On September 25, 2024, KeYe Life's KY1 drug received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for gastric cancer, with application number DRU-2024-10300. This is the second orphan drug designation obtained after the approval for hepatocellular carcinoma in July 2024. The research team at KeYe Life found that the DHX33 helicase protein is highly expressed in various gastric cancer tissues and can promote cancer cell proliferation. Currently, there are few targeted drugs for gastric cancer, with nearly 40% of cases being diagnosed at an inoperable stage. Gastric cancer has one of the highest mortality rates among all cancers in China. As a novel treatment approach for gastric cancer, KY1 offers a new perspective and strategy for treatment.