By Fineline Cube 
Anhui Anke Biotechnology (Group) Co., Ltd. today released interim results from its Phase Ib/II study of HuA21 Injection combined with trastuzumab and chemotherapy for patients with HER2‑positive advanced gastric/gastroesophageal junction adenocarcinoma. The data were presented at the European Society for Medical Oncology (ESMO) 2025 Annual Congress.
Clinical Highlights
- Objective Response Rate (ORR)
- 80.8 % in the 30 mg/kg dose cohort
- 76.7 % in the 20 mg/kg dose cohort
- Safety Profile – Low incidence of adverse events; no clinically significant cardiotoxicity reported.
- Synergistic Activity – HuA21’s unique binding to HER2 subdomains I/II blocks heterodimerization, enhancing trastuzumab efficacy.
These results underscore HuA21’s potential to become a cornerstone therapy for HER2‑positive gastric cancer.
About HuA21 Injection
- Class 1 Innovative Drug – Developed entirely in‑house by Anke Biotechnology.
- Unique Humanized mAb – Comprises an amino‑acid sequence distinct from trastuzumab and pertuzumab, ensuring exclusive intellectual‑property rights.
- Mechanism of Action – Targets HER2 receptor subdomains I/II, preventing HER2/EGFR heterodimer formation and signaling.
- Preclinical Cardiotoxicity Profile – Demonstrated low risk, a critical advantage over existing HER2‑directed therapies.
Strategic Implications
- Accelerated Development Pathway – Positive Phase Ib/II data support progression to Phase III trials and potential regulatory submissions in key markets.
- Competitive Advantage – HuA21’s independent sequence and synergistic profile position it favorably against established HER2 agents.
- Global Expansion – The study’s European presentation aligns with Anke’s strategy to penetrate the Western oncology market.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech