CSPC PHARMA (01093.HK): Anbenitamab plus HB1801 hits Phase III endpoint, 54% lower risk of progression, first NEJM breast cancer paper from mainland China

NewTimeSpace News: CSPC PHARMA (01093.HK) released a voluntary announcement that interim analysis results from the Phase III HEALER study of Anbenitamab Injection in combination with Docetaxel for Injection (Albumin-bound) (HB1801) for the first-line treatment of HER2-positive advanced breast cancer, co-developed by the Group and Jiangsu Alphamab Oncology Co., Ltd., were selected as a Late-breaking Abstract and presented as a Proffered Paper Presentation at the ESMO Congress 2026 on 24 October 2026. The study was published simultaneously as an original article in The New England Journal of Medicine, making it the first clinical achievement in breast cancer from the Chinese Mainland published in the journal.

According to the announcement, the HEALER study was sponsored by the Group and led by Academician Xu Binghe across 76 centres in China. A total of 885 patients with HER2-positive advanced breast cancer who had not received prior chemotherapy or anti-HER2 targeted therapy in the advanced setting were randomised 1:1 to the experimental group or the standard THP regimen control group. The primary endpoint was PFS assessed by a Blinded Independent Review Committee (BIRC) based on RECIST 1.1. BIRC assessment showed 24-month PFS rates of 58.5% versus 34.4%, representing a 54% reduction in the risk of disease progression or death (HR=0.46, 95% CI 0.37-0.56), while the objective response rate was 87.6% against 73.4% in the control group.

On safety, grade 3 or above adverse events occurred in 45.9% of the experimental group versus 34.4% in the control group, mainly haematological toxicities such as neutropenia and leukopenia. Treatment discontinuation due to treatment-emergent adverse events was 5.2% versus 3.4%, and grade 3 or above diarrhoea accounted for only 2.3%, with no subject discontinuing treatment due to diarrhoea. The Company said the regimen significantly improved first-line PFS versus the standard THP regimen with a manageable safety profile, and is expected to become a new first-line treatment option for HER2-positive advanced breast cancer.