CSPC Pharmaceutical Group (01093.HK): Albumin-Bound Docetaxel Combined with Anitumab Granted Breakthrough Therapy Designation

NewTimeSpace News: On 14 July 2026, CSPC Pharmaceutical Group (01093.HK) issued an announcement that the Group’s self-developed albumin-bound docetaxel for injection and Anitumab, a co-developed HER2 bispecific antibody, have obtained breakthrough therapy designation from the NMPA for first-line treatment of HER2-positive advanced breast cancer.

As disclosed in the announcement, the Phase III clinical trial (Healer, KN026-003) has met the primary endpoint of progression-free survival (PFS). The combination therapy demonstrated significantly superior efficacy versus the current standard THP regimen with a favorable safety profile. The Group stated that this combination therapy has completed full-cycle clinical development covering neoadjuvant, adjuvant and first-line advanced treatment for HER2-positive breast cancer, and a New Drug Application (NDA) will be submitted as soon as practicable.

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