SBP GROUP (01177.HK): NDA Accepted for Category 1 Innovative Drug IDH1 Inhibitor TQB3454 for Advanced Biliary Tract Cancer

NewTimeSpace News: On 10 July 2026, SBP GROUP (01177.HK) released a voluntary announcement. TQB3454 Tablets, a Category 1 innovative IDH1 inhibitor independently developed by Chia Tai Tianqing, a subsidiary of the Group, has submitted a New Drug Application to the Center for Drug Evaluation of NMPA and received acceptance for the treatment of advanced biliary tract cancer with IDH1 mutations. The product was granted Breakthrough Therapy Designation by CDE in April 2023 and included into the Priority Review and Approval Procedure in May 2026.

TQB3454 specifically inhibits mutant IDH1 enzyme activity, reduces levels of the oncometabolite 2-HG and induces restored normal differentiation in mutated tumour cells. The NDA is supported by a randomised, double-blind, placebo-controlled, multi-centre Phase III study. Results demonstrated TQB3454 significantly reduces risk of disease progression or death, with statistically prolonged progression-free survival and overall survival. This represents the second positive Phase III study of an IDH1 inhibitor for biliary tract cancer worldwide and the first in China. Biliary tract cancer carries a 5-year survival rate below 5%. No drug targeting the same pathway has been approved domestically. The incidence of IDH1 mutations ranges from approximately 4.9% to 20.0% in intrahepatic cholangiocarcinoma.