{"id":3113,"date":"2026-05-29T06:34:10","date_gmt":"2026-05-29T13:34:10","guid":{"rendered":"https:\/\/xpharma.com.cn\/?p=3113"},"modified":"2026-05-29T06:34:12","modified_gmt":"2026-05-29T13:34:12","slug":"the-first-domestic-her2-bispecific-antibody-anbenitamab-injection-kn026-has-been-approved-for-marketing-from-alphamab-oncology-cspc-pharmaceutical-group","status":"publish","type":"post","link":"https:\/\/xpharma.com.cn\/index.php\/news\/the-first-domestic-her2-bispecific-antibody-anbenitamab-injection-kn026-has-been-approved-for-marketing-from-alphamab-oncology-cspc-pharmaceutical-group\/","title":{"rendered":"The first domestic HER2 bispecific antibody, Anbenitamab injection (KN026), has been approved for marketing, from Alphamab Oncology \/ CSPC Pharmaceutical Group"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Anbenitamab injection&nbsp;(KN026) is an anti-HER2 bispecific antibody independently developed by the Company using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). Anbenitamab can simultaneously bind two non-overlapping epitopes of HER2, resulting in HER2 signal blockade. Through antibody-induced receptor clustering, it enhances antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) effects while promoting the down-regulation of HER2 receptors on the cell surface.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In May 2026, Anbenitamab injection&nbsp;obtained approval for marketing in China for use in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric cancer\/gastroesophageal junction cancer (GC\/GEJ) who have previously received at least one trastuzumab-containing regimen. Currently, multiple registrational clinical trials of Anbenitamab for indications such as first-line treatment of HER2 positive breast cancer (BC), neoadjuvant and adjuvant treatment of HER2 positive BC and first-line treatment of HER2 positive GC\/GEJ are ongoing.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Anbenitamab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive or low expressing GC; it has been granted Breakthrough Therapy Designation by NMPA for the treatment of patients with HER2-positive GC\/GEJ who have failed first-line standard treatment.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. (JMT-Bio), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (CSPC) (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC and GC\/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Anbenitamab injection&nbsp;(KN026) is an anti-HER2 bispecific antibody independently developed by the Company using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). Anbenitamab can simultaneously bind two non-overlapping epitopes of HER2, resulting in HER2 signal blockade. Through antibody-induced receptor clustering, it enhances antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) effects [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":3114,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-3113","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"blocksy_meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The first domestic HER2 bispecific antibody, Anbenitamab injection (KN026), has been approved for marketing, from Alphamab Oncology \/ CSPC Pharmaceutical Group - Xpharma China<\/title>\n<meta name=\"description\" content=\"The first domestic HER2 bispecific antibody, Anbenitamab injection (KN026), has been approved for marketing, 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