Gyre Therapeutics files China NDA for Hydronidone

Gyre Therapeutics, Inc. reported that its majority indirectly owned subsidiary, Gyre Pharmaceuticals Co., Ltd., has submitted a New Drug Application to the Center for Drug Evaluation of China’s National Medical Products Administration for F351 (Hydronidone).

Rhea-AI Filing Summary

Gyre Therapeutics, Inc. reported that its majority indirectly owned subsidiary, Gyre Pharmaceuticals Co., Ltd., has submitted a New Drug Application to the Center for Drug Evaluation of China’s National Medical Products Administration for F351 (Hydronidone). The NDA seeks approval of Hydronidone as a treatment for chronic hepatitis B–induced liver fibrosis.

The filing explains that the submission will first undergo formatting and completeness checks, after which the company expects an acceptance number before the technical review begins. Gyre notes that forward-looking statements about the NDA process are subject to significant risks and uncertainties described in its prior SEC reports.

Positive

• NDA filed for lead asset in China: Gyre’s majority-owned subsidiary has submitted a New Drug Application to China’s CDE for F351 (Hydronidone) to treat chronic hepatitis B–induced liver fibrosis, advancing the lead program from development into the regulatory review phase.

Negative

• None.

Insights

Biotech regulatory and pipeline analyst

NDA submission in China moves Gyre’s lead liver-fibrosis drug into regulatory review.

Gyre Therapeutics states that its subsidiary has filed a New Drug Application with China’s CDE for F351 (Hydronidone) in chronic hepatitis B–induced liver fibrosis. This is a key transition from development to the regulatory phase for the company’s lead product candidate.

The process described includes initial formatting and completeness checks, followed by issuance of an acceptance number and a technical review. Outcomes, timelines, and any approval are not indicated and remain uncertain, with the company pointing to risk factors in its prior SEC reports.

The central item to track from this disclosure is the CDE’s acceptance of the NDA and progression into full technical review, as referenced by the anticipated acceptance number following the initial verification stage.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Gyre Therapeutics (GYRE) announce regarding F351 (Hydronidone)?

Gyre Therapeutics announced that its majority indirectly owned subsidiary submitted a New Drug Application to China’s CDE for F351 (Hydronidone). The NDA seeks approval to treat chronic hepatitis B–induced liver fibrosis, moving the company’s lead product candidate into the formal Chinese regulatory review pathway.

Which regulatory authority is reviewing Gyre Therapeutics’ NDA for Hydronidone?

The New Drug Application for Hydronidone was submitted to the Center for Drug Evaluation of China’s National Medical Products Administration. This authority will first check formatting and completeness, then assign an acceptance number before starting its technical review of the chronic hepatitis B–induced liver fibrosis indication.

What condition would Hydronidone from Gyre Therapeutics (GYRE) treat if approved?

Hydronidone (F351) is being reviewed for the treatment of chronic hepatitis B–induced liver fibrosis. The filing emphasizes this as the lead product candidate’s target indication in China, highlighting liver fibrosis that specifically results from chronic hepatitis B infection in affected patients.

What are the next steps after Gyre Therapeutics’ NDA submission in China?

After submission, the NDA undergoes formatting and completeness checks, with Gyre expecting an acceptance number from the CDE. Once issued, the CDE plans to initiate its technical review process, although the timing and ultimate outcome are not detailed and remain subject to regulatory discretion.

Does Gyre Therapeutics (GYRE) highlight risks related to its Hydronidone NDA?

Yes. The company notes that forward-looking statements about the NDA and potential acceptance are subject to material risks and uncertainties. It directs readers to the risk factors in its latest Form 10-K and subsequent Form 10-Q filings for more detail on regulatory and development risks.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Accepted by SEC EDGAR 03/23/2026 - 07:51 AM EDT Learn about SEC filing dates

false0001124105NASDAQ00011241052026-03-222026-03-22

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): March 22, 2026

Gyre Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	000-51173	56-2020050
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

12770 High Bluff Drive Suite 150 San Diego, CA		92130
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 567-7770

N/A

(Former name or former address, if changed since last report)

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):

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock		GYRE		The Nasdaq Capital Market

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) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 8.01 Other Events.

On March 22, 2026, Gyre Pharmaceuticals Co., Ltd., Gyre Therapeutics, Inc.’s (the “Company”) majority indirectly owned subsidiary, submitted its New Drug Application (the “NDA”) to the Center for Drug Evaluation (the “CDE”) of China’s National Medical Products Administration for F351 (Hydronidone), the Company’s lead product candidate, for the treatment of chronic hepatitis B (“CHB”)-induced liver fibrosis. The submission of the NDA will be subject to initial formatting and completeness verification, and the Company plans to work with the CDE to submit any supplementary materials, if requested by the CDE. Thereafter, the CDE is anticipated to issue to the Company an acceptance number before initiating its technical review process.

Forward Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the Company’s submission of supplementary materials, if requested by the CDE; and the CDE’s issuance of an acceptance number for the Company’s NDA for Hydronidone for the treatment of CHB-induced liver fibrosis. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, its clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. The Company may not actually achieve the forecasts disclosed in its forward-looking statements, and you should not place undue reliance on forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”), as supplemented by its Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the Company, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

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.

	GYRE THERAPEUTICS, INC.
Date: March 23, 2026	By:	/s/ Ruoyu Chen
	Name:	Ruoyu Chen
	Title:	Chief Financial Officer

Filing Exhibits & Attachments

3 documents

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.8 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 21.5 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 15.7 KB