Business Wire·Aug 12, 2026, 9:22 AM ET

Ivonescimab in Combination with Chemotherapy Approved in China by NMPA for First-Line Treatment of Patients with Squamous Non-Small Cell Lung Cancer

SMMT

On August 12, 2026, Akeso received NMPA marketing authorization in China for ivonescimab combined with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer (NSCLC).
This approval marks the third NMPA-approved indication for an ivonescimab-containing regimen in China since the molecule's initial approval in May 2024.
The approval is based on positive results from the HARMONi-6 Phase III trial, which demonstrated statistically significant & clinically meaningful superiority in both progression-free survival (PFS) & overall survival (OS) compared to tislelizumab plus chemotherapy.
HARMONi-6 is the first known Phase III study in NSCLC or any tumor type to show a statistically significant OS benefit over an anti-PD-(L)1 antibody combined with chemotherapy in a head-to-head setting.
Ivonescimab demonstrated an acceptable & manageable safety profile in the HARMONi-6 study, consistent with previous Phase III trials.
Summit Therapeutics holds licensing rights for ivonescimab (designated SMT112) in territories including the US, Europe, & Japan, where the therapy remains investigational & unapproved.
The FDA accepted a Biologics License Application (BLA) for ivonescimab in EGFR-mutated NSCLC in January 2026, with a PDUFA date of November 14, 2026.
Multiple ongoing Phase III trials for ivonescimab are active across various indications, including non-squamous NSCLC, colorectal cancer, & urothelial carcinoma.
Over 4,000 patients have been treated with ivonescimab in global clinical studies, with over 70,000 patients treated commercially in China as of 2026.
Ivonescimab is a novel bispecific antibody designed to block both PD-1 & VEGF pathways within a single molecule to target tumor tissue & the tumor microenvironment.