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Penpulimab is a Chinese PD-1 antibody approved in the US in 2025 for nasopharyngeal carcinoma, the second after toripalimab.
Penpulimab is an IgG1 anti-PD-1 monoclonal antibody engineered so its Fc region does not bind Fc-gamma receptors, avoiding antibody-dependent killing or phagocytosis of the PD-1-positive T cells it is meant to activate. Developed by Akeso (also ivonescimab and cadonilimab), it was first approved in China in 2021 for relapsed or refractory classical Hodgkin lymphoma, later for NPC and NSCLC. The AK105-304 phase 3 trial showed that adding penpulimab to gemcitabine-cisplatin improved progression-free survival in recurrent or metastatic nasopharyngeal carcinoma, and single-agent activity was shown after platinum. The FDA approved it in April 2025 for the first-line combination and for later-line monotherapy, making it the second PD-1 antibody for this cancer in the US after toripalimab. Penpulimab is a checkpoint inhibitor designed to protect the T cells it switches on.
PD-1 blockade with Fc engineered to eliminate FcγR binding, avoiding ADCC/ADCP of PD-1+ T cells. Connects to PD-1.
1.Penpulimab binds PD-1.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Sources: NICE search: penpulimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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| Region | Year | Indication |
|---|---|---|
| CN | 2021 | Relapsed/refractory classical Hodgkin lymphoma; later NPC, NSCLC |
| US | 2025 | Recurrent or metastatic non-keratinising NPC with cisplatin-gemcitabine; monotherapy after platinum and ≥1 other line |
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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.
Shares Michelle Xia (Xia Yu), Akeso, PD-1, Immune checkpoint inhibitors.
Shares Recurrent and metastatic nasopharyngeal carcinoma, Nasopharyngeal carcinoma, PD-1, Immune checkpoint inhibitors.
Shares Michelle Xia (Xia Yu), Akeso, PD-1.
Shares Recurrent and metastatic nasopharyngeal carcinoma, Nasopharyngeal carcinoma, PD-1, Immune checkpoint inhibitors.
Shares Recurrent and metastatic nasopharyngeal carcinoma, Nasopharyngeal carcinoma, Immune checkpoint inhibitors.
Shares Recurrent and metastatic nasopharyngeal carcinoma, Nasopharyngeal carcinoma, Immune checkpoint inhibitors.
Shares Recurrent and metastatic nasopharyngeal carcinoma, Nasopharyngeal carcinoma.
Shares Relapsed and refractory classical Hodgkin lymphoma, Hodgkin lymphoma, Immune checkpoint inhibitors.