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Sino Biopharm says China regulator accepts NDA for TQB3454 IDH1 inhibitor in biliary tract cancer

PUBT·07/10/2026 09:00:17
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Sino Biopharm says China regulator accepts NDA for TQB3454 IDH1 inhibitor in biliary tract cancer
  • Sino Biopharmaceutical’s CTTQ unit won CDE acceptance of a China NDA for TQB3454, an IDH1 inhibitor for IDH1-mutant advanced biliary tract cancer.
  • TQB3454 received CDE Breakthrough Therapy Designation in April 2023; it entered China’s priority review channel in May 2026.
  • The filing was backed by a Phase III trial showing significantly longer progression-free survival, overall survival versus placebo; no new safety signals.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sino Biopharmaceutical Limited published the original content used to generate this news brief via IIS, the regulatory disclosure system operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260710-12240862), on July 10, 2026, and is solely responsible for the information contained therein.