<a href="https://laohu8.com/S/GYRE">Gyre Therapeutics</a> Inc. Granted Breakthrough Therapy Designation by China's NMPA for Hydronidone to Treat CHB-associated Liver Fibrosis
Gyre Therapeutics Inc. (Nasdaq: GYRE), a leader in biotechnology focused on organ fibrosis, announced a significant regulatory milestone for its lead compound, Hydronidone. The compound has achieved a breakthrough therapy designation from China's National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B-associated liver fibrosis. This designation supports its potential as a first-in-class therapy for reversing liver fibrosis in CHB patients. Following the successful completion of a pivotal Phase 3 trial in China, Gyre plans to submit a New Drug Application (NDA) to the NMPA in the third quarter of 2025. This development brings Hydronidone a step closer to approval and availability for patients in China, marking a significant advancement in the treatment of liver fibrosis.
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. Gyre Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9456800-en) on May 22, 2025, and is solely responsible for the information contained therein.
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