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- Roxadustat | FibroGen
Redefining How to Treat Anemia in Chronic Kidney Disease Roxadustat Redefining How to Treat Anemia in Chronic Kidney Disease We are advancing roxadustat, our first-in-class, oral small molecule product candidate for the treatment of anemia associated with chronic kidney disease (CKD), through global Phase 3 clinical development. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, promotes coordinated erythropoiesis through increasing endogenous erythropoietin, improving iron availability, and reducing hepcidin. Administration of roxadustat has been shown to increase red blood cell production while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation, and without a need for supplemental intravenous iron. Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and patients not on dialysis. Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review. The U.S. Food and Drug Administration issued a complete response letter for the roxadustat NDA filing for the treatment of CKD anemia in August 2021. Roxadustat is in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia (CIA). Additional information about roxadustat trials currently recruiting patients can be found at www.clinicaltrials.gov.
- R&D Pipeline | FibroGen
FibroGen is dedicated to creating innovative, first-in-class medicines for the treatment of chronic and life-threatening or debilitating conditions such as anemia in chronic kidney disease (CKD), anemia in myelodysplastic syndromes (MDS) and chemotherapy induced anemia (CIA), idiopathic pulmonary fibrosis (IPF), Duchenne muscular dystrophy (DMD), and locally advanced pancreatic cancer. The products we develop represent more than isolated opportunities or single indications — we see our products as representing broader platforms that enable us to continue to investigate discrete pathways and mediators that are central to multiple diseases. R&D Pipeline FibroGen is dedicated to creating innovative, first-in-class medicines for the treatment of chronic and life-threatening or debilitating conditions such as anemia in chronic kidney disease (CKD), chemotherapy induced anemia (CIA), metastatic pancreatic cancer, locally advanced pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). The products we develop represent more than isolated opportunities or single indications — we see our products as representing broader platforms that enable us to continue to investigate discrete pathways and mediators that are central to multiple diseases. Preclinical Phase 1 Phase 2 Phase 3 Chemotherapy-Induced Anemia ROXADUSTAT (HIF-PHI) FG-3246 (FOR46) (CD46-TARGETING ADC) Metastatic Castration-Resistant Prostate Cancer (mCRPC) FG-3165 (ANTI-GAL-9 ANTIBODY) Solid Tumors FG-3175 (ANTI-CCR8 ANTIBODY) Solid Tumors PARTNERED IN LICENSED FG-3246 FG-3246 is a potential first-in-class fully human antibody-drug conjugate (ADC) targeting CD46 being developed for metastatic castration-resistant prostate cancer and with the potential for additional trials targeting other CD46 expressing cancers. LEARN MORE Roxadustat Roxadustat, the first globally launched oral HIF-PH inhibitor, promotes erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin LEARN MORE
- ESG | FibroGen
ESG ESG ESG Policy Links At FibroGen, we have embraced a corporate vision statement across our enterprise: At FibroGen, our purpose is to develop novel therapies at the frontiers of cancer biology and anemia. Our vision is to be oncology innovators making a meaningful impact on the lives of patients in urgent need of transformative therapies. To reach this goal, our mission is to apply pioneering oncology expertise to deliver breakthrough therapies to patients. Further, to enable our vision of excellence, we established a set of company-wide core values: empowerment, integrity and respec t. Enterprise Level Environmental Policy Human Rights Policy Code of Vendor and Partner Conduct FibroGen Global Code of Ethics for Clinical Trials Corporate Governance Environment, Health and Safety Environment, Health and Safety or pharmaceutical companies, the product life cycle and supply chain require the use of valuable resources. FibroGen is committed to continuously reducing its environmental footprint. We adhere to California environmental, health and safety standards and city ordinances. Reports from city inspections are shared with the management and appropriate corrective actions are executed across the Company. We have implemented programs to recycle or donate electronic equipment when possible, provide organic compost services in the workplace, use environmentally preferred office and janitorial supplies, reduced paper waste, and have worked with our collaboration partners to reduce the amount of our product packaging and to implement good shipping practices to consolidate waste. In addition to adhering to environmental regulations, we offer a subsidized public transit commuter program, onsite electric vehicle