{"id":33311,"date":"2025-05-13T16:49:44","date_gmt":"2025-05-13T08:49:44","guid":{"rendered":"https:\/\/flcube.com\/?p=33311"},"modified":"2025-05-13T16:49:45","modified_gmt":"2025-05-13T08:49:45","slug":"betta-pharmaceuticals-secures-macau-approval-for-ensartinib","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=33311","title":{"rendered":"Betta Pharmaceuticals Secures Macau Approval for Ensartinib"},"content":{"rendered":"\n<p>China-based Betta Pharmaceuticals (<a href=\"https:\/\/www.google.com\/finance\/quote\/300558:SHE\">SHE: 300558<\/a>) announced a market approval filing in Macau for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery. The drug is indicated for first-line treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).<\/p>\n\n\n\n<p><strong>Ensartinib&#8217;s Approval Timeline<\/strong><br>Ensartinib received market approval in China in March 2022 for the treatment of first-line ALK-positive locally advanced or metastatic NSCLC. This indication was included in the National Reimbursement Drug List (NRDL) in 2023. The drug also secured approval in the US in December 2024. Xcovery initiated the market filing for ensartinib with the European Medicines Agency (EMA) for the same indication in February of this year.<\/p>\n\n\n\n<p><strong>Clinical Development<\/strong><br>In addition to its approved indications, ensartinib is undergoing a Phase III study in China as a postoperative adjuvant therapy for ALK-positive NSCLC.<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\/\u8d1d\u8fbe\u836f\u4e1a\uff1a\u5173\u4e8e\u5411\u6fb3\u95e8\u836f\u7269\u7ba1\u7406\u5c40\u9012\u4ea4\u76d0\u9178\u6069\u6c99\u66ff\u5c3c\u80f6\u56ca\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u8d1d\u8fbe\u836f\u4e1a\uff1a\u5173\u4e8e\u5411\u6fb3\u95e8\u836f\u7269\u7ba1\u7406\u5c40\u9012\u4ea4\u76d0\u9178\u6069\u6c99\u66ff\u5c3c\u80f6\u56ca\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-4b0fed35-4b0a-4f49-bbb0-8b33bf4e0f00\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/\u8d1d\u8fbe\u836f\u4e1a\uff1a\u5173\u4e8e\u5411\u6fb3\u95e8\u836f\u7269\u7ba1\u7406\u5c40\u9012\u4ea4\u76d0\u9178\u6069\u6c99\u66ff\u5c3c\u80f6\u56ca\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\u7684\u516c\u544a.pdf\">\u8d1d\u8fbe\u836f\u4e1a\uff1a\u5173\u4e8e\u5411\u6fb3\u95e8\u836f\u7269\u7ba1\u7406\u5c40\u9012\u4ea4\u76d0\u9178\u6069\u6c99\u66ff\u5c3c\u80f6\u56ca\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/\u8d1d\u8fbe\u836f\u4e1a\uff1a\u5173\u4e8e\u5411\u6fb3\u95e8\u836f\u7269\u7ba1\u7406\u5c40\u9012\u4ea4\u76d0\u9178\u6069\u6c99\u66ff\u5c3c\u80f6\u56ca\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-4b0fed35-4b0a-4f49-bbb0-8b33bf4e0f00\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Betta Pharmaceuticals (SHE: 300558) announced a market approval filing in Macau for its ensartinib,&#8230;<\/p>\n","protected":false},"author":1,"featured_media":33315,"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":[231,16,38,1030,33],"class_list":["post-33311","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-betta-pharmaceuticals","tag-cancer","tag-market-approval-filings","tag-she-300558","tag-tkis-egfr-vegf-btk-etc"],"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>Betta Pharmaceuticals Secures Macau Approval for Ensartinib - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Betta Pharmaceuticals (SHE: 300558) announced a market approval filing in Macau for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery. The drug is indicated for first-line treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).\" \/>\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=33311\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Betta Pharmaceuticals Secures Macau Approval for Ensartinib\" \/>\n<meta property=\"og:description\" content=\"China-based Betta Pharmaceuticals (SHE: 300558) announced a market approval filing in Macau for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery. 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