China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation to CSPC Pharmaceutical Group's self-developed albumin-bound docetaxel for injection (HB1801) in combination with anbenitamab (KN026), a HER2 bispecific antibody, for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer.
Anbenitamab is co-developed by Shanghai JMT-BIO Technology, a CSPC subsidiary, and Jiangsu Alphamab Biopharmaceuticals. It had previously received Breakthrough Therapy Designation from the NMPA for HER2-positive advanced gastric cancer after failure of first-line standard treatment.
The designation follows the Phase III Healer study (KN026-003, NCT05838066), which met its primary endpoint of progression-free survival as assessed by an Independent Data Monitoring Committee, with the combination showing statistically significant superiority over the standard THP regimen and a favorable safety profile.
CSPC said the combination has now completed a full clinical layout across the neoadjuvant, adjuvant and first-line advanced settings in HER2-positive breast cancer, and that it plans to submit a New Drug Application for the indication as soon as practicable. HER2-positive disease accounts for roughly 20% to 30% of breast cancers, the second most common malignancy among women in China.