<SEC-DOCUMENT>0001193125-18-308090.txt : 20181026
<SEC-HEADER>0001193125-18-308090.hdr.sgml : 20181026
<ACCEPTANCE-DATETIME>20181025201934
ACCESSION NUMBER:		0001193125-18-308090
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20181025
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20181026
DATE AS OF CHANGE:		20181025

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			FIBROGEN INC
		CENTRAL INDEX KEY:			0000921299
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36740
		FILM NUMBER:		181140094

	BUSINESS ADDRESS:	
		STREET 1:		409 ILLINOIS STREET
		CITY:			SAN FRANCISCO
		STATE:			CA
		ZIP:			94158
		BUSINESS PHONE:		415-978-1200

	MAIL ADDRESS:	
		STREET 1:		409 ILLINOIS STREET
		CITY:			SAN FRANCISCO
		STATE:			CA
		ZIP:			94158
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<FILENAME>d633501d8k.htm
<DESCRIPTION>8-K
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:14pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>of the Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): October&nbsp;25, 2018 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>FibroGen, Inc. </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact
name of registrant as specified in its charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-36740</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">77-0357827</FONT></B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of incorporation)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>FibroGen, Inc. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>409 Illinois Street </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>San
Francisco, CA 94158 </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices, including zip code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(415) <FONT STYLE="white-space:nowrap">978-1200</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Registrant&#146;s telephone number, including area code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Not Applicable </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former
name or former address, if changed since last report.) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below
if the <FONT STYLE="white-space:nowrap">Form&nbsp;8-K</FONT> filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to Rule <FONT STYLE="white-space:nowrap">14a-12</FONT> under the Exchange Act (17
CFR <FONT STYLE="white-space:nowrap">240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to <FONT
STYLE="white-space:nowrap">Rule&nbsp;14d-2(b)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14d-2(b))</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to <FONT
STYLE="white-space:nowrap">Rule&nbsp;13e-4(c)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.13e-4(c))</FONT> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this
chapter) or Rule <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934 <FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of this chapter). </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section&nbsp;13(a) of the Exchange
Act.&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
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<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Other Events </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On October&nbsp;25, 2018, FibroGen, Inc. issued a press release in which it announced the presentation of results from its Phase&nbsp;3 studies
of roxadustat for the treatment of anemia associated with chronic kidney disease conducted in China at the American Society of Nephrology Kidney Week 2018 in San Diego, California. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">A copy of such press release is furnished as Exhibit&nbsp;99.1 to this report and is incorporated herein by reference. </P>
<P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Financial Statements and Exhibits. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(d) Exhibits </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP>99.1</TD>
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<TD VALIGN="top"><A HREF="d633501dex991.htm">Press Release titled &#147;FibroGen Presents Results from Two Phase 3 Studies of Roxadustat for the Treatment of Anemia Associated with Chronic Kidney Disease Conducted in China at American Society of Nephrology
 Kidney Week 2018 Annual Meeting&#148; dated October&nbsp;25, 2018 </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="3"><B>FIBROGEN, INC.</B></TD></TR>
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<TD VALIGN="top">Dated: October&nbsp;25, 2018</TD>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Michael Lowenstein</P></TD></TR>
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<TD VALIGN="top">Michael Lowenstein</TD></TR>
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<TD VALIGN="top">Chief Legal Officer</TD></TR>
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<TYPE>EX-99.1
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<IMG SRC="g633501logo.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>FibroGen Presents Results from Two Phase 3 Studies of Roxadustat for the Treatment of Anemia Associated
with Chronic Kidney Disease Conducted in China at American Society of Nephrology Kidney Week 2018 Annual Meeting </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>San Francisco, CA &#150;
October</B><B></B><B>&nbsp;25, 2018 &#151; </B>FibroGen, Inc. (NASDAQ: FGEN), a leading biopharmaceutical company discovering and developing a pipeline of <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT>
therapeutics, and FibroGen China Medical Technology Development Co., Ltd. (FibroGen China), today announced the presentation of results from two Phase 3 multi-center, randomized, controlled clinical trials of roxadustat <FONT
