AKESO (09926.HK): NMPA Approves Third Indication of Ivonescimab (PD-1/VEGF) for First-Line Treatment of Advanced Squamous NSCLC

NewTimeSpace News: On 12 August 2026, Akeso, Inc. (stock code: 09926) voluntarily announced that the supplemental new drug application (sNDA) for the Company's self-developed, first-in-class bispecific antibody Ivonescimab (PD-1/VEGF) in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) has been approved for marketing by the National Medical Products Administration (NMPA). This is the third approved indication of Ivonescimab.

According to the announcement, the approval of the new indication is based on the significant positive results of the randomised, controlled, multi-centre Phase III clinical study (HARMONi-6/AK112-306, NCT05840016, CTR20231272) of Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in the first-line treatment of advanced sq-NSCLC. The positive interim overall survival (OS) results of the study were presented at the Plenary Session of the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; the positive interim progression-free survival (PFS) results were presented at the Plenary Session of the 2025 European Society for Medical Oncology (ESMO) Annual Meeting. In the ITT population, median OS was 27.89 months versus 23.69 months in the Ivonescimab arm and the control arm respectively (HR=0.66, 95% CI: 0.50-0.87, P=0.0017); median PFS was 11.1 months versus 6.9 months (HR=0.60, 95% CI: 0.46-0.78, P<0.0001). The overall safety of Ivonescimab plus chemotherapy was good, with an overall safety profile comparable to tislelizumab plus chemotherapy.

The HARMONi-6 study enrolled 532 subjects, with 92.3% at clinical stage IV and approximately 63% of central-type squamous carcinoma. Ivonescimab is the Company's self-developed, first-in-class PD-1/VEGF bispecific tumour immunotherapy, which received NMPA approval for marketing on 24 May 2024 for EGFR-mutated locally advanced or metastatic non-squamous NSCLC progressing after EGFR-TKI therapy, and a new indication on 25 April 2025 for the first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC; both indications have been included in the latest National Reimbursement Drug List. Ivonescimab has initiated 60 Phase II/III clinical studies across more than 40 indications including lung cancer, biliary tract cancer, head and neck squamous carcinoma, triple-negative breast cancer, colorectal cancer, pancreatic cancer and urothelial cancer; a total of 16 registrational/Phase III studies are currently being advanced, including 6 international multi-centre Phase III studies. The breakthrough clinical value of Ivonescimab has been fully validated in clinical studies and real-world treatment of over 70,000 patients.

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