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  • FibroGen China | FibroGen

    FibroGen China FibroGen China Commitment to Commercial Expansion in the Chinese Market We are committed to expanding access to transformative medical treatment for patients in China. Roxadustat has gained notable traction in China's healthcare landscape. Roxadustat is currently the category leader in brand share in China for the treatment of anemia in chronic kidney disease (CKD). Healthcare providers in China have increasingly prescribed roxadustat due to its demonstrated efficacy, tolerability, and safety profile. Roxadustat’s approval by the Chinese Health Authority has played a pivotal role in its widespread adoption, offering a valuable alternative for managing anemia in patients with CKD who are on dialysis and patients who are not on dialysis. The convenience of oral administration and the reduced need for traditional injectable erythropoiesis-stimulating agents have contributed to its acceptance among both physicians and patients, marking a significant advancement in the treatment landscape for those suffering from anemia of chronic kidney disease in China. Chemotherapy-induced anemia remains a significantly under-addressed concern in China. Despite the prevalence of anemia as a common side effect of chemotherapy, there is a notable gap in the attention and treatment provided to affected individuals. This under-treatment of chemotherapy-induced anemia not only compromises the quality of life for cancer patients but also hinders the effectiveness of cancer treatments. FibroGen and our partner AstraZeneca filed a supplemental new drug application with the China Health Authority for roxadustat in patients with chemotherapy-induced anemia and expect an approval decision in mid-2024. The potential addition of the chemotherapy-induced anemia indication would create an additional catalyst to the continued sales growth of roxadustat in China.

  • Our Expertise | FibroGen

    Focused Science Meets the Spirit of Exploration Our strength in pharmaceutical development and discovery is built on a deep understanding of the biology of central mediators and internal pathways. Our founding focus on fibrosis allowed us to establish expertise in the area of collagen prolyl 4-hydroxylase enzymes, recombinant collagen synthesis, and extracellular matrix-associated processes and pathologies. Our Expertise Oncology Focused Science Meets the Spirit of Exploration Oncology-Focused Accelerating Therapeutic Possibilities At the core of our focus, lies a deep understanding of the complexities that govern central mediators and internal pathways in the field of oncology. In the complex landscape of oncology, we are accelerating the development of product candidates in our pursuit of cutting-edge treatments. Guided by a commitment to expand what is therapeutically possible, our efforts are focused on breakthrough treatments for cancer and its related conditions. FG-3246 – Fully Human Antibody-Drug Conjugate for Metastatic Castration-Resistant Prostate Cancer FG-3246, our potential first-in-class fully human antibody-drug conjugate (ADC), demonstrates our ability to take a targeted and precision approach, aiming to address specific molecular pathways implicated in castrate-resistant prostate cancer. These therapeutic advancements underscore our multidimensional approach, combining molecular insights with strategic drug development to propel the field of oncology toward more personalized and effective treatments for individuals facing the challenges of cancer. • Anemia • Prostate Cancer Roxadustat - HIF-PH Inhibitor for Myelodysplastic Syndromes Simultaneously, our dedication to addressing cancer and cancer-related conditions is exemplified by our continued work to develop roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”). 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. Explore Our Pipeline We are developing products with the potential to change lives. LEARN MORE