STYLE="white-space:nowrap">(FG-4592</FONT> or <FONT STYLE="font-family:SimHei">&#32599;</FONT><FONT STYLE="font-family:SimHei">&#27801;</FONT><FONT STYLE="font-family:SimHei">&#21496;</FONT><FONT STYLE="font-family:SimHei">&#20182;</FONT><FONT
STYLE="font-family:Times New Roman">1) for the treatment of anemia associated with chronic kidney disease (CKD) conducted in China at the American Society of Nephrology (ASN) Kidney Week 2018 annual meeting in San Diego, California. Roxadustat is a <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> oral hypoxia-inducible factor prolyl hydroxylase inhibitor <FONT STYLE="white-space:nowrap">(HIF-PHI)</FONT> in late-stage development for the treatment of
anemia associated with CKD both in patients on dialysis and in patients not on dialysis. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;The results of two Phase 3 trials in
dialysis-dependent and <FONT STYLE="white-space:nowrap">non-dialysis-dependent</FONT> CKD patients in China showed roxadustat effectively corrected and maintained hemoglobin levels, and are the basis of our new drug application currently under
review by the National Medical Products Administration. These results are consistent with findings from multiple Phase 3 clinical studies reported to date by FibroGen and our partners, supporting roxadustat as the potential first oral drug for the
treatment of anemia associated with chronic kidney disease, a serious and potentially life-threatening condition,&#148; said Peony Yu, M.D., Chief Medical Officer of FibroGen. &#147;If approved in China, roxadustat will be the first <FONT
STYLE="white-space:nowrap">HIF-PHI</FONT> available to help CKD patients with anemia, and patients in China could be first to gain access to treatment with roxadustat.&#148; </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Highlights of China Phase 3 Results Presented </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Title:</B> A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of Roxadustat for Treatment of Anemia in Subjects with CKD on
Dialysis </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Presenters:</B> Chen Nan, Shanghai Ruijin Hospital&nbsp;and Hao Chuanming, Shanghai Huashan Hospital</P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Abstract</B>: <FONT STYLE="white-space:nowrap">TH-PO1152</FONT> </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Results </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">304 CKD patients on chronic dialysis were
randomized and received treatment in this study (204 roxadustat, 100 Kirin brand epoetin alfa); 256 patients (162 roxadustat, 94 epoetin alfa) completed the <FONT STYLE="white-space:nowrap">26-week</FONT> treatment period. The average baseline
hemoglobin overall was 10.4 g/dL. Roxadustat produced a numerically greater mean change in hemoglobin from baseline to Weeks <FONT STYLE="white-space:nowrap">23-27</FONT> of 0.8&nbsp;g/dL (&plusmn;1.1) as compared to epoetin alfa, (0.5 g/dL
&plusmn;1.0) and was statistically <FONT STYLE="white-space:nowrap">non-inferior.</FONT> Roxadustat increased transferrin, maintained serum iron, and attenuated decreases in TSAT versus epoetin alfa (all p&lt;0.01). At Week 27, the decline from
baseline in both total and LDL cholesterol was greater with roxadustat (both </P>
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p&lt;0.0001). Roxadustat reduced hepcidin from baseline by a mean of 30.2 ng/ml (p=0.003) compared to a reduction of 2.3 ng/ml in the epoetin alfa group (p=0.12). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In subgroup analysis based on the baseline CRP levels, which indicates the patient&#146;s inflammation status, roxadustat demonstrated consistent efficacy in
hemoglobin control regardless of CRP levels without increase in roxadustat dose requirements, while epoetin alfa patients with elevated baseline CRP levels showed lower hemoglobin response despite receiving higher average doses of epoetin alfa
compared to the doses patients with normal baseline CRP levels received. In the subgroup of inflamed patients (as measured by elevated CRP), mean change in hemoglobin from baseline to Weeks <FONT STYLE="white-space:nowrap">23-27</FONT> were
significantly higher in roxadustat than EPO, p=0.0034. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Roxadustat appeared to be well-tolerated in this study, there were no safety signals, and the most
frequent treatment emergent adverse events were typical for this population. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Title:</B> A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
of Efficacy and Safety of Roxadustat <FONT STYLE="white-space:nowrap">(FG-4592)</FONT> for Treatment of Anemia in Subjects with CKD Not on Dialysis </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Presenters:</B> Chen Nan, Shanghai Ruijin Hospital&nbsp;and Hao Chuanming, Shanghai Huashan Hospital</P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Abstract:</B> <FONT STYLE="white-space:nowrap">TH-PO1153</FONT> </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Results </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">152 patients were randomized and received either
roxadustat (n=101) or placebo (n=51) in the initial eight weeks. Subjects in the roxadustat arm had a greater mean (+SD) change from baseline in hemoglobin of 1.9 g/dL (&plusmn;1.2) (mean baseline hemoglobin 8.9 (&plusmn;0.8) g/dL), as compared to
