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 7, 2024
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (858 ) 567-7770
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(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):
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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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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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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) 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.
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On May 8, 2024, GNI Group Ltd., a company incorporated under the laws of Japan with limited liability which holds an indirect controlling interest in Gyre
Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that Gyre Pharmaceuticals Co., Ltd., a company organized under the laws of the People’s Republic of China (“Gyre Pharmaceuticals”), which is the
Company’s majority indirectly owned subsidiary, has entered into a comprehensive agreement with Jiangsu Wangao Pharmaceutical Co., Ltd. (“Jiangsu Wangao”) to acquire the rights to generic drug Nintedanib, a competing drug to ETUARY®.
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 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, regardless of any general incorporation language in such filing.
| Item 8.01 |
Other Events.
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On May 7, 2024, Gyre Pharmaceuticals entered into a comprehensive agreement with Jiangsu Wangao to acquire rights to generic drug Nintedanib, a competing drug to
ETUARY. With this acquisition, Gyre Pharmaceuticals is acquiring a new product approved for the treatment of idiopathic pulmonary fibrosis and expects to provide patients more choices and benefits, leverage its PRC nationwide sales network, and
further enhance Gyre Pharmaceuticals’ leading position in the pulmonary fibrosis market.
Forward-Looking Statements
This report 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 the press release furnished as Exhibit 99.1 and this
Current Report on Form 8-K, including statements concerning expectations regarding Gyre Pharmaceuticals’ position in the pulmonary fibrosis market, expectations regarding annual sales revenue of Nintedanib and the expansion of Gyre
Pharmaceuticals’ portfolio of therapeutic drugs for the treatment of idiopathic pulmonary fibrosis, are forward-looking statements. 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 report. 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 report, including the timeline for centralized procurement of Nintedanib and the risk that expected revenues may not be realized. 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. Additional risks and factors are identified under “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 27, 2024 and subsequent
reports filed with the Securities and Exchange Commission.
| Item 9.01. |
Financial Statements and Exhibits.
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(d) Exhibits. The following exhibits are being furnished herewith:
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Exhibit Number
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Exhibit Title or Description
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Press Release, dated May 8, 2024
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNATURES
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 8, 2024
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By:
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/s/ Ruoyu Chen
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Name:
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Ruoyu Chen
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Title:
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Chief Financial Officer
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Exhibit 99.1
Notification of Conclusion of License Agreement by Gyre Pharmaceuticals Co.
GNI Group (“the Company”) is pleased to announce that Gyre Pharmaceuticals Co. Ltd., aka Beijing Continent Pharmaceuticals Co., Ltd. (“BC”), a
consolidated subsidiary of the Company, has executed a comprehensive agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. to acquire the rights to generic Nintedanib, a competing drug for ETUARY®.
ETUARY®, which is manufactured and marketed by BC, has been growing at a high rate in the past, with sales growing 15-20% annually. In addition,
according to Frost & Sullivan data, the idiopathic pulmonary fibrosis (“IPF”) drug market in the PRC is expected to reach approximately \22.4 billion by 2022 and \127.4 billion by 2031. In the case of overall pulmonary fibrosis drug market, it is
expected to be several times larger than the IPF drug market. Although we have been increasing production and expanding the sales network, we have not been able to fully respond to the rapid growth of the market. Currently, ETUARY® is approved only
for the treatment of IPF among fibrosis, and its Phase 3 trial is ongoing for pulmonary fibrosis associated with other factors. With the conclusion of this agreement, we will
acquire a new product lineup that acts on IPF and other similar diseases and will further enhance our leading position in fibrosis.
IPF is recognized as a rare disease. Therapeutic drugs for rare diseases have stable drug prices, and with this license purchase, if not incorporated
into the centralized purchasing system, we expect annual sales of over \4 billion. ETUARY® is not included in the centralized purchasing system.
We will continue to enhance pipelines for rare disease treatments to offer more options and benefits to patients.
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Outline of the counterparty to this agreement
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(1)
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Name
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Jiangsu Wangao Pharmaceutical Co., Ltd.
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(2)
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Adress
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No. 688 Dinghai Road, Haimen Economic and Technological Development Zone, Nantong, Jiangsu Province
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(3)
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Title and name of the representative
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Junhua Yao
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(4)
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Business
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Research, development and manufacture of pharmaceutical products
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(5)
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Capital stock
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Not available due to confidentiality agreement
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(6)
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Date of Establishment
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2003
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(7)
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Major Shareholders and Shareholding Ratio
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Not available due to confidentiality agreement
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(8)
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The relationship between the counterparty and the Company
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Capital relationships
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Not applicable.
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Human resource relationships
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Not applicable.
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Business relationships
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Not applicable.
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Related Party Status
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Not applicable.
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(9)
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The operating results and financial positions of the counterparty in the last 3 years
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Not available due to confidentiality agreement
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| 2. |
Date
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(1)
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Date of BOD resolution
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May 7, 2024
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(2)
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Date of conclusion
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May 7, 2024
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(3)
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Date of commencement of sales
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To be determined upon consultation between the parties
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| 3. |
Forecasts
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We are currently examining the impact on this fiscal year’s performance and will report the results as soon as they are known.