AKESO(HK:09926) Mei Ri Jing Ji Xin Wen·2025-09-07 14:01Core Insights - The global multi-center phase III clinical study HARMONi for AK112 (Evosinib) has successfully met its primary endpoint of progression-free survival (PFS) [1][2] - Evosinib is the world's first PD-1/VEGF dual antibody, showing potential to replace Merck's PD-1 drug, Pembrolizumab, based on its superior PFS results in previous studies [1][2] - The study included 438 patients, with a significant portion (38%) from North America and Europe, indicating a diverse patient demographic [2] Group 1 - The HARMONi study demonstrated a statistically significant improvement in PFS with a hazard ratio (HR) of 0.52, while the overall survival (OS) showed a positive trend but did not reach statistical significance with an HR of 0.79 (p=0.057) [2] - The updated data from Summit Therapeutics revealed an improved OS HR of 0.78 (95% CI: 0.62–0.98, p=0.0332) after a median follow-up of 13.7 months, indicating a notable enhancement in survival outcomes [3] - The results from the international HARMONi study align with the domestic HARMONi-A study, showcasing consistent clinical performance in both PFS and OS, highlighting Evosinib's global market potential [4] Group 2 - The chairman of the company expressed strong confidence in AK112 despite the stock price fluctuations, emphasizing the importance of clinical validation in the development of dual antibodies [2][3] - The study's findings underscore the therapeutic advantages of Evosinib, including rapid efficacy and effective disease control, as well as a favorable immune therapy tail effect [4] - The data from the North American cohort showed significant survival benefits, with the control group having a median OS of 14.0 months and an HR of 0.70, further supporting the drug's efficacy [3]