Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM domain protein (TIGIT), in combination with the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10) and Hanbeitai, a biosimilar of Roche’s Avastin (bevacizumab, HLX04), for the treatment of first-line locally advanced or metastatic hepatocellular carcinoma (HCC).
TIGIT, an immune receptor found on certain T cells and natural killer cells, is anticipated to be effective in cancers such as lung, gastric, melanoma, multiple myeloma, and other solid tumors and hematological malignancies. Pre-clinical studies have demonstrated that HLX53 shows significant tumor inhibition effects with a favorable safety profile.
HanSiZhuang and Hanbeitai are both already commercially available in China, with HanSiZhuang being a PD-1 inhibitor that enhances the immune system’s ability to fight cancer cells, and Hanbeitai being a biosimilar version of the widely used anti-cancer drug Avastin.- Flcube.com
