KeChow Pharma’s chemoprotective agent, HL-003, has received clinical approval from the National Medical Products Administration (NMPA) and will soon enter clinical research in China. 

This Phase I clinical study aims to assess the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of HL-003 in humans. The trial will begin with a dose escalation study in healthy individuals (Phase Ia) and, upon determining a safe dosage, will proceed with safety and efficacy evaluations in chemoradiotherapy patients (Phase Ib).

HL-003 is a small molecule antioxidant designed to efficiently remove excess free radicals in the body. It is intended for use in chemoprotection, addressing conditions such as oral dryness induced by radiotherapy and acute kidney injury caused by chemotherapy in cancer patients. Preclinical studies have demonstrated that oral administration of HL-003 can effectively protect experimental animals from various chemoradiotherapy-induced injuries, exhibiting high activity in vivo, good oral absorption in rats and dogs, and a wide safety margin in animals. To date, no similar orally administered chemoprotective agents are available or pending on the market.

While radiotherapy and chemotherapy remain pivotal in treating malignant tumors, their non-selective nature often leads to significant side effects, adversely affecting patients’ quality of life. One major contributor to tissue and organ damage is the excessive production of reactive oxygen species (ROS). Safe and effective antioxidants offer significant potential in preventing and treating ROS-related conditions.

Dr. Tian Hongqi, Chairman of KeChow Pharma, commented: “The clinical approval of HL-003 expands our clinical pipeline significantly. KeChow Pharma is committed to advancing rapid development, verifying our preclinical findings, and exploring additional indications. We remain dedicated to addressing unmet clinical needs and improving patient outcomes.”

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.