The first domestic HER2 bispecific antibody, Anbenitamab injection (KN026), has been approved for marketing, from Alphamab Oncology / CSPC Pharmaceutical Group
Anbenitamab injection (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.
In May 2026, Anbenitamab injection 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.
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.
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).
