Sino Biopharmaceutical Limited (SINO BIOPHARM, 01177) announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group (CTTQ), has achieved positive interim results from the randomized, double-blind, placebo-controlled, multicenter Phase III study (TQB3454-III-01, NCT05987358) evaluating the IDH1 inhibitor TQB3454 in patients with advanced biliary tract cancer (BTC) harboring IDH1 mutations who had progressed after gemcitabine- and fluorouracil-based therapies.

The Independent Data Monitoring Committee confirmed that both pre-specified primary endpoints—progression-free survival (PFS) and overall survival (OS)—were met, with TQB3454 demonstrating a statistically significant reduction in the risk of disease progression or death versus placebo. Safety findings were consistent with the established risk profile and no new safety signals emerged.

SINO BIOPHARM has obtained written agreement from China’s Center for Drug Evaluation (CDE) to submit a marketing application “shortly.” TQB3454 received CDE Breakthrough Therapeutic Designation in April 2023; the latest data make it the second IDH1 inhibitor worldwide—and the first in China—to achieve a successful Phase III outcome in BTC.

BTC, encompassing cholangiocarcinoma and gallbladder cancer, accounts for roughly 3 % of digestive system tumors. Global incidence exceeded 0.20 million new cases in 2021, and the five-year survival rate remains below 5 %. No IDH1-targeted therapies are currently approved in China, underscoring the potential clinical impact of TQB3454.

Detailed Phase III data are scheduled for presentation at an international academic conference later this year.