Cadonilimab
A Chinese two-armed antibody that blocks PD-1 and CTLA-4 together, approved in China for cervical cancer and extending survival even in PD-L1-negative tumours.
Cadonilimab is Akeso's tetravalent PD-1/CTLA-4 bispecific. NMPA approval June 2022 (second-line cervical cancer, ORR ~33%) and 2024 for first-line combination with chemotherapy ± bevacizumab (COMPASSION-16, OS HR 0.64). Also approved in China for first-line gastric cancer (COMPASSION-15, 2024). Designed for tumour-enriched dual blockade with lower immune toxicity than ipilimumab + nivolumab. It had not been approved in the US or EU by 2026.
1.Two arms bind PD-1 and CTLA-4 on the same exhausted T cell
- Route
- Intravenous
- Schedule
- 10 mg/kg every 3 weeks with platinum-paclitaxel ± bevacizumab
- Monitoring
- Thyroid, liver, glucose, skin; immune-related adverse events
- Medicare
- Not covered (not FDA-approved)
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
- Commercial insurance
- unknown
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: cadonilimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
- 29 Jun 2022ApprovalChina
First PD-1×CTLA-4 bispecific approved anywhere
- Sept 2024ApprovalChina
First-line cervical cancer (COMPASSION-16) source
Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2022 | Recurrent/metastatic cervical cancer after platinum |
| China | 2024 | First-line persistent/recurrent/metastatic cervical cancer with chemotherapy ± bevacizumab; first-line gastric cancer with chemotherapy |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Grade ≥3 treatment-related adverse events | — | 82% |
| Immune-related adverse events, any grade | 52% | — |
COMPASSION-16 cadonilimab arm (mostly chemotherapy-related haematologic). 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Cadonilimab" OR ABSTRACT:"Cadonilimab" OR TITLE:"Kaitanni" OR ABSTRACT:"Kaitanni" OR TITLE:"AK104" OR ABSTRACT:"AK104") 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 Cadonilimab, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductPenpulimab
Shares Akeso, PD-1 / PD-L1 immune checkpoint & T-cell activation, PD-1, Immune checkpoint inhibitors.
- TrialKEYNOTE-006
Shares CTLA-4, PD-1, Immune checkpoint inhibitors.
- TargetVISTA
Shares CTLA-4, PD-1 / PD-L1 immune checkpoint & T-cell activation, PD-1, Immune checkpoint inhibitors.
- InstitutionHunan Cancer Hospital
Shares Cervical cancer, Gastric & gastro-oesophageal junction cancer, Immune checkpoint inhibitors.
- ProductRetifanlimab
Shares PD-1 / PD-L1 immune checkpoint & T-cell activation, PD-1, Immune checkpoint inhibitors.
- InstitutionDartmouth Cancer Center
Shares CTLA-4, PD-1, Immune checkpoint inhibitors.
- PersonPadmanee Sharma
Shares CTLA-4, PD-1, Immune checkpoint inhibitors.
- Key paperHARMONi-2: ivonescimab, a PD-1 x VEGF bispecific, beats pembrolizumab head-to-head in PD-L1-positive lung cancer
Shares Akeso, Bispecific antibodies, PD-1, Immune checkpoint inhibitors.