KeChow Pharma announced that its MEK inhibitor, HL-085, for treating advanced NRAS-mutant melanoma, has achieved the primary endpoint in a Phase II pivotal registration clinical study. Conducted as a single-arm, multi-center trial, the study demonstrated both the efficacy and controllable safety of HL-085 capsules in patients with this condition. The Company plans to submit a pre-marketing communication application to the Center for Drug Evaluation of the National Medical Products Administration shortly.

Dr. Tian Hongqi, Chairman of KeChow Pharma, commented: “We are extremely proud of the results achieved by Tunlametinib in this pivotal Phase II study. These outcomes are a testament to the KeChow team’s relentless efforts over the years. We remain committed to further exploration and to bringing benefits to patients as quickly as possible.” 

About the Study

The Phase II clinical trial is a single-arm, multi-center study focused on evaluating the efficacy and safety of HL-085 capsules in patients with advanced NRAS-mutant melanoma. The study was led by Professor Guo Jun of Peking University Cancer Hospital and conducted across 20 centers in China. It featured an independent imaging review committee (IRC) to comprehensively assess efficacy. The primary endpoint was the objective response rate (ORR) according to RECIST v1.1 standards, with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), and duration of response (DoR).

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.