Kaiyue Life Sciences Announces FDA IND Clearance for First-in-Class Small Molecule Targeting RNA Helicase DHX33

After fifteen years of dedicated effort and accumulation in basic research, followed by three years of independent translation of scientific achievements from research institutes to corporate application, Shenzhen Kaiyue Life Technology Co., Ltd. (“Kaiyue Life”) recently announced a milestone achievement in its drug development journey: obtaining clinical trial approval from the U.S. FDA. This marks a breakthrough from zero to one for the company’s globally unique RNA helicase drug target, which has led to the development of a first-in-class (FIC) therapeutic with independent intellectual property rights worldwide for the treatment of broad-spectrum solid tumors.

Based on over a decade of foundational research, Kaiyue Life has developed unique therapeutic targets against specific RNA helicase proteins for cancer treatment. This achievement is internationally leading and original, classified as a Class 1.1 innovative new drug. It represents an original drug target independently developed by Kaiyue Life, spanning ten years from the initiation of basic scientific research to target validation, and two and a half years from Preclinical Candidate (PCC) selection to Investigational New Drug (IND) approval.

Shenzhen Kaiyue Life Technology Co., Ltd. has long been deeply engaged in the field of RNA helicases, serving as a pioneer in RNA helicase research and development. The founding team members have been conducting helicase research since 2008 and have published dozens of high-impact scientific papers to date.

RNA helicases play a crucial role in gene expression in eukaryotes. Their functions are involved in embryonic development, cell proliferation, hematopoiesis, metabolism, cancer, immune regulation, inflammatory responses, and autoimmune diseases. Dysregulation of these enzymes can lead to various human diseases, such as cancer, viral infections, and inflammation. Certain DEAD/H-box proteins are considered potential therapeutic targets for diseases; for instance, inhibitors of eIF4A and DDX3X are currently being developed as novel targeted drugs for the treatment of human cancers. Given the close association between RNA helicases and human diseases, several helicase inhibitors have entered clinical trials as therapeutics for indications including cancer and viral infections.

Dr. Zhang Yandong, Founder of Kaiyue Life, stated that drug development in the field of RNA helicases is gaining momentum. He anticipates that more druggable targets will be discovered and brought to market to address unmet clinical needs. He expressed gratitude to the founding team for their perseverance and courage in overcoming challenges; to investors across all funding rounds for their steadfast support and trust; and to the company’s employees for their dedication, unity, and professionalism. The receipt of Investigational New Drug (IND) approval signifies regulatory recognition of the company’s original research achievements in novel target technologies, and we look forward to advancing our drug candidate into clinical trials as soon as possible. Moving forward, the company will continue to expand its pipeline using self-developed new drugs. By addressing industry pain points, we aim to continuously develop high-quality, affordable, safe, and effective broad-spectrum anti-solid tumor therapeutics, positioning ourselves as pioneers in the field of RNA helicase-targeted drug development.