CSPC PHARMA(01093.HK): Phase III Study of Anistolimab Combined with HB1801 for HER2-positive Advanced Breast Cancer Meets Primary Endpoint

NewTimeSpace News: CSPC Pharmaceutical Group Limited (01093.HK) issued a voluntary announcement on June 10, 2026. Assessed by the Independent Data Monitoring Committee, the Phase III clinical trial (Protocol No.: KN026-003) of Anistolimab (KN026) combined with the Group's self-developed Docetaxel (Albumin-bound) for Injection (HB1801) has achieved the primary endpoint of progression-free survival (PFS). This combination regimen serves as first-line therapy for HER2-positive advanced breast cancer. It significantly prolonged patients' PFS, reduced the risk of disease progression or death, and showed a trend of overall survival benefit compared with the THP regimen. Detailed data will be presented at upcoming international academic conferences.
Anistolimab Injection was approved for marketing by the National Medical Products Administration on May 28, 2026, for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. As a flagship drug developed on the Group's nanomedicine technology platform, HB1801 contains no Tween-80 or ethanol, delivering improved safety and better patient compliance.

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