  • Our Company | FibroGen

    Pioneering Therapies that Expand What is Possible Our Company Pioneering Oncology Therapies that Expand What is Possible We accelerate the delivery of innovative treatments that operate at the cutting edge of cancer research. Our teams have identified and are developing potential first-in-class medicines for the treatment of life-threatening conditions such as metastatic pancreatic cancer, locally advanced pancreatic cancer (LAPC), and chemotherapy-induced anemia (CIA). We are keenly focused on leveraging the body’s natural pathways to treat cancer and its related conditions. OUR ONCOLOGY CANDIDATES: Roxadustat Roxadustat, is an oral small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase, the enzyme that regulates HIF activity. By transiently inhibiting the enzyme, roxadustat induces the body’s natural coordinated process of producing red blood cells, increasing iron absorption, mobilization, and transport. Chemotherapy-induced anemia (CIA) is one of the most common side effects of chemotherapy, it is often not recognized and is frequently undertreated. Roxadustat is in late-stage development for the treatment of CIA in China. FibroGen and our partner AstraZeneca filed a supplemental new drug application with the China Health Authority for roxadustat in patients with chemotherapy-induced anemia and expect an approval decision in mid-2024. Roxadustat is approved in China, Europe, Japan, and over 40 other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and patients not on dialysis. FG-3246 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 (CD46) 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 initial clinical data to support additional clinical studies. FG-3246 is currently in two Phase I studies, being conducted by Fortis and UCSF, with initial data expected in the first half of 2024. We anticipate the initiation of the Phase II trial in metastatic castration-resistant prostate cancer in the second half of 2024. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. Our Strategy Discover how we have built a company that will change lives. LEARN MORE

  • Our Strategy | FibroGen

    We are applying our deep expertise in the biology of the body’s central mediators and internal pathways to build a biopharmaceutical company with a strong product pipeline, offering new approaches to the treatment of anemia, fibrosis, cancer, and other serious medical conditions. Our Strategy Utilizing biological mediators and pathways, FibroGen is accelerating a pipeline of treatments focusing on cancer and its related conditions. Our near-term strategies include: Initiation of a Phase II trial of FG-3246 for metastatic castration-resistant prostate cancer in the second half of 2024. Continue to progress our Phase 3 development plan in anemia associated with lower-risk myelodysplastic syndromes ("MDS"). Our Leadership We are putting substantial expertise to work in developing and commercializing novel therapeutics. LEARN MORE

  • Prostate Cancer | FibroGen

    Prostate cancer is the most diagnosed non-cutaneous malignancy and is the second leading cause of death in men worldwide Prostate Cancer Understanding Prostate Cancer Prostate cancer is the most diagnosed non-cutaneous malignancy and is the second leading cause of death in men worldwide. Prostate cancer develops when malignant cells form and grow in the prostate gland. Approximately 290,000 new diagnoses of prostate cancer and nearly 35,000 deaths were estimated for the US in 2023. Metastatic Castration-Resistant Prostate Cancer If prostate cancer spreads beyond the prostate, it is called “metastatic.” This means it is found growing in nearby organs or tissues. Metastatic castration-resistant prostate cancer (mCRPC) is a form of advanced prostate cancer that shows signs of growth, like a rising PSA (prostate-specific antigen), even with low levels of testosterone. With mCRPC, the cancer stops responding to hormone treatments and can be life-threatening if it spreads to other parts of the body such as nearby lymph nodes, bones, the bladder, rectum, liver, lungs, and maybe the brain. Death from prostate cancer is typically the result of mCRPC, and historically the median survival for men with mCRPC has been less than two years. While multiple options now exist for non-metastatic castration-resistant prostate cancer patients, the unfortunate reality remains that mCRPC is an incurable disease. 1. Seer.cancer.gov https://seer.cancer.gov/statfacts/html/prost.html 2. Lowrance, et al. Journal of Urology, 2018 Castration-Resistant Prostate Cancer: AUA Guideline Amendment 2018 1 2 1 Explore Our Pipeline We are developing products with the potential to change lives. LEARN MORE

