{"id":38304,"date":"2025-03-13T12:01:22","date_gmt":"2025-03-13T05:01:22","guid":{"rendered":"https:\/\/saigonbiz.com.vn\/shilpa-medicare-dam-bao-sec-cdsco-chap-thuan-cho-vien-nen-axit-nor-ursodeoxycholic-ra-mat-thi-truong-cho-nash\/"},"modified":"2025-03-13T12:01:22","modified_gmt":"2025-03-13T05:01:22","slug":"shilpa-medicare-dam-bao-sec-cdsco-chap-thuan-cho-vien-nen-axit-nor-ursodeoxycholic-ra-mat-thi-truong-cho-nash","status":"publish","type":"post","link":"https:\/\/saigonbiz.com\/vn\/shilpa-medicare-dam-bao-sec-cdsco-chap-thuan-cho-vien-nen-axit-nor-ursodeoxycholic-ra-mat-thi-truong-cho-nash\/","title":{"rendered":"Shilpa Medicare \u0111\u1ea3m b\u1ea3o SEC-CDSCO ch\u1ea5p thu\u1eadn cho vi\u00ean n\u00e9n axit nor-ursodeoxycholic, ra m\u1eaft th\u1ecb tr\u01b0\u1eddng cho NASH"},"content":{"rendered":"<div>\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2489785\/5209033\/Shilpa_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\">RAICHUR, \u1ea4n \u0110\u1ed9<\/span>, <span class=\"legendSpanClass\">ng\u00e0y 13 th\u00e1ng 3 n\u0103m 2025<\/span> \/PRNewswire\/ &#8212;\u00a0<a href=\"http:\/\/www.vbshilpa.com\/\" target=\"_blank\" rel=\"nofollow noopener\">Shilpa Medicare Limited<\/a> (BSE: 530549) (NSE: SHILPAMED), m\u1ed9t nh\u00e0 s\u1ea3n xu\u1ea5t API v\u00e0 c\u00f4ng th\u1ee9c h\u00e0ng \u0111\u1ea7u, th\u00f4ng b\u00e1o r\u1eb1ng \u1ee6y ban Chuy\u00ean m\u00f4n (SEC) c\u1ee7a CDSCO \u0111\u00e3 ph\u00ea duy\u1ec7t Thu\u1ed1c M\u1edbi \u0111ang Nghi\u00ean c\u1ee9u (IND) \u2013 Vi\u00ean n\u00e9n Axit Nor Ursodeoxycholic (Nor UDCA) 500 mg \u2013 v\u00e0 khuy\u1ebfn ngh\u1ecb c\u1ea5p ph\u00e9p l\u01b0u th\u00f4ng tr\u00ean th\u1ecb tr\u01b0\u1eddng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1ec7nh gan nhi\u1ec5m m\u1ee1 kh\u00f4ng do \u0111\u1ed3 u\u1ed1ng c\u00f3 c\u1ed3n (NAFLD).<\/p>\n<p>NAFLD, c\u0103n b\u1ec7nh gan ph\u1ed5 bi\u1ebfn nh\u1ea5t, g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn kho\u1ea3ng 25% d\u00e2n s\u1ed1 to\u00e0n c\u1ea7u (1,2 t\u1ef7 ng\u01b0\u1eddi), trong \u0111\u00f3 c\u00f3 188 tri\u1ec7u ng\u01b0\u1eddi \u1edf \u1ea4n \u0110\u1ed9. N\u1ebfu kh\u00f4ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb, NAFLD c\u00f3 th\u1ec3 ti\u1ebfn tri\u1ec3n th\u00e0nh vi\u00eam gan nhi\u1ec5m m\u1ee1 kh\u00f4ng do \u0111\u1ed3 u\u1ed1ng c\u00f3 c\u1ed3n (NASH), m\u1ed9t t\u00ecnh tr\u1ea1ng nghi\u00eam tr\u1ecdng v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng g\u00e2y t\u1eed vong.