Alphamab Oncology announced that China’s National Medical Products Administration (NMPA) has accepted, and granted priority review status to, the new drug application (NDA) for Anbenitamab (trade name: 恩尼妥®, R&D code: KN026) in combination with docetaxel (albumin-bound) for injection (HB1801) as a neoadjuvant treatment for HER2-positive early or locally advanced breast cancer. The bispecific antibody was co-developed with Shanghai JMT-Bio Technology Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited.

The filing is supported by the pivotal phase III KN026-004/“Neo-Healer” trial, which compared Anbenitamab + HB1801 (with or without carboplatin) against the current standard regimen of trastuzumab + pertuzumab + docetaxel (with or without carboplatin). Blinded Independent Review Committee data showed a total pathological complete response (tpCR) rate of 62.40% (95% CI: 56.20–68.23) for the Anbenitamab arm, achieving statistical superiority with a one-sided P-value of 0.0036 and a manageable safety profile.

Approximately 75% of breast-cancer patients in China are diagnosed at an early or locally advanced stage where neoadjuvant therapy is recommended. The KN026-004 results mark the first head-to-head phase III demonstration of a HER2 bispecific antibody outperforming the dual-antibody combination of trastuzumab and pertuzumab in this setting, positioning Anbenitamab + HB1801 as a potential new standard of care.

Anbenitamab, developed on Alphamab’s proprietary CRIB (Charge Repulsion Induced Bispecific) platform, is already approved in China—via priority review—for use with chemotherapy in previously treated HER2-positive gastric or gastroesophageal junction cancer. The antibody holds U.S. FDA Orphan Drug Designation for HER2-positive or HER2-low gastric cancer and two NMPA Breakthrough Therapy Designations for HER2-positive gastric cancer and first-line unresectable or metastatic HER2-positive breast cancer.

Docetaxel (albumin-bound) HB1801, developed by CSPC Group, eliminates Tween-80 and ethanol, requires no steroid premedication, and has demonstrated favourable efficacy and safety profiles. HB1801 also carries NMPA Breakthrough Therapy Designation for first-line unresectable or metastatic HER2-positive breast cancer.

Alphamab Oncology retains a broad pipeline of antibody-drug conjugates, monoclonal antibodies and bispecific antibodies, with two NMPA-approved products and multiple late-stage assets across oncology indications.