PJ016

PJ016 is a Class 1 innovative long-acting therapeutic enzyme developed by Chongqing Peg-Bio Biopharm (also known as Paijin Biopharm) for the treatment of advanced solid tumors. It is a PEGylated recombinant human arginase (rhArg) designed to deplete systemic levels of L-arginine. Many solid tumors are arginine-auxotrophic, meaning they lack the enzyme argininosuccinate synthetase 1 (ASS1) and cannot synthesize arginine internally, making them dependent on extracellular arginine for survival and proliferation. By enzymatically converting arginine into L-ornithine and urea, PJ016 starves these tumor cells, leading to metabolic stress, cell cycle arrest, and apoptosis. The drug utilizes Chongqing Peg-Bio's proprietary PEGylation and protein modification platforms to extend its circulating half-life and reduce potential immunogenicity. In November 2024, PJ016 received approval from China's Center for Drug Evaluation (CDE) to commence clinical trials.

Other names

PEGylated recombinant human arginasePEG-rhArg