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FibroGen Announces Approval of Sale of FibroGen China to AstraZeneca by the China State Administration for Market Regulation

Key Takeaway: FibroGen, Inc. has received approval from the China State Administration for Market Regulation for the sale of FibroGen International (Hong Kong) Ltd. to AstraZeneca Treasury Limited. The transaction is set to close in the third quarter of 2025, pending other contractual conditions. FibroGen continues to focus on developing novel therapies, including roxadustat and FG-3246.

Market Sentiment Analysis

POSITIVE FACTORS

  • Approval of the sale by the China State Administration for Market Regulation.
  • Transaction expected to close in the third quarter of 2025.
  • FibroGen's ongoing development of innovative therapies.

Full Press Release Details

SAN FRANCISCO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the China State Administration for Market Regulation approved the sale of FibroGen International (Hong Kong) Ltd. to AstraZeneca Treasury Limited, pursuant to the Share Purchase Agreement, dated February 20, 2025.
The closing of the transaction remains subject to other contractual closing conditions and deliverables and remains on track to close in the third quarter of 2025.
About FibroGenFibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visitwww.fibrogen.com.
Forward-Looking StatementsThis release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs. These forward-looking statements include, but are not limited to, statements regarding regulatory interactions, the closing of the sale of FibroGen China, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

For Investor Inquiries:David DeLucia, CFASenior Vice President and Chief Financial Officerir@fibrogen.com

Frequently Asked Questions

What was approved by the China State Administration?

The approval was for the sale of FibroGen International (Hong Kong) Ltd. to AstraZeneca.

When is the transaction expected to close?

The transaction is expected to close in the third quarter of 2025.

What therapies is FibroGen developing?

FibroGen is developing roxadustat for anemia and FG-3246 for prostate cancer.

What is roxadustat approved for?

Roxadustat is approved for treating anemia in chronic kidney disease patients.

Last updated: Aug 18, 2025