Alphamab Oncology:Anbenitamab is planned to be submitted for marketing approval.
On June 11, Kangning Jierui announced that the Phase III clinical study (KN026-003, NCT05838066) of Annitumumab (KN026) in combination with docetaxel (albumin-bound) (HB1801) as a first-line treatment for HER2-positive advanced breast cancer has met its primary endpoint of progression-free survival (PFS), with a favorable trend in overall survival (OS).
KN026-003 is a randomized, controlled, open-label, multicenter Phase III clinical study that enrolled approximately 880 patients with HER2-positive advanced breast cancer, randomized 1:1 to either the experimental arm (KN026 + HB1801) or the control arm (THP). The primary endpoint was PFS assessed by a blinded independent review committee (BIRC).
The results showed that the KN026 + HB1801 regimen was superior to the current standard of care (the THP regimen: trastuzumab + pertuzumab + docetaxel) in terms of PFS, with statistically significant superiority and important clinical value. The overall safety profile was favorable, positioning this regimen as a potential first-line treatment of choice for HER2-positive advanced breast cancer. Detailed data will be presented at an upcoming international academic conference.
KN026 is a HER2 bispecific antibody developed collaboratively by Kangning Jierui and CSPC Pharmaceutical Group. It simultaneously and precisely binds two non-overlapping epitopes of the HER2 receptor (domain IV and domain II), specifically binding to multiple HER2 proteins on tumor cell membranes to comprehensively block downstream signaling pathways. In May 2026, this product was approved for second-line treatment of HER2-positive gastric cancer.
HB1801 is a novel drug developed by CSPC Pharmaceutical Group based on a nanoparticle platform, in which docetaxel is encapsulated in human albumin. Due to the absence of Tween-80 and ethanol, it offers improved safety and efficacy compared with conventional docetaxel injection.
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