On February 21, 2025, Shenzhen KeYe Life Technology Co., Ltd. (hereinafter referred to as "KeYe Life") achieved a significant milestone as its second drug candidate, KY2, received an Investigational New Drug (IND) implicit approval from the U.S. Food and Drug Administration (FDA). This approval allows KY2 to proceed with Phase I clinical trials in the United States targeting advanced solid tumors. This marks the second major breakthrough for KeYe Life, following the IND approval of its earlier product, KY1, and represents a significant advancement in the company's long-term commitment to the RNA helicase field and drug development.

KY2 is an orally administered small-molecule drug approved for the treatment of advanced cancers with high expression of the RNA helicase DHX33 protein, particularly in cases where standard therapies have failed. As the world's first original oral small-molecule drug targeting the RNA helicase DHX33, KY2 offers precise treatment and features a longer half-life in vivo. Compared to injectable formulations, oral small-molecule drugs provide better patient compliance and convenience, along with broader market potential.

The development of the KY2 formulation was independently completed by KeYe Life. The FDA's approval of KY2 represents a crucial step forward for KeYe Life toward its goals, with the potential to bring new hope to thousands of patients worldwide seeking innovative cancer treatments. The company plans to focus its resources on conducting clinical trials in the coming years and anticipates that KY2 could become a superior alternative to existing traditional cancer treatments for patients with advanced cancer.