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: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.