<SEC-DOCUMENT>0001193125-17-022530.txt : 20170130
<SEC-HEADER>0001193125-17-022530.hdr.sgml : 20170130
<ACCEPTANCE-DATETIME>20170130070556
ACCESSION NUMBER:		0001193125-17-022530
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20170130
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170130
DATE AS OF CHANGE:		20170130

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:		17555361

	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
<SEQUENCE>1
<FILENAME>d339420d8k.htm
<DESCRIPTION>8-K
<TEXT>
<HTML><HEAD>
<TITLE>8-K</TITLE>
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 <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 8-K
</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:12pt; 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): January&nbsp;30, 2017 </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>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:8pt" ALIGN="center">


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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>001-36740</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>77-0357827</B></TD></TR>
<TR STYLE="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) 978-1200 </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 Form 8-K 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 WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </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>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </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>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </TD></TR></TABLE> <P STYLE="font-size:10pt;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> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>

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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Other Events </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January 30, 2017, FibroGen, Inc. issued a press release in which it
reported topline results from its two ongoing Phase 3 studies in China of roxadustat, its first-in-class, orally administered small molecule for treatment of anemia in dialysis-dependent and non-dialysis-dependent chronic kidney disease patients.
</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>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Financial Statements and Exhibits. </B></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">(d)</TD>
<TD ALIGN="left" VALIGN="top">Exhibits </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:8pt" ALIGN="center">


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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">Exhibit</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1.00pt solid #000000; width:23.50pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">No.</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; width:37.25pt; font-size:8pt; font-family:Times New Roman">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Press Release titled &#147;FibroGen&#146;s Roxadustat (FG-4592) Meets Primary Endpoints in Two Phase 3 Anemia Studies in China&#148; dated January 30, 2017</TD></TR>
</TABLE>

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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="bottom" COLSPAN="3"><B>F<SMALL>IBROGEN</SMALL>, I<SMALL>NC</SMALL>.</B></TD></TR>
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<TD VALIGN="top">Dated: January 30, 2017</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">By:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"> <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"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Michael Lowenstein</TD></TR>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Chief Legal Counsel</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>INDEX TO EXHIBITS </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">Exhibit</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1.00pt solid #000000; width:23.50pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">No.</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; width:37.25pt; font-size:8pt; font-family:Times New Roman">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Press Release titled &#147;FibroGen&#146;s Roxadustat (FG-4592) Meets Primary Endpoints in Two Phase 3 Anemia Studies in China&#148; dated January 30, 2017</TD></TR>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d339420dex991.htm
<DESCRIPTION>EX-99.1
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 <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="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>FibroGen&#146;s Roxadustat <FONT STYLE="white-space:nowrap">(FG-4592)</FONT> Meets Primary Endpoints in Two Phase 3 Anemia Studies in China
</B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Roxadustat: effective in dialysis (hemodialysis and peritoneal dialysis) and </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><FONT STYLE="white-space:nowrap">non-dialysis</FONT> chronic kidney disease (CKD) patients </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SAN FRANCISCO - January 30, 2017 - FibroGen, Inc. (NASDAQ: FGEN), a science-based biopharmaceutical company, and its subsidiary FibroGen China Medical
Technology Development Co., Ltd. (FibroGen China), today reported positive topline results from the two Phase 3 clinical studies of roxadustat <FONT STYLE="white-space:nowrap">(FG-4592</FONT> or <B>


