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Research record

Tunlametinib / HL-085

A MEK-targeting medicine to discuss only in a China-connected NRAS-mutant melanoma situation, especially after PD-1/PD-L1 treatment has stopped working.

What this is

A MEK-targeting medicine to discuss only in a China-connected NRAS-mutant melanoma situation, especially after PD-1/PD-L1 treatment has stopped working.

Why it may come up

  • melanoma that has spread or cannot be removed easily
  • after a PD-1 or PD-L1 immune treatment stopped working

What not to assume

  • No dosage guidance in public UI.
  • Do not call tunlametinib globally approved.
  • Do not call tunlametinib plus nivolumab standard care without a source.

At a glance

Tunlametinib / HL-085

Approved in some placesWhere it is available depends on the country.
Type
Targeted therapy
Mutation result
NRAS
Where
China
Evidence status
Conditionally approved
Last checked
2026-05-20

What we know

  • Official NMPA English page is the primary availability source.
  • ClinicalTrials.gov records support HL-085/tunlametinib melanoma trial context.
  • Exact tunlametinib plus nivolumab melanoma trial remains unresolved.

What is unclear

  • No dosage guidance in public UI.
  • Do not call tunlametinib globally approved.
  • Do not call tunlametinib plus nivolumab standard care without a source.

Questions to ask

  • Is this exactly tunlametinib / HL-085 / 妥拉美替尼 / 科露平?
  • Is it being used under China approval, a trial, local protocol, or off-label combination practice?
  • Would prior MEK-inhibitor exposure affect whether later trials fit?

Timeline

  1. trial2019: HL-085 phase I/II trial record

    ClinicalTrials.gov record for HL-085 in NRAS-mutant advanced melanoma.

  2. publication2023: Phase I publication

    Peer-reviewed publication of first-in-human selective MEK inhibitor HL-085 study.

  3. trial2023: Phase III comparator trial

    Tunlametinib versus investigator-chosen chemotherapy after prior immunotherapy.

  4. approval2024: China NMPA conditional approval

    Conditional marketing approval in China after anti-PD-1/PD-L1 failure.

  5. research-gap2026: Tunlametinib + nivolumab lead remains unresolved

    No exact melanoma trial record found yet for this specific combination.

Related trial leads

NCT03973151

Study of HL-085 in NRAS Mutant Advanced Melanoma

Primary early clinical trial record for HL-085/tunlametinib in NRAS-mutant melanoma that has spread or cannot be removed easily.

This record is not the exact tunlametinib plus nivolumab combination remembered by the user.

NCT06008106

Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma

Phase III comparator trial after prior immunotherapy; useful for duration-of-response and trial-timing questions.

A trial listing match does not mean the trial fits. The trial team must confirm.

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