Akeso Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer

Core Viewpoint - Akeso, Inc. has received its fifth Breakthrough Therapy Designation for ivonescimab, a bispecific antibody targeting PD-1 and VEGF, for the first-line treatment of advanced biliary tract cancer, highlighting its clinical potential across multiple tumor types [1][2]. Company Overview - Akeso is a leading biopharmaceutical company focused on the research, development, manufacturing, and commercialization of innovative biological medicines, with a robust R&D ecosystem centered on its proprietary Tetrabody bispecific antibody platform and other advanced technologies [9][10]. - The company has a pipeline of over 50 innovative assets, with 26 candidates currently in clinical trials, including 15 bispecific/multispecific antibodies and bispecific ADCs [10]. Clinical Development - The Phase III clinical study (AK112-309/HARMONi-GI1) is evaluating ivonescimab in combination with chemotherapy against durvalumab plus chemotherapy for advanced biliary tract cancer, with patient enrollment completed [3]. - Encouraging results from a Phase 1b/II study showed ivonescimab plus chemotherapy achieved an Objective Response Rate (ORR) of 63.6% and a Disease Control Rate (DCR) of 100%, with a median Progression-Free Survival (mPFS) of 8.5 months and a median Overall Survival (mOS) of 16.8 months [4][5].