<IMG SRC="g339420ex991pg01a.jpg" ALT="LOGO">
</B><SUP STYLE="font-size:85%; vertical-align:top">1</SUP>) designed to support new drug application submission in China. Roxadustat is a
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class,</FONT></FONT> orally administered small molecule for treatment of anemia in dialysis-dependent CKD <FONT STYLE="white-space:nowrap">(DD-CKD)</FONT> and <FONT
STYLE="white-space:nowrap">non-dialysis-dependent</FONT> CKD <FONT STYLE="white-space:nowrap">(NDD-CKD)</FONT> patients. Both of the Phase 3 studies met their primary efficacy endpoints, which were evaluated in the comparator-controlled portions of
the studies. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the double-blind, placebo-controlled eight-week portion of the <FONT STYLE="white-space:nowrap">26-week</FONT> <FONT
STYLE="white-space:nowrap">NDD-CKD</FONT> trial, 151 anemia patients were randomized 2:1 to receive roxadustat (n=101) or placebo (n=50). Roxadustat met its primary efficacy endpoint of correcting anemia, by achieving a statistically significant
increase in hemoglobin (Hb) levels compared to placebo over eight weeks. Furthermore, the secondary endpoint of Hb response was met as Hb response was achieved by a higher proportion of patients in the roxadustat arm than in the placebo arm. </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="9%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Roxadustat-treated patients achieved a mean Hb increase of 1.9g/dL from baseline (8.9g/dL) over eight weeks of treatment vs. a mean change in Hb of <FONT STYLE="white-space:nowrap">-0.4g/dL</FONT> (from 8.9 g/dL
baseline) in the placebo arm (<I>p&lt;0.00001</I>). </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="9%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">A significantly higher proportion of roxadustat patients achieved Hb response (an increase <FONT STYLE="FONT-FAMILY:SYMBOL">&#179;</FONT>1g/dL from baseline) after eight weeks vs. placebo patients, 84.2% compared to
0.0% (<I>p&lt;0.00001</I>). </TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the dialysis study, 304 patients (271 hemodialysis and 33 peritoneal dialysis patients) previously on
epoetin alfa were randomized to and treated with roxadustat (n=204) or epoetin alfa (n=100) for 26 weeks. All the patients randomized to the active comparator arm were treated with <B>


<IMG SRC="g339420ex991pg01b.jpg" ALT="LOGO">
</B><SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (&#147;Li Xue Bao&#148;) epoetin alfa, manufactured in Japan and marketed in China by Kyowa Hakko Kirin China Pharmaceutical Co., Ltd. (Kirin EPO). The
primary endpoint was Hb change from baseline to the Hb level averaged during the final five weeks of the <FONT STYLE="white-space:nowrap">26-week</FONT> treatment period. </P> <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>
<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">Roxadustat met the predefined <FONT STYLE="white-space:nowrap">non-inferiority</FONT> criterion for its primary endpoint in comparison to Kirin EPO in both full analysis set (FAS) and per protocol set (PPS) analyses.
</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>
<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">Furthermore, on superiority testing of the primary endpoint, the mean Hb increase observed in the roxadustat arm was higher than in the Kirin EPO arm, 0.75g/dL vs. 0.46g/dL (p=0.037) in PPS analysis. </TD></TR></TABLE>
<P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:10%">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><I><SUP STYLE="font-size:85%; vertical-align:top">1</SUP>&nbsp;</I></TD>
<TD ALIGN="left" VALIGN="top"><I>China Approved Drug Name or China generic name</I><B><I> </I></B><I>for &#147;roxadustat&#148; </I></TD></TR></TABLE>

<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">

 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Initial findings suggest that adverse events were consistent with previous clinical trials of roxadustat in the
CKD patient population with no new or unexpected safety signals identified. The <FONT STYLE="white-space:nowrap">52-week</FONT> safety assessment in at least 100 patients is ongoing with expected study completion in June 2017. Full results from
these Phase 3 trials are expected to be reported in due course. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;We are grateful for the opportunity to advance development of treatment for anemia
associated with CKD, a serious and potentially life-threating condition, for patients in China and worldwide,&#148; said Tom Neff, Chief Executive Officer of FibroGen. &#147;We are very encouraged by the topline results of these two pivotal Phase 3
studies for roxadustat, which bring us closer to the first oral anemia therapy that does not require injectable administration or IV iron supplementation. In addition, use of roxadustat is free of the burden of cold-chain storage and maintaining
sterility, and costly distribution infrastructure. Data from these two studies will be used to complete our new drug application submission in China later this year.&#148; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">FibroGen and AstraZeneca (NYSE: AZN) are collaborating for the development and commercialization of roxadustat in China, the U.S., and other markets. In
China, FibroGen is conducting all clinical trials and will hold all roxadustat regulatory licenses and permits to be issued by China regulatory authorities. After market approval, FibroGen China will manage manufacturing and medical affairs and
AstraZeneca will manage launch and commercialization activities in China. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About the <FONT STYLE="white-space:nowrap">FGCL-4592-808</FONT> and <FONT
STYLE="white-space:nowrap">FGCL-4592-806</FONT> Studies </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-4592-808</FONT> Phase 3 Study in CKD patients not on
dialysis in China:</B> This is a double-blind, placebo-controlled multi-center study in 151 patients, 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 Hb levels every four weeks as needed. After the initial eight-week period, placebo-treated patients are crossed over to receive 18 weeks
of roxadustat treatment, while the active arm continues on roxadustat for the same period. Primary efficacy endpoint is Hb 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 will receive 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-4592-806</FONT>
Phase 3 Study in CKD patients on dialysis in China:</B> This is a multi-center, randomized, epoetin alfa-controlled, open-label study in 304 patients over 26 weeks. CKD patients on chronic dialysis (whose anemia was 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 Hb levels every four weeks as needed. A subset of roxadustat-treated patients entered the ongoing open-label extension for safety assessment and will receive roxadustat for up to 52 weeks of
continuous exposure. </P>

