Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug HL-085, aimed at treating advanced melanoma with NRAS mutations in patients who have experienced failure with anti-PD-1/PD-L1 therapies.
HL-085 is a groundbreaking ATP non-competitive MEK inhibitor that specifically targets NRAS mutations by binding to MEK1/2 within the RAS-RAF-MEK-ERK signaling pathway. This mechanism effectively blocks downstream signaling, thereby inhibiting tumor growth. Notably, HL-085 is the world’s first and only approved MEK inhibitor for advanced melanoma with NRAS mutations and represents the first independently developed MEK inhibitor in China. The approval follows a pivotal Phase II regulatory study, which demonstrated a confirmed objective response rate (ORR) of 34.7%, a median progression-free survival (mPFS) of 4.2 months, and a one-year overall survival (OS) rate of 57.2% as of February 19, 2023. Among patients previously treated with immunotherapy, the ORR reached 39.1%.
HL-085 is currently undergoing multiple clinical trials, both as a monotherapy and in combination with other treatments, for advanced melanoma with NRAS mutations, non-small cell lung cancer (NSCLC), metastatic colorectal cancer, and various other solid tumors. Competing MEK inhibitors available in China include Novartis’s Mekinist (trametinib) and AstraZeneca’s Koselugo (selumetinib).- Flcube.com
