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Changed Risks for FIBROGEN INC (FGEN)

Business – Government Regulation – Regulation in China

If our product candidates obtain marketing approval, we will be subject to more extensive healthcare laws, regulation and enforcement and our failure to comply with those laws could have a material adverse effect on our results of operations and financial condition

No or limited reimbursement or insurance coverage of our approved products, if any, by third party payors may render our products less attractive to patients and healthcare providers

inter partes

Certain of the components of our product candidates are acquired from single-source suppliers and have been purchased without long-term supply agreements The loss of any of these suppliers, or their failure to supply us with supplies of sufficient quantity and quality to complete our drug substance or finished drug product of acceptable quality and an acceptable price, would materially and adversely affect our business

As an organization, we have not successfully commercialized any drug product Therefore, we may not be able to efficiently execute our development and commercialization plans

As a Company, we have no commercialization experience, and the time and resources to develop such experience are significant If we fail to achieve and sustain commercial success for roxadustat in China, either directly or with AstraZeneca, our business would be harmed

Clinical trials of our product candidates may not uncover all possible adverse effects that patients may experience

The impact of recent US healthcare reform, its potential partial or full repeal, and other changes in the healthcare industry and in healthcare spending is currently unknown, and may adversely affect our business model

Risks Related to Government Regulation

Intellectual property rights do not address all potential threats to any competitive advantage we may have