{"entity":{"id":"tunlametinib","kind":"drug","name":"Tunlametinib","aka":[],"tldr":"Tunlametinib is a Chinese MEK inhibitor approved in 2024 for advanced melanoma with an NRAS mutation, a group with no targeted therapy elsewhere in the world, and in phase 3 trials with vemurafenib for BRAF-mutant disease and for colorectal cancer.","summary":"Shanghai Kechow Pharma's tunlametinib (HL-085) received NMPA approval in 2024 for advanced NRAS-mutant melanoma after prior immunotherapy, a first for that molecular group. NRAS mutations are common in the acral and mucosal melanomas that predominate in East Asia. Phase 3 trials test tunlametinib with vemurafenib in BRAF V600-mutant melanoma and in combinations for metastatic colorectal cancer.","status":"approved","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov: trials of Tunlametinib","url":"https://clinicaltrials.gov/search?intr=HL-085"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","colorectal"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["mek"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct06008106","nct06008119"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2, curated)","editedOn":"2026-09-16"},"code":"HL-085","modality":"Oral MEK1/2 inhibitor","mechanism":"An allosteric inhibitor of MEK1 and MEK2 that shuts off the MAPK pathway downstream of RAS and RAF, the route NRAS-mutant melanoma depends on.","approvals":[{"region":"CN","year":2024,"indication":"Advanced NRAS-mutant melanoma after prior immunotherapy"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/tunlametinib/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"mek","kind":"target","name":"MEK1/2","route":"/targets/mek/"}],"trial":[{"id":"nct06008106","kind":"trial","name":"Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma","route":"/trials/nct06008106/"},{"id":"nct06008119","kind":"trial","name":"Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer","route":"/trials/nct06008119/"}]}}