Drug intelligence / Profile preview

dalmelitinib

Development stage
Phase 3
Lead developer
Hansoh Pharmaceutical Group
Modality
Small Molecules
Administration
Oral
01

Overview

Dalmelitinib (HS-10241) is an orally active, highly selective small molecule inhibitor of the hepatocyte growth factor receptor (c-Met/HGFR) tyrosine kinase. Developed by Hansoh Pharma, dalmelitinib binds to the ATP-binding region of c-Met, preventing its phosphorylation and disrupting downstream c-Met-dependent signaling pathways, such as AKT and ERK. This inhibition potently suppresses the proliferation of cancer cells harboring MET amplification or MET exon 14-skipping mutations. Dalmelitinib is primarily being developed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification, particularly in combination with the third-generation EGFR tyrosine kinase inhibitor aumolertinib (Ameile) in patients who have progressed on prior EGFR TKI therapy. In February 2026, a New Drug Application (NDA) for the combination of dalmelitinib and aumolertinib was accepted by the National Medical Products Administration (NMPA) of China.

Other names
HS 10241HS10241HS-10241dalmelitinib mesylatedalmelitinib mesylate tablets
02

Targets

MET (Mesenchymal-epithelial transition factor receptor)

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