IND Application for the Clinical Trial of HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the 1L Treatment of Locally Advanced or Metastatic HCC Patients Approved by NMPA

“HLX53 is an anti-TIGIT Fc fusion protein independently developed by Henlius, consisting of variable domain of heavy chain of heavy-chain antibody (VHH) and wildtype IgG1 Fc. Pre-clinical studies have demonstrated that HLX53 exhibits excellent tumour inhibition[11] with good safety. In addition, Henlius has initiated a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HLX53 in patients with advanced or metastatic solid tumours or lymphomas who have no standard therapy or failed the standard therapy. Considering the good efficacy of immune checkpoint inhibitor such as anti-PD-1/PD-L1 antibody plus anti-angiogenic drug in the first-line treatment of patients with advanced HCC, as well as the synergistic effect of TIGIT and PD-1/PD-L1 signaling pathway, Henlius intends to further combine TIGIT inhibitor based on the standard therapy in order to bring greater clinical benefits to patients with advanced HCC.”