康方生物早盘涨超3% 依沃西方案一线治疗TNBC更新数据于ESMO IO 2025发布

Core Viewpoint - Kangfang Biotech's PD-1/VEGF bispecific antibody, Ivosidenib, shows promising efficacy in treating locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) in a phase II clinical study, highlighting its potential in first-line therapy [1] Group 1: Clinical Development - Ivosidenib has been included in the Breakthrough Therapy Designation (BTD) list by the National Medical Products Administration (NMPA) for its excellent efficacy and safety in treating TNBC [1] - A multicenter, randomized, double-blind phase III clinical study (HARMONi-BC1/AK112-308) for Ivosidenib in this indication is currently progressing efficiently [1] Group 2: Product Approval and Market Position - Ivosidenib is the world's first PD-1/VEGF bispecific antibody for tumor immunotherapy, with its first indication expected to receive approval from the NMPA in May 2024 for locally advanced or metastatic non-small cell lung cancer (nsq-NSCLC) after progression on EGFR-TKI treatment [2] - In November 2024, Ivosidenib was included in the national medical insurance catalog, enhancing its market accessibility [2]