Gyre Therapeutics Announces Alignment with China’s CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting

Rhea-AI Summary

Gyre Therapeutics (Nasdaq: GYRE) completed a Pre-NDA meeting with China’s CDE that agreed existing Phase 3 data for Hydronidone generally support a conditional approval NDA and indicated priority review eligibility, subject to formal filing and review. The Phase 3 topline showed 52.85% of treated patients achieved ≥1-stage fibrosis regression at Week 52 vs 29.84% for placebo (p=0.0002).

The company expects to submit an NDA for conditional approval in the first half of 2026 and will run a confirmatory Phase 3c trial in China to evaluate liver-related clinical outcomes needed to convert conditional approval to regular approval. Hydronidone previously received Breakthrough Therapy designation from the NMPA (March 2021).

Positive

• Phase 3 primary endpoint met: 52.85% vs 29.84% (p=0.0002)
• CDE alignment that data support a conditional approval NDA
• Priority review eligibility indicated by CDE, subject to filing
• Breakthrough Therapy designation granted in March 2021

Negative

• Approval is conditional and requires a confirmatory Phase 3c trial to secure regular approval
• NDA submission timing is subject to final data readiness and regulatory procedures

News Market Reaction – GYRE

+16.30% 1.5x vol

25 alerts

+16.30% News Effect

+9.8% Peak Tracked

-5.6% Trough Tracked

+$107M Valuation Impact

$766M Market Cap

1.5x Rel. Volume

On the day this news was published, GYRE gained 16.30%, reflecting a significant positive market reaction. Argus tracked a peak move of +9.8% during that session. Argus tracked a trough of -5.6% from its starting point during tracking. Our momentum scanner triggered 25 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $107M to the company's valuation, bringing the market cap to $766M at that time. Trading volume was above average at 1.5x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Fibrosis regression rate: 52.85% Placebo regression rate: 29.84% P-value: p=0.0002 +5 more

8 metrics

Fibrosis regression rate 52.85% Phase 3 Hydronidone, treated patients with ≥1-stage regression at Week 52

Placebo regression rate 29.84% Phase 3 Hydronidone, placebo group ≥1-stage regression at Week 52

P-value p=0.0002 Primary endpoint of Phase 3 Hydronidone liver fibrosis trial

Assessment timepoint Week 52 Duration before evaluating fibrosis regression in Phase 3 trial

Breakthrough Therapy date March 2021 NMPA Breakthrough Therapy Designation for Hydronidone

Planned NDA timing First half of 2026 Target submission window for conditional approval NDA in China

Phase 3c trial Confirmatory trial Planned liver-outcome trial to support conversion to regular approval

Disease setting CHB-associated liver fibrosis including compensated cirrhosis Target population for Hydronidone in China

Market Reality Check

Price: $8.28 Vol: Ahead of this positive re...

low vol

$8.28 Last Close

Volume Ahead of this positive regulatory update, volume 60,795 was below the 20-day average of 92,807. low

Technical Shares at $6.81 were trading below the $8.06 200-day moving average, near the 52-week low of $6.11 and well under the $13.75 52-week high.

Peers on Argus

GYRE was down 3.54% while close biotech peers were mixed: AVBP +2.72%, GHRS +3.4...

1 Up

GYRE was down 3.54% while close biotech peers were mixed: AVBP +2.72%, GHRS +3.44%, IMTX -0.57%, KALV -4.45%, MNMD +1.04%. GHRS also appeared in momentum scanners with a 16.3100004196167% move on FDA-related clinical news, suggesting stock-specific catalysts rather than a broad sector shift.

Common Catalyst Both GYRE and GHRS reported regulatory and late-stage clinical developments, highlighting ongoing focus on advanced trial progress and regulatory interactions in biotech.

Historical Context

5 past events · Latest: Nov 07 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 07	Earnings update	Negative	-1.8%	Q3 2025 results with guidance cut despite revenue and income growth.
Oct 15	Clinical trial progress	Positive	+10.7%	Completion of enrollment in 52-week Phase 3 pirfenidone pneumoconiosis trial.
Oct 14	Clinical data presentation	Positive	-4.5%	Announcement of positive Phase 3 Hydronidone liver fibrosis results for AASLD.
Sep 05	Conference participation	Positive	+2.6%	Participation in H.C. Wainwright investment conference with company presentation.
Aug 22	Management change	Positive	+8.3%	Appointment of experienced clinical trials executive Dan Weng to board.

