ANKE BIO(SZ:300009) Ge Long Hui·2025-10-21 00:57Core Viewpoint - Anke Bio (300009.SZ) presented the latest research results of its self-developed biological innovative drug HuA21 at the ESMO annual meeting in Berlin, demonstrating promising efficacy and safety in treating HER2-positive advanced gastric/GEJ adenocarcinoma [1][2]. Summary by Sections Research Overview - The study titled "HuA21 combined with trastuzumab and chemotherapy in HER2-positive advanced gastric/GEJ adenocarcinoma: Phase Ib/II dose-escalation and expansion study" was led by researchers from Fudan University and Anhui Medical University [2]. - HuA21 is a monoclonal antibody targeting HER2 with a unique amino acid sequence, distinct from trastuzumab and pertuzumab, and possesses independent intellectual property rights [2]. Mechanism of Action - HuA21 induces internalization and downregulation of the HER2 receptor, disrupting cancer cell signaling pathways, inhibiting growth and proliferation, promoting apoptosis, and reducing tumor angiogenesis [2]. Clinical Trial Details - Early clinical trials indicated good safety (no dose-limiting toxicities observed at doses ≤15 mg/kg) and significant anti-tumor activity (objective response rate of 63.6% when combined with trastuzumab and chemotherapy) [3]. - The study enrolled 60 patients with HER2-positive advanced gastric/GEJ adenocarcinoma, utilizing a "3+3" design for dose escalation and expansion [3]. Efficacy Results - The objective response rates (ORR) were 80.8% for the HuA21 (30 mg/kg) group and 76.7% for the HuA21 (20 mg/kg) group, indicating strong anti-tumor activity [4]. - Disease control rates (DCR) were 96.2% for the 30 mg/kg group and 100% for the 20 mg/kg group, with mPFS and mOS data still maturing [4]. Safety Profile - Overall safety was good, with treatment-emergent adverse events (TEAE) occurring in 100% of the 30 mg/kg group and 96.7% of the 20 mg/kg group, primarily grade 1-2 [4]. - Serious adverse events (SAE) occurred in 6.7% of the 30 mg/kg group and 23.3% of the 20 mg/kg group, with manageable common TEAEs including thrombocytopenia, anemia, and elevated liver enzymes [4]. Conclusion - The HuA21 (30 mg/kg) group showed a higher ORR of 80.8% compared to the 20 mg/kg group, with a lower incidence of SAEs, supporting the recommendation of 30 mg/kg as the phase III dose for HER2-positive advanced gastric cancer or GEJ cancer [5].