China approves ivonescimab plus chemo for squamous NSCLC

China's National Medical Products Administration (NMPA) approved ivonescimab in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC) on August 12, 2026, according to a statement from Summit Therapeutics Inc. (NASDAQ: SMMT).

The approval is the third NMPA-granted indication for an ivonescimab-containing regimen in China since the molecule's initial authorization in May 2024. It is based on results from the HARMONi-6 Phase III trial, a single-region, multi-center study conducted in China and sponsored by Akeso Inc. (HKEX: 9926.HK), which engineered the bispecific antibody.

HARMONi-6 compared ivonescimab plus platinum-based chemotherapy against tislelizumab, a PD-1 inhibitor, plus platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC regardless of PD-L1 expression. The trial showed statistically significant improvement in both progression-free survival and overall survival (OS). Summit and Akeso claim this is the first known Phase III study in NSCLC, or any tumor type, to demonstrate a statistically significant OS benefit over an anti-PD-(L)1 antibody combined with chemotherapy in a head-to-head setting.

OS data from HARMONi-6 were presented at the 2026 American Society of Clinical Oncology Annual Meeting.

Ivonescimab is a bispecific antibody that blocks both PD-1 and VEGF. More than 4,000 patients have been treated with the therapy in clinical studies globally, with over 70,000 patients treated commercially in China, according to Akeso.

Ivonescimab is not approved by any regulatory authority in Summit's licensed territories, which include the United States and Europe. A Biologics License Application for a separate indication was accepted by the U.S. Food and Drug Administration in January 2026, with a PDUFA target date of November 14, 2026.

Summit is headquartered in Miami, Florida, and lists its shares on the Nasdaq Global Market.

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