{"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":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05652894","nct06976190","nct07479485","nct07586124"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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/"}],"company":[{"id":"lepu-biopharma","kind":"company","name":"Lepu Biopharma","route":"/companies/lepu-biopharma/"}],"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":"nct07649980","kind":"trial","name":"Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II","route":"/trials/nct07649980/"},{"id":"nct07105852","kind":"trial","name":"Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma","route":"/trials/nct07105852/"},{"id":"nct07312422","kind":"trial","name":"LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study","route":"/trials/nct07312422/"},{"id":"nct07448142","kind":"trial","name":"Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer","route":"/trials/nct07448142/"},{"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/"},{"id":"nct06770270","kind":"trial","name":"Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)","route":"/trials/nct06770270/"},{"id":"nct06872606","kind":"trial","name":"Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for","route":"/trials/nct06872606/"},{"id":"nct07598318","kind":"trial","name":"Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations","route":"/trials/nct07598318/"},{"id":"nct07514533","kind":"trial","name":"The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma","route":"/trials/nct07514533/"}]}}