  • Privacy Notice | FibroGen

    Privacy Notice FibroGen Privacy Notice Scope FibroGen, Inc and its subsidiaries (“FibroGen”) recognize the importance of and are committed to respecting and protecting your privacy. This Privacy Notice applies to our collection and use of “Personal Information” (which means any information from which an individual can be directly or indirectly identified) through our website, through our medical information call center, and through our offline business-related interactions with you not including data from clinical trial data subjects (except where noted below). Please read this Privacy Notice carefully to understand how we process Personal Information. If you do not agree with our use of your Personal Information as described in this Privacy notice, please do not use the Site, or otherwise provide Personal Information to us. Privacy Notice Updates FibroGen may need to update this Privacy Notice from time to time. If so, FibroGen will post its updated Privacy Notice on our website located at www.fibrogen.com so users are always aware of what personally identifiable information we may collect and how we may use this information. FibroGen encourages you to review this Privacy Notice regularly for any changes. Your continued use of this website will be subject to the then-current Privacy Notice. Information Collection and Use You can generally visit our website without revealing any personally identifiable information about yourself. However, to access certain options we may ask you to provide certain personally identifiable information such as, your name, email address, telephone number, professional credentials. Without providing such personally identifiable information, you may be unable to access certain options and services. We (and our third party partners) generally collect personally identifiable information about you only if you voluntarily provide it to us. You have the option not to provide any personally identifiable information, but we may not be able to provide you with the requested services. Note that this Privacy Notice does not apply to information that we may collect through our clinical trials, which are governed by separate terms and agreements. Certain personal data, such as information about medical or health conditions, racial or ethnic origin, political opinions, religious or philosophical beliefs, is considered “Sensitive Information”. Other than Sensitive Information collected through our clinical trials, as noted above, FibroGen does not collect Sensitive Information. In addition, we automatically collect basic technical information from all visitors to the Site. We collect technical information during your visit to the Site through our automatic data collection tools, which may include cookies and other commonly used technologies. These tools collect certain standard information that your browser sends to the Site such as your browser type and language, access times, and the address of the Site from which you came to the Site. They may also collect information about your Internet Protocol (IP) address, or click stream data within the Site (i.e. the actions taken in connection with the Site). Please see “Cookies and other similar technologies” below for additional detail about the information we collect through cookies and other commonly used technologies. How we use your Personal Information Subject to applicable data protection laws, we may use your Personal Information for the following purposes: (i) to provide you with the services and information offered through the Site; (ii) to contact you and respond to your requests and inquiries; (iii) for business administration, including answering questions or inquiries, job submissions, and statistical analysis; (iv) to personalize your visit to the Site and to assist you while you use the Site; (v) to improve the Site by helping us understand who uses the Site; (vi) for fraud prevention and detection and to comply with applicable laws, regulations or codes of practice. Sharing of your Personal Information We may provide your personally identifiable information that we collect, and the data generated by cookies to a parent, subsidiary or affiliate entity related to FibroGen, partner entities, and the vendors and service agencies that we may engage to assist us. Any organization to which we provide such personally identifiable information is required to respect the security of your personal data and keep your personally identifiable information confidential in accordance with this Privacy Notice. We do not allow our third-party service providers to use your personal data for their own purposes and only permit them to process your personal data for specified purposes and in accordance with our instructions Similarly, we may share your Personal Information as required or permitted by law to comply with a subpoena or similar legal process or government request, or when we believe in good faith that disclosure is legally required or otherwise necessary to protect our rights and property, or the rights, property or safety of others, including to advisers, law enforcement, judicial and regulatory authorities. We may also transfer your Personal Information to a third party in the event of any reorganization, merger, sale, joint venture, assignment, transfer or other disposition of all or any portion of our business, assets, or shares (including in connection with any bankruptcy or similar proceedings.) The servers used in the operation of the Site automatically identify a computer by its IP address. If we, in good faith, determine that