FibroGen

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FibroGen, Inc. is a biopharmaceutical company headquartered in San Francisco, California. It focuses on the development of drugs to treat anemia, fibrosis, and cancer.

Contents

History

FibroGen was founded in 1993 by investment banker Thomas B. Neff and Finnish biochemist Kari Kivirikko, a professor at the University of Oulu. [1]

The company originally explored supplying synthetic collagen for use in plastic surgery but later abandoned this strategy. [1] FibroGen shifted its focus to the development of drugs that stimulate red blood cell production to treat anemia. [1]

FibroGen went public on the Nasdaq in 2014. In 2019, it was around the peak of its market capitalization of about US$4 billion. [1]

Founder Thomas B. Neff served as chief executive officer from 1993 until his death in 2019. [1]

In September 2025, FibroGen completed the sale of its Chinese subsidiary, FibroGen China, to AstraZeneca. The transaction closed on September 2, 2025, comprising approximately US$85 million in enterprise value plus about US$135 million in net cash held in the China subsidiary, for a total of around US$220 million. Part of the proceeds was used to fully repay its term loan facility to Morgan Stanley Tactical Value for approximately US$81 million, simplifying the company's capital structure and extending its cash runway into 2028. [2]

Products and research

FibroGen's most prominent product candidate is roxadustat, a drug that stimulates the body's production of red blood cells. [1] FibroGen also works on antibody drugs targeting fibrosis and cancer. [1]

Roxadustat received regulatory approval in China in December 2018 and was commercially launched in July 2019. It achieved sales of over 1 billion yuan in 2021 and surpassed 2 billion yuan in 2023, becoming the leading treatment for anemia in patients with chronic kidney disease. [3]

Roxadustat is a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor. Its mechanism was discovered by scientists who later received the Nobel Prize in Physiology or Medicine in 2019. William Kaelin, one of these laureates, has served as chairman of FibroGen's Scientific Advisory Board in the United States. [3] FibroGen's development of Roxadustat began in the early 2000s, initially focused on anti-fibrosis research, but pivoted to anemia after preclinical observations. The compound FG-4592 was selected as the preferred candidate. Key licensing deals include a 2006 agreement with Astellas, valued at $300 million upfront plus milestones and equity, and a 2013 strategic agreement with AstraZeneca, including a $350 million upfront payment and up to 20% sales royalties. [3] In China, FibroGen established FibroGen (China) in 2011 to conduct Phase III trials, ultimately achieving Class 1 innovative drug status. Roxadustat was approved in December 2018 and launched commercially in July 2019. It was successfully included in the Chinese medical insurance catalog multiple times, helping drive consistent sales growth from 500 million yuan in 2020 to 2 billion yuan in 2023. [3]

Roxadustat faced challenges in the U.S. market, including FDA requests for further safety data and an eventual Complete Response Letter in August 2021. AstraZeneca returned commercial rights for the U.S. and other regions to FibroGen in February 2024, retaining only Chinese and Korean market rights. [3]

In 2015, roxadustat, then still in clinical trials, was linked to doping cases in professional cycling. Two cyclists, Fabio Taborre of Italy and Carlos Oyarzun of Chile, tested positive for the substance, which is banned by the World Anti-Doping Agency despite not being commercially available at the time. [4]

In the mid-2000s, FibroGen was described as one of the most closely watched potential competitors to Amgen's monopoly on injectable anemia drugs. Its approach was distinct in that its drug candidate was taken orally and worked by activating the body's natural response to low oxygen levels, rather than by directly supplying erythropoietin. This was seen as potentially more convenient and less costly than existing therapies. [5]

SEC investigation

In September 2025, FibroGen agreed to pay $1.25 million to the SEC to settle allegations that its former chief medical officer manipulated clinical trial data for roxadustat. According to the SEC, between 2019 and 2021 the executive “reverse engineered” Phase III trial results to make the drug appear superior to existing treatments when it was in fact only comparable. The misleading claims were alleged to have been made in SEC filings, press releases, earnings calls, and a published article. The SEC also alleged that the company misrepresented the FDA’s position on the statistical methods used. FibroGen did not admit wrongdoing but agreed to pay the settlement over the following year. [6]

References

  1. 1 2 3 4 5 6 7 Hagerty, James R. (September 13, 2019). "Thomas Neff Founded FibroGen and Developed Anemia Drug". The Wall Street Journal.
  2. ↑ "FibroGen Completes Sale of FibroGen China to AstraZeneca for Approximately $220 Million". TipRanks. September 2, 2025.
  3. 1 2 3 4 5 "The Past and Present of 'Miraculous Medicine' Roxadustat". DrugTimes. July 12, 2024.
  4. ↑ Kolata, Gina (July 29, 2015). "A Drug Hits Cycling Before It Hits the Market". The New York Times.
  5. ↑ Pollack, Andrew (December 23, 2005). "Rivals Laying Siege to Amgen's Near Monopoly in Anemia Drugs". The New York Times.
  6. ↑ "FibroGen pays SEC $1.2M over allegations former exec 'reverse engineered' roxadustat data". FierceBiotech. September 11, 2025.
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