the mean change in the placebo group of <FONT STYLE="white-space:nowrap">-0.4</FONT> g/dL (&plusmn;0.8) from a mean baseline of (8.9 (&plusmn;0.7) g/dL (p&lt;0.0001). At Week 9, patients in roxadustat group had a greater mean reduction in hepcidin
of <FONT STYLE="white-space:nowrap">-56.14</FONT> (&plusmn;63.40) (p&lt;0.0001) vs. <FONT STYLE="white-space:nowrap">-15.10</FONT> (&plusmn;48.06) ng/ml (p=0.17) in the placebo group (p&lt;0. 0001 between groups). At Week 9, the decline from
baseline in total cholesterol and LDL cholesterol in the roxadustat arm were larger than placebo (p&lt;0.0001). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Following the initial eight-week period,
all subjects continuing on study received roxadustat for an <FONT STYLE="white-space:nowrap">18-week,</FONT> open-label treatment period enabling patients initially randomized to placebo to have crossover to roxadustat. Among subjects treated with
roxadustat during the initial eight weeks, hemoglobin remained stable for the subsequent <FONT STYLE="white-space:nowrap">18-week,</FONT> open-label period with an overall change from baseline of +1.9 (&plusmn;1.3) g/dL over Weeks <FONT
STYLE="white-space:nowrap">23-27,</FONT> with 79.7% of subjects achieving a hemoglobin <FONT STYLE="FONT-FAMILY:SYMBOL">&#179;</FONT>11.0 g/dL during the <FONT STYLE="white-space:nowrap">26-week</FONT> treatment, and 71.1% achieved a mean hemoglobin
<FONT STYLE="FONT-FAMILY:SYMBOL">&#179;</FONT>10.0 g/dL averaged over Weeks <FONT STYLE="white-space:nowrap">23-27.</FONT> Among patients treated with placebo during the initial double-blind period, hemoglobin increased from baseline by 2.0
(&plusmn;1.5) g/dL upon crossing over to roxadustat treatment (p&lt;0.0001), 72.1% of subjects achieved a hemoglobin &gt;11.0 g/dL during the last <FONT STYLE="white-space:nowrap">18-weeks</FONT> of treatment, and 86.0% achieved a mean hemoglobin
&gt;10.0 g/dL averaged over Weeks <FONT STYLE="white-space:nowrap">23-27.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Roxadustat appeared to be well-tolerated in this study, there were no
safety signals, and the most frequent treatment emergent adverse events were typical for this population. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Studies
<FONT STYLE="white-space:nowrap">FGCL-4592-808</FONT> and <FONT STYLE="white-space:nowrap">FGCL-4592-806</FONT> in China </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><FONT
STYLE="white-space:nowrap">FGCL-4592-806</FONT> </B>is a multi-center, randomized, epoetin alfa-controlled, open-label Phase 3 study in 304 patients on dialysis conducted over 26 weeks. CKD patients on chronic dialysis (whose anemia was
</P>
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previously treated with stable doses of one or more of nine brands of commercially available epoetin alfa) were randomized 2:1 to roxadustat or Kirin EPO, with 202 patients receiving roxadustat
(initial dose of 100 mg or 120 mg TIW, based on body weight) and 100 patients receiving Kirin EPO, followed by dose titration to hemoglobin levels every four weeks as needed. A subset of roxadustat-treated patients entered the ongoing open-label
extension for safety assessment and received roxadustat for up to 52 weeks of continuous exposure. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><FONT STYLE="white-space:nowrap">FGCL-4592-808</FONT> </B>is a double-blind, placebo-controlled multi-center Phase 3 study in 151 patients not on dialysis,
who were randomized 2:1 to roxadustat or placebo for the first eight weeks, during which 101 patients received roxadustat (initial dose of 70 mg or 100 mg, based on body weight) and 50 patients received placebo three times weekly (TIW), followed by
dose titration to hemoglobin levels every four weeks as needed. After the initial eight-week period, placebo-treated patients were crossed over to receive 18 weeks of roxadustat treatment, while the active arm continued on roxadustat for the same
period. The primary efficacy endpoint is hemoglobin change from baseline at the end of Week 8. A subset of roxadustat-treated patients entered the ongoing open-label extension for safety assessment and received roxadustat for up to 52 weeks of
continuous exposure. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Anemia Associated with CKD in China </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Anemia commonly develops in association with chronic kidney disease and is linked to significant morbidity and mortality in both the dialysis and <FONT
STYLE="white-space:nowrap">non-dialysis</FONT> populations. CKD affects an estimated 119.5&nbsp;million patients in China. Although CKD may occur at any age, it is more common in aging populations, and its prevalence is increasing. CKD can be both a
cause and a consequence of cardiovascular disease and is a critical healthcare issue. With the exception of kidney transplantation, there is no treatment available that is curative, or has the ability to stop kidney deterioration.</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The dialysis population in China, which is estimated to be more than 400,000 patients, has been growing at a double-digit rate. The number of patients that
require anemia therapy in China is expected to increase steadily, as the CKD population continues to grow and the number of dialysis patients increases. There is a significant opportunity for roxadustat to treat patients on dialysis (both
hemodialysis and peritoneal dialysis) and not on dialysis, as well as to address unmet need in the large number of currently treated patients whose anemia remains undertreated or untreated in China. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Roxadustat </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Roxadustat <FONT