you have or are attempting to misuse or harm the Site, we may investigate and cooperate with appropriate law enforcement to protect our rights or property. International data transfers By using the Site or otherwise providing Personal Information to us, you hereby expressly consent to the transfer of your Personal Information outside your country or region. FibroGen complies with applicable privacy laws to ensure an adequate level of data protection. You can request more information about these measures by contacting us at the phone number or email address below. Data Privacy Framework FibroGen complies with the EU-U.S. Data Privacy Framework (EU-U.S. DPF), the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. Data Privacy Framework (Swiss-U.S. DPF) as set forth by the U.S. Department of Commerce. FibroGen has certified to the U.S. Department of Commerce that it adheres to the EU-U.S. Data Privacy Framework Principles (EU-U.S. DPF Principles) with regard to the processing of personal data received from the European Union and the United Kingdom in reliance on the EU-U.S. DPF and the UK Extension to the EU-U.S. DPF. FibroGen has certified to the U.S. Department of Commerce that it adheres to the Swiss-U.S. Data Privacy Framework Principles (Swiss-U.S. DPF Principles) with regard to the processing of personal data received from Switzerland in reliance on the Swiss-U.S. DPF. If there is any conflict between the terms in this privacy policy and the EU-U.S. DPF Principles and/or the Swiss-U.S. DPF Principles, the EU-U.S. DPF Principles and/or the Swiss-U.S. DPF Principles shall govern. To learn more about the Data Privacy Framework (DPF) program, and to view our certification, please visit https://www.dataprivacyframework.gov/s/. FibroGen shall remain liable under the EU-U.S. DPF Principles and/or Swiss-U.S. DPF Principlesif a third party agent uses or discloses Personal Information received from FibroGen in a manner inconsistent with the U-U.S. DPF Principles and/or Swiss-U.S. DPF Principles, unless FibroGen proves that it is not responsible for the event giving rise to the damage. Your rights Access Upon request, FibroGen will provide individuals with reasonable access to Personal Information about them. FibroGen will also take reasonable steps to allow individuals to review Personal Information for the purposes of correcting, amending, or deleting such information in instances where Personal Information is demonstrated to be incomplete or inaccurate. California Residents have rights under the California Consumer Privacy Act (CCPA) as follows: The right to know about the Personal Information a business collects about and how it is used and shared. The right to delete Personal Information collected from (with some exceptions); The right to opt-out of the sale of their Personal Information; and The right to non-discrimination for exercising their CCPA rights. California’s “Shine The Light” law permits California residents to annually request and obtain information free of charge about what Personal Information is disclosed to third parties for third-party direct marketing purposes in the preceding calendar year. FibroGen does not distribute your Personal Information to third parties for third-party direct marketing purposes, except as provided for in this Privacy Notice. FibroGen does not sell personal Information. Per the CCPA, Individuals can contact FibroGen at [email protected] or at 1 (888) 810-0874 to request access or to make inquiries regarding limiting the use and disclosure of Personal Information about them. Individuals in certain jurisdictions have data subject rights which may be subject to limitations and/or restrictions. These rights may include the right to: (i) request access to and correction or erasure of their Personal Information; (ii) obtain restriction of processing or to object to processing of their Personal Information; and (iii) require data portability. If you wish to exercise one of the above-mentioned rights, please send us your request via email to: [email protected] . Individuals from the European Union, Switzerland, and UK also have the right to lodge a complaint about the processing of their Personal Information with their local data protection supervisory authority. FibroGen has appointed an EU Representative for GDPR: ActiveMind.legal Rechtsanwaltsgesellschaft m.b.h Postdamer Strasse 3 D-80802 Munich Germany +49 (0) 89 / 919 29 49 00HYPERLINK "mailto:[email protected]"[email protected] Furthermore, FibroGen has also appointed an UK Representative for UK GDPR: activeMind.legal UK Ltd No 1 Royal Exchange London, EC3V EDG United Kingdom +44 (0) 20 893 836 08 HYPERLINK "mailto:[email protected]"[email protected] Choice If personal data covered by this Privacy Notice is to be used for a new purposes that is materially different from that for which the personal data was originally collected or subsequently authorized, or is to be disclosed to a non-agent third party in a manner not specified by this Privacy Notice, FibroGen will provide you with an opportunity to choose whether to have your personal data so used or disclosed. Requests to opt out of such uses or disclosures of personal Data should be sent to us at HYPERLINK "mailto:[email protected] "[email protected] . No fee usually required You will not have to pay a fee to access your personal data (or to exercise any of the other rights). However, we may charge a reasonable fee if your request is clearly unfounded, repetitive, or excessive. Alternatively, we may refuse to comply with your request in these circumstances. What we may need from you We may