Gyre Therapeutics (GYRE) wins NMPA review acceptance for F351 liver fibrosis NDA
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Gyre Therapeutics, Inc. announced that China’s National Medical Products Administration, through its Center for Drug Evaluation, has accepted a New Drug Application for F351 (hydronidone) to treat chronic hepatitis B-induced liver fibrosis. The NDA was submitted via its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd., and follows the product’s earlier priority review status. F351 is Gyre’s lead liver fibrosis candidate and has also been developed for MASH-associated liver fibrosis, with plans to file a U.S. IND by the end of 2026.
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Insights
NMPA NDA acceptance for Gyre’s F351 advances its China liver fibrosis program.
Gyre Therapeutics has achieved acceptance of a New Drug Application for F351 (hydronidone) by the Center for Drug Evaluation of China’s NMPA for chronic hepatitis B-induced liver fibrosis. This follows an earlier priority review designation, which is intended to accelerate the regulatory review process.
F351 is the company’s lead development candidate for liver fibrosis and has shown statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 trial in CHB-associated liver fibrosis in the PRC. It also holds Breakthrough Therapy designation from the CDE as of March 2021.
The company plans to file a U.S. Investigational New Drug application for F351 by the end of 2026, aiming to initiate a Phase 2 trial if the IND becomes effective. As of March 31, 2026, Gyre Therapeutics owns 69.7% of Gyre Pharmaceuticals, so any eventual commercial success in China would be meaningfully attributable to Gyre.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
NDA status: Accepted for review
Breakthrough Therapy designation date: March 2021
Pivotal trial duration: 52 weeks
+4 more
7 metrics
NDA status
Accepted for review
F351 for CHB-induced liver fibrosis by China NMPA CDE
Breakthrough Therapy designation date
March 2021
F351 designation by CDE of the NMPA
Pivotal trial duration
52 weeks
F351 Phase 3 CHB-associated liver fibrosis trial in PRC
Stake in Gyre Pharmaceuticals
69.7% equity interest
As of March 31, 2026
Planned U.S. IND timing
End of 2026
Planned F351 IND filing for MASH-associated fibrosis
Priority review framework start
2017
Establishment of China’s priority review system
ETUARY China approval year
2011
First IPF treatment approval in PRC
Key Terms
New Drug Application, priority review, Breakthrough Therapy designation, Investigational New Drug (IND), +2 more
6 terms
New Drug Application regulatory
"has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment"
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.
priority review regulatory
"the NMPA previously granted priority review status for F351 in March"
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
"F351 received Breakthrough Therapy designation by the CDE of the NMPA 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.
Investigational New Drug (IND) regulatory
"Gyre plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026"
An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.
chronic hepatitis B (CHB)-induced liver fibrosis medical
"for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment"
targeted protein degrader medical
"focused on the discovery and development of targeted protein degrader and degrader-antibody conjugate (DAC) therapies"
A targeted protein degrader is a designed molecule that sticks to a specific disease-related protein and recruits the cell’s natural disposal machinery to remove that protein instead of merely blocking it. Think of it like tagging a broken appliance so the recycling service takes it away rather than just turning it off. For investors, this strategy can open treatments against proteins that were previously hard to drug, creating new commercial opportunities and clear value inflection points tied to clinical progress.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 12, 2026
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Registrant’s telephone number, including area code: (858 ) 284-0115
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)
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Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 |
Regulation FD Disclosure.
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On May 12, 2026, Gyre Therapeutics, Inc. (the “Company”) issued a press release announcing that Gyre Pharmaceuticals Co., Ltd., the Company’s majority
indirectly owned subsidiary, received notification of acceptance of its New Drug Application from the Center for Drug Evaluation of China’s National Medical Products Administration for F351 (Hydronidone), the Company’s lead product candidate, for the
treatment of chronic hepatitis B-induced liver fibrosis.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished
under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor
shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
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Financial Statements and Exhibits
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99.1
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Press Release, dated May 12, 2026
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
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GYRE THERAPEUTICS, INC.
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Date: May 12, 2026
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By:
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/s/ Thomas Eastling
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Name:
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Thomas Eastling
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Chief Financial Officer
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Exhibit 99.1
Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment
San Diego, CA May 12, 2026 – Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage
biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351
(hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). 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 Co., Ltd. (Gyre Pharmaceuticals). This marks the second major product for which
Gyre has submitted an NDA to the NMPA, and is a significant milestone for the Company in the commercialization of a new medication for the treatment of CHB-induced liver fibrosis.
Dr. Ying Luo, President and Chief Executive Officer of Gyre, commented, “This is another
significant achievement for Gyre. This NDA is our third submission accepted for review by the NMPA, and the first one for our F351 program. Our interactions with the CDE have been very positive to date, reinforcing the agency’s support for
addressing the medical need to treat liver fibrosis and the potential of F351 as an innovative therapeutic option. If approved, F351 could address the tens of millions of patients in China with HBV infection, many of whom will develop liver
fibrosis and potentially cirrhosis. We look forward to working closely with CDE to progress F351 towards commercial approval.”
