By Fineline Cube 
China-based Akeso Biopharma (HKG: 9926) announced on July 24, 2025, that the first patient has been enrolled in the pivotal/registration Phase III study (AK112-310/HARMONi-GI2) of its self-developed, global first-in-class PD-1/VEGF bispecific antibody, ivonescimab. This study evaluates ivonescimab in combination with chemotherapy, with or without lafamilimab (a CD47 monoclonal antibody), for the first-line treatment of metastatic pancreatic cancer.
Innovative Therapeutic Approach
Ivonescimab is a groundbreaking PD-1/VEGF bispecific tumor immunotherapy drug independently developed by Akeso. It received marketing approval from China’s National Medical Products Administration (NMPA) in May 2024 for locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) that progressed after EGFR-TKI treatment. This approval made ivonescimab the world’s first bispecific antibody new drug with a “tumor immunity + anti-angiogenesis” synergistic anti-tumor mechanism.
Market Recognition
In November 2024, ivonescimab and its approved indication were included in China’s 2024 National Reimbursement Drug List. This inclusion underscores the drug’s significance in addressing unmet medical needs in oncology.-Fineline Info & Tech