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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): January 5, 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 7.01
Regulation FD Disclosure.
 
On January 5, 2026, Gyre Therapeutics, Inc. (the “Company”) issued a press release announcing 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.
 
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.
 
Item 9.01
Financial Statements and Exhibits.
 
(d) Exhibits.
 
EXHIBIT INDEX

Exhibit
No.
  
Description
 
  
 
 
Press Release, dated January 5, 2026
 
  
 
104
  
Cover page interactive data file (embedded within the inline XBRL document)


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: January 5, 2026
By:
/s/ Ping Zhang
 
Name: 
Ping Zhang
 
Title:
Executive Chairman and Interim Chief Executive Officer