YH004 is a humanized IgG1 anti-4-1BB agonist. In pre-clinical studies, YH004 has demonstrated a favorable safety and efficacy profile. We have obtained CTN approval from the TGA in June 2021. We are initiating a Phase I clinical trial of YH004 in Australia in the third quarter of 2021. The planned Phase I clinical trial is a first in human, multi-center, open-label, Phase I dose escalation study of YH004, both as a single agent and in combination with toripalimab in subjects with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma.
We are also applying for a Phase I clinical trial of anti-4-1BB YH004 in combination with toripalimab in China. We plan to submit the IND applications to the NMPA in the second half of 2021. Depending on the results of the Phase I clinical trial, we may conduct a Phase II MRCT to evaluate YH004 in combination with anti-PD-1 antibodies for the treatment of solid tumors in China, the United States, Australia, and potentially other countries or regions.