Akeso's Ivonescimab Approved for Third Indication: First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
Nashnova编辑部
Akeso's bispecific antibody ivonescimab won NMPA approval for first-line advanced squamous lung cancer, its third approved indication; Phase III data showed overall survival 4.2 months longer than the control arm, filling a long-standing gap in anti-angiogenic treatment for this cancer type.
What exactly was just approved?
Ivonescimab (Yidafang®) plus chemotherapy received NMPA approval for first-line treatment of advanced squamous non-small-cell lung cancer (sqNSCLC).
Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody — a single drug that locks onto both the immune checkpoint and the angiogenesis target simultaneously. This is its third approved indication.
This means → Akeso's indication map around ivonescimab is expanding fast; each new approval raises the drug's commercial ceiling another notch.
What did the Phase III data show?
Approval rests on HARMONi-6 (AK112-306), a Phase III trial. The control arm used tislelizumab — an already-marketed PD-1 monoclonal antibody — plus chemotherapy.
Overall survival (OS, time from treatment start to death): ivonescimab arm 27.89 months vs control 23.69 months, HR = 0.66, P = 0.0017. In plain terms = patients on ivonescimab had a 34% lower risk of death than the control group.
Progression-free survival (PFS, how long tumors stay controlled): ivonescimab arm 11.1 months vs control 6.9 months, HR = 0.60, P < 0.0001 — tumor control lasted more than 4 extra months.
Why does the squamous-lung-cancer indication matter so much?
Squamous lung cancer had a long-standing "treatment no-go zone": bevacizumab — the dominant anti-angiogenic drug — could not be used in squamous patients because of bleeding risk.
Ivonescimab targets the VEGF pathway (the signaling route that feeds tumor blood-vessel growth) through its bispecific mechanism, while maintaining safety comparable to the control arm. This means → it sidesteps bevacizumab's bleeding problem and brings anti-angiogenic therapy into squamous lung cancer for the first time.
This reflects a new balance the bispecific-antibody approach has struck between efficacy and safety, filling a clinical gap that persisted for years.
What comes next?
The clinical data have already been presented at the two top global oncology forums: OS results at the 2026 ASCO plenary, PFS results at the 2025 ESMO plenary — academic validation is in place.
In plain terms = the clinical hurdle is cleared; the next key question is commercialization — whether the survival advantage translates into real market share and prescription volume.
The squamous-lung-cancer patient pool is large, yet it lacked any anti-angiogenic option until now. Ivonescimab faces a niche with virtually no direct competitor.
Content is for reference only, not financial advice.