Gyre Pharmaceuticals Reaches Pre-NDA Consensus with China's CDE for Hydronidone Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
0mins
Source: Globenewswire
- Clear Regulatory Pathway: Gyre Pharmaceuticals has reached consensus with China's CDE that existing Phase 3 clinical data supports a conditional approval filing for Hydronidone, with plans to submit an NDA in the first half of 2026, marking a significant advancement in the anti-fibrotic treatment landscape.
- Clinical Data Validation: In the Phase 3 trial, Hydronidone demonstrated that 52.85% of patients achieved ≥1-stage fibrosis regression at Week 52, significantly outperforming the placebo group's 29.84% (p=0.0002), establishing a strong foundation for its market potential.
- Priority Review Eligibility: The CDE confirmed that Hydronidone meets the criteria for inclusion in China's Priority Review Program for Innovative Drugs, which is expected to expedite the approval process, enabling the company to quickly capture market share and address urgent patient needs.
- Follow-up Clinical Trial Plans: The company plans to conduct an additional confirmatory clinical trial (Phase 3c) to support the transition from conditional approval to full approval, further solidifying its position in the Chinese market.
Get Free Real-Time Notifications for Any Stock
Monitor tickers like GYRE with instant alerts to capture every critical market movement.
Sign up for free to build your custom watchlist and receive professional-grade stock notifications.
Analyst Views on GYRE
Wall Street analysts forecast GYRE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for GYRE is 19.00 USD with a low forecast of 18.00 USD and a high forecast of 20.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 8.030
Low
18.00
Averages
19.00
High
20.00
Current: 8.030
Low
18.00
Averages
19.00
High
20.00
About GYRE
Gyre Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the United States. It is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230. F351 is a structural derivative of ETUARY. F573 is its clinical-stage product candidate for the treatment of acute/acute-on-chronic liver failure (ALF/ACLF) in Phase 2 clinical trials in the PRC. F528 is a preclinical-stage candidate targeting chronic obstructive pulmonary disease. F230 is a clinical-stage compound for the treatment of pulmonary arterial hypertension. It is focused on commercializing therapies for the treatment of pulmonary fibrosis through its two therapeutic products: ETUARY (pirfenidone) and nintedanib. It is also focused on commercializing the avatrombopag product.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Altimmune Inc Receives FDA Breakthrough Therapy Designation for Pemvidutide, Shares Surge 23.6%
- FDA Certification Impact: Altimmune Inc's Pemvidutide received FDA Breakthrough Therapy Designation, leading to a 23.6% surge in shares to $4.34 on Monday, indicating strong market confidence in its potential efficacy and possibly accelerating its path to market.
- Clinical Progress: GH Research PLC's GH001 lifted from FDA clinical hold saw shares rise 33.8% to $17.72, reflecting significant advancements in drug development that are expected to enhance its competitive position in the market.
- Executive Change: Rayonier Advanced Materials Inc appointed Scott M. Sutton as the new CEO, resulting in a 14.1% increase in shares to $6.68, suggesting that this leadership change could bring new strategic directions and growth opportunities for the company.
- Market Rebound: The overall market showed strong performance with the S&P 500 index rising, reflecting investor optimism about economic recovery, which may drive more capital inflows into the stock market.
Continue Reading
Gyre Pharmaceuticals Reaches Pre-NDA Consensus with China's CDE for Hydronidone Approval
- Clear Regulatory Pathway: Gyre Pharmaceuticals has reached consensus with China's CDE that existing Phase 3 clinical data supports a conditional approval filing for Hydronidone, with plans to submit an NDA in the first half of 2026, marking a significant advancement in the anti-fibrotic treatment landscape.
- Clinical Data Validation: In the Phase 3 trial, Hydronidone demonstrated that 52.85% of patients achieved ≥1-stage fibrosis regression at Week 52, significantly outperforming the placebo group's 29.84% (p=0.0002), establishing a strong foundation for its market potential.
- Priority Review Eligibility: The CDE confirmed that Hydronidone meets the criteria for inclusion in China's Priority Review Program for Innovative Drugs, which is expected to expedite the approval process, enabling the company to quickly capture market share and address urgent patient needs.
- Follow-up Clinical Trial Plans: The company plans to conduct an additional confirmatory clinical trial (Phase 3c) to support the transition from conditional approval to full approval, further solidifying its position in the Chinese market.
Continue Reading