Ivonescimab
A Chinese bispecific that beat Keytruda head-to-head on progression-free survival in lung cancer, the first drug ever to do so.
HARMONi-2 (China): PFS 11.1 vs 5.8 months versus pembrolizumab in PD-L1+ first-line NSCLC. Approved in China (2024) for EGFR-mutant NSCLC after TKI (HARMONi-A) and first-line PD-L1+ NSCLC. Summit Therapeutics holds Western rights; HARMONi (global, EGFR-mutant post-TKI) met PFS but OS was not statistically significant in 2025; HARMONi-3 (squamous and non-squamous first-line) ongoing. Spawned a wave of PD-(L)1×VEGF bispecifics (Pfizer/3SBio, BMS/BioNTech, Merck/LaNova).
No public structure of ivonescimab; representative IgG shown.
1.Tetravalent antibody binds VEGF-A in the tumour microenvironment
- Route
- IV infusion
- Schedule
- 20 mg/kg every 3 weeks (China label; HARMONi-2)
- Dose modifications
- Standard immune-mediated event algorithm plus VEGF-class precautions (bleeding, hypertension, proteinuria)
- Monitoring
- Blood pressure, urine protein, thyroid, LFTs
Source: www.akesobio.com. Doses are for orientation; the current label governs.
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- 24 May 2024ApprovalChina
EGFR-mutant NSCLC after TKI, with chemotherapy (HARMONi-A) source
- Apr 2025ApprovalChina
First-line PD-L1+ NSCLC (HARMONi-2) source
- Jan 2026Filing / dealUS
BLA submitted by Summit for EGFR-mutant NSCLC after TKI (HARMONi) source
- 14 Nov 2026PDUFA dateUS
PDUFA target date source
Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2024 | EGFR-mutant NSCLC after TKI (with chemotherapy); first-line PD-L1+ NSCLC |
| Adverse event |
|---|
| Proteinuria |
| Hypertension |
| Anaemia |
| AST increased |
| Hypothyroidism |
| Haemorrhage (low grade) |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| China | NMPA approved 2024; NRDL inclusion 2025 | not disclosed | — |
| United States | Investigational; BLA under review (PDUFA 14 November 2026) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Ivonescimab" OR ABSTRACT:"Ivonescimab" OR TITLE:"AK112" OR ABSTRACT:"AK112" OR TITLE:"SMT112" OR ABSTRACT:"SMT112") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Ivonescimab, not a curated reading list.
Pages like this
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Shares Angiogenesis, PD-1 blockade + VEGF inhibition, HARMONi-2: ivonescimab, a PD-1 x VEGF bispecific, beats pembrolizumab head-to-head in PD-L1-positive lung cancer, VEGF angiogenesis.