AKESO (09926) has announced that its independently developed, globally first-in-class bispecific antibody, Ivonescimab (marketed as Yidaifang®), has received approval from the China National Medical Products Administration (NMPA) for a new drug application (sNDA) as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) when combined with chemotherapy. This marks the third approved indication for Ivonescimab.

The approval of this new indication is based on significant positive results from a randomized, controlled, multicenter Phase III clinical trial (HARMONi-6/AK112-306) comparing Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as a first-line treatment for advanced sq-NSCLC. The interim overall survival (OS) analysis results were presented at the 2026 American Society of Clinical Oncology (ASCO) Plenary Session, while the interim progression-free survival (PFS) analysis results were showcased at the 2025 European Society for Medical Oncology (ESMO) Plenary Session.

In the intent-to-treat (ITT) population, the median OS was 27.89 months for the Ivonescimab group versus 23.69 months for the control group, yielding an OS hazard ratio (HR) of 0.66 (95% CI: 0.50–0.87, P=0.0017, below the significance threshold of 0.0049). The median PFS was 11.1 months for the Ivonescimab group versus 6.9 months for the control group, with a PFS HR of 0.60 (95% CI: 0.46–0.78, P<0.0001). The overall safety profile of the Ivonescimab combination was favorable and comparable to that of the tislelizumab combination.

These clinical findings comprehensively demonstrate the transformative clinical value of the Ivonescimab combination regimen over the PD-1 plus chemotherapy regimen, addressing a clinical gap left by the anti-angiogenic agent bevacizumab in sq-NSCLC treatment. The results highlight the excellent efficacy and good safety of Ivonescimab therapy, and with the NMPA approval, it is expected to bring new hope to more patients with advanced squamous NSCLC in China.