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

Rhea-AI Summary

FibroGen (NASDAQ: FGEN) has received a crucial regulatory approval from the China State Administration for Market Regulation for the sale of FibroGen International (Hong Kong) Ltd. to AstraZeneca Treasury Limited. This approval marks a significant milestone in the transaction that was initially announced on February 20, 2025.

The deal remains subject to other contractual closing conditions and deliverables, with the transaction expected to close in the third quarter of 2025.

Positive

• Received key regulatory approval from Chinese authorities for the sale
• Transaction remains on schedule for Q3 2025 closing

Negative

• Sale remains subject to additional closing conditions and deliverables

• Sale of FibroGen China remains on track to close in 3Q 2025
  

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 FibroGen
FibroGen, 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 visit www.fibrogen.com.

Forward-Looking Statements
This 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, CFA
Senior Vice President and Chief Financial Officer
ir@fibrogen.com

FAQ

What is the status of FibroGen's sale to AstraZeneca in China?

The sale has received approval from the China State Administration for Market Regulation and is expected to close in Q3 2025, subject to other closing conditions.

When did FibroGen announce the sale agreement with AstraZeneca?

FibroGen announced the Share Purchase Agreement with AstraZeneca Treasury Limited on February 20, 2025.

What regulatory approval did FGEN receive for the AstraZeneca deal?

FibroGen received approval from the China State Administration for Market Regulation for the sale of FibroGen International (Hong Kong) Ltd.

What conditions remain for the FibroGen-AstraZeneca deal to close?

The transaction remains subject to other contractual closing conditions and deliverables, though it's still on track for Q3 2025 closing.