Sino Biopharmaceutical Limited (SBP Group) announced that China’s Center for Drug Evaluation has accepted the New Drug Application (NDA) for TQB3454, an orally administered IDH1 inhibitor developed by subsidiary Chia Tai Tianqing Pharmaceutical Group. The filing seeks approval for use in patients with advanced biliary tract cancer (BTC) harboring IDH1 mutations who have progressed after gemcitabine- and fluoropyrimidine-based regimens.

TQB3454 selectively inhibits mutant IDH1, lowering oncometabolite 2-HG levels, reversing DNA and histone hypermethylation, and restoring normal cellular differentiation pathways to exert anti-tumor effects. The compound previously received Breakthrough Therapy Designation from the CDE in April 2023 and entered Priority Review procedures in May 2026.

The NDA is supported by data from a randomized, double-blind, placebo-controlled, multicenter Phase III study (TQB3454-III-01). In patients with advanced BTC and IDH1 mutations, TQB3454 significantly reduced the risk of disease progression or death versus placebo and delivered statistically significant improvements in both progression-free survival and overall survival. Safety findings were consistent with the known risk profile, and no new safety signals emerged. This study represents the first positive domestic Phase III trial—and only the second globally—for an IDH1 inhibitor in BTC.

BTC, encompassing cholangiocarcinoma and gallbladder carcinoma, accounts for about 3% of all digestive system tumors and carries a 5-year survival rate below 5%. Incidence is rising worldwide, with Asia showing the highest rates. IDH1 mutations are most common in intrahepatic cholangiocarcinoma, occurring in roughly 4.9%–20.0% of cases. No IDH1-targeted therapies are currently approved for BTC in China, positioning TQB3454 to address a significant unmet clinical need.