By Fineline Cube 
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to conduct a Phase III clinical study of its Category 1 drug TQB2868. The study will evaluate TQB2868 as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC).
Drug Mechanism
TQB2868 is a PD-1/TGF-β bifunctional fusion protein designed to block the interaction between PD-1 and its ligand PD-L1. This action helps relieve the inhibition of T cells by tumor cells and activates T cell-mediated antitumor responses. Additionally, TQB2868 neutralizes TGF-β signaling, counteracting tumor cell immune escape mechanisms.
Clinical Trial Results
In a Phase II clinical trial, TQB2868 demonstrated significant efficacy when combined with anlotinib and chemotherapy. The regimen achieved a 63.9% objective response rate (ORR), a 100% disease control rate (DCR), and 86% 6-month progression-free survival (PFS). These results highlight the drug’s potential as a first-line treatment for mPDAC.-Fineline Info & Tech