# Penpulimab

Source: https://onco.cc/drugs/penpulimab/  
OnCo record `penpulimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Penpulimab-kcqx
- 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.
- Approvals: 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

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Penpulimab
- FDA novel approvals 2025: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025

## Connected records

- cancers: [Hodgkin lymphoma](https://onco.cc/cancers/hodgkin-lymphoma/), [Nasopharyngeal carcinoma](https://onco.cc/cancers/nasopharyngeal/), [Recurrent and metastatic nasopharyngeal carcinoma](https://onco.cc/cancers/recurrent-metastatic-nasopharyngeal-carcinoma/), [Relapsed and refractory classical Hodgkin lymphoma](https://onco.cc/cancers/relapsed-refractory-hodgkin-lymphoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- companies: [Akeso](https://onco.cc/companies/akeso/)
- pathways: [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/)
- trials: [A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs W](https://onco.cc/trials/nct06048315/), [A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma](https://onco.cc/trials/nct04974398/), [Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.](https://onco.cc/trials/nct05862337/), [Clinical Studies for the Treatment of Advanced Solid Tumors](https://onco.cc/trials/nct06825494/), [Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C](https://onco.cc/trials/nct06821503/), [Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (A](https://onco.cc/trials/nct04846634/), [SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer](https://onco.cc/trials/nct05576480/)
- people: [Michelle Xia (Xia Yu)](https://onco.cc/people/xia-michelle/)
- collections: [CSCO guidelines (China)](https://onco.cc/collections/csco-guidelines/)

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