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Sino Biopharmaceutical Wins China Breakthrough Therapy Designation for Two Hepatitis B Drugs

By Public Technologies
  • Sino Biopharmaceutical announced October 27, 2026, that China’s drug regulator granted breakthrough therapy designations to hepatitis B candidates TQ-A3334 and TQA3605.
  • In Phase II, TQA3605 combined with nucleos(t)ide analogues achieved HBV DNA below 20 IU/mL in nearly 90% of patients at week 24.
  • The combination outperformed nucleos(t)ide analogue monotherapy (p<0.0001), supporting TQA3605’s potential for treating low-level viremia.
  • TQ-A3334’s designation rested on Phase II data showing potential improvements in key efficacy endpoints toward a functional cure.
  • TQA3605 has begun Phase III trials; TQ-A3334 is about to enter Phase III.


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-20261027-12383796), on October 26, 2026, and is solely responsible for the information contained therein.

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