{"id":46879,"date":"2025-11-12T16:02:02","date_gmt":"2025-11-12T08:02:02","guid":{"rendered":"https:\/\/flcube.com\/?p=46879"},"modified":"2025-11-12T16:02:03","modified_gmt":"2025-11-12T08:02:03","slug":"laekna-and-qilu-pharma-sign-exclusive-china-license-for-akt-inhibitor-lae002-afuresertib","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46879","title":{"rendered":"Laekna and Qilu Pharma Sign Exclusive China License for AKT Inhibitor LAE002 (Afuresertib)"},"content":{"rendered":"\n<p>Sino-US biotech <strong>Laekna Therapeutics<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2105:HKG\">HKG: 2105<\/a>) and <strong>Qilu Pharmaceutical Co., Ltd.<\/strong> announced today an <strong>exclusive licensing agreement<\/strong> that gives Qilu Pharma sole rights to <strong>research, develop and commercialise<\/strong> Laekna\u2019s AKT\u2011targeted drug <strong>LAE002 (afuresertib)<\/strong> across <strong>Mainland China, Hong\u202fKong SAR, Macau SAR and Taiwan<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-deal-highlights\">Deal Highlights<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Licensed product<\/strong><\/td><td>LAE002 (afuresertib) \u2013 a pan\u2011AKT inhibitor (AKT1\/2\/3)<\/td><\/tr><tr><td><strong>Territory<\/strong><\/td><td>China (Mainland, HK, Macau, Taiwan)<\/td><\/tr><tr><td><strong>Scope<\/strong><\/td><td>Research, development, regulatory filing, and commercialisation<\/td><\/tr><tr><td><strong>Up\u2011front \/ Milestone payments to Laekna<\/strong><\/td><td>Up to <strong>RMB\u202f530\u202fm<\/strong> on NDA approval for the first indication; total potential <strong>RMB\u202f2.045\u202fbn<\/strong> in upfront + milestones<\/td><\/tr><tr><td><strong>Royalty structure<\/strong><\/td><td>Tiered royalties on net sales, ranging <strong>low\u2011teens\u202f% to low\u2011twenties\u202f%<\/strong><\/td><\/tr><tr><td><strong>Clinical responsibility<\/strong><\/td><td>Laekna will complete the <strong>Phase\u202f3 AFFIRM\u2011205<\/strong> trial in HR\u207a\/HER2\u2011 breast cancer<\/td><\/tr><tr><td><strong>Projected timeline<\/strong><\/td><td>\u2022 Enrollment complete: Q4\u202f2025<br>\u2022 NDA submission to NMPA CDE: 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-scientific-amp-commercial-rationale\">Scientific &amp; Commercial Rationale<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pan\u2011AKT inhibition:<\/strong> LAE002 blocks all three AKT isoforms, positioning it as <strong>one of only two AKT inhibitors in late\u2011stage development<\/strong> for breast and prostate cancers worldwide.<\/li>\n\n\n\n<li><strong>Unmet need:<\/strong> HR\u207a\/HER2\u2011 breast cancer patients who progress on endocrine therapy lack effective targeted options; AKT inhibition addresses a key resistance pathway.<\/li>\n\n\n\n<li><strong>Market potential:<\/strong> The Chinese HR\u207a\/HER2\u2011 breast cancer market is valued at <strong>\u2248\u202f\u00a5120\u202fbn<\/strong> and is expected to grow >\u202f8\u202f% CAGR through 2032. Successful NDA filing could unlock a multi\u2011billion\u2011yuan revenue stream for Qilu Pharma.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-pathway\">Regulatory Pathway<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase\u202f3 AFFIRM\u2011205:<\/strong> Currently enrolling; recruitment on schedule with >\u202f80\u202f% of target sites activated.<\/li>\n\n\n\n<li><strong>NMPA CDE filing:<\/strong> Laekna plans to submit a <strong>New Drug Application (NDA)<\/strong> in 2026, leveraging its existing Chinese clinical infrastructure and data from earlier Phase\u202f2 studies.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Accelerated market entry for Qilu Pharma:<\/strong> The exclusive licence eliminates domestic competition for a high\u2011value oncology asset.<\/li>\n\n\n\n<li><strong>Milestone\u2011driven upside for Laekna:<\/strong> Up\u2011front cash and milestone payments de\u2011risk Laekna\u2019s pipeline while retaining upside through royalties.<\/li>\n\n\n\n<li><strong>Strengthened China\u2011centric oncology pipeline:<\/strong> Both parties deepen their foothold in China\u2019s fast\u2011growing cancer\u2011drug market, aligning with government incentives for innovative therapies.<\/li>\n<\/ol>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the licensing agreement, clinical timelines, regulatory approvals, and commercial expectations for LAE002. Actual results may differ due to risks including clinical outcomes, regulatory review, market acceptance, and execution of the partnership.<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\/11\/2025111200164_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025111200164_c.\"><\/object><a id=\"wp-block-file--media-1b4d4945-f338-438f-8e2f-e8140c65190d\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111200164_c.pdf\">2025111200164_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111200164_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-1b4d4945-f338-438f-8e2f-e8140c65190d\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sino-US biotech Laekna Therapeutics (HKG: 2105) and Qilu Pharmaceutical Co., Ltd. announced today an exclusive&#8230;<\/p>\n","protected":false},"author":1,"featured_media":46884,"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":[7,10,11],"tags":[16,1448,3592,208],"class_list":["post-46879","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-deals","category-drug","tag-cancer","tag-hkg-2105","tag-laekna-therapeutics","tag-qilu-pharmaceutical"],"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>Laekna and Qilu Pharma Sign Exclusive China License for AKT Inhibitor LAE002 (Afuresertib) - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sino-US biotech Laekna Therapeutics (HKG: 2105) and Qilu Pharmaceutical Co., Ltd. announced today an exclusive licensing agreement that gives Qilu Pharma sole rights to research, develop and commercialise Laekna\u2019s AKT\u2011targeted drug LAE002 (afuresertib) across Mainland China, Hong\u202fKong SAR, Macau SAR and Taiwan.\" \/>\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=46879\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Laekna and Qilu Pharma Sign Exclusive China License for AKT Inhibitor LAE002 (Afuresertib)\" \/>\n<meta property=\"og:description\" content=\"Sino-US biotech Laekna Therapeutics (HKG: 2105) and Qilu Pharmaceutical Co., Ltd. announced today an exclusive licensing agreement that gives Qilu Pharma sole rights to research, develop and commercialise Laekna\u2019s AKT\u2011targeted drug LAE002 (afuresertib) across Mainland China, Hong\u202fKong SAR, Macau SAR and Taiwan.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=46879\" \/>\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=\"2025-11-12T08:02:02+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-12T08:02:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1205.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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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