{"id":34387,"date":"2025-05-29T12:10:43","date_gmt":"2025-05-29T04:10:43","guid":{"rendered":"https:\/\/flcube.com\/?p=34387"},"modified":"2025-05-29T12:10:43","modified_gmt":"2025-05-29T04:10:43","slug":"changchun-pharma-wins-fda-approval-for-gensci128-in-tp53-y220c-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=34387","title":{"rendered":"Changchun Pharma Wins FDA Approval for GenSci128 in TP53 Y220C Solid Tumors"},"content":{"rendered":"\n<p>China-based Changchun High &amp; New Technology Industries (Group) Inc., (<a href=\"https:\/\/www.google.com\/finance\/quote\/000661:SHE\">SHE:000661<\/a>) announced that its subsidiary Changchun GeneScience Pharmaceutical Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug GenSci128. This drug is indicated for the treatment of locally advanced or metastatic solid tumors harboring the TP53 Y220C mutation.<\/p>\n\n\n\n<p><strong>GenSci128 Mechanism and Preclinical Results<\/strong><br>GenSci128 is a p53 Y220C activator that has demonstrated promising efficacy and safety in preclinical studies. TP53 is the most frequently mutated gene in human cancers, with the Y220C mutation accounting for approximately 1.8% of all TP53 mutations. Currently, there are no approved targeted therapies for this specific mutation, highlighting a significant area of unmet medical need.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci128\u7247\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci128\u7247\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-42b9b9b6-c11f-48c3-93c2-b0861e7d78a6\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci128\u7247\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u7684\u516c\u544a.pdf\">\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci128\u7247\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/\u957f\u6625\u9ad8\u65b0\uff1a\u5173\u4e8e\u5b50\u516c\u53f8GenSci128\u7247\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-42b9b9b6-c11f-48c3-93c2-b0861e7d78a6\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Changchun High &amp; New Technology Industries (Group) Inc., (SHE:000661) announced that its subsidiary Changchun&#8230;<\/p>\n","protected":false},"author":1,"featured_media":34389,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,2929,62,358,4110],"class_list":["post-34387","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-changchun-high-new-technology-industries","tag-clinical-trial-approval-initiation","tag-genescience-pharmaceutical","tag-she000661"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Changchun Pharma Wins FDA Approval for GenSci128 in TP53 Y220C Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Changchun High &amp; New Technology Industries (Group) Inc., (SHE:000661) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug GenSci128. This drug is indicated for the treatment of locally advanced or metastatic solid tumors harboring the TP53 Y220C mutation.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=34387\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Changchun Pharma Wins FDA Approval for GenSci128 in TP53 Y220C Solid Tumors\" \/>\n<meta property=\"og:description\" content=\"China-based Changchun High &amp; New Technology Industries (Group) Inc., (SHE:000661) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug GenSci128. 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