FibroGen Receives Approval for Sale to AstraZeneca, Closing Scheduled for Q3 2025

FibroGen has announced that the China State Administration for Market Regulation has approved the sale of FibroGen International to AstraZeneca. The transaction is expected to close in Q3 2025, subject to other contractual conditions. This development comes after the two companies signed a Share Purchase Agreement on February 20.

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

The deal, which was first announced in February, is expected to close in the third quarter of 2025, subject to other contractual conditions and deliverables. The approval from China's regulatory body is a major step forward, indicating that AstraZeneca will gain regional rights to the oral anemia drug roxadustat in China.

Under the terms of the agreement, AstraZeneca will obtain all rights to roxadustat in China, where the drug is a category leader for treating anemia in chronic kidney disease. This move allows AstraZeneca to expand its foothold in the Chinese market with a strategic asset, while FibroGen will simplify its capital structure and extend its cash runway into 2027 by repaying debt with the proceeds.

FibroGen is a biopharmaceutical company focused on developing therapies for cancer and anemia. Its product roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease 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.

Additionally, FibroGen is developing FG-3246, an antibody-drug conjugate (ADC) targeting CD46 for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker.

The sale is part of a longer-standing partnership between the two companies around roxadustat, which AstraZeneca markets under the brand name Evrenzo in China. The deal reflects AstraZeneca’s confidence in the growth potential of its China business despite recent challenges.

FibroGen's stock has seen a surge of ~13% in the past week, according to InvestingPro data, following the announcement of the regulatory approval. The company's stock price has been volatile, with recent earnings reports highlighting challenges in meeting market expectations.

The transaction is subject to other contractual closing conditions and deliverables, which introduce uncertainty regarding the transaction's successful completion. Concerns about the progress and timing of FibroGen's clinical programs may negatively impact investor confidence and perception of the company's future prospects.

References:

[1] https://www.stocktitan.net/news/FGEN/fibro-gen-announces-approval-of-sale-of-fibro-gen-china-to-astra-cjtyr9k2bufv.html
[2] https://eurasiabusinessnews.com/2025/08/18/china-approves-sale-of-fibrogen-china-to-astrazeneca/
[3] https://www.investing.com/news/company-news/china-approves-fibrogens-sale-to-astrazeneca-closing-expected-in-q3-93CH-4197374
[4] https://www.quiverquant.com/news/FibroGen%2C+Inc.+Announces+Approval+for+Sale+of+FibroGen+China+to+AstraZeneca%2C+On+Track+for+3Q+2025+Closing