AKESO(09926) 格隆汇· Ge Long Hui·2025-06-05 06:22Company Update - The company announced the results of the global multicenter Phase III clinical trial HARMONi for AK112 in 2L EGFRm NSCLC, achieving a PFS HR of 0.52 and an OS HR of 0.79, indicating a successful primary endpoint for PFS and a significant trend in OS benefit [1] - The results from the international HARMONi trial are consistent with the domestic HARMONi-A trial, which reported a PFS HR of 0.46 and an OS HR of 0.80 (52% data maturity) [1] - The HARMONi clinical program enrolled 420 patients, with 38% from Europe and the US, supporting the extrapolation of domestic clinical data to global data [1] Market Context - Currently, no FDA-approved drugs have achieved statistically significant OS in 2L EGFRm NSCLC, with the OS p-value for HARMONi being 0.057 [2] - The lack of statistically significant OS data in the market indicates a substantial unmet clinical need for 2L+ EGFRm NSCLC treatments [2] - AK112 shows promise based on positive PFS and OS data, potentially addressing the needs of 2L+ EGFRm NSCLC patients [2] Financial Forecast and Valuation - The company maintains its profit forecasts for 2025 and 2026 unchanged [2] - The target price is set at HKD 120.0, indicating a 60% upside potential from the current stock price [2]