<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">

 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About CKD Anemia 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 (CKD) 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 (Zhang et al. <I>Lancet </I>2012; 379: 815&#150;822). 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. Currently, there is no treatment available that is curative or has the ability to stop kidney
deterioration in patients with CKD with the exception of kidney transplantation.</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The dialysis population in China, exceeding 400,000 patients, has been
growing at a double-digit rate. The number of patients that require anemia therapy in China and other emerging markets is expected to increase steadily, as the CKD population continues to grow and the number of hemodialysis and peritoneal dialysis
patients increases. We believe there is a significant opportunity for roxadustat to treat CKD anemia patients on dialysis (hemodialysis and peritoneal dialysis) and not on dialysis, as well as to address need in the large number of 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 currently in global Phase 3 clinical development as a potential therapy for anemia associated with 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 &#150; 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">Roxadustat is currently advancing through Phase 3 clinical trials
worldwide, supported by extensive Phase 2 clinical data demonstrating correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. To date, roxadustat has been evaluated in Phase 1 and Phase 2 studies, involving
more than 1,400 subjects. Globally, a total of 15 Phase 3 studies, with target enrollment of about 10,000 patients worldwide, are currently being conducted to support independent regulatory approvals of roxadustat in both <FONT
STYLE="white-space:nowrap">NDD-CKD</FONT> and <FONT STYLE="white-space:nowrap">DD-CKD</FONT> patients in the U.S., Europe, Japan, and China. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">AstraZeneca
and FibroGen are collaborating for the development and commercialization of roxadustat in the U.S., China, and other markets. In China, FibroGen China is conducting all clinical trials and will hold all roxadustat regulatory licenses and permits to
be issued by China regulatory authorities. After market approval, FibroGen China will manage manufacturing and medical affairs and AstraZeneca will manage launch and commercialization activities in China. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Astellas and FibroGen are collaborating for the development and commercialization of roxadustat in Europe, Japan, the Commonwealth of Independent States, the
Middle East, and Africa. </P>

<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">

 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Roxadustat is also entering a Phase 3 clinical trial in the U.S. for treatment of anemia in patients with
myelodysplastic syndrome (MDS). In China, a roxadustat MDS Phase 2/3 clinical trial application (CTA) is currently under review by the China Food and Drug Administration (CFDA). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For information about roxadustat studies currently recruiting patients, please visit clinicaltrials.gov at this link: </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U><FONT STYLE="white-space:nowrap">https://clinicaltrials.gov/ct2/results?term=FG-4592&amp;Search=Search</FONT> </U></P>
<P STYLE="margin-top:18pt; 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 with subsidiary offices in Beijing and Shanghai, is a leading science-based 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 fibrosis and hypoxia-inducible factor (HIF) biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat <FONT
STYLE="white-space:nowrap">(FG-4592),</FONT> the company&#146;s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity in Phase 3 clinical development for the treatment of anemia in
CKD.&nbsp;Pamrevlumab <FONT STYLE="white-space:nowrap">(FG-3019),</FONT> a fully-human monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), is in Phase 2 clinical development for the treatment of idiopathic
pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne&#146;s muscular dystrophy (DMD).&nbsp;FibroGen is also developing a biosynthetic cornea in China. For more information, please visit <U>www.fibrogen.com</U>. </P>
<P STYLE="margin-top:18pt; 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, including statements regarding the potential ability of roxadustat to treat anemia in CKD patients, and the potential commercial market for roxadustat worldwide, including in China and emerging markets, timelines for
study completion, reporting data, and clinical and regulatory developments for roxadustat. Our actual results may differ materially from these early data and any forward-looking statements due to risks and uncertainties that are described in our
Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> and our quarterly reports on Form <FONT STYLE="white-space:nowrap">10-Q</FONT> filed with the Securities and Exchange Commission, 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:18pt; 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">VP, Investor Relations and Corporate Communications </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+1.415.978.1433 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">kbergman@fibrogen.com </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
