AKESO (09926): The application for the third indication of Yidafang (Ivosidenib, PD-1/VEGF) has been approved by the National Medical Products Administration for first-line treatment of SQ-NSCLC.

AKESO (09926) announced that its independently developed, globally innovative bispecific antibody Iwoshu (PD-1/VEGF) combined with chemotherapy has received approval from the National Medical Products Administration (NMPA) in China for a new drug application (sNDA) as a first-line treatment for advanced squamous non-small cell lung cancer (sqNSCLC). This marks the third indication for which Iwoshu has been approved. The approval for Iwoshu combined with chemotherapy as a new indication for first-line treatment of sq-NSCLC is based on significant positive results obtained from a randomized, controlled, multicenter Phase III clinical study (HARMONi-6/AK112-306, NCT05840016, CTR20231272) comparing Iwoshu combined with chemotherapy to Toripalimab combined with chemotherapy in advanced sqNSCLC. The interim analysis of overall survival (OS) from this study was prominently presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; the interim analysis of progression-free survival (PFS) results was prominently presented at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting: In the intent-to-treat (ITT) population, the median overall survival (OS) for the Iwoshu group was 27.89 months compared to 23.69 months for the control group, with an OS hazard ratio (HR) of 0.66 (95% CI: 0.500.87), P=0.0017 (<0.0049). In the ITT population, the median progression-free survival (m PFS) for the Iwoshu group was 11.1 months, while it was 6.9 months for the control group, with a PFS HR of 0.60 (95% CI: 0.460.78), P<0.0001. The overall safety profile of Iwoshu combined with chemotherapy was good, with safety characteristics comparable to those of Toripalimab combined with chemotherapy. The results of this clinical study comprehensively demonstrate the transformative clinical value of the Iwoshu combined with chemotherapy regimen compared to the PD-1 combined chemotherapy regimen, filling a clinical gap in the treatment of sq-NSCLC with the anti-angiogenic drug Bevacizumab. These results showcase the outstanding efficacy and good safety of the Iwoshu therapy, and with the NMPA's approval, it brings renewed hope to more patients with advanced squamous NSCLC in China.