By Fineline Cube 
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the completion of first patient dosing in a Phase I/III clinical study for HLX13, a biosimilar of Bristol-Myers Squibb’s (BMS, NYSE: BMY) Yervoy (ipilimumab). The trial is focused on first-line unresectable advanced hepatocellular carcinoma (HCC) in China.
Clinical Study Design
The multi-center, randomized, double-blinded, parallel-controlled Phase I/III study aims to evaluate the pharmacokinetics (PK), efficacy, safety, and immunogenicity similarity of HLX13 compared with Yervoy in naïve unresectable HCC patients.
HLX13 Development and Applications
HLX13 is a cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody (mAb) being developed for the treatment of liver cancer, melanoma, advanced renal cell carcinoma, and metastatic colorectal cancer with highly unstable microsatellite or mismatch repair defect. In April of this year, Henlius Bio entered into a licensing deal with Sandoz (SIX: SDZ), granting the Swiss pharmaceutical company development, manufacturing, and commercialization rights to HLX13 in Australia, Canada, Europe, Japan, and the US.-Fineline Info & Tech