# Tunlametinib

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

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- 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: CN 2024: Advanced NRAS-mutant melanoma after prior immunotherapy

## Sources

- ClinicalTrials.gov: trials of Tunlametinib: https://clinicaltrials.gov/search?intr=HL-085

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [MEK1/2](https://onco.cc/targets/mek/)
- trials: [Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma](https://onco.cc/trials/nct06008106/), [Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer](https://onco.cc/trials/nct06008119/)

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