need to request specific information from you to help us confirm your identity and ensure your right to access your personal data (or to exercise any of your other rights). This is a security measure to ensure that personal data is not disclosed to any person who has no right to receive it. We may also contact you to ask you for further information in relation to your request. Security and retention of your Personal Information The security of your Personal Information is important to us. We take reasonable steps, including technical, administrative, and physical safeguards, designed to protect the Personal Information submitted to us from loss, misuse and unauthorized access, disclosure, alteration, and destruction. However, no method of security or method of transmission over the Internet is entirely secure. You should always use caution when transmitting Personal Information over the Internet. We may retain your Personal Information for as long as your account is active or as needed for the specific business purpose for which it was collected. In some cases, we may be required to retain information to comply with laws or regulations or other legal obligations, resolve disputes and enforce our agreements. Cookies and Other Similar Technologies Cookies are small text files that are stored on computer hard drives by websites that you visit. There are two general types of cookies, session cookies and persistent cookies. Session cookies are only used during a session online and will be deleted once you leave a website. Persistent cookies have a longer life and will be retained by the website and used each time you visit a website. Both session and persistent cookies can be deleted by you at anytime through your browser settings. We use the following session and persistent cookies on the Site: Strictly necessary cookies: these session cookies are essential for visitors to move around the Site and use its features. Analytical / performance cookies: these session cookies allow us to recognize and count the number of visitors and to see how visitors move around our Site when they are using it. This helps us to improve the way our Site works, for example, by ensuring that users are finding what they are looking for easily. Functionality cookies: these persistent cookies are used to recognize you when you return to our Site. This enables us to personalize our content for you and remember your preferences. We may track the total number of visitors to our website or use such information, individually or in the aggregate, to analyze trends, administer the website, track user’s movement, and gather broad demographic information for use. We may share this information with our corporate partners and contracted vendors to assist us in operating the website and to enable them to better understand FibroGen’s business. Web browsers often allow you to erase existing cookies from your hard drive, block the use of cookies and/or be notified when cookies are encountered. If you elect to block cookies, please note that you may not be able to take full advantage of the features and functions of the Site. To find out more about cookies, including how to see what cookies have been set and how to manage and delete them, please visit www.allaboutcookies.org . Please note that third parties (including, for example, advertising networks and providers of external services like web traffic analysis services) may also use cookies on our website, over which we have no control. External links The Site contains links to external Sites operated by third parties. We are not responsible for these third party Sites or the content of such third party sites. Once you have left the Site, we cannot be responsible for the protection and privacy of any information, which you provide. You should exercise caution and look at the privacy notice for the website you visit. Children This Site is not directed towards children under 18 years of age, nor do we knowingly collect information from children under 18. If you are under 18, please do not use the Site or submit any Personal Information to us. If you believe that we have unintentionally collected Personal Information about your child, you can contact us as described below. Dispute Resolution With respect to Personal Information transferred or received pursuant to the Data Privacy Framework, FibroGen is subject to the investigatory and enforcement powers of the U.S. Federal Trade Commission. In certain instances, FibroGen may be required to disclose Personal Information in response to lawful requests by public authorities, including to meet national security or law enforcement requirements. FibroGen commits to resolve complaints about our collection or use of your personal information. Individuals from European Union, UK, and Switzerland with inquiries or complaints regarding our notice should first contact FibroGen at: Address: 350 Bay Street, Suite 100 #6009 San Francisco, California 94133 Tel.: +1 415.978.1200 Email: [email protected] FibroGen has further committed to refer unresolved complaints to JAMS program, an alternative dispute resolution provider located in the United States. If you do not receive timely acknowledgment of your complaint from us, or if we have not addressed your complaint to your satisfaction, please visit https://www.jamsadr.com/DPF-Dispute-Resolution for more information or to file a complaint. Contacting JAMS is at no cost to you. Under certain circumstances, an individual may choose to invoke binding arbitration to resolve any Data Privacy Framework disputes that have not been resolved by other means.

