OnCo
drugsProductNot mapped hereapproved

Penpulimab

Penpulimab is a Chinese PD-1 antibody approved in the US in 2025 for nasopharyngeal carcinoma, the second after toripalimab.

AK105-304 phase 3: penpulimab plus gemcitabine-cisplatin improved PFS in recurrent/metastatic NPC; single-agent activity after platinum. FDA approval April 2025 for first-line combination and later-line monotherapy. Developed by Akeso (also ivonescimab, cadonilimab).

Schematic of the modality · Anti-PD-1 monoclonal antibody (IgG1, Fc-engineered null) · not a molecule; see the Immune checkpoint inhibitors page
How it works, step by step · animated schematic, not to scale
Immune checkpoint inhibitors
Modality
Anti-PD-1 monoclonal antibody (IgG1, Fc-engineered null)
Mechanism
PD-1 blockade with Fc engineered to eliminate FcγR binding, avoiding ADCC/ADCP of PD-1+ T cells.
Brand / code
Penpulimab-kcqx
Not appraisedSearch NICE
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: penpulimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
CN2021Relapsed/refractory classical Hodgkin lymphoma; later NPC, NSCLC
US2025Recurrent or metastatic non-keratinising NPC with cisplatin-gemcitabine; monotherapy after platinum and ≥1 other line

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
61 studies19 recruiting57 Phase 26 Phase 3
Search “Penpulimab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Penpulimab
intervention: Penpulimab
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Penpulimab" OR ABSTRACT:"Penpulimab" OR TITLE:"Penpulimab-kcqx" OR ABSTRACT:"Penpulimab-kcqx") 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 Penpulimab, not a curated reading list.

Connected

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