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. [1] Group 1 - HLX13 is a biosimilar of ipilimumab, targeting multiple cancers including melanoma, renal cell carcinoma, colorectal cancer, HCC, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The mechanism of HLX13 involves blocking CTLA-4 to enhance immune response against tumors [2] - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023, and further approvals for other cancers were granted in November 2023 [2] Group 2 - In April 2025, the company signed a licensing agreement with Sandoz AG, granting exclusive rights for the commercialization of HLX13 in the U.S., certain European regions, Japan, Australia, and Canada [2]
复宏汉霖(02696.HK)：伊匹木单抗生物类似药HLX13(重组抗CTLA-4全人单克隆抗体注射液)一线治疗不可切除的肝细胞癌(HCC)患者的临床试验申请获美国FDA批准