eb7c s\u1eed d\u1ee5ng thu\u1ed1c \u1ee9c ch\u1ebf mi\u1ec5n d\u1ecbch \u2013 nh\u1eefng ng\u01b0\u1eddi c\u00f3 th\u1ec3 kh\u00f4ng t\u1ef1 sinh \u0111\u01b0\u1ee3c mi\u1ec5n d\u1ecbch \u0111\u1ea7y \u0111\u1ee7 v\u1edbi v\u1eafc xin COVID-19, c\u0169ng nh\u01b0 nh\u1eefng c\u00e1 nh\u00e2n kh\u00f4ng \u0111\u01b0\u1ee3c khuy\u1ebfn c\u00e1o ti\u00eam v\u1eafc xin COVID-19. Nh\u1eefng li\u1ec1u \u0111\u1ea7u ti\u00ean c\u1ee7a li\u1ec7u ph\u00e1p d\u1ef1 ki\u1ebfn s\u1ebd s\u1edbm c\u00f3 m\u1eb7t trong nh\u1eefng ng\u00e0y t\u1edbi.<\/p>\n

Kho\u1ea3ng 2% d\u00e2n s\u1ed1 to\u00e0n c\u1ea7u \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 l\u00e0 c\u00f3 t\u0103ng nguy c\u01a1 kh\u00f4ng \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 v\u1edbi v\u1eafc xin ph\u00f2ng COVID-19.3,4<\/sup> Ng\u00e0y c\u00e0ng c\u00f3 nhi\u1ec1u b\u1eb1ng ch\u1ee9ng cho th\u1ea5y vi\u1ec7c b\u1ea3o v\u1ec7 nh\u00f3m d\u00e2n s\u1ed1 d\u1ec5 b\u1ecb t\u1ed5n th\u01b0\u01a1ng kh\u1ecfi nhi\u1ec5m b\u1ec7nh COVID-19 s\u1ebd gi\u00fap ng\u0103n ng\u1eeba vi r\u00fat ti\u1ebfn h\u00f3a \u2013 m\u1ed9t y\u1ebfu t\u1ed1 quan tr\u1ecdng t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn s\u1ef1 xu\u1ea5t hi\u1ec7n c\u1ee7a nh\u1eefng bi\u1ebfn th\u1ec3 m\u1edbi.5<\/sup><\/p>\n

Th\u00eam v\u00e0o \u0111\u00f3, th\u1eed nghi\u1ec7m \u0111i\u1ec1u tr\u1ecb ngo\u1ea1i tr\u00fa TACKLE pha III c\u1ee7a AZD7442 cho th\u1ea5y li\u1ec7u ph\u00e1p n\u00e0y gi\u00fap gi\u1ea3m 50% nguy c\u01a1 ph\u00e1t tri\u1ec3n t\u1eeb b\u1ec7nh COVID-19 m\u1ee9c \u0111\u1ed9 nh\u1eb9 \u0111\u1ebfn trung b\u00ecnh th\u00e0nh b\u1ec7nh n\u1eb7ng ho\u1eb7c t\u1eed vong (b\u1ea5t k\u1ec3 nguy\u00ean nh\u00e2n n\u00e0o) so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n xu\u1ea5t hi\u1ec7n tri\u1ec7u ch\u1ee9ng trong 7 ng\u00e0y ho\u1eb7c \u00edt h\u01a1n.6<\/sup><\/p>\n

