KYNTRA BIO, INC.

FibroGen was founded in 1993 by investment banker Thomas B. Neff and Finnish biochemist Kari Kivirikko, a professor at the University of Oulu. The company’s early ambition was to commercialize synthetic collagen for use in plastic surgery. Over time, FibroGen redirected its main focus toward a broader goal: developing medicines that could stimulate red blood cell production for patients suffering from anemia. FibroGen established a Finnish subsidiary, FibroGen Europe Oy, in Oulu in 1996 to develop recombinant collagen technologies, and the subsidiary was briefly considered as a potential IPO candidate in 2000, but it never materialized and the operation eventually became dormant. (The company's early work in recombinant collagen biomaterials would later inform development of corneal regeneration in China in the 2010s and 2020s.)

By the 2000s, FibroGen had gathered momentum around a promising compound that boosted red blood cell production, a drug that would eventually be known as roxadustat. The company signed partnership agreements with Astellas in 2004 and 2006, granting rights in Japan, Europe, and other regions. The 2006 agreement was viewed within the industry as highly favorable to FibroGen.

In the following decade, FibroGen established a partnership with AstraZeneca, which was seeking to rebuild its development pipeline. The 2013 collaboration granted AstraZeneca rights to roxadustat in the United States, China, and other territories not covered by Astellas, setting the stage for the company’s 2014 Nasdaq IPO. By then, FibroGen faced a tightening race, as GlaxoSmithKline ( Daprodustat ) and the Ohio-based startup Akebia Therapeutics ( Vadadustat ) advanced rival HIF-PH inhibitors. But FibroGen retained a crucial lead. In what Fierce Pharma called "a rare event, if not a singular one in the biopharma world," roxadustat became "the first first-in-class drug developed by multinational pharmaceutical companies to be approved in China before the United States, European Union, or Japan" when Chinese regulators gave their approval at the end of 2018, followed by its commercial rollout the next year.

That milestone marked the peak of FibroGen’s ascent. By 2018–19, its market capitalization had reached roughly US$4 billion. Founder Thomas Neff, who had served as CEO and chairman since the company’s inception, lived to see his vision realized with roxadustat’s approval and at the cusp of launch in China before his unexpected death on August 25, 2019. In the years following his passing, the company faced growing management turmoil, fraudulent clinical data, failed trials, and a sharp decline in its fortunes.

In 2021, FibroGen disclosed that efficacy data for roxadustat submitted to the US Food and Drug Administration had been manipulated, prompting regulatory scrutiny and a subsequent rejection of its approval application. Over the next few years, multiple late-stage clinical trials across its pipeline failed, leading the company to significantly reduce its workforce in 2023 and 2024. In July 2024, FibroGen discontinued pamrevlumab following failed trials in pancreatic cancer, triggering further layoffs and a broader restructuring that eliminated most of its US-based staff. In October 2024, the company paid $10 million to terminate its lease for its longtime Mission Bay headquarters, citing the reduced need for office space. Meanwhile, rival Akebia Therapeutics won FDA approval for its competing anemia drug in March 2024, capturing the US market for anemia in dialysis patients with chronic kidney disease.

In August 2025, FibroGen sold its Chinese subsidiary, FibroGen China, to AstraZeneca for approximately US$220 million, including enterprise value and cash held in the country. The total consideration was initially set at around US$160 million when first announced in February 2025 and was revised upward twice (first to US$185 million and then finally to US$220 million) reflecting stronger than expected roxadustat sales in China. The proceeds from the sale was necessary to pay off a loan of approximately US$81 million with Morgan Stanley Tactical Value and to provide the company with a longer financial runway into 2028.

Following the sale of its Chinese subsidiary, FibroGen is now left primarily with FG-3246, an asset it acquired from Fortis Therapeutics, a defunct biotech company, at no upfront cost with a large milestone due only if the drug advances into Phase 3. FibroGen's future largely depends on the development of this unpromising drug.