Gyre Therapeutics' F351 NDA Accepted by China's NMPA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 12 2026
0mins
Gyre Therapeutics announced that the Center for Drug Evaluation, or CDE, of China's National Medical Products Administration, or NMPA, has accepted its new drug application, or NDA, for F351 as a treatment for chronic hepatitis B-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus. The acceptance comes after the NMPA previously granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals. This marks the second major product for which Gyre has submitted an NDA to the NMPA.
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Current: 5.740
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Current: 5.740
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About GYRE
Gyre Therapeutics, Inc. is a biopharmaceutical company 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 controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, and F528. 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. 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 and discovery and development of targeted protein degrader and degrader antibody conjugate therapies.
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.
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- Revenue Growth: The company achieved Q4 revenue of $37.2 million, a 33.5% year-over-year increase, surpassing market expectations by $1.76 million, demonstrating strong product demand and market performance.
- Full-Year Guidance: Gyre provided revenue guidance for 2026 of $100.5 to $111.0 million, reflecting confidence in future growth and offering investors clear financial expectations.
- Market Reaction: Although the EPS fell short of expectations, the robust revenue growth and positive future guidance may alleviate some investor concerns and enhance market confidence in the company.
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See More
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- Priority Review Eligibility: Hydronidone meets the criteria for inclusion in China's Priority Review and Approval Program for Innovative Drugs, which is expected to expedite the approval process and address the urgent market need for anti-fibrotic therapies in China, presenting substantial market potential.
- Significant Market Demand: Approximately 2.6 million patients in China are eligible for anti-fibrotic intervention, and the launch of Hydronidone will fill this critical medical gap, likely enhancing Gyre's market share and revenue significantly.
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See More
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See More
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- Earnings Report: Gyre Therapeutics reported a Q4 GAAP EPS of -$0.02, missing expectations by $0.09, indicating challenges in profitability despite revenue growth.
- Revenue Growth: The company achieved Q4 revenue of $37.2 million, a 33.5% year-over-year increase, surpassing market expectations by $1.76 million, demonstrating strong product demand and market performance.
- Full-Year Guidance: Gyre provided revenue guidance for 2026 of $100.5 to $111.0 million, reflecting confidence in future growth and offering investors clear financial expectations.
- Market Reaction: Although the EPS fell short of expectations, the robust revenue growth and positive future guidance may alleviate some investor concerns and enhance market confidence in the company.
See More
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- Acquisition Details: Gyre Therapeutics announced its acquisition of Cullgen in an all-stock transaction valued at approximately $300 million, with Cullgen set to become a wholly owned subsidiary, and the deal expected to close in early Q2 2026 pending U.S. regulatory approvals.
- Market Reaction: Following the announcement, GYRE's shares rose by 8%, indicating a positive market response to the acquisition, although the stock has lost 22% over the past 12 months, reflecting cautious optimism among investors regarding future growth prospects.
- Challenges for Pulmatrix: Pulmatrix's stock plummeted 36% after the termination of its merger agreement with Cullgen, and the company is now actively seeking alternative merger opportunities, highlighting the uncertainty and pressure faced in the industry consolidation landscape.
- Regulatory Hurdles: Pulmatrix noted that it did not receive the necessary approval from the China Securities Regulatory Commission, which led to the termination of the deal with Cullgen, underscoring the complexities and potential risks associated with cross-border transactions.
See More
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- 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.
See More
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- 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.
See More
Gyre Pharmaceuticals Reaches Pre-NDA Consensus with China's CDE for Hydronidone Approval
- Clinical Data Support: Gyre Pharmaceuticals reached consensus with China's CDE that existing Phase 3 clinical data supports a conditional approval filing for Hydronidone, expected to be submitted in the first half of 2026, marking a significant advancement in the anti-fibrotic treatment space.
- Priority Review Eligibility: Hydronidone meets the criteria for inclusion in China's Priority Review and Approval Program for Innovative Drugs, which is expected to expedite the approval process and address the urgent market need for anti-fibrotic therapies in China, presenting substantial market potential.
- Significant Market Demand: Approximately 2.6 million patients in China are eligible for anti-fibrotic intervention, and the launch of Hydronidone will fill this critical medical gap, likely enhancing Gyre's market share and revenue significantly.
- Follow-up Clinical Trial Plans: The company plans to conduct an additional Phase 3c confirmatory clinical trial to support the transition from conditional approval to regular approval, further solidifying Hydronidone's position in the market.
See More
GYRE THERAPEUTICS, INC. Reports Increase in Q3 Earnings
Earnings Growth: GYRE THERAPEUTICS, INC. reported a profit of $3.61 million for Q3, up from $1.12 million in the same period last year.
Earnings Per Share: The company's earnings per share (EPS) increased to $0.03, compared to $0.01 in the previous year.
Revenue Increase: Revenue for the quarter rose by 19.9% to $30.56 million, up from $25.49 million last year.
Financial Summary: Key financial figures include earnings of $3.61 million, EPS of $0.03, and revenue of $30.56 million, reflecting significant growth year-over-year.
See More