<\/p>\n<p>Shilpa Medicare Ltd. tr\u01b0\u1edbc \u0111\u00f3 \u0111\u00e3 ho\u00e0n th\u00e0nh c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng giai \u0111o\u1ea1n 3 c\u1ee7a s\u1ea3n ph\u1ea9m m\u1edbi n\u00e0y l\u00e0 vi\u00ean n\u00e9n Axit SMLNUD07 \u2013 Nor Ursodeoxycholic (Nor UDCA) &#8211; v\u00e0 \u0111\u00e3 tr\u00ecnh b\u00e0y k\u1ebft qu\u1ea3 c\u1ee7a th\u1eed nghi\u1ec7m c\u00f3 t\u00ean &#8220;Nghi\u00ean c\u1ee9u giai \u0111o\u1ea1n III, Ng\u1eabu nhi\u00ean, M\u00f9 \u0110\u00f4i, c\u00f3 \u0111\u1ed1i ch\u1ee9ng gi\u1ea3 d\u01b0\u1ee3c, \u0111a trung t\u00e2m, Nh\u00f3m song song&#8221; nh\u1eb1m \u0111\u00e1nh gi\u00e1 \u0111\u1ed9 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a Axit Nor-Ursodeoxycholic 500 mg \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n m\u1eafc b\u1ec7nh gan nhi\u1ec5m m\u1ee1 kh\u00f4ng do \u0111\u1ed3 u\u1ed1ng c\u00f3 c\u1ed3n cho SEC.<\/p>\n<p>Th\u1eed nghi\u1ec7m n\u00e0y \u0111\u00e3 \u0111\u00e1p \u1ee9ng t\u1ea5t c\u1ea3 c\u00e1c m\u1ee5c ti\u00eau ch\u00ednh v\u1ec1 \u0111\u1ed9 hi\u1ec7u qu\u1ea3, cho th\u1ea5y s\u1ef1 c\u1ea3i thi\u1ec7n \u0111\u00e1ng k\u1ec3 \u1edf giai \u0111o\u1ea1n gan nhi\u1ec5m m\u1ee1. <b>Nh\u1eefng ph\u00e1t hi\u1ec7n ch\u00ednh g\u1ed3m:<\/b><\/p>\n<ul type=\"disc\">\n<li><b>\u0110\u1ea3o ng\u01b0\u1ee3c T\u00ecnh tr\u1ea1ng X\u01a1 gan<\/b>: 83,3% s\u1ed1 ng\u01b0\u1eddi tham gia c\u00f3 t\u00ecnh tr\u1ea1ng x\u01a1 gan \u0111\u01b0\u1ee3c \u0111\u1ea3o ng\u01b0\u1ee3c, nh\u1eefng ng\u01b0\u1eddi c\u00f2n l\u1ea1i c\u00f2n l\u1ea1i c\u00f3 t\u00ecnh tr\u1ea1ng \u1ed5n \u0111\u1ecbnh.<\/li>\n<li><b>Chu\u1ea9n h\u00f3a ALT<\/b>: N\u1ed3ng \u0111\u1ed9 alanine transaminase (ALT) t\u0103ng cao, m\u1ed9t d\u1ea5u hi\u1ec7u ch\u00ednh c\u1ee7a NAFLD, \u0111\u00e3 tr\u1edf l\u1ea1i m\u1ee9c b\u00ecnh th\u01b0\u1eddng \u1edf kho\u1ea3ng 90% s\u1ed1 ng\u01b0\u1eddi tham gia trong v\u00f2ng 12 tu\u1ea7n.<\/li>\n<\/ul>\n<p>Nh\u1eefng k\u1ebft qu\u1ea3 n\u00e0y \u0111\u01b0a Nor UDCA tr\u1edf th\u00e0nh li\u1ec7u ph\u00e1p \u0111\u1ed9t ph\u00e1 \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb NAFLD, mang l\u1ea1i nhi\u1ec1u \u01b0u \u0111i\u1ec3m h\u01a1n UDCA th\u00f4ng th\u01b0\u1eddng, bao g\u1ed3m t\u00e1c d\u1ee5ng l\u1ee3i m\u1eadt t\u0103ng c\u01b0\u1eddng, kh\u1ea3 n\u0103ng kh\u00e1ng amid h\u00f3a, \u0111\u1eb7c t\u00ednh ch\u1ed1ng vi\u00eam v\u00e0 gi\u1ea3m x\u01a1 gan.<\/p>\n<p>B\u00ecnh lu\u1eadn v\u1ec1 s\u1ef1 ph\u00e1t tri\u1ec3n n\u00e0y, <b>\u00d4ng Vishnukant Bhutada \u2013 Gi\u00e1m \u0111\u1ed1c \u0110i\u1ec1u h\u00e0nh, Shilpa Medicare Limited<\/b>, cho bi\u1ebft: &#8220;Ch\u00fang t\u00f4i r\u1ea5t h\u00e0i l\u00f2ng v\u1edbi s\u1ef1 ch\u1ea5p thu\u1eadn n\u00e0y t\u1eeb SEC v\u00e0 hy v\u1ecdng s\u1ebd s\u1edbm \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t \u0111\u1ec3 l\u01b0u th\u00f4ng tr\u00ean th\u1ecb tr\u01b0\u1eddng. Ch\u00fang t\u00f4i cam k\u1ebft h\u1ee3p t\u00e1c ch\u1eb7t ch\u1ebd v\u1edbi c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd \u0111\u1ec3 \u0111\u01b0a ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb ti\u00ean ti\u1ebfn n\u00e0y \u0111\u1ebfn v\u1edbi b\u1ec7nh nh\u00e2n nhanh nh\u1ea5t c\u00f3 th\u1ec3 v\u00e0 hy v\u1ecdng c\u00f3 th\u1ec3 ra m\u1eaft t\u1ea1i \u1ea4n \u0110\u1ed9 trong n\u0103m t\u00e0i