Pattern Detected

Positive clinical milestones often drew strong reactions, but one prior positive Hydronidone update saw a share price decline, indicating occasional divergence between data quality and near-term trading.

Recent Company History

Over the last six months, Gyre advanced both its commercial and clinical profile. On Aug 11, 2025 and Nov 7, 2025, filings and earnings highlighted growing revenue, continued profitability and added product launches. Clinically, a Phase 3 pirfenidone trial for pneumoconiosis completed enrollment of 272 patients on Oct 15, 2025, and positive Phase 3 Hydronidone liver fibrosis data were featured at AASLD on Nov 7, 2025. Board and leadership changes in August 2025 added experienced clinical and regulatory expertise. Today’s CDE alignment builds directly on the previously disclosed positive Phase 3 Hydronidone results and China-focused strategy.

Market Pulse Summary

The stock surged +16.3% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +16.3% in the session following this news. A strong positive reaction aligns with the clear regulatory progress signaled by CDE support for a conditional approval NDA and priority review eligibility for Hydronidone. The move would also fit prior strong responses to clinical milestones, such as the double‑digit gain after Phase 3 pirfenidone enrollment completion. However, past divergence after positive Hydronidone data and the need for a confirmatory Phase 3c outcomes trial highlight that regulatory and clinical execution risks could still temper longer‑term gains.

Key Terms

pre-nda, new drug application, conditional approval, priority review, +4 more

8 terms

pre-nda regulatory

"completed a Pre–New Drug Application (Pre-NDA) communication meeting with the Center"

A "pre-nda" is an early-stage agreement where parties share confidential information before fully committing to a deal or partnership. It acts like a promise to keep shared details private, allowing them to explore opportunities safely. For investors, it signals serious interest and helps ensure that sensitive information remains protected as discussions progress.

new drug application regulatory

"plans to submit an NDA in the first half of 2026 and conduct"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

conditional approval regulatory

"data support a conditional approval filing for Hydronidone and priority review"

Conditional approval is a formal confirmation that a product or plan is permitted to proceed, provided certain specified requirements are met within a designated timeframe. For investors, it signals that approval is nearly complete but depends on the fulfillment of specific conditions, which could influence the final outcome or timeline. This status helps stakeholders assess the likelihood of success while identifying any remaining hurdles.

priority review regulatory

"support a conditional approval filing for Hydronidone and priority review eligibility"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

breakthrough therapy designation regulatory

"The NMPA previously granted Hydronidone Breakthrough Therapy Designation in March 2021"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

ishak fibrosis score medical

"liver fibrosis as measured by the Ishak fibrosis score, are generally supportive"

A clinical scale that grades how much scarring (fibrosis) is in the liver, usually on a numeric scale from 0 (no scarring) to 6 (severe scarring/cirrhosis). Investors care because changes in the Ishak fibrosis score are commonly used as a clear measure of a drug’s effectiveness and disease progression in trials, which can affect a therapy’s regulatory approval chances, market potential and valuation—much like a vehicle’s inspection score affects its resale value.

chronic hepatitis b medical

"for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis"

Chronic hepatitis B is a long-term viral infection of the liver where the hepatitis B virus persists and causes ongoing liver inflammation and damage, like a smoldering fire that can slowly weaken the organ over years. It matters to investors because it defines a steady, large market for treatments and diagnostics, shapes regulatory and clinical trial risks, and influences healthcare costs and the potential value of companies developing new therapies.

anti-fibrotic therapy medical

"Hydronidone, the Company’s first-in-class anti-fibrotic therapy"

Anti-fibrotic therapy is a medical treatment designed to prevent, slow or reverse fibrosis — the build-up of scar-like tissue that stiffens organs and impairs function. For investors, these therapies matter because they target diseases with chronic, often progressive damage (like lungs, liver, or heart), offering potential for large unmet medical need and commercial opportunity if shown to improve long-term outcomes; think of it as medicines that soften a stiffened engine to restore performance.

AI-generated analysis. Not financial advice.

• Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE, which agreed that the existing Phase 3 clinical data support a conditional approval filing for Hydronidone and priority review eligibility, subject to formal approval.
• Gyre Pharmaceuticals plans to submit an NDA in the first half of 2026 and conduct a confirmatory clinical trial to support full approval in China.

SAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that its majority-owned subsidiary in China, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), completed a Pre–New Drug Application (Pre-NDA) communication meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) 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 (CHB)-associated liver fibrosis, including early (compensated) 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 previously disclosed on May 22, 2025, Gyre reported topline results from its Phase 3 trial in CHB-associated liver fibrosis demonstrating that Hydronidone met its primary endpoint, with 52.85% of treated patients achieving ≥1-stage fibrosis regression at Week 52, compared with 29.84% in the placebo group (p=0.0002), based on centralized, blinded Ishak histologic assessment. The trial also achieved a key secondary endpoint evaluating improvement in liver inflammation without fibrosis progression and demonstrated a favorable safety profile consistent with prior clinical experience.

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.

“Hydronidone addresses a significant unmet medical need in patients with CHB-associated liver fibrosis, for whom there are currently no approved anti-fibrotic therapies,” said Ping Zhang, Interim Chief Executive Officer of Gyre. “We are encouraged by the positive and constructive Pre-NDA dialogue with the CDE and the alignment achieved on a clear regulatory pathway. This milestone reflects the strength of our Phase 3 clinical data and supports our plans to advance Hydronidone toward conditional approval in China.”

About Hydronidone

Hydronidone is a novel, orally administered anti-fibrotic agent designed to target key liver fibrosis pathways. It attenuates hepatic stellate cell activation and fibrogenesis, at least in part, by suppressing TGF-β1-induced signal transduction, including reduced p38γ phosphorylation and upregulated Smad7 expression. This upregulation of Smad7 subsequently leads to downregulation of TGF-βRI and inhibition of Smad2/3 activation, thereby disrupting canonical TGF-β/Smad signaling and reducing fibrotic gene expression in HSCs.

The drug has completed Phase 3 clinical evaluation in China for CHB-associated liver fibrosis, including early (compensated) cirrhosis, and is being evaluated for its potential applicability across additional fibrotic diseases in region-specific development programs.

About the CHB Fibrosis Market in China

CHB-associated liver fibrosis represents a significant unmet medical need in China. According to China’s national hepatitis B serological survey and internal epidemiological modeling, it is estimated that 60–70 million people in China are infected with hepatitis B virus, of whom approximately 14.7 million are diagnosed. Among these patients, an estimated 2.6 million have diagnosed, compensated, clinically significant liver fibrosis (F2–F4), excluding decompensated cirrhosis, and may be eligible for anti-fibrotic intervention.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY^® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of the third quarter of 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and the timing of expected clinical readouts and regulatory filings, including the anticipated timing of the filing of Gyre’s NDA with the NMPA for the conditional approval of Hydronidone for the treatment of CHB-associated liver fibrosis and early cirrhosis and the initiation of the confirmatory Phase 3c clinical trial of Hydronidone to support full approval in China. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

For Investors:
David Zhang, Chief Business Officer
david.zhang@gyretx.com 

FAQ

What did Gyre (GYRE) announce about Hydronidone on January 5, 2026?

Gyre announced CDE alignment that existing Phase 3 data generally support a conditional approval NDA and indicated priority review eligibility, with an NDA expected in H1 2026.

What were the Phase 3 topline results for Hydronidone reported by Gyre?

Hydronidone met the primary endpoint: 52.85% of treated patients had ≥1-stage fibrosis regression at Week 52 vs 29.84% for placebo (p=0.0002).

When does Gyre expect to submit the NDA for Hydronidone in China (GYRE)?

The company currently expects to submit an NDA for conditional approval in the first half of 2026, subject to final data readiness and regulatory procedures.

What regulatory steps are required after conditional approval for Hydronidone (GYRE)?

Gyre plans a confirmatory Phase 3c trial in China to evaluate liver-related clinical outcomes needed to convert conditional approval to regular approval.

Does Hydronidone have any prior regulatory designations in China for GYRE investors to note?

Yes; Hydronidone received Breakthrough Therapy designation from the NMPA in March 2021, which supports priority review eligibility.

How does the CDE decision affect Hydronidone's review timeline for GYRE shareholders?

CDE's agreement on conditional approval support and indicated priority review eligibility could accelerate regulatory review, but final timing depends on formal filing and acceptance.