Summit Therapeutics announced that partner Akeso Inc. received marketing authorization from China’s National Medical Products Administration. The approval covers ivonescimab plus chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer. This marks the third NMPA approval for an ivonescimab-containing regimen since May 2024.
The HARMONi-6 Phase III trial demonstrated statistically significant superiority in both progression-free survival and overall survival. Ivonescimab outperformed the combination of a PD-1 inhibitor and chemotherapy. Researchers presented these results at the 2026 American Society of Clinical Oncology Annual Meeting.
Ivonescimab is a potential first-in-class bispecific antibody. The drug simultaneously blocks both PD-1 and VEGF.