Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm” or “the Group”, HKEx:00950) is pleased to announce that, on 26 October 2022, AU409, an investigational new drug candidate, drug product manufactured by Zhaoke Pharmaceutical (Guangzhou) Limited (“Zhaoke Guangzhou”), a wholly-owned subsidiary of the Group, has been approved by the United States Food and Drug Administration (“US FDA”) to conduct clinical trial in patients with advanced primary liver cancers or advanced solid tumor with liver predominant metastatic disease in the United States.