China's National Medical Products Administration (NMPA) has approved ivonescimab plus chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC), giving Akeso, Inc.'s (HKEX: 9926.HK) PD-1×VEGF bispecific antibody its third lung cancer indication in China.
The approval, which applies regardless of PD-L1 expression, further broadens a franchise that has rapidly expanded since ivonescimab's first Chinese approval in 2024. The antibody was initially cleared for EGFR-mutant non-squamous NSCLC following EGFR tyrosine kinase inhibitor treatment, followed by a first-line monotherapy approval in PD-L1-positive NSCLC in 2025. Ivonescimab is a tetravalent bispecific IgG1 antibody designed to simultaneously block PD-1 and VEGF, combining checkpoint inhibition with anti-angiogenic activity in a single molecule.
The latest approval is based on the 532-patient Phase III HARMONi-6 study, whose efficacy results were previously reported by AllSci. Ivonescimab plus chemotherapy beat tislelizumab plus chemotherapy on both progression-free survival (PFS) and overall survival (OS), reducing the risk of progression or death by 40% and the risk of death by 34%. Median OS was 27.9 months versus 23.7 months (HR=0.66; p=0.0017).
The active-comparator result is significant because ivonescimab did not simply demonstrate activity in a checkpoint-responsive setting, but improved outcomes over an established PD-1-based regimen. It also extends the PD-1×VEGF approach into squamous NSCLC, where conventional VEGF inhibition has historically been difficult to deploy because of bleeding concerns associated with anti-angiogenic therapy.
The approval provides another validation point for Summit Therapeutics (Nasdaq: SMMT), which licensed ivonescimab rights in the US, Canada, Europe, and Japan from Akeso. Ivonescimab's expanding China label strengthens the clinical and regulatory track record behind the asset as the company seeks to translate Akeso's success into Western markets.