{"id":65224,"date":"2026-05-13T23:37:17","date_gmt":"2026-05-13T15:37:17","guid":{"rendered":"https:\/\/flcube.com\/?p=65224"},"modified":"2026-05-13T23:37:18","modified_gmt":"2026-05-13T15:37:18","slug":"sichuan-kelun-biotech-receives-nmpa-approval-for-itgb6-targeted-adc-skb105-in-advanced-solid-tumors-following-crescent-biopharma-licensing-deal","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=65224","title":{"rendered":"Sichuan Kelun-Biotech Receives NMPA Approval for ITGB6-Targeted ADC SKB105 in Advanced Solid Tumors Following Crescent Biopharma Licensing Deal"},"content":{"rendered":"\n<p><strong>Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/6990:HKG\">HKG: 6990<\/a>) announced it has received <strong>clinical approval from China&#8217;s National Medical Products Administration (NMPA)<\/strong> for its <strong>integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC) SKB105<\/strong>, which will now be evaluated in <strong>advanced solid tumors<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-amp-partnership-milestone\">Development &amp; Partnership Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990)<\/td><\/tr><tr><td><strong>Drug Candidate<\/strong><\/td><td>SKB105 (ITGB6-targeted ADC)<\/td><\/tr><tr><td><strong>Original Designation<\/strong><\/td><td>CR-001 (Crescent Biopharma)<\/td><\/tr><tr><td><strong>Regulatory Approval<\/strong><\/td><td>NMPA clinical study authorization<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced solid tumors<\/td><\/tr><tr><td><strong>Licensing Agreement<\/strong><\/td><td>December 2025 with Crescent Biopharma, Inc. (US)<\/td><\/tr><tr><td><strong>Territory Rights<\/strong><\/td><td>Mainland China, Hong Kong, Macau, Taiwan (exclusive)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-global-clinical-development-program\">Global Clinical Development Program<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-ascend-phase-i-ii-study\">ASCEND Phase I\/II Study<\/h3>\n\n\n\n<p>The drug is already enrolled in the <strong>global Phase I\/II ASCEND study<\/strong>:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Study Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Study Name<\/strong><\/td><td>ASCEND<\/td><\/tr><tr><td><strong>Phase<\/strong><\/td><td>I\/II<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Locally advanced or metastatic solid tumors<\/td><\/tr><tr><td><strong>Global Approval<\/strong><\/td><td>January 2026<\/td><\/tr><tr><td><strong>Planned Enrollment<\/strong><\/td><td>290 patients<\/td><\/tr><tr><td><strong>Geographic Scope<\/strong><\/td><td>Multi-center, international<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-chinese-clinical-integration\">Chinese Clinical Integration<\/h3>\n\n\n\n<p>The newly granted NMPA approval enables:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Chinese patient enrollment<\/strong> in the global ASCEND study<\/li>\n\n\n\n<li><strong>Local clinical data generation<\/strong> for potential China-specific regulatory submissions<\/li>\n\n\n\n<li><strong>Expanded access<\/strong> to Chinese patient populations with advanced solid tumors<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-target-rationale-amp-therapeutic-innovation\">Target Rationale &amp; Therapeutic Innovation<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-integrin-beta-6-itgb6-biology\">Integrin Beta-6 (ITGB6) Biology<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Tumor-selective expression<\/strong>: ITGB6 overexpressed in multiple epithelial cancers while limited in normal tissues<\/li>\n\n\n\n<li><strong>Metastasis association<\/strong>: High ITGB6 expression correlates with aggressive disease and poor prognosis<\/li>\n\n\n\n<li><strong>Therapeutic window<\/strong>: Target profile supports selective ADC delivery with reduced off-target toxicity<\/li>\n\n\n\n<li><strong>Multiple tumor types<\/strong>: Expression validated across lung, pancreatic, colorectal, and other solid malignancies<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-adc-platform-advantages\">ADC Platform Advantages<\/h3>\n\n\n\n<p>SKB105 leverages established ADC technology with novel target application:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Precision targeting<\/strong>: Antibody component specifically binds ITGB6 on tumor cells<\/li>\n\n\n\n<li><strong>Controlled payload delivery<\/strong>: Cytotoxic agent released intracellularly following internalization<\/li>\n\n\n\n<li><strong>Bystander effect potential<\/strong>: May impact neighboring tumor cells in heterogeneous tumors<\/li>\n\n\n\n<li><strong>Combination compatibility<\/strong>: Suitable