Zhengda Tianqing's Class 1 Innovative Drug TQB3454 Achieves Positive Phase III Results in IDH1-Mutant Biliary Tract Cancer

On March 12, Sino Biopharmaceutical Co., Ltd. announced that CHIATAI TIANQING, its subsidiary, had independently developed a Class 1 innovative drug in China.TQB3454(IDH1 Inhibitor)Phase III Clinical Study of Treatment for Advanced Biliary Tract Cancer with IDH1 Mutation Completed Pre-planned Interim Analysis, the Independent Data Monitoring Committee (IDMC) assessed the primary endpointProgression-Free Survival(PFS)、Overall Survival(OS)All reached the pre-set superior efficacy boundary values of the protocol.。

The announcement shows that this isThe 2nd in the world, the 1st in ChinaPhase III Clinical Study of IDH1 Inhibitor Achieves Success in Biliary Tract Cancer.

TQB3454-III-01 Study (NCT05987358) is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial designed to evaluate the efficacy and safety of TQB3454 tablets in patients with advanced biliary tract cancer harboring IDH1 mutations who have failed prior treatment with gemcitabine and fluoropyrimidine-based combination regimens.

The interim analysis results showed that,Compared with the control group, TQB3454 can significantly reduce the risk of disease progression or death in patients with advanced biliary tract cancer, and significantly prolong patients' PFS and OS.Its safety data is consistent with the known risks, and no new safety signals have been identified. CHIATAI TIANQING plans to disclose detailed study data at an authoritative international academic conference to be held this year.

TQB3454 was included in the breakthrough therapy drug program by the CDE in April 2023. CHIATAI TIANQING has communicated with the CDE regarding the marketing application for this indication and received written approval from the CDE.Will submit an application for listing in the near future.

The First IDH1 Inhibitor Approved for Biliary Tract Cancer Worldwide IsIvosidenib (Aivonib), co-developed by Servier and CStone Pharmaceuticals, was approved by the U.S. FDA in 2021. The pipeline under research includesBayer's BAY1436032, Novartis' IDH305, Daiichi Sankyo's DS-1001b, and Chi-Med's HMPL-306, etc.。

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