{"id":41256,"date":"2025-09-12T15:51:16","date_gmt":"2025-09-12T07:51:16","guid":{"rendered":"https:\/\/flcube.com\/?p=41256"},"modified":"2025-09-12T15:51:17","modified_gmt":"2025-09-12T07:51:17","slug":"cspc-pharmaceutical-group-submits-anbenitamab-for-nmpa-approval-in-her2%e2%80%91positive-gastric-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41256","title":{"rendered":"CSPC Pharmaceutical Group Submits Anbenitamab for NMPA Approval in HER2\u2011Positive Gastric Cancer"},"content":{"rendered":"\n<p><strong>CSPC Pharmaceutical Group (<a href=\"https:\/\/www.google.com\/finance\/quote\/1093:HKG\">HKG: 1093<\/a>)<\/strong> announced today that <strong>Anbenitamab Antibody Injection (KN026)<\/strong>, co\u2011developed with <strong>Alphamab Oncology (<a href=\"https:\/\/www.google.com\/finance\/quote\/9966:HKG\">HKG: 9966<\/a>)<\/strong>, has been filed with the <strong>National Medical Products Administration (NMPA)<\/strong> for marketing approval. The submission targets patients with <strong>HER2\u2011positive locally advanced, recurrent, or metastatic gastric\/gastroesophageal junction adenocarcinoma<\/strong> who have progressed after at least one line of systemic therapy that included trastuzumab plus chemotherapy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence\">Clinical Evidence<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pivotal Trial<\/strong> \u2013 The approval application is grounded in the <strong>KC\u2011WISE Phase\u202fII\/III study<\/strong>.<\/li>\n\n\n\n<li><strong>Interim Results<\/strong> \u2013 Compared with standard of care, Anbenitamab plus chemotherapy produced:<\/li>\n\n\n\n<li><strong>Significant improvement in clinical efficacy<\/strong><\/li>\n\n\n\n<li><strong>Prolonged progression\u2011free survival (PFS)<\/strong><\/li>\n\n\n\n<li><strong>Extended overall survival (OS)<\/strong><\/li>\n\n\n\n<li><strong>Safety Profile<\/strong> \u2013 No new safety signals; low incidence of cardiotoxicity and immunogenicity.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile\">Drug Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism<\/strong> \u2013 An anti\u2011HER2 bispecific antibody that binds two non\u2011overlapping HER2 epitopes, effectively shutting down HER2 signaling.<\/li>\n\n\n\n<li><strong>First\u2011in\u2011class<\/strong> \u2013 First anti\u2011HER2 bispecific antibody to achieve positive results for the <strong>second\u2011line<\/strong> gastric cancer indication in China.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Date<\/th><\/tr><\/thead><tbody><tr><td>Breakthrough Therapy Designation<\/td><td>Nov\u202f4\u202f,\u202f2023<\/td><\/tr><tr><td>Priority Review &amp; Approval Status<\/td><td>Aug\u202f28\u202f,\u202f2025<\/td><\/tr><tr><td>NMPA Marketing Application Submitted<\/td><td>Today<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Market Gap<\/strong> \u2013 No approved anti\u2011HER2 therapies exist for second\u2011line treatment of HER2\u2011positive gastric cancer in China; Anbenitamab could become the first of its kind.<\/li>\n\n\n\n<li><strong>Pipeline Expansion<\/strong> \u2013 The approval would broaden CSPC\u2019s oncology portfolio and reinforce its partnership with Alphamab Oncology.<\/li>\n\n\n\n<li><strong>Competitive Advantage<\/strong> \u2013 The bispecific design offers enhanced tumor localization and potentially reduced systemic toxicity compared with existing HER2 agents.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\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\/09\/2025091101221_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025091101221_c.\"><\/object><a id=\"wp-block-file--media-3dca170d-0a92-46e6-9158-584cb61447fc\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025091101221_c.pdf\">2025091101221_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025091101221_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3dca170d-0a92-46e6-9158-584cb61447fc\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CSPC Pharmaceutical Group (HKG: 1093) announced today that Anbenitamab Antibody Injection (KN026), co\u2011developed with Alphamab&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41259,"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":[187,16,171,855,854,38],"class_list":["post-41256","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-alphamab-oncology","tag-cancer","tag-cspc-pharmaceutical","tag-hkg-1093","tag-hkg-9966","tag-market-approval-filings"],"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>CSPC Pharmaceutical Group Submits Anbenitamab for NMPA Approval in HER2\u2011Positive Gastric Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"CSPC Pharmaceutical Group (HKG: 1093) announced today that Anbenitamab Antibody Injection (KN026), co\u2011developed with Alphamab Oncology (HKG: 9966), has been filed with the National Medical Products Administration (NMPA) for marketing approval. 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