{"id":72377,"date":"2026-08-12T17:51:08","date_gmt":"2026-08-12T09:51:08","guid":{"rendered":"https:\/\/flcube.com\/?p=72377"},"modified":"2026-08-12T17:51:08","modified_gmt":"2026-08-12T09:51:08","slug":"laeknas-nda-for-akt-inhibitor-afuresertib-accepted-by-cde-in-hr-her2-breast-cancer-after-qilu-licensing-deal","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=72377","title":{"rendered":"Laekna&#8217;s NDA for AKT Inhibitor Afuresertib Accepted by CDE in HR+\/HER2\u2011 Breast Cancer After Qilu Licensing Deal"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Laekna Therapeutics Shanghai Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/2105:HKG\">HKG: 2105<\/a>) announced that the <strong>New Drug Application (NDA)<\/strong> for <strong>LAE002 (afuresertib hydrochloride tablets)<\/strong> has been <strong>accepted by the Center for Drug Evaluation (CDE)<\/strong> of China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for the treatment of patients with <strong>locally advanced or metastatic HR+\/HER2\u2011 breast cancer with PIK3CA\/AKT1\/PTEN alterations<\/strong>, following <strong>recurrence or progression on or after endocrine therapy(-ies)<\/strong> (with or without a <strong>CDK4\/6 inhibitor<\/strong>).<\/p>\n\n\n\n<h2 id=\"h-nda-overview\" class=\"wp-block-heading\">NDA Overview<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Laekna Therapeutics Shanghai Co., Ltd. (HKG: 2105)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>LAE002 (afuresertib hydrochloride tablets)<\/td><\/tr><tr><td><strong>Modality<\/strong><\/td><td>Potent AKT inhibitor (AKT1, AKT2, AKT3)<\/td><\/tr><tr><td><strong>Regulatory Agency<\/strong><\/td><td>CDE, NMPA (China)<\/td><\/tr><tr><td><strong>Status<\/strong><\/td><td>NDA accepted<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Locally advanced or metastatic HR+\/HER2\u2011 breast cancer with PIK3CA\/AKT1\/PTEN alterations, after recurrence or progression on endocrine therapy \u00b1 CDK4\/6 inhibitor<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>12 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-clinical-evidence\" class=\"wp-block-heading\">Drug Profile &amp; Clinical Evidence<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> <strong>Afuresertib<\/strong> is a <strong>potent AKT inhibitor<\/strong> that inhibits <strong>AKT1, AKT2, and AKT3<\/strong>, targeting a key node in the PI3K\/AKT\/mTOR signaling pathway implicated in endocrine resistance.<\/li>\n\n\n\n<li><strong>Phase 3 Read\u2011Out:<\/strong> The <strong>AFFIRM\u2011205<\/strong> trial <strong>met its primary endpoint of progression\u2011free survival (PFS)<\/strong>, demonstrating <strong>statistically significant and clinically meaningful benefits<\/strong> in patients with <strong>HR+\/HER2\u2011 breast cancer<\/strong>.<\/li>\n\n\n\n<li><strong>Biomarker\u2011Defined Population:<\/strong> The targeted indication focuses on tumors harboring <strong>PIK3CA\/AKT1\/PTEN alterations<\/strong>, aligning with the precision\u2011oncology approach of AKT pathway inhibition.<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-qilu-pharmaceutical-licensing-deal\" class=\"wp-block-heading\">Qilu Pharmaceutical Licensing Deal<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Deal Date:<\/strong> <strong>November 2025<\/strong> \u2014 Laekna entered into an <strong>exclusive licensing agreement with Qilu Pharmaceutical<\/strong>, granting Qilu the rights to afuresertib <strong>in China<\/strong>.<\/li>\n\n\n\n<li><strong>Deal Value:<\/strong> Laekna is eligible to receive <strong>up to RMB 2,045 million in total<\/strong> in <strong>upfront and milestone payments<\/strong>.<\/li>\n\n\n\n<li><strong>Royalties:<\/strong> Tiered royalties on future net sales in the licensed territory, ranging from the <strong>low teens to the low twenties<\/strong> percentage.<\/li>\n\n\n\n<li><strong>Global Strategy:<\/strong> Laekna plans to pursue <strong>strategic partnerships in ex\u2011China regions<\/strong> to accelerate development and commercialization of afuresertib in international markets.<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Endocrine\u2011Resistant Breast Cancer:<\/strong> HR+\/HER2\u2011 breast cancer patients progressing on endocrine therapy plus CDK4\/6 inhibitors represent a large population with limited subsequent targeted options \u2014 AKT inhibition is emerging as a validated strategy, notably alongside approved capivasertib.<\/li>\n\n\n\n<li><strong>China Commercialization Partnered:<\/strong> With Qilu Pharmaceutical \u2014 one of China&#8217;s largest generic and oncology marketers \u2014 as its China partner, Laekna has de\u2011risked local commercialization while retaining upside through milestones and royalties.<\/li>\n\n\n\n<li><strong>Ex\u2011China Upside:<\/strong> Retaining rights outside China preserves optionality for out\u2011licensing deals in global markets, where the biomarker\u2011defined positioning could support differentiated regulatory strategies.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory timing, milestone achievement, and partnership plans for afuresertib. Actual results may differ due to risks including the NMPA decision, market adoption, and competitive dynamics.<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\/2026\/08\/2026081200066_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026081200066_c.\"><\/object><a id=\"wp-block-file--media-58f38a6a-81a5-4506-acbc-f702a7420239\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2026081200066_c.pdf\">2026081200066_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2026081200066_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-58f38a6a-81a5-4506-acbc-f702a7420239\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Laekna Therapeutics Shanghai Co., Ltd. (HKG: 2105) announced that the New Drug Application (NDA) for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[1],"tags":[1448,3592],"class_list":["post-72377","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-hkg-2105","tag-laekna-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Laekna&#039;s NDA for AKT Inhibitor Afuresertib Accepted by CDE in HR+\/HER2\u2011 Breast Cancer After Qilu Licensing Deal - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Laekna Therapeutics Shanghai Co., Ltd. (HKG: 2105) announced that the New Drug Application (NDA) for LAE002 (afuresertib hydrochloride tablets) has been accepted by the Center for Drug Evaluation (CDE) of China&#039;s National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+\/HER2\u2011 breast cancer with PIK3CA\/AKT1\/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4\/6 inhibitor).\" \/>\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=72377\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Laekna&#039;s NDA for AKT Inhibitor Afuresertib Accepted by CDE in HR+\/HER2\u2011 Breast Cancer After Qilu Licensing Deal\" \/>\n<meta property=\"og:description\" content=\"Laekna Therapeutics Shanghai Co., Ltd. (HKG: 2105) announced that the New Drug Application (NDA) for LAE002 (afuresertib hydrochloride tablets) has been accepted by the Center for Drug Evaluation (CDE) of China&#039;s National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+\/HER2\u2011 breast cancer with PIK3CA\/AKT1\/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4\/6 inhibitor).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=72377\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-08-12T09:51:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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