CSPC Pharmaceutical Group Limited (CSPC Pharma) announced that its in-house asset Docetaxel for Injection (Albumin-bound, HB1801) and Anbenitamab (KN026)​—co-developed with subsidiary Shanghai JMT-BIO Technology and Jiangsu Alphamab Biopharmaceuticals—have received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA). The designation covers the combination of HB1801 and KN026 as a first-line treatment for unresectable or metastatic HER2-positive breast cancer in adults.

Breast cancer is the second-most prevalent malignancy among women in China, with HER2-positive cases representing approximately 20 %–30 % of all diagnoses. About 20 % of Chinese patients present at an advanced stage, and 10 % of early-stage HER2-positive patients relapse within three years after surgery. Despite the current international standard THP regimen—trastuzumab, pertuzumab and docetaxel—roughly 50 % of patients experience disease progression inside two years, indicating a significant unmet need.

The Phase III “Healer” study (KN026-003) evaluating HB1801 plus KN026 achieved its primary endpoint of progression-free survival (PFS), demonstrating statistically significant and clinically meaningful superiority versus the THP standard of care, while maintaining a favorable safety profile. Detailed data will be presented at an upcoming international conference, and an NDA submission for the new regimen is planned.

CSPC Pharma has now completed clinical development coverage of the HB1801-KN026 combination across neoadjuvant, adjuvant and first-line advanced settings for HER2-positive breast cancer. Additional Phase III trials are under way for breast and gastric cancer indications. The NMPA’s BTD is expected to expedite both development and regulatory review, positioning the regimen to potentially redefine first-line treatment standards for HER2-positive advanced breast cancer in China.