Polaris Group announced the submission to TFDA of the protocol amendment submission of Initial Investigational New Drug Application (IND) for the development of ADI-PEG 20 as a treatment for Hepatocellular Carcinoma (HCC) on 04 May 2023. This is a randomized, double-blinded, multi-center trial, and approximately 300 participants will be randomized in the study. The primary endpoint is OS with PFS as a secondary endpoint.

Planned development stages is Phase 3.