{"entity":{"id":"pucotenlimab","kind":"drug","name":"Pucotenlimab","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov: trials of Pucotenlimab","url":"https://clinicaltrials.gov/search?intr=HX008"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct05652894"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2, curated)","editedOn":"2026-09-16"},"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":[{"region":"CN","year":2022,"indication":"Previously treated MSI-high or dMMR advanced solid tumours; unresectable or metastatic melanoma after prior therapy"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/pucotenlimab/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"trial":[{"id":"nct05652894","kind":"trial","name":"A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer","route":"/trials/nct05652894/"},{"id":"nct06976190","kind":"trial","name":"A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcin","route":"/trials/nct06976190/"},{"id":"nct07479485","kind":"trial","name":"MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)","route":"/trials/nct07479485/"},{"id":"nct04616443","kind":"trial","name":"OH2 Injection in Combination With HX008 for Melanoma.","route":"/trials/nct04616443/"},{"id":"nct07586124","kind":"trial","name":"Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma","route":"/trials/nct07586124/"}]}}