Ghi ch\u00fa<\/u><\/strong><\/p>\n

AZD7442<\/strong><\/p>\n

AZD7442,<\/em> c\u00f2n c\u00f3 t\u00ean l\u00e0 Evusheld<\/em>, l\u00e0 s\u1ef1 k\u1ebft h\u1ee3p c\u1ee7a hai LAAB – tixagevimab (AZD8895) v\u00e0 cilgavimab (AZD1061) \u2013 c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb t\u1ebf b\u00e0o B do b\u1ec7nh nh\u00e2n ph\u1ee5c h\u1ed3i sau khi nhi\u1ec5m virus SARS-CoV-2 hi\u1ebfn t\u1eb7ng. \u0110\u01b0\u1ee3c ph\u00e1t hi\u1ec7n b\u1edfi Trung t\u00e2m Y t\u1ebf \u0110\u1ea1i h\u1ecdc Vanderbilt v\u00e0 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho AstraZeneca v\u00e0o th\u00e1ng 6 n\u0103m 2020, c\u00e1c kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng c\u1ee7a ng\u01b0\u1eddi li\u00ean k\u1ebft v\u1edbi c\u00e1c v\u1ecb tr\u00ed ri\u00eang bi\u1ec7t tr\u00ean protein gai7<\/sup> c\u1ee7a SARS-CoV-2 v\u00e0 \u0111\u01b0\u1ee3c AstraZeneca t\u1ed1i \u01b0u h\u00f3a v\u1edbi th\u1eddi gian b\u00e1n h\u1ee7y k\u00e9o d\u00e0i v\u00e0 gi\u1ea3m vi\u1ec7c li\u00ean k\u1ebft gi\u1eefa th\u1ee5 th\u1ec3 Fc v\u00e0 b\u1ed5 th\u1ec3 C1q. Th\u1eddi gian b\u00e1n h\u1ee7y n\u00e0y gi\u00fap k\u00e9o d\u00e0i h\u01a1n g\u1ea5p ba l\u1ea7n \u0111\u1ed9 b\u1ec1n ho\u1ea1t \u0111\u1ed9ng c\u1ee7a kh\u00e1ng th\u1ec3 so v\u1edbi c\u00e1c kh\u00e1ng th\u1ec3 truy\u1ec1n th\u1ed1ng v\u00e0 c\u00f3 th\u1ec3 cung c\u1ea5p kh\u1ea3 n\u0103ng b\u1ea3o v\u1ec7 ch\u1ed1ng l\u1ea1i COVID-19 l\u00ean \u0111\u1ebfn 12 th\u00e1ng sau m\u1ed9t l\u1ea7n ti\u00eam;8-10<\/sup> D\u1eef li\u1ec7u t\u1eeb th\u1eed nghi\u1ec7m PROVENT Giai \u0111o\u1ea1n III cho th\u1ea5y kh\u1ea3 n\u0103ng b\u1ea3o v\u1ec7 k\u00e9o d\u00e0i \u00edt nh\u1ea5t s\u00e1u th\u00e1ng.11<\/sup> Vi\u1ec7c gi\u1ea3m li\u00ean k\u1ebft th\u1ee5 th\u1ec3 Fc nh\u1eb1m m\u1ee5c \u0111\u00edch gi\u1ea3m thi\u1ec3u nguy c\u01a1 t\u0103ng c\u01b0\u1eddng b\u1ec7nh t\u1eadt ph\u1ee5 thu\u1ed9c v\u00e0o kh\u00e1ng th\u1ec3 – m\u1ed9t hi\u1ec7n t\u01b0\u1ee3ng trong \u0111\u00f3 c\u00e1c kh\u00e1ng th\u1ec3 \u0111\u1eb7c hi\u1ec7u v\u1edbi virus th\u00fac \u0111\u1ea9y, thay v\u00ec \u1ee9c ch\u1ebf, vi\u1ec7c l\u00e2y nhi\u1ec5m v\u00e0\/ho\u1eb7c ti\u1ebfn tri\u1ec3n b\u1ec7nh.12 <\/sup><\/p>\n

V\u00e0o th\u00e1ng 12 n\u0103m 2021, C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) c\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p (EUA) cho AZD7442 (tixagevimab k\u1ebft h\u1ee3p c\u00f9ng cilgavimab) cho d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m (ph\u00f2ng ng\u1eeba) COVID-19. \u0110\u00e2y l\u00e0 li\u1ec7u ph\u00e1p kh\u00e1ng th\u1ec3 duy nh\u1ea5t \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t t\u1ea1i Hoa K\u1ef3 nh\u1eb1m ng\u0103n ng\u1eeba tri\u1ec7u ch\u1ee9ng COVID-19 tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m v\u1edbi vi r\u00fat. AZD7442 <\/em>c\u0169ng \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p cho ph\u00f2ng ng\u1eeba COVID-19 t\u1ea1i m\u1ed9t s\u1ed1 qu\u1ed1c gia kh\u00e1c.<\/p>\n

