Shanghai Yingli Pharmaceutical announces FDA Orphan Drug Designation for YY-20394 for both indications (FL and CLL/SLL)
Oct. 11, 2018, Shanghai Yingli Pharmaceutical Co., Ltd. (“Yingli Pharma”) announces today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to YY-20394, a novel anti-cancer agent independently developed by Yingli Pharma, in both indications of follicular lymphoma (FL) and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). YY-20394 is a novel selective inhibitor of PI3Kδ (the delta isoform of phosphoinositide 3-kinase). A phase 1 dose escalation trial in patients with relapsed or refractory B-cell malignant hematologic tumors has been completed in China. Initial clinical trials have shown that oral administration of YY-20394 once daily induces significant clinical benefit in patients with relapsed or refractory B-cell hematologic malignancies and demonstrated higher overall response rate and better safety profile as compared to marketed products in the same class.