charging stations, a flexible work from home policy, global access to video conferencing and meetings, and online medical monitoring to reduce travel. Ensuring that we have numerous programs in place to increase safety is critical to our success and fosters an experience of excellence at FibroGen. We continue to invest in lab and employee safety as well as employee health. We are also continuing to make investments in product safety and quality, and patient safety through our support of patient advocacy groups, patient support groups, expanded drug access programs, and clinical trial extensions. See our Enterprise-Level Environmental Policy Social, Diversity, Equity, and Inclusion The biotechnology industry is an extremely competitive labor market and recruiting and retaining employees is critical to the continued success of our business. We are highly committed to building a diverse, dedicated, and impassioned team to deliver innovative therapies to patients facing serious unmet medical needs. Our core values of empowerment, integrity, and respect for people are fundamental to how we attract, grow, engage, and retain our people. We focus on recruiting, retaining, and developing employees from a diverse range of backgrounds to conduct our research, development, commercialization, and administrative activities. Our offerings include competitive, innovative and equitable pay practices, comprehensive health and wellness benefits, retirement and life insurance offerings, learning and giving programs, and flexible work arrangements. We also sponsor an annual promotions nomination and approval process. On our Board of Directors, 2 of 5 members (40%) are female and 1 of 5 members (20%) identify as Asian. As of March 2025, our U.S. workforce is 54% female. Our U.S. employees that self-report ethnicity are 62% Asian, Hispanic or Black. See our Human Rights Policy Governance and Risk Management To enhance our corporate governance efforts, we maintain an internal audit function, made substantial improvements to our Sarbanes-Oxley compliance program and strengthened our internal controls over financial reporting. Throughout the year, the Board and its Committees engage with management to discuss a wide range of enterprise risks, such as risks related to FibroGen’s businesses, cybersecurity, and enterprise risk management, and they confirm the alignment of risk assessment and mitigation with business strategy. We implemented an ERM program in 2022 and since then, we have performed enterprise risk assessments to help us identify and manage risks and seize opportunities that may arise as we seek to accomplish our corporate goals. ERM affects all areas of our business, including how we approach new or emerging challenges and opportunities and allocate resources. One of the organic benefits of a formal ERM process is that it builds and strengthens the risk awareness across the organization (enterprise-level, functional, and project-level risks) with a patient-first mindset. As we pursue our mission of delivering therapies in areas of significant unmet need, ERM facilitates and supports the delivery of our corporate objectives. This will be achieved through understanding and identifying risks and opportunities while putting the appropriate plans in place to capitalize on the ERM. With respect to cybersecurity risks, our Board of Directors recognizes that cybersecurity represents an important component of the Company's overall enterprise risk management. Throughout the year, our Board of Directors and its Committees engage with management to discuss and mitigate a wide range of enterprise risks, including cybersecurity. We seek to mitigate cybersecurity risks through a cross-functional approach, including our Cybersecurity Committee, focused on preserving the confidentiality, security, and availability of the information that the Company collects and stores by identifying, preventing and mitigating cybersecurity threats and effectively responding to and remediating cybersecurity incidents as and if they occur. We continually invest in information and cybersecurity services and technologies. Technical safeguards are designed to protect the Company's information systems from cybersecurity threats, including firewalls, continuous intrusion detection and response system(s), data leak prevention strategies, enhanced email protection software, antimalware functionality and access controls. These safeguards are evaluated and improved through periodic assessments and review of cybersecurity threat intelligence. We rely on third parties to support its cybersecurity program, including but not limited to email security management, security operations and vulnerability management. We provide regular (at least annual) training regarding cybersecurity threats to equip our personnel with effective tools to address cybersecurity threats, and to communicate the Company's evolving information security procedures. Our compliance program is an essential application