Kaiyue Biopharma’s independently developed small molecule new drug targeting RNA helicase has obtained clinical trial approval (IND) from the US FDA

On October 30, 2023 Shenzhen Kaiyue Life Science Co., Ltd. (hereinafter referred to as "Kaiyue Life"), a world-first RNA helicase drug target, has developed the first-in-class (FIC) drug with independent intellectual property rights worldwide for a wide spectrum of solid tumors, reported the first milestone event in drug development: obtaining clinical trial approval from the US FDA, achieving a leap from zero to one (Press release, KeYe Life Technologies, OCT 30, 2023, View Source;article_id=78 [SID1234644609]).

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Based on more than ten years of basic research, Kaiyue Life has developed a unique target for special RNA helicase proteins as cancer treatment, which is internationally leading and original, and is classified as a Class 1.1 original new drug. This is an original drug target developed by us. It took ten years from the start of basic research to target confirmation, and two and a half years from PCC to IND approval.

Kaiyue Life has been deeply involved in the field of RNA helicase and is a pioneer in the field of RNA helicase research and development. The founder of the team has been engaged in helicase research since 2008 and has published dozens of high-level scientific research papers to date.

RNA helicase plays an important role in the gene expression process of eukaryotes. Its functions involve embryonic development, cell proliferation, hematopoiesis, metabolism, cancer, immune regulation, inflammatory response and autoimmune diseases. Their disorders can cause a variety of human diseases, such as cancer, viral infection, inflammation, etc. Some DEAD/H box proteins are considered to be therapeutic targets for diseases. For example, inhibitors of eIF4A and DDX3X are currently being developed as new targeted drugs for the treatment of human cancer. In view of the close correlation between RNA helicase and human diseases, several helicase inhibitors have entered clinical research as drugs for indications such as tumors and antivirals.

Dr. Zhang Yandong, founder of Kaiyue Life, said: Drug research and development in the field of RNA helicase is in the ascendant.