FibroGen (NASDAQ: FGEN) wins China approval to sell FibroGen China to AstraZeneca

Rhea-AI Filing Summary

FibroGen, Inc. announced that Chinese regulators approved the proposed sale of FibroGen International (Hong Kong) Ltd. and its subsidiaries (“FibroGen China”) to AstraZeneca Treasury Limited under a share purchase agreement dated February 20, 2025.

The China State Administration for Market Regulation decided not to prohibit AstraZeneca’s acquisition of FibroGen China, which includes all of FibroGen’s roxadustat assets in China. The transaction is subject to customary closing conditions and deliverables and is expected to close in the third quarter of 2025.

FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd. will sell all issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd. to AstraZeneca, FibroGen’s long-time commercialization partner for roxadustat in greater China and South Korea. FibroGen will retain rights to roxadustat in the United States, Canada, Mexico, and in markets not already held by AstraZeneca or licensed to Astellas Pharma Inc. in Europe, Japan, and certain other territories.

Insights

Biopharma transactions analyst

China clears FibroGen’s sale of its roxadustat China business to AstraZeneca, with closing targeted for Q3 2025.

FibroGen has obtained approval from the China State Administration for Market Regulation for the sale of FibroGen China to AstraZeneca Treasury Limited under a February 20, 2025 share purchase agreement. FibroGen and its subsidiary will transfer all issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd., including all roxadustat assets in China, to AstraZeneca, which has been its long-time commercialization partner for roxadustat in greater China and South Korea.

The deal restructures geographic control of roxadustat: AstraZeneca consolidates ownership of the China business, while FibroGen retains rights in the United States, Canada, Mexico, and other markets not already held by AstraZeneca or licensed to Astellas Pharma Inc. in Europe, Japan, and certain other territories. The transaction still depends on customary closing conditions and deliverables, and is expected to close in the third quarter of 2025, so its ultimate impact will hinge on successful completion and subsequent execution in the remaining territories where FibroGen holds rights.

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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): August 18, 2025

FIBROGEN, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-36740	77-0357827
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
350 Bay Street Suite 100 #6009
San Francisco, California				94133
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 415 978-1200

(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:

☐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, $0.01 par value		FGEN		The Nasdaq Global Select 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 August 18, 2025, FibroGen, Inc. (the “Company”) issued a press release in which the Company announced that it received China regulatory approval for the sale of FibroGen International (Hong Kong) Ltd., (including its subsidiaries, “FibroGen China”) to AstraZeneca Treasury Limited (“AstraZeneca”), pursuant to the Share Purchase Agreement, dated February 20, 2025. After review, the China State Administration for Market Regulation decided not to prohibit the proposed acquisition of FibroGen China by AstraZeneca. The closing of the transaction is subject to customary closing conditions and deliverables, and is expected to close in the third quarter of 2025.

FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd. agreed to sell all of the issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd. (including all of its roxadustat assets in China) to AstraZeneca, the Company’s long-time commercialization partner for roxadustat in greater China and South Korea.

FibroGen will retain the rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas Pharma Inc., our collaboration partner in Europe, Japan, and certain other territories.

A copy of the Company's press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated August 18, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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.

			FIBROGEN, INC.
Date:	August 18, 2025	By:	/s/ John Alden
			John Alden General Counsel

FAQ

What did FibroGen (FGEN) announce in this 8-K filing?

FibroGen announced that it received China regulatory approval for the sale of FibroGen International (Hong Kong) Ltd. and its subsidiaries (“FibroGen China”) to AstraZeneca Treasury Limited under a share purchase agreement dated February 20, 2025.

Which FibroGen assets are included in the sale to AstraZeneca?

The sale includes all issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd. and all of its roxadustat assets in China, which are being sold to AstraZeneca Treasury Limited.

What role does AstraZeneca play in FibroGen’s roxadustat business?

AstraZeneca is described as FibroGen’s long-time commercialization partner for roxadustat in greater China and South Korea, and it is now the buyer of FibroGen China, which holds roxadustat assets in China.

What roxadustat rights will FibroGen keep after the China sale?

FibroGen will retain the rights to roxadustat in the United States, Canada, Mexico, and in all markets not already held by AstraZeneca or licensed to Astellas Pharma Inc., its collaboration partner in Europe, Japan, and certain other territories.

Has the acquisition of FibroGen China by AstraZeneca been fully completed?

Chinese regulators decided not to prohibit the proposed acquisition, but the closing of the transaction remains subject to customary closing conditions and deliverables and is expected to occur in the third quarter of 2025.

Which Chinese regulator reviewed FibroGen’s sale of its China business?

The proposed acquisition of FibroGen China by AstraZeneca was reviewed by the China State Administration for Market Regulation, which decided not to prohibit the transaction.

Where can investors find more details on FibroGen’s announcement?

Additional details are provided in FibroGen’s press release dated August 18, 2025, which is filed as Exhibit 99.1 and incorporated by reference in the 8-K.