of our core value of integrity. Employees are enrolled in the annual compliance program, which emphasizes the shared responsibility for all colleagues to be good stewards of our organization through our commitment to maintaining the highest standards of business conduct and ethics. The annual compliance program includes certifications to confirm that employees understand and agree to abide by FibroGen’s corporate policies and guidelines, including our Anti-Bribery Policy, Code of Business Conduct and Ethics, Insider Trading and Trading Window Policy, Speak-Up and Reporting Policy, Social Media Policy, and Related Persons Transactions & SEC Compliance Policy, as well as engaging video program and presentations to enhance the understanding of the Foreign Corrupt Practices Act in general and to clarify our anti-bribery and data privacy guidelines. 100% of employees completed the 2024 annual compliance program. All new hires are also enrolled into such compliance program after they are hired. In addition, the Company operates a telephone hotline and whistleblower website available 24 hours a day, 7 days a week, that allow employees to report unethical practices anonymously. See our Code of Vendor and Partner Conduct See our Global Code of Ethics for Clinical Trials Social, Diversity, Equity, and Inclusion Empowerment – We lead, inspire, trust and encourage each other to share ideas and assume new challenges to excel. We are accountable to each other and our commitment to our patients. Integrity – We intend to hold ourselves to the highest ethical standards in all we do: our work to bring therapies to market, the science we perform and our commitment to each other. Respect for People – We strive to foster individual growth and promote an environment that supports continued learning. We stand together as a community to build and sustain a culture of diversity, equity & inclusion; and value each other’s opinion and work collaboratively to achieve optimal outcomes while treating each other with high regard and dignity. We also believe it is critical to conserve our world’s resources and strive to create a safe and healthy environment for our employees and patients. These values are an integral part of our culture, our rewards, and recognition and performance management systems. In 2023, we performed an environmental, social, and governance (“ESG”) assessment of our operations, finding that we accomplished most of our ESG goals, including adopting a policy to increase patient diversity in clinical trials. In 2024, we adopted a cybersecurity incidence response policy and committee charter and approved a 2024 Equity Incentive Plan. Governance and Risk Management
- Our Partners | FibroGen
Advancing Therapeutic Options Around the World Our Partners Advancing Therapeutic Options Around the World Astellas Anemia Partnership FibroGen and Astellas have been collaborating on hypoxia-inducible factor (HIF) anemia programs since 2004, first for Japan, and then for a broader territory covering Europe, the Middle East, the Commonwealth of Independent States, and South Africa. The strategic collaboration between the two companies delivered roxadustat as the first among all hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors to be approved in Japan, Europe, and numerous countries. Eluminex Biosynthetic Cornea Partnership In July 2021, Eluminex exclusively licensed global rights from FibroGen to develop and commercialize an investigational biosynthetic cornea derived from recombinant human collagen Type III for patients with corneal blindness. The Eluminex biosynthetic cornea (EB-301) is a clinical stage corneal stromal substitute that will be developed for the China market initially. Additionally, Eluminex licensed all rights globally to develop other products based on the underlying recombinant human collagen Type III. Fortis Partnership In May 2023, FibroGen entered into an exclusive license with Fortis Therapeutics for FOR46 (FG-3246), a potential first-in-class Phase I antibody-drug conjugate (ADC) targeting a novel epitope on CD46. FG-3246 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). FibroGen anticipates the initiation of a Phase II trial in metastatic castration-resistant prostate cancer, or mCRPC, in the second half of 2024 with the potential for additional trials targeting other CD46 expressing cancers. As part of the clinical development strategy, FibroGen will also continue to work with UCSF to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody (PET46) for patient selection. Partnering Opportunities If you are interested in partnering with us, please use the link below. CONTACT US
- Executive Team | FibroGen
FibroGen Executive team Executive Team Under the leadership of Chief Executive Officer Thane Wettig, FibroGen’s executive team includes accomplished leaders with deep and broad experience. We are focused on delivering first-in-class medicines for the treatment of unmet medical needs. Thane Wettig Chief Executive Officer David DeLucia, CFA Chief Financial Officer John Alden General Counsel Our Leadership We are putting substantial expertise to work in developing and commercializing novel therapeutics. LEARN MORE
