Alphamab Oncology (ALPHAMAB-B) announced that the first patient has been dosed in a Phase III trial (KN026-007) evaluating KN026, a next-generation bispecific HER2 antibody, in combination with CSPC Pharmaceutical Group’s albumin-bound docetaxel (HB1801) plus chemotherapy as adjuvant treatment for resectable HER2-positive breast cancer.
The randomized, controlled, open-label study plans to enroll about 1,800 patients in mainland China with histologically confirmed involvement of four or more regional lymph nodes after surgery. Participants will be randomized 1:1 to receive either: • KN026 + HB1801 + chemotherapy • Trastuzumab + pertuzumab + chemotherapy
The primary endpoint is investigator-assessed invasive disease-free survival (iDFS); secondary endpoints include DFS, RFI, DRFI, overall survival, safety, pharmacokinetics and immunogenicity.
Clinical rationale HER2-positive tumors represent roughly 20%–30% of breast cancer cases in China. Despite current adjuvant standards, lymph-node-positive patients—particularly those with ≥4 positive nodes—remain at high risk of recurrence. Dual-targeted regimens have shown superior risk reduction versus trastuzumab-only protocols, underscoring the need for more effective combinations.
Asset profile 1. KN026 (Anbenitamab) • Simultaneously targets two HER2 epitopes (II and IV) with a wild-type Fc region. • Designated a Breakthrough Therapy by China’s NMPA for second-line or later HER2-positive gastric/GEJ cancer; NDA for this indication accepted in September 2025. • Holds U.S. FDA Orphan Drug status for HER2-positive or HER2-low gastric cancer. • Additional Phase III studies are ongoing in first-line and neoadjuvant HER2-positive breast cancer settings.
2. HB1801 (albumin-bound docetaxel) • Encapsulates docetaxel in human serum albumin, removing the need for corticosteroid premedication and enabling higher dosing intensity. • Multiple Phase III programs in breast and gastric cancers are underway, with clinical data indicating favorable efficacy and safety.
Corporate context Alphamab Oncology is a China-based biopharmaceutical group specializing in antibody-drug conjugates, bispecific antibodies and multi-functional protein engineering. Its pipeline includes one marketed product and several late-stage candidates, supported by proprietary platforms.
Regulatory note The company cautions that successful development and commercialization of KN026 are not guaranteed, in accordance with Hong Kong Listing Rule 18A.05.