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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).
Backbone ribbon from PDB 1IGT. RCSB PDB 1IGT. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
No public structure of ivonescimab; representative IgG shown.
Tetravalent PD-1×VEGF-A bispecific with cooperative binding: VEGF binding increases PD-1 affinity, concentrating activity in tumour. Connects to PD-1 and VEGF / VEGFR.
1.Tetravalent antibody binds VEGF-A in the tumour microenvironment
Source: www.akesobio.com. Doses are for orientation; the current label governs.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2022-12-06 | Akeso to Summit Therapeutics Ivonescimab (AK112, SMT112), PD-1 x VEGF bispecific | Licence | $500m | up to $5.0bn | source |
The first head-to-head test of the PD-1 x VEGF bispecific against pembrolizumab in a Western population. Timing is our estimate from the registry record; the sponsor has not given a date. Source
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EGFR-mutant NSCLC after TKI, with chemotherapy (HARMONi-A) source
First-line PD-L1+ NSCLC (HARMONi-2) source
BLA submitted by Summit for EGFR-mutant NSCLC after TKI (HARMONi) source
PDUFA target date source
| 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.
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Query 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.
Shares A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC), An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer, Michelle Xia (Xia Yu), A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC..
Shares A Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and Hig, Paclitaxel Polymeric Micelles Plus Ivonescimab in Recurrent or Refractory SCLC, A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103), AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor.
Shares A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer, A Study of Ivonescimab in First-Line ES-SCLC, Akeso, Triple-negative breast cancer (TNBC).