STYLE="white-space:nowrap">(FG-4592)</FONT> is a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class,</FONT></FONT> orally administered small molecule completing global Phase 3 clinical development as a potential therapy
for anemia associated with chronic kidney disease (CKD). Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor <FONT STYLE="white-space:nowrap">(HIF-PHI)</FONT> that promotes erythropoiesis through increasing endogenous
erythropoietin, improving iron regulation, and reducing hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis &#150; increasing red blood cell count 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.</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">FibroGen and collaboration partners are pursuing four approval pathways in major jurisdictions to prepare for commercialization worldwide: </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Page 3 of 5 </P>

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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment
of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the
treatment of anemia in the U.S., China, other markets in the Americas, Australia/New Zealand, as well as Southeast Asia. </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">FibroGen and
its partners have completed 35 Phase 1 and Phase 2 studies. The Phase 2 clinical studies have consistently demonstrated anemia correction and maintenance of hemoglobin levels in multiple subpopulations across a wide spectrum of CKD patients. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Globally, the Phase 3 program encompasses a total of 15 Phase&nbsp;3 studies of roxadustat in both
<FONT STYLE="white-space:nowrap">non-dialysis-dependent</FONT> and dialysis-dependent CKD patients to support independent regulatory approvals in the U.S., Europe, Japan, and China. To date, positive topline results have been announced for seven of
the Phase 3 studies, with two supporting the China NDA for treatment of anemia in CKD patients on dialysis and not on dialysis, four supporting the Japan NDA for treatment of anemia in CKD patients on dialysis, and one supporting the U.S./EU
submissions. The China and Japan NDAs are both under review by the respective regulatory agencies. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Roxadustat is currently in Phase 3 clinical
development for the treatment of anemia associated with myelodysplastic syndromes (MDS) in the U.S. and in Phase 2/3 development for MDS in China. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About FibroGen </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">FibroGen, Inc., headquartered in San
Francisco, California, with subsidiary offices in Beijing and Shanghai, People&#146;s Republic of China, is a leading biopharmaceutical company discovering and developing a pipeline of
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> therapeutics.&nbsp;The company applies its pioneering expertise in hypoxia-inducible factor (HIF), connective tissue growth factor (CTGF) biology, and
clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company&#146;s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity,
completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), with a New Drug Application (NDA) currently under review by the National Medical Products Administration in China. Our partner Astellas
submitted a NDA for the treatment of anemia in CKD patients on dialysis in Japan and currently under review by the Pharmaceuticals and Medical Devices Agency (PMDA). Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase
2/3 development in China for anemia associated with myelodysplastic syndromes (MDS).&nbsp;Pamrevlumab, an anti-CTGF human monoclonal antibody, is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF)
and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This release contains
forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development of the company&#146;s product candidates pamrevlumab and roxadustat, the potential safety and efficacy profile of our
product candidates, and our clinical, regulatory plans, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts
and typically are </P>
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identified by use of terms such as &#147;may,&#148; &#147;will&#148;, &#147;should,&#148; &#147;on track,&#148; &#147;could,&#148; &#147;expect,&#148; &#147;plan,&#148; &#147;anticipate,&#148;
&#147;believe,&#148; &#147;estimate,&#148; &#147;predict,&#148; &#147;potential,&#148; &#147;continue&#148; and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those
indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other
matters that are described in our Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the fiscal year ended December&nbsp;31, 2017, and our Quarterly Report on Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the fiscal
quarter ended June&nbsp;30, 2018 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of
the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"># # # </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Contact </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">FibroGen, Inc. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Karen L. Bergman </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Vice President, Investor Relations and Corporate Communications </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">1 (415) <FONT STYLE="white-space:nowrap">978-1433</FONT> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>kbergman@fibrogen.com </U></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Page 5 of 5 </P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
