CSPC PHARMA(01093.HK): NDA for Neoadjuvant Therapy of Anitumab Combined with HB1801 in HER2‑positive Breast Cancer Accepted and Granted Priority Review

NewTimeSpace News: CSPC Pharmaceutical Group Limited (01093.HK) released a voluntary announcement on 4 August 2026. The New Drug Application for neoadjuvant therapy of Anitumab (KN026), co‑developed by the Group’s subsidiary Shanghai Jinmante and Alphamab Oncology, combined with the Group’s in‑house‑developed Docetaxel (Albumin‑Bound) for Injection (HB1801), has been accepted by NMPA and granted priority review and approval procedure. The indication covers adult patients with early or locally advanced HER2‑positive breast cancer.

Anitumab Injection is a HER2 bispecific antibody capable of binding two non‑overlapping epitopes of HER2 simultaneously and is currently approved for marketing. HB1801 is one of the representative candidates developed under the Group’s nanomedicine technology platform. Docetaxel is encapsulated in human serum albumin. Compared with conventional docetaxel injection, it features safety advantages such as no requirement for steroid pre‑medication and high‑concentration rapid administration. Pre‑clinical and clinical studies have also demonstrated enhanced anti‑tumour activity.

This NDA is mainly supported by the pivotal Phase III clinical study (KN026‑004 / Neo‑Healer). Study outcomes showed that neoadjuvant treatment with Anitumab plus HB1801 ± carboplatin for early or locally advanced HER2‑positive breast cancer significantly elevated the overall pathological complete response rate versus the existing standard‑of‑care regimen (trastuzumab plus pertuzumab and docetaxel ± carboplatin). The efficacy improvement achieved both statistical significance and clinical relevance with a manageable overall safety profile.

This represents the world’s first Phase III study in which a HER2 bispecific antibody combined with albumin‑bound docetaxel for injection outperforms the current anti‑HER2 dual‑mAb plus chemotherapy neoadjuvant standard‑of‑care. It is expected to deliver a brand‑new therapeutic option for patients suffering from HER2‑positive breast cancer.

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