# Pucotenlimab

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

## TL;DR

Pucotenlimab is Lepu Biopharma's PD-1 antibody, approved in China in 2022 for mismatch-repair-deficient solid tumours and for melanoma, and in a phase 3 trial in colorectal cancer.

## Summary

Taizhou Hanzhong (Lepu Biopharma) developed pucotenlimab (HX008), approved by the NMPA in July 2022 for previously treated MSI-high or mismatch-repair-deficient advanced solid tumours, China's first tissue-agnostic PD-1 approval, and for unresectable or metastatic melanoma after prior therapy. A phase 3 trial in metastatic colorectal cancer is registered.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Code: HX008
- Modality: Anti-PD-1 monoclonal antibody, intravenous
- Mechanism: Blocks PD-1 on T cells so tumour cells cannot switch them off through PD-L1.
- Approvals: CN 2022: Previously treated MSI-high or dMMR advanced solid tumours; unresectable or metastatic melanoma after prior therapy

## Sources

- ClinicalTrials.gov: trials of Pucotenlimab: https://clinicaltrials.gov/search?intr=HX008

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- trials: [A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer](https://onco.cc/trials/nct05652894/), [A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcin](https://onco.cc/trials/nct06976190/), [MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)](https://onco.cc/trials/nct07479485/), [OH2 Injection in Combination With HX008 for Melanoma.](https://onco.cc/trials/nct04616443/), [Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma](https://onco.cc/trials/nct07586124/)

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