Gyre Therapeutics Communicates Hydronidone Application with China's Drug Administration
Gyre Therapeutics announced that its majority-owned subsidiary in China, Gyre Pharmaceuticals Co., Ltd., completed a Pre-New Drug Application communication meeting with the Center for Drug Evaluation of China's National Medical Products Administration regarding Hydronidone, the company's first-in-class anti-fibrotic therapy. During the meeting, Gyre Pharmaceuticals and the CDE reached consensus that existing Phase 3 clinical data for Hydronidone, based on histologic improvement in liver fibrosis as measured by the Ishak fibrosis score, are generally supportive of submission of a conditional approval NDA for the treatment of chronic hepatitis B-associated liver fibrosis, including early cirrhosis. The CDE further indicated that Hydronidone meets the criteria for inclusion in China's Priority Review and Approval Program for Innovative Drugs, subject to formal filing, acceptance and regulatory review. The NMPA previously granted Hydronidone Breakthrough Therapy Designation in March 2021, recognizing its potential to address a serious condition with significant unmet medical need. This designation supports eligibility for priority review, which is intended to facilitate an accelerated regulatory review process for innovative therapies. As part of the agreed regulatory pathway, the company plans to conduct an additional confirmatory clinical trial, referred to as a Phase 3c trial in China, designed to evaluate liver-related clinical outcomes to support potential conversion from conditional approval to regular approval. The company currently expects to submit an NDA for conditional approval of Hydronidone in the first half of 2026, subject to final data readiness and applicable regulatory procedures.
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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.
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.
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.
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.
Fresh Strong Sell Stocks for October 17th
Stocks Added to Zacks Rank #5: Gyre Therapeutics, Darling Ingredients, and Cresco Labs have been added to the Zacks Rank #5 (Strong Sell) List due to significant downward revisions in their earnings estimates over the past 60 days.
Investment Opportunities: Despite their current rankings, these stocks were selected by Zacks experts as potential high-growth investments, with previous recommendations achieving substantial gains.
Gyre Therapeutics Emerges as a Notable Player in Liver Fibrosis Drug Development
Gyre Therapeutics Overview: Gyre Therapeutics Inc. is a biopharmaceutical company focusing on organ fibrosis treatments, with its flagship product ETUARY being the first approved treatment for idiopathic pulmonary fibrosis in China.
Financial Performance: The company reported second-quarter sales of $26.78 million, falling short of expectations, but anticipates revenue growth in 2025 driven by new product launches and existing sales.
Hydronidone Development: Gyre's lead asset, hydronidone, has shown promising results in clinical trials for liver fibrosis and is expected to enter Phase 2 assessment in the U.S. by late 2025, with plans for accelerated approval in China.
Market Potential: Analysts predict significant market potential for hydronidone, estimating it could generate approximately $6 billion in annual sales by 2033, similar to the success anticipated for Madrigal Pharmaceuticals' recent liver disease treatment.
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.
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.
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.
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.
Fresh Strong Sell Stocks for October 17th
Stocks Added to Zacks Rank #5: Gyre Therapeutics, Darling Ingredients, and Cresco Labs have been added to the Zacks Rank #5 (Strong Sell) List due to significant downward revisions in their earnings estimates over the past 60 days.
Investment Opportunities: Despite their current rankings, these stocks were selected by Zacks experts as potential high-growth investments, with previous recommendations achieving substantial gains.
Gyre Therapeutics Emerges as a Notable Player in Liver Fibrosis Drug Development
Gyre Therapeutics Overview: Gyre Therapeutics Inc. is a biopharmaceutical company focusing on organ fibrosis treatments, with its flagship product ETUARY being the first approved treatment for idiopathic pulmonary fibrosis in China.
Financial Performance: The company reported second-quarter sales of $26.78 million, falling short of expectations, but anticipates revenue growth in 2025 driven by new product launches and existing sales.
Hydronidone Development: Gyre's lead asset, hydronidone, has shown promising results in clinical trials for liver fibrosis and is expected to enter Phase 2 assessment in the U.S. by late 2025, with plans for accelerated approval in China.
Market Potential: Analysts predict significant market potential for hydronidone, estimating it could generate approximately $6 billion in annual sales by 2033, similar to the success anticipated for Madrigal Pharmaceuticals' recent liver disease treatment.
