Core Insights - Company announced the completion of the first patient dosing in a Phase 1 clinical trial for HLX13, a biosimilar of ipilimumab, for the treatment of unresectable hepatocellular carcinoma (HCC) in China [1] - The trial is a multicenter, randomized, double-blind, parallel-controlled study aimed at evaluating the pharmacokinetics, safety, efficacy, and immunogenicity of HLX13 compared to the original drug YERVOY® in previously untreated advanced HCC patients [1][2] - HLX13 is also being developed for multiple indications including melanoma, renal cell carcinoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The global sales of ipilimumab are projected to be approximately $2.873 billion in 2024 [3] Group 1 - HLX13 is a biosimilar of ipilimumab, designed to enhance immune response by blocking CTLA-4, thereby targeting tumors [2] - The Phase 1 trial involves a 1:1 random allocation of participants to receive either HLX13 or YERVOY® combined with OPDIVO® treatment [1] - The primary endpoint of the trial is the area under the concentration-time curve (AUC) from dosing to 21 days post-administration [1] Group 2 - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023 [2] - The company has entered into a licensing agreement with Sandoz AG for the commercialization of HLX13 in the U.S. and select European regions, Japan, Australia, and Canada [2] - The sales figure for ipilimumab indicates a significant market potential for HLX13 as a biosimilar in the oncology sector [3]
复宏汉霖(02696.HK)：伊匹木单抗生物类似药HLX13一线治疗不可切除的肝细胞癌(HCC)患者的国际多中心1期临床研究于中国境内完成首例患者给药