Core 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].

Core Viewpoint - Anke Bio announced the presentation of its self-developed biological innovative drug HuA21 at the ESMO annual meeting, showcasing its efficacy in treating HER2-positive advanced gastric/GEJ adenocarcinoma in combination with trastuzumab and chemotherapy [1] Group 1: Study 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, possessing independent intellectual property rights [2] Group 2: Efficacy and Safety - Early clinical trials indicated that HuA21 demonstrated good safety with no dose-limiting toxicities observed at doses ≤15 mg/kg and significant anti-tumor activity, achieving an objective response rate (ORR) of 63.6% when combined with trastuzumab and chemotherapy [3] - The study enrolled 60 patients with HER2-positive advanced gastric/GEJ adenocarcinoma, using a "3+3" design for dose escalation and expansion [3] - The ORR for the HuA21 (30 mg/kg) group was 80.8%, while the ORR for the HuA21 (20 mg/kg) group was 76.7%, indicating strong anti-tumor activity [4] Group 3: Safety Profile - The overall safety profile was good, with treatment-emergent adverse events (TEAEs) occurring in 100% of the HuA21 (30 mg/kg) group and 96.7% of the HuA21 (20 mg/kg) group, primarily grade 1-2 [4] - Serious adverse events (SAEs) occurred at rates of 6.7% for the HuA21 (30 mg/kg) group and 23.3% for the HuA21 (20 mg/kg) group [4] - Common TEAEs included thrombocytopenia, anemia, neutropenia, leukopenia, and elevated aspartate aminotransferase, all of which were manageable [4] Group 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]

Core Viewpoint - Anke Bio (300009.SZ) announced the presentation of its self-developed biological innovative drug, recombinant anti-HER2 humanized HuA21 monoclonal antibody injection, at the European Society for Medical Oncology (ESMO) annual meeting in Berlin from October 17 to 21, 2025, showcasing promising clinical research results for treating HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma [1] Group 1 - The clinical research data presented at ESMO further confirms the good anti-tumor activity and tolerable safety of HuA21 in combination with trastuzumab and chemotherapy for HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma [1] - The positive clinical data supports the progression to Phase III clinical trials, accelerating the drug development process [1] - The encouraging results will provide strong support for the market prospects of the product, enhancing the future market competitiveness of the company's offerings [1]