  • Policies | FibroGen

    Policies Policies 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. Code of Vendor and Partner Conduct To fulfill our vision in improving the lives of people globally, FibroGen partners with third-party individuals and organizations who share FibroGen’s values and commitments to act in an ethical, compliant and socially responsible manner throughout the business engagement and continue to improve their efforts on advancing performance over time. These vendors and other third-parties are expected to operate in full compliance with all applicable laws, rules and regulations, at a minimum, as well as adopt and comply with their own code of business ethics and conduct, which should include ethical principles and standards regarding labor and human rights, equal opportunity and non-discrimination, diverse workforce and pay equity, health and safety, environmental sustainability, anti-bribery, data privacy and information protection, trade sanctions and exports control, quality, and management systems. 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 Clinical 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. Human Rights Policy Code of Vendor and Partner Conduct Enterprise Level Environmental Policy FibroGen Global Code of Ethics for Clinical Trials

  • 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

  • Hispanic Heritage Month | FibroGen

    Advancing Therapeutic Options Around the World Hispanic Heritage Month Happy Hispanic Heritage Month from FibroGen! During Hispanic Heritage Month, from September 15 – October 15, we celebrate the many contributions of Hispanic members of our community. In honor of this year’s Hispanic Heritage Month, we spoke with Juan Graham , Chief Financial Officer, (pictured with wife Jes and daughter Journee), about what his Hispanic heritage means to him. Where were you born? I was born in Cuernavaca - a town south of Mexico City. However, I grew up in Monterrey, Mexico, as my parents relocated there to be closer to family when I was four. When did you come to the United States? I was born in Cuernavaca - a town south of Mexico City. However, I grew up in Monterrey, Mexico, as my parents relocated there to be closer to family when I was four. How does your heritage influence your work? I believe everyone’s heritage and background allows them to view the world from different perspectives. In my case, I was fortunate enough to have a father who was a physician. My father contracted polio as a child, and he lived a life that required him to work differently. At times this disadvantage provided him with daily challenges in which he needed to be creative in solving problems. I saw my father apply this same perspective professionally and personally raising a family of three with my mother. It is this perspective that influences my work the most. Things are not always what they appear. This perspective reminds me to stay curious, and that enables me to look at challenges (and solutions) in a variety of ways—that is not always easy in the finance function. How are you raising your daughter in ways that celebrate her heritage? My daughter was born in Tokyo, Japan to a Mexican father and Nuyorican (Puerto Rican from New York) mother. There is no shortage of celebrating cultures in our household. From celebrating holidays (not just Mexican, but others), eating traditional Mexican foods, and speaking English and Spanish, my hope is that she celebrates all cultures. We hope she honors her culture as she gets older and further identifies in different ways. For now, let’s just say (and I hate to sound cliche) but there is a lot of salsa dancing, Marc Anthony and mariachi music playing at different times throughout her day. Do you feel that people of Hispanic heritage have equal opportunities in the workplace, or do we still have a way to go? I believe this question is best answered by looking at data. Minorities are underrepresented in a variety of ways from access to healthcare, under representation in clinical trials, and generally in business. This holds true for other groups too (disabled populations, economic disparities, educational disadvantages). I believe we are making progress in ways beyond representation that are starting to impact our society, and if we continue to progress, we can affect and change the trajectory of these communities. That makes me excited. What is your advice to young people of Hispanic heritage looking to get their start in biotech or finance? Learn as much as possible from the people that are willing to support and help. Find these people. Find your people - they may be in your immediate community, but they may not. The good news is there are more and more increased networks that are available. Also, have an open mind towards your career and take as many opportunities as possible and challenges that will allow you to accelerate your learning. I love Formula 1 racing and follow the only Mexican driver in the circuit – Sergio (Checo) Perez. Despite ups and downs on race weekends, he shows resilience, a steady temperament and a mindset to never give up. I am inspired by this attitude, and we have our share of ups and downs in biotech and finance… I believe the same mindset is applicable to Hispanic and non-Hispanic minorities. Is there anything else you’d like to share? I am a proud Mexican. That allows me to celebrate all things that make life grand- family, food, music, love! BUT these are things all cultures celebrate and so in that way, my celebration of these things is a celebration of ALL cultures. At FibroGen, we also honor Hispanic Heritage Month by featuring several Hispanic-owned businesses in our weekly lunch rotation, including Cuban Kitchen , Guerrero’s Taqueria , and others. How do you celebrate your heritage? Let us know in the comments! Partnering Opportunities If you are interested in partnering with us, please use the link below. CONTACT US

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