An announcement from SBP GROUP (01177) reveals that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has submitted a New Drug Application (NDA) for its self-developed Class 1 innovative drug, TQB3454 tablets (an "IDH1 inhibitor"), to China's Center for Drug Evaluation (CDE). The application has been accepted for review.
The drug is intended for the treatment of advanced biliary tract cancer (BTC) with IDH1 mutations. Due to its significant clinical benefits, TQB3454 was designated as a Breakthrough Therapy by the CDE in April 2023 and was included in the Priority Review and Approval process in May 2026.
TQB3454 is a self-developed IDH1 inhibitor that specifically inhibits the activity of the mutated IDH1 enzyme. This action reduces levels of the downstream oncogenic metabolite 2-HG, reverses the DNA and histone hypermethylation caused by abnormally high 2-HG, restores normal chromatin structure, and thereby induces mutated cells to resume normal differentiation and development, exerting an anti-tumor effect.
This market application is based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (TQB3454-III-01). The study aimed to evaluate the efficacy and safety of TQB3454 in patients with advanced IDH1-mutated biliary tract cancer who had previously failed treatment with gemcitabine and fluorouracil-based regimens.
The study results demonstrated that, compared to a placebo, TQB3454 significantly reduced the risk of disease progression or death in patients. Both progression-free survival (PFS) and overall survival (OS) were significantly extended. The safety profile was consistent with known risks, with no new safety signals identified.
This study represents the second globally and the first in China to report positive Phase III results for an IDH1 inhibitor in the field of biliary tract cancer. Biliary tract cancer primarily includes cholangiocarcinoma (intrahepatic, perihilar, and distal) and gallbladder cancer, accounting for about 3% of all digestive system tumors. It is predominantly adenocarcinoma, highly aggressive, with an extremely poor prognosis and a five-year survival rate of less than 5%.
Globally, the incidence of biliary tract cancer is rising year by year, with the highest rates observed in Asian countries. Among biliary tract malignancies, IDH1 mutations occur mainly in intrahepatic cholangiocarcinoma, with a mutation rate of approximately 4.9% to 20.0%.
Currently, no drugs targeting this specific mechanism are approved in China for the treatment of biliary tract cancer, indicating a significant unmet clinical need. TQB3454 has the potential to address this market gap, offering a new and effective treatment option for Chinese patients with IDH1-mutated biliary tract cancer.
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