Core Viewpoint - Kangfang Biopharma (09926) experienced a significant stock increase of 6.15%, reaching HKD 127.8, with a trading volume of HKD 789 million, following the approval of an important update to the product label of its innovative PD-1/VEGF bispecific antibody, Ivosidenib (brand name: Yidafang) by the National Medical Products Administration [1] Group 1 - The update includes final analysis data from the AK112-301/HARMONi-A study, demonstrating statistically significant and clinically meaningful dual benefits in progression-free survival (PFS) and overall survival (OS) for Ivosidenib in treating locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) after progression on EGFR-TKI therapy [1] - The HARMONi-A study is noted as the first global Phase III clinical trial in the EGFR-TKI resistant nsq-NSCLC treatment field to achieve clinically meaningful and statistically significant benefits in both PFS and OS endpoints [1] - This trial is also recognized as the first randomized, double-blind Phase III clinical trial to achieve dual positive results in both PFS and OS, reaffirming the groundbreaking clinical value of Ivosidenib as the world's first tumor immune + anti-angiogenesis mechanism bispecific antibody [1]

Core Viewpoint - Kangfang Biopharma (09926) has seen a stock increase of over 6%, currently trading at 127.8 HKD with a transaction volume of 789 million HKD, following the approval of a significant update to the product label of its innovative PD-1/VEGF bispecific antibody, Ivosidenib (brand name: Yidafang) by the National Medical Products Administration [1] Group 1 - The update includes final analysis data from the AK112-301/HARMONi-A study, demonstrating statistically significant and clinically meaningful dual benefits in progression-free survival (PFS) and overall survival (OS) for Ivosidenib in treating locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) after progression on EGFR-TKI therapy [1] - The HARMONi-A study is the first global Phase III clinical trial in the EGFR-TKI resistant nsq-NSCLC treatment field to achieve clinically meaningful and statistically significant benefits in both PFS and OS endpoints [1] - This trial is also the first randomized, double-blind Phase III clinical trial to achieve dual positive results in PFS and OS, reaffirming the groundbreaking clinical value of Ivosidenib as the world's first tumor immune + anti-angiogenesis mechanism bispecific antibody [1]