复宏汉霖(02696):HLX13一线治疗不可切除的肝细胞癌(HCC)患者的1期临床试验申请获美国FDA批准
Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX13, intended for the first-line treatment of unresectable hepatocellular carcinoma (HCC) patients, and plans to conduct an international multi-center clinical trial in the U.S. once conditions are met [1] Group 1 - The company is focused on developing HLX13, a recombinant anti-CTLA-4 fully human monoclonal antibody injection [1] - The IND application for HLX13 has been approved by the U.S. Food and Drug Administration (FDA) [1] - The company aims to initiate the clinical trial in the U.S. when conditions allow [1]