AKESO(HK:09926) Guoxin Securities·2025-06-03 13:51Investment Rating - The investment rating for the company is "Outperform the Market" (maintained) [1][4][22]. Core Viewpoints - The HARMONi clinical trial has achieved its primary endpoint of progression-free survival (PFS), demonstrating statistically significant efficacy in both Asian and non-Asian populations [3][5]. - The company’s partner, Summit, announced that the HARMONi trial reached its primary clinical endpoint, indicating strong potential for the drug Ivonescimab in treating EGFRm NSCLC [2][5]. - The clinical data from HARMONi shows that Ivonescimab combined with chemotherapy has a significant PFS benefit (HR=0.52) and a positive trend in overall survival (OS) (HR=0.79) [3][5][6]. - The company has initiated multiple phase 3 clinical trials across various cancer types, including NSCLC, TNBC, BTC, CRC, and SCLC, indicating a robust pipeline [3][19]. Summary by Sections Clinical Trial Results - The HARMONi trial included approximately 38% of patients from Europe and the US, aligning with other recent international trials for EGFRm NSCLC [5][6]. - The trial results showed a median PFS of 7.06 months for the experimental group compared to 4.80 months for the control group, with a hazard ratio (HR) of 0.46 [11][18]. - The trial also reported an overall response rate (ORR) of 50.6% in the experimental group versus 35.4% in the control group [11][18]. Financial Projections - The company is expected to generate revenues of 33.0 billion, 52.0 billion, and 79.0 billion yuan for the years 2025, 2026, and 2027, respectively, with net profits of 0.29 billion, 7.30 billion, and 17.93 billion yuan [4][22][26]. Competitive Landscape - Ivonescimab has shown superior efficacy compared to PD-1 monoclonal antibodies in head-to-head trials, positioning it as a potential cornerstone in immunotherapy [19][20]. - The clinical data indicates that Ivonescimab has a favorable safety profile compared to other treatments, with a lower incidence of grade 3 or higher adverse events [16][18].