On April 4, 2023, the Center for Drug Evaluation of the National Medical Products Administration approved KeChow Pharma’s independently developed MEK inhibitor, Tunlametinib (HL-085) capsules, for use in combination with Vemurafenib to treat BRAF V600E-mutant mCRC. 

Following this approval, KeChow Pharma will initiate a confirmatory Phase III clinical study in China to further evaluate the efficacy and safety of Tunlametinib combined with Vemurafenib in patients with this mutation.

Data from the Phase II single-arm clinical study (HL-085-201) and the early solid tumor study (HL-085-102) demonstrated that Tunlametinib, when used with Vemurafenib, showed promising anti-tumor efficacy in patients with BRAF V600E-mutant mCRC. Additionally, the adverse events observed were manageable and controllable.

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.