CSPC PHARMA (01093): The phase III study of the combination of Anetumab ravtansine (KN026) with albumin-bound paclitaxel (HB1801) for first-line treatment for HER2-positive advanced breast cancer has reached its primary endpoint.

CSPC PHARMA (01093) announced that its subsidiary, Shanghai Jinmant Bio-Technology Co., Ltd. (Jinmant Bio), in collaboration with Jiangsu Koning Jerry Biopharmaceutical Co., Ltd., has successfully achieved the pre-defined primary endpoint of progression-free survival (PFS) in a Phase III clinical study (Study Protocol No.: KN026-003) of the combination therapy of the monoclonal antibody Anetumab Ravtansine (KN026) developed by Jinmant Bio and the injection of Albumin-Bound Docetaxel (HB1801) independently developed by the CSPC Pharma Group for the first-line treatment of HER2-positive advanced breast cancer. The results have demonstrated significant statistical and clinical significance, as well as good safety. Breast cancer is the second most common malignant tumor in women in China, with the HER2-positive subtype accounting for approximately 20% to 30% of cases. In China, around 20% of breast cancer patients are diagnosed at an advanced stage, and about 10% of HER2-positive early-stage breast cancer patients will experience disease recurrence within 3 years after curative surgery. The combination of Trastuzumab, Pertuzumab, and Docetaxel (THP regimen) remains the first-line treatment for HER2-positive advanced breast cancer both domestically and internationally. Although this treatment has significantly prolonged the PFS of such patients, approximately 50% of patients still experience disease progression within 2 years, indicating an urgent need to meet clinical demands. The Healer (KN026-003) study is a randomized, controlled, open-label, multicenter, Phase III clinical trial that aims to compare the effectiveness and safety of the combination of KN026 with HB1801 versus the THP regimen for the first-line treatment of HER2-positive advanced breast cancer. The study plans to include approximately 880 patients and has shown that the combination of KN026 with HB1801 significantly extended PFS and reduced the risk of disease progression or death compared to the THP regimen, with a trend towards overall survival (OS) benefit. Detailed data from the study will be presented at an upcoming international academic conference. Anetumab Ravtansine injection is a HER2 bispecific antibody that was approved by the National Medical Products Administration of China (NMPA) through priority review on May 28, 2026. It is indicated for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adult patients who have previously received a Trastuzumab-containing regimen. The Phase III clinical study of Anetumab Ravtansine injection as neoadjuvant therapy for HER2-positive breast cancer has also met its primary endpoint and will soon undergo a new drug application (NDA) submission. In addition, several clinical studies for the treatment of HER2-positive breast cancer and first-line treatment of HER2-positive gastric cancer are currently ongoing. Anetumab Ravtansine injection has been granted orphan drug status by the US Food and Drug Administration (FDA) for the treatment of HER2-expressing gastric cancer and breakthrough therapy designation by the NMPA for the treatment of first-line standard treatment failure in HER2-positive gastric cancer. Albumin-Bound Docetaxel injection (HB1801) is one of the representative drugs developed independently by the CSPC Pharma Group's nanomedicine technology platform. HB1801 encapsulates Docetaxel in human serum albumin and offers advantages over Docetaxel injection by not containing Polysorbate 80 (Tween-80) and ethanol, including: (1) Safety: no allergic reactions, no need for pre-treatment with steroids, and can be administered at high concentrations rapidly, enhancing safety and patient compliance; (2) Effectiveness: preclinical and clinical studies have shown significant anti-tumor activity, allowing for higher dosing in clinical practice and greater efficacy. Currently, HB1801 has entered Phase III clinical trials for indications such as breast cancer and gastric cancer.