About Priority Review Designation by the NMPA in China
Priority review was established in China in 2017 to facilitate drug registration and accelerate the development of new drugs with clinical value under the
guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval. According to these guidelines, the NMPA will prioritize the review of these applications and allocate additional evaluation resources, which is
expected to accelerate the review process.
About F351 (hydronidone)
F351 is Gyre’s lead development candidate for the treatment of liver fibrosis that is being
developed for two different indications. It is a structurally modified derivative of pirfenidone designed to optimize metabolic properties while targeting the TGF-β1 signaling pathway, a key mediator of
fibrogenesis. Gyre is developing F351 for two primary indications: Chronic hepatitis B (CHB)-associated liver fibrosis in the People’s Republic of China (PRC) and MASH-associated liver
fibrosis initially in the United States.
In the United States, Gyre has completed a Phase 1 clinical trial in healthy volunteers evaluating F351’s safety, tolerability, and PK. Gyre plans to file an
Investigational New Drug (IND) application in the U.S. by the end of 2026, and, if the IND becomes effective, to initiate a Phase 2 clinical trial.
About CHB-Induced Liver Fibrosis
Liver fibrosis is a condition where healthy tissues in the liver become scarred in response to chronic inflammation. If left untreated, it can progress to
cirrhosis—the final, severe stage where extensive scarring permanently distorts the liver’s architecture and significantly impairs its vital functions. Viral hepatitis is estimated to cause up to 50% of fibrosis and 65% of cirrhosis worldwide.
Without intervention, liver fibrosis and cirrhosis typically progress from manageable organ damage to systemic, life-threatening liver failure and hepatocellular carcinoma (HCC). No non-viral directed therapy has been shown to reduce fibrosis in
viral induced hepatitis.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc., 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 over the past several years. In addition, Gyre Pharmaceuticals’ pipeline includes F351 (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. F351 received Breakthrough Therapy designation by the CDE of the NMPA 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 March 31, 2026, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a commercial-stage biopharmaceutical company headquartered in San Diego, CA focused on the development and commercialization of
small-molecule therapeutics with its most advanced programs addressing organ fibrosis and inflammatory diseases.
Gyre’s wholly-owned subsidiary, Cullgen Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein
degrader and degrader-antibody conjugate (DAC) therapies for critical conditions including cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader and DAC product candidates designed to
potently and efficiently eliminate therapeutically relevant proteins in patients.
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 development and commercial potential and potential benefits of F351; the timing and progression of commercial approval of F351; and the timing of Gyre’s IND application in the U.S., and, if the IND becomes
effective, initiation of a Phase 2 clinical trial for F351. 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:
unexpected costs, charges or expenses resulting from the acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the risk that the combined company may not be
able to successfully integrate the businesses and realize the expected benefits of the acquisition in a timely manner or at all; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the
clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional
capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to
realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the
possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for
the year ended December 31, 2025 filed on March 13, 2026, 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.
CONTACTS:
Gyre Therapeutics, Inc.
Thomas Eastling, CFO
ir@gyretx.com
Investors
Chuck Padala
Managing Director, LifeSci Advisors
chuck@lifesciadvisors.com
FAQ
What did Gyre Therapeutics (GYRE) announce about F351 in China?
Gyre Therapeutics announced that China’s NMPA, through its Center for Drug Evaluation, accepted a New Drug Application for F351 to treat chronic hepatitis B-induced liver fibrosis. The NDA was submitted by majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd., marking a key regulatory step toward potential commercialization.
What is F351 (hydronidone) in Gyre Therapeutics’ (GYRE) pipeline?
F351 (hydronidone) is Gyre’s lead development candidate for liver fibrosis. It is a structurally modified derivative of pirfenidone targeting the TGF-β1 signaling pathway, and is being developed for CHB-associated liver fibrosis in China and MASH-associated liver fibrosis initially in the United States.
What prior regulatory designations has F351 received according to Gyre Therapeutics (GYRE)?
F351 previously received priority review status from China’s NMPA after NDA submission and was granted Breakthrough Therapy designation by the CDE in March 2021. These designations are intended to prioritize and accelerate review of drugs with significant clinical value, reflecting regulatory interest in the program.
How much of Gyre Pharmaceuticals does Gyre Therapeutics (GYRE) own?
As of March 31, 2026, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals Co., Ltd. This majority stake means Gyre is positioned to benefit significantly from any future commercial success of products such as F351 and ETUARY in the People’s Republic of China.
What future plans does Gyre Therapeutics (GYRE) have for F351 in the United States?
Gyre plans to file a U.S. Investigational New Drug application for F351 by the end of 2026. If the IND becomes effective, the company intends to initiate a Phase 2 clinical trial evaluating F351 for MASH-associated liver fibrosis, expanding its development beyond China.
What evidence supports F351’s potential in CHB-associated liver fibrosis per Gyre Therapeutics (GYRE)?
Gyre reports that F351 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. This clinical result, alongside Breakthrough Therapy designation, underpins the rationale for the newly accepted NDA in China.