Alphamab Oncology (Alphamab) announced that pivotal Phase III data for its HER2-targeting bispecific antibody KN026, developed with Shanghai JMT-Bio Technology (a subsidiary of CSPC Pharmaceutical Group), will be featured in the Late-Breaking Abstract (LBA) Oral Presentation session at the American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for 29 May–2 June 2026 in Chicago.
The multicentre, randomised, open-label study (KN026-004) compared KN026 combined with CSPC’s albumin-bound docetaxel (HB1801) ± carboplatin against the current standard-of-care regimen of trastuzumab + pertuzumab with docetaxel ± carboplatin (TCbHP) as neoadjuvant therapy for early and locally advanced HER2-positive breast cancer. Results showed a statistically significant improvement in total pathological complete response (tpCR) for the KN026 combination, marking the first head-to-head Phase III trial where a HER2 bispecific antibody surpassed the dual-antibody standard while maintaining a manageable safety profile. Alphamab highlighted the potential for this regimen to become a new standard of care.
KN026 (Anbenitamab) is engineered using Alphamab’s CRIB (Charge Repulsion-Induced Bispecific) platform, enabling simultaneous binding to two distinct HER2 epitopes, enhanced ADCC/CDC activity and receptor down-regulation. The antibody holds U.S. FDA Orphan Drug Designation for HER2-positive or HER2-low gastric cancer and NMPA Breakthrough Therapy Designation for second-line or later HER2-positive gastric/gastroesophageal junction cancer, with a new-drug application under review since September 2025. Additional registrational studies are ongoing in gastric and breast cancer across first-line, neoadjuvant and adjuvant settings.
HB1801, originating from CSPC’s nanomedicine platform, encapsulates docetaxel in human serum albumin, eliminating Tween-80 and ethanol to reduce hypersensitivity reactions, permit higher dosing concentrations and improve clinical convenience. Early-stage trials have indicated superior safety and antitumour activity versus conventional docetaxel injections, and the agent is in pivotal Phase III trials for breast and gastric cancers.
Under a 2021 licence agreement, JMT-Bio holds exclusive development and commercialisation rights for KN026 in breast and gastric cancer indications within Mainland China (excluding Hong Kong, Macau and Taiwan).
Alphamab cautioned that successful development and commercialisation of KN026 remain subject to ongoing clinical, regulatory and commercial risks. Shareholders and potential investors are advised to exercise due care when dealing in the company’s shares.