- Anemia | FibroGen
Understanding Anemia of Chronic Kidney Disease (CKD), Chemotherapy Induced Anemia (CIA) and Myelodysplastic Syndromes (MDS) Anemia Myelodysplastic Syndromes We believe there is a significant need for a safe, effective, and convenient option to address anemia in patients with lower-risk MDS. Roxadustat, our orally administered small molecule hypoxia-inducible prolyl hydroxylase (“HIF-PH”) inhibitor, stimulates the body’s natural mechanism of red blood cell production and iron hemostasis based on cellular-level oxygen-sensing and iron-regulation mechanisms. Unlike ESAs which are limited to providing exogenous EPO, roxadustat activates a coordinated erythropoietic response in the body that includes the stimulation of red blood cell progenitors, an increase in the body’s production of endogenous EPO, and an increase in iron availability for hemoglobin synthesis, which we believe is important in a broad range of MDS patients. Moreover, in anemia of CKD, roxadustat has demonstrated the ability in clinical trials to increase and maintain hemoglobin levels in the presence of inflammation as measured by C-reactive protein (“CRP”), where ESAs have shown limited effect. We believe that roxadustat has the potential to replicate this result in MDS anemia patients, where it is not uncommon for patients to present with autoimmune and inflammatory conditions. MDS are a diverse group of bone marrow disorders characterized by ineffective production of healthy blood cells and premature destruction of blood cells in the bone marrow, leading to anemia. In most MDS patients, the cause of the disease is unknown. The diagnosed prevalence of MDS in the U.S. is estimated to be between 60,000 and 170,000, and continues to rise as more therapies become available and patients are living longer with MDS. Annual incidence rates are estimated to be 4.9/100,000 adults in the U.S. Anemia is the most common clinical presentation in MDS, seen in approximately 80% of MDS patients, and produces symptoms of fatigue, weakness, exercise intolerance, shortness of breath, dizziness, and cognitive impairment." Explore Our Pipeline We are developing products with the potential to change lives. LEARN MORE
- Board of Directors | FibroGen
FibroGen Board of Directors Board of Directors James A. Schoeneck Chairman of the Board Thane Wettig Chief Executive Officer and Director Maykin Ho, Ph.D. Director Michael G. Kauffman, MD, PhD Director Jeffrey L. Edwards Director Our Partners We are interested in building strong partnerships that complement our strengths. LEARN MORE
- FG-3246 Trials | FibroGen
Pamrevlumab, our proprietary fully human antibody, targets connective tissue growth factor (CTGF), the central mediator of tissue remodeling and fibrosis. Pamrevlumab represents a potential treatment for a broad array of fibrotic and proliferative disorders that affect organ systems throughout the body. Pamrevlumab is in Phase 3 clinical studies for the treatment of idiopathic pulmonary fibrosis, Duchenne muscular dystrophy, and locally advanced pancreatic cancer. FG-3246 Trials FG-3246 Trials FG-3246 is a potential first-in-class fully human antibody-drug conjugate (ADC), in-licensed from Fortis and being developed with FibroGen for metastatic castration-resistant prostate cancer and other tumor types. FG-3246 binds to a cell receptor target that internalizes upon antibody binding and is present at high levels in prostate cancer and other tumor types, but that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate. FG-3246 is comprised of an anti-CD46 antibody, YS-5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. In both preclinical and phase I clinical studies Fortis has reported data to support additional clinical studies. The below clinical trials are being conducted by Fortis and UCSF. Prostate Cancer Phase 1 Study of FG-3246 (FOR46) in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) > Active, not recruiting Phase 1b/2 Study of FG-3246 (FOR46) in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer > Active, not recruiting
- Human Rights Policy | FibroGen
Human Rights Policy Return to ESG Page Human Rights Policy Human Rights Policy FibroGen’s responsibility to respect human dignity and human rights is engrained in the work we do. Human rights are fundamental rights and freedoms that we believe all people are entitled, regardless of race, sex, nationality, ethnicity, religion, or any other status. We practice this belief every day in fulfilling our mission to improve the lives of patients globally. We encourage and expect all employees, contractors and business associates to practice and promote human rights at all times, as exemplified in the United Nations Universal Declaration of Human Rights and the International Bill of Human Rights.
