CSPC PHARMA (01093.HK): NDA for KN026 Plus HB1801 as First-Line Treatment for Advanced Breast Cancer Accepted by NMPA

NewTimeSpace News: On 18 August 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) announced that the new drug application for Anbenitamab (KN026), developed in collaboration with Shanghai Jinmant Biotech and Jiangsu Alphamab Biopharmaceuticals, in combination with the Group's self-developed docetaxel albumin-bound injection (HB1801) as first-line treatment for unresectable or metastatic HER2-positive adult breast cancer, has been accepted by the National Medical Products Administration (NMPA) and included in the priority review and approval procedure. The combination had previously been granted breakthrough therapy designation by the NMPA.

According to the announcement, the application is primarily based on the pivotal Phase III study (KN026-003/Healer), which showed that the combination significantly improved progression-free survival versus the current standard of care (trastuzumab plus pertuzumab and docetaxel) with statistically significant differences and a good overall safety profile. The study is the world's first Phase III trial of a HER2 bispecific antibody combination to head-to-head beat the standard regimen in this indication. The KN026 and HB1801 combination has completed clinical positioning across neoadjuvant, adjuvant and first-line advanced settings for HER2-positive breast cancer, with the neoadjuvant NDA accepted on 4 August 2026.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.