Akeso secures third NMPA approval for Ivonescimab combination in China

CHINA—Akeso has secured approval from China’s National Medical Products Administration (NMPA) for ivonescimab in combination with chemotherapy as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC).

The approval, announced in partnership with Summit Therapeutics, represents the third NMPA-approved indication for an ivonescimab-containing regimen in China since the molecule first received regulatory authorization in May 2024.

Approval supported by Phase III data

The latest marketing authorization draws on results from HARMONi-6, a multicentre Phase III clinical trial conducted in China.

Akeso independently generated, managed and analysed the study data.

The trial evaluated ivonescimab combined with platinum-based chemotherapy against tislelizumab, a programmed cell death protein 1 (PD-1) inhibitor, combined with platinum-based chemotherapy.

HARMONi-6 enrolled patients with locally advanced or metastatic squamous NSCLC regardless of their programmed death-ligand 1 (PD-L1) expression status.

The study found that treatment with ivonescimab plus chemotherapy delivered statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) compared with the tislelizumab-based regimen.

According to Akeso and Summit, the safety profile of the combination remained consistent with findings from previous studies evaluating ivonescimab alongside chemotherapy.

Summit highlights survival findings

Summit Therapeutics chairman and co-CEO Bob Duggan said the approval represented another milestone for ivonescimab and highlighted the clinical evidence generated so far.

“HARMONi-6 is the first known Phase III study in NSCLC—or any tumour type—to demonstrate a statistically significant and clinically meaningful overall survival benefit over an anti-PD-(L)1 antibody plus chemotherapy regimen in a head-to-head setting,” Duggan said.

Ivonescimab is an investigational bispecific antibody that targets both vascular endothelial growth factor (VEGF) and PD-1 pathways.

Summit refers to the molecule as SMT112 in territories covered by its licence agreement with Akeso.

Despite its approval in China, ivonescimab remains investigational in the United States and Europe and has not received regulatory approval from authorities in either region.

More than 4,000 patients treated in trials

Akeso said more than 4,000 patients worldwide have received ivonescimab in clinical trials. In China, more than 70,000 patients have received the medicine in commercial use.

The latest approval expands the clinical use of ivonescimab in China and follows previous NMPA authorisations for regimens containing the molecule.

The company continues to evaluate ivonescimab across multiple cancer types and treatment settings through ongoing clinical development programmes.

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