Akeso has won in China. The FDA is the next test

The technology

Akeso's business rests on bispecific antibodies, single molecules that hit two targets at once. The lead drug, ivonescimab, blocks PD-1, an immune checkpoint, and VEGF, a signal that helps tumors grow blood vessels. Akeso calls it the world's first approved bispecific antibody that combines both mechanisms. Its second big drug, cadonilimab, blocks PD-1 and CTLA-4 and is approved for three indications in gastric and cervical cancer.

The clinical record for ivonescimab now includes several head-to-head survival wins. In HARMONi-2, ivonescimab alone beat pembrolizumab on survival in PD-L1 positive lung cancer, with median overall survival of 30.8 months versus 22.6 months and a hazard ratio of 0.73. In HARMONi-6, ivonescimab plus chemotherapy beat tislelizumab plus chemotherapy in squamous lung cancer with a hazard ratio for death of 0.66. In biliary tract cancer, HARMONi-GI1 met its overall survival endpoint against a durvalumab regimen.

The odds

All of those wins came from trials run in China. That matters because Western regulators judge drugs on global data. Summit Therapeutics licensed ivonescimab for the U.S., Europe, Japan and other regions. Summit's FDA application in EGFR-mutated lung cancer, built on the global HARMONi trial, has a PDUFA goal date of November 14, 2026. An updated HARMONi analysis showed a survival hazard ratio of 0.76 in both Asian and Western patients, per the same Summit report.

Industry data give a frame. The BIO, Informa and QLS study of 2011 to 2020 found that 57.8% of phase 3 programs reach a filing and 90.6% of filings win approval. Ivonescimab is past that stage in China, where it holds three lung cancer approvals. The open question is how well Chinese trial data carry over to Western filings, and that is what the November FDA decision will test.

The money

Akeso reported first-half 2026 product sales of about RMB 1,803.2 million, up 28.7% from a year earlier. Cash, cash equivalents and other short-term financial assets stood at RMB 9,160.0 million on the reporting date. All 12 approved indications of its five self-sold drugs were on China's national reimbursement list by the end of 2025, which Akeso says took effect January 1, 2026.

Outside China, the economics run through Summit. Akeso licensed those rights under an agreement with a total potential value of up to US$5 billion. That makes Summit's ability to fund global trials, and the outcome of its FDA filing, a direct driver of Akeso's Western income.

The risks

Side effects were higher than on pembrolizumab. In an earlier published analysis of HARMONi-2, grade 3 or worse treatment-related adverse events occurred in 29% of ivonescimab patients versus 16% on pembrolizumab, according to Targeted Oncology. In HARMONi-6 the figures were 69.2% versus 58.9% against tislelizumab plus chemotherapy.

Subgroups also vary. In HARMONi-2 the survival hazard ratio was 0.58 in patients with high PD-L1 but 0.85 in the 1% to 49% group, with a confidence interval that crossed 1. Summit's global HARMONi-3 trial in first-line lung cancer will read out its squamous cohort in the second half of 2026, and a miss there would weigh on the global case.

Our read

Akeso has beaten standard drugs head to head on survival several times, and built a growing domestic sales line on top. The China story looks settled. The global story is not, and it depends on a U.S. partner and on whether FDA reviewers accept data that come mostly from Asian patients. The November 14 FDA date and the HARMONi-3 squamous readout will tell investors far more than another China trial win.