CSPC PHARMA (01093): The new drug applications for Anritokizumab (KN026) and injectable docetaxel (albumin-bound) (HB1801) for neoadjuvant treatment have been accepted by the National Medical Products Administration.

CSPC PHARMA (01093) announced that its subsidiary, Shanghai Jinmant Biotech Co., Ltd., has developed a new drug application for neoadjuvant therapy of Anituzumab (KN026) in combination with the Group's independently developed injectable Docetaxel (albumin-bound) (HB1801). This application has been accepted by the National Medical Products Administration of the People's Republic of China and is included in the priority review and approval process. The indication for this application is the neoadjuvant treatment of early or locally advanced HER2-positive adult breast cancer with Anituzumab in combination with Docetaxel (albumin-bound) Carboplatin. Anituzumab injection is a bispecific antibody targeting HER2, capable of simultaneously binding to two non-overlapping epitopes of HER2, blocking HER2 signaling, enhancing HER2 internalization, downregulating HER2 expression, and retaining the Fc segment-mediated ADCC effect. This product has already been approved for sale in China. HB1801 is one of the representative drugs developed independently by the Groups nanomedicine technology platform. HB1801 encapsulates Docetaxel within human serum albumin, offering the following advantages compared to Docetaxel injection: (1) Safety: no allergic reactions, no need for hormone pretreatment, and the potential for high-concentration rapid administration, enhancing safety and patient compliance; (2) Efficacy: preclinical and clinical studies have shown significant antitumor activity, allowing for larger clinical doses that improve efficacy. This new drug application mainly relies on a pivotal Phase III clinical trial (study number: KN026-004/Neo-Healer), which enrolled patients with early or locally advanced HER2-positive breast cancer. The study results indicate that Anituzumab in combination with injectable Docetaxel (albumin-bound) Carboplatin for neoadjuvant treatment of HER2-positive early or locally advanced breast cancer can significantly improve the overall pathological complete response rate (tpCR) compared to the existing standard treatment (Trastuzumab in combination with Pertuzumab and Docetaxel Carboplatin), with improved efficacy showing both statistical significance and clinical relevance, while overall safety is manageable. In China, about 75% of breast cancer patients are diagnosed at an early or locally advanced stage. Neoadjuvant therapy is the standard recommended treatment for HER2-positive early or locally advanced breast cancer, and achieving tpCR through neoadjuvant treatment is an effective means of improving the long-term prognosis of these patients, holding significant clinical value. KN026-004/Neo-Healer is the world's first Phase III study demonstrating that the efficacy of HER2 bispecific antibody in combination with injectable Docetaxel (albumin-bound) surpasses the existing neoadjuvant standard treatment of anti-HER2 dual monoclonal antibody combined with chemotherapy, marking a historic breakthrough for dual antibody drugs in neoadjuvant therapy for breast cancer. It is also the first domestically developed product (combination) to achieve superior efficacy results compared to the existing standard neoadjuvant treatment, expected to provide a new and promising treatment option for HER2-positive breast cancer patients in China. Currently, multiple key registered clinical studies are underway for the use of Anituzumab in combination with Docetaxel (albumin-bound) targeting first-line HER2-positive breast cancer treatment, as well as for auxiliary therapy indications in HER2-positive breast cancer. Recently, Anituzumab and HB1801 have been granted breakthrough therapy designation by the National Medical Products Administration for first-line treatment of unresectable or metastatic HER2-positive breast cancer.