FibroGen Simplifies Strategy, Focuses on Pipeline After China Asset Sale

By Patrick Walker

BOSTON – FibroGen, Inc. is undergoing a strategic shift following the completion of its $220 million sale of its China operations to AstraZeneca. The move, designed to fortify the company’s financial position and streamline its focus, marks a significant turning point for the biopharmaceutical firm as it navigates the competitive landscape of cancer and kidney disease treatments.

FibroGen anticipates the deal will extend its cash runway into 2028, providing crucial breathing room to advance its clinical programs, notably the first-in-class antibody-drug conjugate (ADC) FG-3246 and roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). The company has repaid an $81 million term loan facility, simplifying its capital structure, but faces continued financial pressures as indicated by recent analyst assessments.

China Exit and Financial Restructuring

The sale of FibroGen’s China business, encompassing rights to roxadustat in the region, allows AstraZeneca to expand its presence in the lucrative Chinese market. For FibroGen, the decision wasn’t simply about generating revenue; it was about prioritizing programs with the highest potential for success in its core markets. "The transaction allows us to focus on our U.S. and European programs," a source familiar with the company's strategy explained. “It’s about making strategic choices and allocating resources where they can have the greatest impact.”

However, the move isn't without risk. While the extended runway provides stability, some financial analysts express concern about the company’s overall financial health. "While the sale is a positive step, FibroGen still faces financial pressures and the need for future funding rounds to support its clinical programs,” noted one analyst report. "The Altman Z-Score and Piotroski F-Score suggest potential vulnerabilities in the company's operations.”

FG-3246: A Promising First-in-Class ADC

FibroGen is pinning significant hopes on FG-3246, a novel ADC targeting CD46, a protein highly expressed in various cancers, including metastatic castration-resistant prostate cancer (mCRPC). The company initiated a Phase 2 trial of FG-3246 in mCRPC, with an interim analysis expected in the second half of 2026. An investigator-sponsored study combining FG-3246 with enzalutamide, a standard-of-care AR pathway inhibitor, is also underway at UCSF, with topline results anticipated in Q1 2026.

While the ADC space is increasingly competitive, FG-3246 stands out as a first-in-class agent targeting CD46. "There's a lot of excitement around CD46 as a potential target for cancer therapy,” a source close to the UCSF trial explained. “FG-3246 could offer a new approach for patients who have failed other treatments.” The focus on combination therapy with enzalutamide aims to leverage existing therapies and potentially enhance treatment efficacy.

However, navigating the competitive landscape requires demonstrating a clear clinical benefit. Several other ADCs and targeted therapies are in development for prostate cancer, including those targeting PSMA. Demonstrating superior efficacy and safety will be crucial for FG-3246 to gain market share.

Roxadustat: Navigating Regulatory Hurdles

Roxadustat, already approved in several countries for the treatment of anemia associated with chronic kidney disease (CKD), has faced regulatory setbacks in the U.S. The FDA declined to approve the drug in 2021, citing concerns about cardiovascular safety and the need for additional data.

FibroGen is now refocusing its U.S. efforts on developing roxadustat for anemia associated with lower-risk myelodysplastic syndromes (LR-MDS), a patient population with high unmet needs. The company has reached an agreement with the FDA on the design of a pivotal Phase 3 trial, with protocol submission anticipated by the end of 2025.

“The shift to LR-MDS is a strategic move to address a patient population where the benefit-risk profile might be more favorable,” explained a regulatory consultant familiar with the development of anemia therapies. “FibroGen is trying to learn from past setbacks and focus on an indication where roxadustat can have a meaningful impact.”

The success of roxadustat in the U.S. will depend on demonstrating a compelling clinical benefit and addressing previous safety concerns. The FDA’s scrutiny will be intense, and FibroGen will need to present robust data to secure approval.

Looking Ahead

The sale of its China business represents a bold move for FibroGen, allowing the company to streamline its operations and focus on advancing its most promising clinical programs. The next 12-18 months will be critical as the company progresses its Phase 2 trials of FG-3246 and prepares for the pivotal Phase 3 trial of roxadustat in LR-MDS.

While financial challenges remain, the extended cash runway provides a degree of stability. The company's success will ultimately depend on its ability to demonstrate the clinical value of its therapies and navigate the complex regulatory landscape. The coming data readouts from FG-3246 and roxadustat will be closely watched by investors and the broader biopharmaceutical community.