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HS022

Development stage: Phase 3
Lead developer: Zhejiang Hisun Pharmaceutical
Modality: Monoclonal Antibodies → Antibody-Based Therapeutics
Administration: Intravenous

Overview

**HS022** is a recombinant humanized anti-HER2 monoclonal-antibody biosimilar to trastuzumab, marketed in China as **Anruiza**. It was developed by Zhejiang Hisun-associated biologics companies and approved by China's National Medical Products Administration in March 2023 as an injectable trastuzumab biosimilar for HER2-positive metastatic breast cancer, early breast cancer, and metastatic gastric cancer. HS022 binds the extracellular domain of human epidermal growth factor receptor 2, suppressing HER2-driven tumor-cell signaling and proliferation while enabling Fc-mediated antibody-dependent cellular cytotoxicity against HER2-overexpressing tumor cells.

Brand names: Anruiza
Other names: trastuzumab biosimilar

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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