for combination with immunotherapy and targeted agents<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-partnership-framework\">Strategic Partnership Framework<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-crescent-biopharma-licensing-deal\">Crescent Biopharma Licensing Deal<\/h3>\n\n\n\n<p>The December 2025 agreement established comprehensive regional rights:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Partnership Element<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Licensing Partner<\/strong><\/td><td>Crescent Biopharma, Inc. (US)<\/td><\/tr><tr><td><strong>Asset Acquired<\/strong><\/td><td>SKB118\/CR-001 (now SKB105)<\/td><\/tr><tr><td><strong>Exclusive Territories<\/strong><\/td><td>Greater China (Mainland China, Hong Kong, Macau, Taiwan)<\/td><\/tr><tr><td><strong>Rights Scope<\/strong><\/td><td>Development, manufacturing, and commercialization<\/td><\/tr><tr><td><strong>Global Coordination<\/strong><\/td><td>Integration with ongoing international clinical program<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-strategic-rationale-for-kelun-biotech\">Strategic Rationale for Kelun-Biotech<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pipeline diversification<\/strong>: Adds novel ADC mechanism to existing oncology portfolio<\/li>\n\n\n\n<li><strong>International validation<\/strong>: Leverages US-developed asset with global clinical data<\/li>\n\n\n\n<li><strong>Market access<\/strong>: Exclusive Greater China rights provide significant commercial opportunity<\/li>\n\n\n\n<li><strong>Development acceleration<\/strong>: Builds on existing global clinical program rather than starting de novo<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-competitive-landscape\">Market Context &amp; Competitive Landscape<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-adc-market-evolution\">ADC Market Evolution<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Target innovation<\/strong>: Shift toward novel targets like ITGB6 beyond traditional HER2\/TROP2<\/li>\n\n\n\n<li><strong>Solid tumor focus<\/strong>: Growing emphasis on epithelial cancers with high unmet need<\/li>\n\n\n\n<li><strong>Chinese ADC leadership<\/strong>: Domestic companies increasingly developing innovative ADC platforms<\/li>\n\n\n\n<li><strong>Global partnerships<\/strong>: Cross-border licensing deals accelerating Chinese biotech globalization<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-solid-tumor-treatment-gap\">Solid Tumor Treatment Gap<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Advanced disease challenge<\/strong>: Limited effective options for metastatic solid tumors post-standard therapy<\/li>\n\n\n\n<li><strong>Target validation<\/strong>: ITGB6 represents emerging target with strong biological rationale<\/li>\n\n\n\n<li><strong>Combination potential<\/strong>: ADC platform suitable for integration with existing treatment paradigms<\/li>\n<\/ul>\n\n\n\n<p>The NMPA approval positions SKB105 as a <strong>promising addition<\/strong> to China&#8217;s growing ADC pipeline, combining international innovation with domestic development expertise to address significant unmet needs in advanced solid tumors.<\/p>\n\n\n\n<p><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory pathways, and partnership outcomes. Actual results may differ due to risks including clinical trial outcomes, safety profile, 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\/05\/2026051300082_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026051300082_c.\"><\/object><a id=\"wp-block-file--media-5f13e51e-e390-4388-b993-fa2a563df4fe\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/2026051300082_c.pdf\">2026051300082_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/2026051300082_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-5f13e51e-e390-4388-b993-fa2a563df4fe\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced it has received clinical approval from China&#8217;s&#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_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":[1],"tags":[16,62,971,1832,28],"class_list":["post-65224","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-cancer","tag-clinical-trial-approval-initiation","tag-hkg-6990","tag-kelun-biotech-biopharmaceutical","tag-multi-specific-antibodies"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sichuan Kelun-Biotech Receives NMPA Approval for ITGB6-Targeted ADC SKB105 in Advanced Solid Tumors Following Crescent Biopharma Licensing Deal - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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