V\u00e0o th\u00e1ng 8 n\u0103m 2021, AstraZeneca th\u00f4ng b\u00e1o r\u1eb1ng AZD7442 \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh gi\u1ea3m \u0111\u00e1ng k\u1ec3, c\u00f3 \u00fd nh\u0129a th\u1ed1ng k\u00ea \u0111\u1ed1i v\u1edbi nguy c\u01a1 m\u1eafc COVID-19 c\u00f3 tri\u1ec7u ch\u1ee9ng trong th\u1eed nghi\u1ec7m PROVENT; hi\u1ec7u l\u1ef1c l\u00e0 83% so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c trong ph\u00e2n t\u00edch s\u00e1u th\u00e1ng \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 v\u00e0o ng\u00e0y 18 th\u00e1ng 11 n\u0103m 2021. V\u00e0o th\u00e1ng 10 n\u0103m 2021, AstraZeneca \u0111\u00e3 c\u00f4ng b\u1ed1 k\u1ebft qu\u1ea3 t\u1ed5ng qu\u00e1t t\u00edch c\u1ef1c t\u1eeb th\u1eed nghi\u1ec7m \u0111i\u1ec1u tr\u1ecb ngo\u1ea1i tr\u00fa AZD7442 TACKLE giai \u0111o\u1ea1n III.<\/p>\n

AZD7442 c\u0169ng \u0111ang \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u nh\u01b0 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb ti\u1ec1m n\u0103ng cho b\u1ec7nh nh\u00e2n COVID-19 \u0111\u00e3 nh\u1eadp vi\u1ec7n, thu\u1ed9c th\u1eed nghi\u1ec7m ACTIV-3 c\u1ee7a Vi\u1ec7n Y t\u1ebf Qu\u1ed1c gia v\u00e0 trong m\u1ed9t th\u1eed nghi\u1ec7m h\u1ee3p t\u00e1c v\u1ec1 \u0111i\u1ec1u tr\u1ecb khi \u0111\u00e3 nh\u1eadp vi\u1ec7n.<\/p>\n

AZD7442 \u0111ang \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n v\u1edbi s\u1ef1 h\u1ed7 tr\u1ee3 c\u1ee7a Ch\u00ednh ph\u1ee7 M\u1ef9, bao g\u1ed3m c\u00e1c qu\u1ef9 li\u00ean bang t\u1eeb B\u1ed9 Y t\u1ebf v\u00e0 D\u1ecbch v\u1ee5 Nh\u00e2n sinh; V\u0103n ph\u00f2ng Tr\u1ee3 l\u00fd B\u1ed9 tr\u01b0\u1edfng Chu\u1ea9n b\u1ecb v\u00e0 \u1ee8ng ph\u00f3; C\u01a1 quan Nghi\u00ean c\u1ee9u v\u00e0 Ph\u00e1t tri\u1ec3n Ti\u00ean ti\u1ebfn Y sinh h\u1ee3p t\u00e1c v\u1edbi B\u1ed9 Qu\u1ed1c ph\u00f2ng; V\u0103n ph\u00f2ng \u0110i\u1ec1u h\u00e0nh Ch\u01b0\u01a1ng tr\u00ecnh Chung v\u1ec1 Ph\u00f2ng th\u1ee7 H\u00f3a h\u1ecdc, Sinh h\u1ecdc, Ph\u00f3ng x\u1ea1 v\u00e0 H\u1ea1t nh\u00e2n, theo H\u1ee3p \u0111\u1ed3ng s\u1ed1 W911QY-21-9-0001.<\/p>\n

Theo c\u00e1c \u0111i\u1ec1u kho\u1ea3n c\u1ee7a th\u1ecfa thu\u1eadn c\u1ea5p ph\u00e9p v\u1edbi Vanderbilt, AstraZeneca s\u1ebd tr\u1ea3 ti\u1ec1n b\u1ea3n quy\u1ec1n m\u1ed9t ch\u1eef s\u1ed1 cho doanh thu thu\u1ea7n trong t\u01b0\u01a1ng lai.<\/p>\n

