AKESO(HK:09926) 智通财经网·2025-12-11 02:01Core Viewpoint - Kangfang Biopharma's innovative 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][2] Group 1: Clinical Development - Ivosidenib has demonstrated superior efficacy data in a phase II clinical study presented at the ESMO IO conference, indicating significant clinical potential for TNBC treatment [1] - The drug has been included in the Breakthrough Therapy Designation (BTD) list by the National Medical Products Administration (NMPA) in China, based on its excellent efficacy and safety profile [1] - A multicenter, randomized, double-blind phase III clinical study (HARMONi-BC1/AK112-308) for Ivosidenib in TNBC is currently progressing efficiently [1] Group 2: Regulatory Approvals - Ivosidenib is the first PD-1/VEGF bispecific antibody globally, 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] - The drug was included in the national medical insurance catalog in November 2024, enhancing its accessibility [2]