ch\u00ednh t\u1edbi. Vi\u1ec7c ph\u00ea duy\u1ec7t ph\u00e2n t\u1eed NCE n\u00e0y th\u1ec3 hi\u1ec7n tinh th\u1ea7n th\u1ef1c s\u1ef1 c\u1ee7a Shilpa, &#8216;\u0110\u1ed5i m\u1edbi v\u00ec ch\u0103m s\u00f3c s\u1ee9c kh\u1ecfe gi\u00e1 ph\u1ea3i ch\u0103ng&#8217;, lu\u00f4n h\u01b0\u1edbng \u0111\u1ebfn nh\u1eefng nhu c\u1ea7u ch\u01b0a \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng c\u1ee7a m\u1ed9t nh\u00f3m b\u1ec7nh nh\u00e2n l\u1edbn. V\u1edbi ph\u00ea duy\u1ec7t t\u1ea1i \u1ea4n \u0110\u1ed9, ch\u00fang t\u00f4i c\u00f3 k\u1ebf ho\u1ea1ch li\u00ean h\u1ec7 v\u1edbi c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd to\u00e0n c\u1ea7u \u0111\u1ec3 t\u00ecm ki\u1ebfm l\u1eddi khuy\u00ean khoa h\u1ecdc cho vi\u1ec7c gi\u1edbi thi\u1ec7u s\u1ea3n ph\u1ea9m m\u1edbi n\u00e0y ra qu\u1ed1c t\u1ebf.&#8221;<\/p>\n<p>\u0110\u01b0\u1ee3c th\u00e0nh l\u1eadp v\u00e0o n\u0103m 1987,\u00a0<a href=\"http:\/\/www.vbshilpa.com\/\" target=\"_blank\" rel=\"nofollow noopener\"><b>Shilpa Medicare<\/b><\/a>\u00a0cung c\u1ea5p API, C\u00f4ng th\u1ee9c v\u00e0 S\u1ea3n ph\u1ea9m Sinh h\u1ecdc v\u1edbi c\u00e1c c\u01a1 s\u1edf \u0111\u01b0\u1ee3c c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd l\u1edbn ph\u00ea duy\u1ec7t. C\u00f4ng ty c\u0169ng \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn l\u00e0 \u0111\u01a1n v\u1ecb cung c\u1ea5p c\u00e1c gi\u1ea3i ph\u00e1p CDMO tr\u1ecdn g\u00f3i cho c\u00e1c kh\u00e1ch h\u00e0ng tr\u00ean to\u00e0n c\u1ea7u.<\/p>\n<p>\u0110\u1ec3 \u0111\u01b0\u1ee3c gi\u1ea3i \u0111\u00e1p th\u1eafc m\u1eafc:\u00a0<a href=\"mailto:info@vbshilpa.com\" target=\"_blank\" rel=\"nofollow noopener\"><b>info@vbshilpa.com<\/b><\/a>.<\/p>\n<p>Logo: <a href=\"https:\/\/mma.prnasia.com\/media2\/2489785\/5209033\/Shilpa_Logo.jpg?p=medium600\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/mma.prnasia.com\/media2\/2489785\/5209033\/Shilpa_Logo.jpg?p=medium600<\/a><\/p>\n<p>\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>RAICHUR, \u1ea4n \u0110\u1ed9, ng\u00e0y 13 th\u00e1ng 3 n\u0103m 2025 \/PRNewswire\/ &#8212;\u00a0Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED), m\u1ed9t nh\u00e0 s\u1ea3n xu\u1ea5t API v\u00e0 c\u00f4ng th\u1ee9c h\u00e0ng \u0111\u1ea7u, th\u00f4ng b\u00e1o r\u1eb1ng \u1ee6y ban Chuy\u00ean m\u00f4n (SEC) c\u1ee7a CDSCO \u0111\u00e3 ph\u00ea duy\u1ec7t Thu\u1ed1c M\u1edbi \u0111ang Nghi\u00ean c\u1ee9u (IND) \u2013 Vi\u00ean n\u00e9n Axit Nor Ursodeoxycholic (Nor UDCA) 500 [&#8230;]\n","protected":false},"author":2604,"featured_media":50415,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[2293],"tags":[],"class_list":["post-38304","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Shilpa Medicare \u0111\u1ea3m b\u1ea3o SEC-CDSCO ch\u1ea5p thu\u1eadn cho vi\u00ean n\u00e9n axit nor-ursodeoxycholic, ra m\u1eaft th\u1ecb tr\u01b0\u1eddng 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