Lingzhi Zhiyuan's RAS G12V TCR×CD3 Bispecific ES502 Cleared for Trials in China

Shanghai Lingzhi Zhiyuan Biotechnology's ES502 injection has received implicit clinical trial clearance from China's CDE, clearing it to start trials there. ES502 is described as a first-in-class TCR×CD3 bispecific antibody targeting RAS G12V-mutant peptide-HLA complexes, discovered via the TCM Miner-free TCR Miner platform, recruiting polyclonal T cells to kill RAS G12V-positive solid tumour cells. The clearance follows FDA approval of a Phase I trial in March 2026, advancing dual US-China development.