AstraZeneca<\/strong><\/p>\n

AstraZeneca (LSE \/ STO \/ Nasdaq: AZN) l\u00e0 m\u1ed9t c\u00f4ng ty d\u01b0\u1ee3c sinh h\u1ecdc to\u00e0n c\u1ea7u t\u1eadp trung v\u00e0o vi\u1ec7c kh\u00e1m ph\u00e1, ph\u00e1t tri\u1ec3n v\u00e0 th\u01b0\u01a1ng m\u1ea1i h\u00f3a c\u00e1c lo\u1ea1i thu\u1ed1c k\u00ea \u0111\u01a1n trong Ung th\u01b0, C\u00e1c b\u1ec7nh hi\u1ebfm g\u1eb7p v\u00e0 D\u01b0\u1ee3c ph\u1ea9m sinh h\u1ecdc, bao g\u1ed3m Tim m\u1ea1ch, Th\u1eadn & Chuy\u1ec3n h\u00f3a v\u00e0 H\u00f4 h\u1ea5p & Mi\u1ec5n d\u1ecbch h\u1ecdc. C\u00f3 tr\u1ee5 s\u1edf t\u1ea1i Cambridge, V\u01b0\u01a1ng qu\u1ed1c Anh, AstraZeneca ho\u1ea1t \u0111\u1ed9ng t\u1ea1i h\u01a1n 100 qu\u1ed1c gia v\u00e0 c\u00e1c lo\u1ea1i thu\u1ed1c ti\u00ean ti\u1ebfn c\u1ee7a c\u00f4ng ty \u0111\u00e3 \u0111\u01b0\u1ee3c h\u00e0ng tri\u1ec7u b\u1ec7nh nh\u00e2n tr\u00ean to\u00e0n th\u1ebf gi\u1edbi s\u1eed d\u1ee5ng. Vui l\u00f2ng truy c\u1eadp astrazeneca.com v\u00e0 theo d\u00f5i C\u00f4ng ty tr\u00ean Twitter @AstraZeneca.<\/p>\n

Li\u00ean h\u1ec7 <\/strong><\/p>\n

Li\u00ean h\u1ec7 b\u1ed9 ph\u1eadn Truy\u1ec1n th\u00f4ng c\u1ee7a AstraZeneca Vi\u1ec7t Nam t\u1ea1i: communication-vietnam@astrazeneca.com.<\/p>\n

T\u00e0i li\u1ec7u tham kh\u1ea3o <\/strong><\/p>\n

    \n
  1. National Center for Advancing Translational Sciences OpenData Portal. SARS-CoV-2 Variants & Therapeutics, All Variants Reported in vitro Therapeutic Activity. Available at: https:\/\/opendata.ncats.nih.gov\/variant\/activity [Last accessed: December 2021].<\/li>\n
  2. Neerukonda, S.N. et al. Establishment of a well-characterized SARS-CoV-2 lentiviral pseudovirus neutralization assay using 293T cells with stable expression of ACE2 and TMPRSS2. PLOS ONE March 10, 2021. Available at https:\/\/journals.plos.org\/plosone\/article?id=10.1371\/journal.pone.0248348 [Last accessed December 2021].<\/li>\n
  3. Oliver, S. Data and clinical considerations for additional doses in immunocompromised people. ACIP Meeting July 22, 2021. Available at:\u00a0https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/downloads\/slides-2021-07\/07-COVID-Oliver-508.pdf. [Last accessed: December 2021].<\/li>\n
  4. AstraZeneca data on file.<\/li>\n
  5. Corey L, et al. SARS-CoV-2 Variants in Patients with Immunosuppression. N\u00a0Engl\u00a0J Med.<\/em> 2021; 385:562-566. DOI: 10.1056\/NEJMsb2104756.<\/li>\n
  6. AstraZeneca news release.\u00a0Evusheld\u00a0reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial. Available at:\u00a0https:\/\/www.astrazeneca.com\/content\/astraz\/media-centre\/press-releases\/2021\/Evusheld-phiii-trial-positive-in-covid-outpatients.html. [Last accessed:\u00a0December\u00a02021].<\/li>\n
  7. Dong J, et al. Genetic and structural basis for recognition of SARS-CoV-2 spike protein by a two-antibody cocktail.\u00a0bioRxiv. 2021; doi: 10.1101\/2021.01.27.428529.<\/li>\n
  8. Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults.\u00a0Antimicrob Agents Chemother<\/em>. 2013; 57 (12): 6147-53.<\/li>\n
  9. Griffin MP, et al. Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults.\u00a0Antimicrob Agents Chemother<\/em>. 2017; 61(3): e01714-16.<\/li>\n
  10. Domachowske JB, et al. Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion F-targeting monoclonal antibody administered as a single dose to healthy preterm infants.\u00a0Pediatr Infect Dis J<\/em>. 2018; 37(9): 886-892.<\/li>\n
  11. AstraZeneca news release. New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention.\u00a0 Available at:\u00a0https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2021\/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html. [Last accessed: December 2021].<\/li>\n
  12. van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease.\u00a0Front Immunol<\/em>. 2019; 10: 548.<\/li>\n
  13. <\/li>\n<\/ol>\n
    \n
    \n

    Th\u00f4ng c\u00e1o b\u00e1o ch\u00ed ph\u00e1t h\u00e0nh b\u1edfi agency\u00a0Truy\u1ec1n th\u00f4ng EloQ<\/a>.<\/em><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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