AKESO (09926) surged more than 6% again. At the time of writing, the stock was up 6.15% to HK$127.8, with a turnover of HK$789 million. On the news front, AKESO announced that the National Medical Products Administration has approved a significant update to the prescribing information for its self-developed, first-in-class PD-1/VEGF bispecific antibody, Ivonescimab (brand name: Yidafang). The update incorporates the final analysis data from the AK112-301/HARMONi-A study, which demonstrated statistically significant and clinically meaningful dual benefits in both progression-free survival (PFS) and overall survival (OS) for the Ivonescimab combination therapy in treating locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) that progressed after EGFR-TKI therapy. The core significance of this update lies in the fact that the HARMONi-A study is the world's first Phase III clinical trial of an immunotherapy in the EGFR-TKI resistant nsq-NSCLC treatment field to achieve clinically meaningful and statistically significant benefits on both co-primary endpoints of PFS and OS. It is also the first randomized, double-blind Phase III trial to achieve dual positive results for both PFS and OS, once again validating the breakthrough clinical value of Ivonescimab as the world's first bispecific antibody combining tumor immunotherapy and anti-angiogenesis mechanisms.
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