- In Memoriam | FibroGen
In Memoriam A Tribute to Founder, CEO, and Chairman, Tom Neff We are forever grateful to Tom for his decades of leadership and passionate commitment to driving innovation in areas of urgent therapeutic need in the biopharmaceutical field. Tom reached the lives of many through his visionary thinking and entrepreneurial spirit. He was intimately involved in the advancement of the roxadustat and pamrevlumab programs, and the underlying technologies supporting these. Tom’s contribution as a pioneer in the biotechnology industry will be measured by the lives he has and will continue to touch through FibroGen’s development of medicines for unmet medical needs. The FibroGen Board and management team are committed to fulfill and build on Tom’s vision. Our Company Pioneering innovative therpeutic options for patients who need them the most. LEARN MORE
- Enterprise Level Environmental Policy | FibroGen
Enterprise Level Environmental Policy Return to ESG Page Enterprise Level Environmental Policy Enterprise Level Environmental Policy For pharmaceutical companies, general operations and the product life cycle and supply chain require the use of valuable water, energy and other resources. FibroGen is committed to complying with all applicable environmental rules and regulations, and continuing our efforts to reduce our environmental footprint, conserve natural resourc es, improve energy efficiency, prevent water contamination, and implement waste management practices. We strive to protect our employees, facilities and the community from harmful environmental influences, and at the same time, promote environmental awareness and sustainability.
- FibroGen Global Code of Ethics for Clini | FibroGen
FibroGen Global Code of Ethics for Clinical Trials Global Code of Ethics for Clinical Trials Return to ESG Page FibroGen Global Code of Ethics for Clinic al Trials FibroGen’s mission is to improve the lives of people globally by developing innovative therapies anchored in high-quality science and our passion for patients. We treat patient safety as a top priority and hold ourselves accountable to maintain high ethical principles and standards in our clinical trials wherever they are conducted, whether by ourselves or collaboratively with our partners, contract research organizations or other third parties. All FibroGen-sponsored clinical trials are conducted in accordance with the applicable regulations, Health Authority standards, and Good Clinical Practice (GCP) guidelines. FibroGen maintains internal procedures to ensure compliance with the applicable clinical trial standards as it pertains to: Appropriateness: All research should be designed to address a legitimate scientific question or need. Selection of Investigators: FibroGen selects clinical investigators who have the required qualifications, training, research, clinical expertise, and the potential to recruit research participants. The independence of clinical investigators and others involved in clinical research is critical to protect the best interest of research participants. FibroGen does not engage any clinical investigators who have been debarred, disqualified, or restricted from participating in clinical research. Ethical Review: FibroGen sponsored trials undergo an ethical review by a qualified independent committee (Institutional Review Board/Independent Ethics Committee) prior to study initiation. Privacy: FibroGen is committed to protecting patients’ privacy, collecting minimal subject identifiers, and complying with all applicable privacy laws and regulations. Integrity of Clinical Data: FibroGen ensures data are reliable and have been processed and reported correctly by using established data integrity standards. Informed Consent: FibroGen requires voluntary informed consent from research participants, outlining known benefits and risks of the trial, and taking additional steps to ensure the protection of minors. Safety Monitoring: FibroGen monitors patient safety throughout trials, including long-term follow-up as needed. FibroGen ensures that adverse event information regarding its products is appropriately collected, processed, reported, analyzed and communicated. FibroGen ensures clinical investigators appropriately report adverse event information and appropriately update research participants and others, as appropriate. Compensation: We ensure that any payments, injury compensation, and other benefits provided to research participants are appropriate and do not unduly influence their decision to participate in a clinical research study. FibroGen payments to investigators will be within Fair Market Value (FMV) and shall be based upon the services rendered. Investigator’s Meetings: FibroGen ensures that investigator’s meetings are modest in location and cost for the purpose of training study staff on participating in a FibroGen clinical trial. FibroGen does not pay the investigators for their time but pays for modest accommodations in compliance with FibroGen’s HCP/FMV policy and local country requirements. Transparency: FibroGen makes information about its clinical trials publicly available in compliance with the applicable regulations, Health Authority standards, and GCP guidelines. We are also committed to publishing clinical trial results regardless of clinical trial outcome or regulatory approval. Diversity: FibroGen strives to conduct clinical trials without bias. We are committed to identifying and reducing the potential barriers to clinical trial access and participation, and continue to improve our subject recruitment, enrollment, and retention process to ensure disease-appropriate subject representation and greater inclusion of patients across racial, ethnic, gender, age and socioeconomic groups in our clinical trials.
