AKESO(HK:09926) Ge Long Hui·2025-10-21 15:57Company Dynamics - On October 19, the company presented impressive interim analysis data from the HARMONi-6 trial at The Lancet & ESMO [1] - The company revised the HARMONi-3 trial protocol to conduct independent statistical analyses based on histological types [2] Clinical Trial Results - The interim analysis of HARMONi-6 showed a median progression-free survival (mPFS) of 11.1 months compared to 6.9 months, with a hazard ratio (HR) of 0.60 (P<0.0001), indicating a significant improvement [1] - The absolute difference in mPFS between the two groups was 4.24 months, with consistent results across subgroups regardless of PD-L1 expression or liver metastasis [1] - Treatment-related serious adverse events (SAE) were reported at 32.3% for the experimental group versus 30.2% for the control group, with no overall survival (OS) data available yet [1] HARMONi-3 Trial Updates - The HARMONi-3 trial will be divided into two parts: sq-NSCLC (600 patients) and nsq-NSCLC (1000 patients), with separate statistical analyses planned [2] - Enrollment for sq-NSCLC is expected to complete in the first half of 2026, with OS analysis anticipated around the same time [2] - The nsq-NSCLC group aims to complete enrollment in the second half of 2026, with PFS event numbers expected in the first half of 2027 [2] Expansion of Clinical Indications - The company plans to initiate a global multi-regional clinical trial (HARMONi-GI3) for AK112 in colorectal cancer, based on promising II phase data [2] - The trial will compare AK112 combined with chemotherapy against bevacizumab combined with chemotherapy, with an enrollment target of 600 patients [2] Earnings Forecast and Valuation - The company maintains its earnings per share (EPS) forecasts for 2025 and 2026 at 0.09 CNY and 0.59 CNY, respectively [2] - The target price has been adjusted down by 18.2% to 184.00 HKD, reflecting a 50.1% upside potential [3]