KeChow Pharma’s independently developed MEK inhibitor, Tunlametinib (HL-085), in combination with Vemurafenib, was approved by the Center for Drug Evaluation of the National Medical Products Administration for a Phase II registration clinical study on January 6, 2023.
This study focuses on treating unresectable locally advanced or NSCLC with a BRAF V600E mutation, as approved. Following this approval, KeChow Pharma will conduct a single-arm Phase II registration clinical study in China to evaluate the efficacy of Tunlametinib combined with Vemurafenib in NSCLC patients with this specific mutation.
Previous data from the HL-085-102 study on solid tumors with a BRAF V600 mutation indicated that Tunlametinib combined with Vemurafenib exhibited promising anti-tumor efficacy in patients with BRAF V600E-Mutant NSCLC, with manageable adverse events.
About KeChow Pharma
KeChow Pharma is dedicated to developing innovative treatments for tumors, free radical-related diseases, and other therapeutic areas. Its pipeline includes MEK inhibitor, chemoprotective agents, KRASG12C inhibitor, pan-RAF inhibitor, and multiple other tumor-targeted inhibitors. Notably, its MEK inhibitor, Tunlametinib (HL-085), has submitted a new drug application in China and is included in the CSCO guidelines. Another novel drug, a chemoprotective agent, demonstrates superior efficacy and safety compared to current clinical counterparts. All research efforts aim to address unmet clinical needs globally and within China by developing original small molecule drugs with “best-in-class” potential, bridging domestic gaps and fulfilling scientific aspirations to enhance quality of life.