TQB-3454

Sino Biopharmaceutical (HKEX: 01177) has submitted TQB3454, an oral IDH1 inhibitor tablet developed by its subsidiary Chia Tai Tianqing Pharmaceutical Group, for priority review by China’s National Medical Products Administration Center for Drug Evaluation, seeking approval in patients with locally advanced, recurrent, or metastatic biliary tract cancer harboring IDH1 mutations who have progressed on gemcitabine- and fluorouracil-based regimens. The CDE’s inclusion of TQB3454 in its priority review and approval procedures follows a breakthrough therapy designation granted to the asset in April 2023. The filing targets a genomically defined second-line population — patients whose tumors carry IDH1 mutations and who have exhausted both gemcitabine- and fluorouracil-based treatment options, a sequencing requirement that positions TQB3454 in a late-line setting where no approved targeted therapy currently exists in China. The company said it expects to present detailed trial data at a major international academic conference before the end of 2026. No PDUFA-equivalent date has been disclosed. The application is supported by the Phase III TQB3454-III-01 trial (NCT05987358), a randomized, double-blind, placebo-controlled, multicenter study in patients with IDH1-mutant advanced biliary tract cancer. The company announced in March 2026 that a pre-specified interim analysis had met both co-primary endpoints — progression-free survival and overall survival — each crossing protocol-defined superiority thresholds. The company said the safety profile was consistent with known risks and that no new safety signals were identified. Quantitative efficacy data, including hazard ratios and p-values, have not yet been publicly disclosed and are expected to be presented at a forthcoming conference. TQB3454 inhibits the mutant IDH1 enzyme, reducing production of the oncometabolite 2-hydroxyglutarate and thereby alleviating the downstream DNA and histone hypermethylation that drives differentiation blockade in IDH1-mutant tumors. The mechanism is shared with ivosidenib (Tibsovo, Servier), which received US FDA approval in August 2021 for previously treated IDH1-mutant cholangiocarcinoma based on the ClarIDHy Phase III trial — the only globally approved IDH1-directed therapy for biliary tract cancer. Ivosidenib has not been approved by the NMPA, leaving Chinese patients without an authorized targeted option in this molecular subgroup. TQB3454 adds to a competitive landscape that includes biomarker-selected agents across multiple targets, including zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) for HER2-positive biliary tract cancer and zenocutuzumab-zbco (Bizengri, Partner Therapeutics) for NRG1 fusion-positive cholangiocarcinoma, both approved by the US FDA. The company described TQB3454-III-01 as the second successful Phase III study of an IDH1 inhibitor in biliary tract cancer globally, and the first conducted in China. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.