Akeso’s ivonescimab wins China approval in sq-lung cancer

China’s’ Akeso (9926.HK) announced that the China National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for ivonescimab injection in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC).

The approval of ivonescimab combination therapy as a first-line treatment for squamous NSCLC marks the third lung cancer indication for ivonescimab. In a randomized, double-blind Phase III trial, this regimen demonstrated statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared with a PD-1 inhibitor plus chemotherapy. These results establish a new first-line standard of care for squamous NSCLC and mark a major milestone in the treatment of lung cancer worldwide.