CSPC PHARMA (01093): The new drug application for Anizumab (KN 026) and injectable Docetaxel (albumin-bound) (HB1801) for first-line treatment of advanced breast cancer has been accepted by the National Medical Products Administration.

CSPC PHARMA (01093) announced that its subsidiary, Shanghai Jinnan Biotechnology Co., Ltd., has had its new drug application for the antibody Anituzumab ("KN 026") in combination with the independently developed injection of docetaxel (albumin-bound) ("HB1801") for first-line treatment of advanced breast cancer accepted by the National Medical Products Administration (NMPA) of the People's Republic of China and included in the priority review and approval process. The indication for this application is for the combination of Anituzumab and docetaxel (albumin-bound) as a first-line treatment for adult patients with unresectable or metastatic human epidermal growth factor receptor 2 ("HER2") positive breast cancer. Previously, the combination of KN 026 and HB1801 for this indication had been granted breakthrough therapy designation by the NMPA. KN 026 is a bispecific antibody that can simultaneously bind to two non-overlapping epitopes of HER2, blocking HER2 signaling, enhancing HER2 internalization capacity, downregulating HER2 expression, while preserving the antibody-dependent cell-mediated cytotoxicity (ADCC) effect. Currently, this product has been approved for market release in China. HB1801 is one of the representative drugs independently developed by the groups nanomedicine technology platform. HB1801 encapsulates docetaxel in human serum albumin, offering significant advantages over traditional docetaxel injections: (1) Safety: No risk of allergic reactions, no need for hormone pre-treatment, allows for high-concentration rapid administration, effectively improving medication safety and patient treatment compliance; (2) Efficacy: Multiple preclinical and clinical studies have confirmed its superior antitumor activity, allowing for higher dose administration in clinical settings, further enhancing efficacy. This new drug application is primarily based on a pivotal phase III clinical study (study number: KN 026-003/Healer), the results of which show that the combination therapy of KN 026 and HB1801 significantly improves progression-free survival ("PFS") in first-line treatment of advanced HER2-positive breast cancer compared to the current standard treatment regimen (trastuzumab combined with pertuzumab and docetaxel), with statistically significant and clinically meaningful differences, and overall good safety. Detailed clinical data from this study will be officially released at an upcoming international academic conference. In China, approximately 20% of breast cancer patients are diagnosed at an advanced stage, and around 10% of patients with early-stage HER2-positive breast cancer will experience disease recurrence within three years post-surgery. Currently, the combination of trastuzumab with pertuzumab and docetaxel remains the first-line treatment option for HER2-positive advanced breast cancer both domestically and internationally. Despite this treatment regimen significantly extending PFS for these patients, about 50% will experience disease progression within two years, indicating an urgent clinical need. The Healer study is the first global phase III study focusing on HER2-positive advanced breast cancer involving the combination of a HER2 bispecific antibody and HB1801, directly challenging and confirming its efficacy beyond trastuzumab and pertuzumab + docetaxel. The success of this study marks a historic breakthrough for the aforementioned novel combination therapy in the first-line treatment of HER2-positive advanced breast cancer, potentially offering patients with HER2-positive advanced breast cancer in China a more effective, safe, and convenient new treatment option. Currently, the KN 026 and HB1801 combination therapy has completed the clinical layout for the entire disease course in neoadjuvant, adjuvant, and advanced first-line treatment for HER2-positive breast cancer. Among them, the new drug application for the combination therapy in neoadjuvant treatment of early or locally advanced HER2-positive adult breast cancer has been accepted by the NMPA on August 4, 2026, and included in the priority review and approval process.