<SEC-DOCUMENT>0001193125-25-005814.txt : 20250114
<SEC-HEADER>0001193125-25-005814.hdr.sgml : 20250114
<ACCEPTANCE-DATETIME>20250114084053
ACCESSION NUMBER:		0001193125-25-005814
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		6
CONFORMED PERIOD OF REPORT:	20250114
FILED AS OF DATE:		20250114
DATE AS OF CHANGE:		20250114

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				133529324
		STATE OF INCORPORATION:			I0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31368
		FILM NUMBER:		25527849

	BUSINESS ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017
		BUSINESS PHONE:		33153774400

	MAIL ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI-AVENTIS
		DATE OF NAME CHANGE:	20040826

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI SYNTHELABO SA
		DATE OF NAME CHANGE:	20010104
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d914171d6k.htm
<DESCRIPTION>6-K
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<TITLE>6-K</TITLE>
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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">6-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:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF
FOREIGN PRIVATE ISSUER </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR
<FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of January 2025 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</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:24pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of
registrant&#146;s name into English) </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" ALIGN="center"><B>46, avenue de
la Grande Arm&eacute;e, 75017 Paris, FRANCE </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) </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">Indicate by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT
STYLE="white-space:nowrap">40-F.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F&#8194;&#9746;&#8195;&#8195;&#8195;Form</FONT> <FONT
STYLE="white-space:nowrap">40-F&#8194;&#9744;</FONT> </P> <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>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In January 2025, Sanofi published the press releases attached hereto as Exhibits 99.1 and 99.2 which are
incorporated herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d914171dex991.htm">Press Release dated January&nbsp;9, 2025 : New Sarclisa subcutaneous formulation met <FONT STYLE="white-space:nowrap">co-primary</FONT> endpoints in the IRAKLIA phase 3 study in multiple myeloma</A></TD></TR>
<TR STYLE="font-size:1pt">
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<TD VALIGN="top" NOWRAP>Exhibit 99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d914171dex992.htm">Press Release dated January&nbsp;13, 2025 : Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma </A></TD></TR>
</TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SIGNATURES </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, thereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: January&nbsp;14, 2025</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; text-indent:4.00em; font-size:10pt; font-family:Times New Roman">SANOFI</P></TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<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/ Alexandra Roger <BR></P></TD></TR>
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<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Alexandra Roger <BR></TD></TR>
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<TD VALIGN="bottom">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Head of Legal Corporate&nbsp;&amp; Finance</TD></TR>
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 <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" ALIGN="center">3 </P>

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<TYPE>EX-99.1
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" 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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<TD VALIGN="bottom"><FONT STYLE="font-family:Verdana; font-size:14pt"><B>Press Release</B></FONT></TD>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Verdana"><FONT COLOR="#7800e6"><I>New Sarclisa subcutaneous formulation met <FONT STYLE="white-space:nowrap">co-primary</FONT> endpoints in the
IRAKLIA phase 3 study in multiple myeloma </I></FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Sarclisa SC formulation added to Pd for the treatment of R/R MM met the
<FONT STYLE="white-space:nowrap">co-primary</FONT> endpoints in the IRAKLIA phase 3 study, demonstrating <FONT STYLE="white-space:nowrap">non-inferiority</FONT> compared to Sarclisa IV </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">IRAKLIA is the first global phase 3 study to evaluate the SC administration of a cancer treatment via an OBDS
</P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">OBDS is an alternative delivery method designed to improve the patient experience and currently available SC
administration </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><B>Paris, January</B><B></B><B>&nbsp;9, 2025.</B> Results from the investigational, randomized, open-label
IRAKLIA phase 3 study demonstrated that Sarclisa administered at a fixed dose subcutaneously (SC) via an <FONT STYLE="white-space:nowrap">on-body</FONT> delivery system (OBDS) in combination with pomalidomide and dexamethasone (Pd) met its <FONT
STYLE="white-space:nowrap">co-primary</FONT> endpoints of <FONT STYLE="white-space:nowrap">non-inferior</FONT> objective response rate (ORR) and observed concentration before dosing (C trough) at steady state compared to intravenous
(IV)&nbsp;Sarclisa administered at a weight-based dose in combination with Pd in patients with relapsed or refractory multiple myeloma (R/R MM). Key secondary endpoints, including very good partial response (VGPR), incidence rate of infusion
reactions and C trough at cycle 2 were also achieved. The study is ongoing, and the full results will be presented at a forthcoming medical meeting. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><B><I>Sikander Ailawadhi, MD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify">Professor of Medicine, Division of Hematology/Oncology at Mayo Clinic Florida and principal investigator of the study </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:Verdana" ALIGN="justify"><I>&#147;The consistent overall response rate and comparable efficacy and safety profile observed in the IRAKLIA study
for subcutaneous Sarclisa represent an exciting advancement, offering insight into a potential new administration option for patients. The results from IRAKLIA, in patients with relapsed or refractory multiple myeloma, support the potential of an <FONT
STYLE="white-space:nowrap">on-body</FONT> delivery system to help ease the delivery of a new formulation without impacting patient outcomes.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The IRAKLIA study was conducted using Enable Injections&#146; enFuse<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> hands-free OBDS, which
was designed to administer high-volume medicines subcutaneously through an automated drug delivery technology. The enFuse device leverages a hidden and retractable needle that is thinner compared to commonly used SC injection needles. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><B><I>Houman Ashrafian, MD, PhD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify">Executive Vice President, Head of Research and Development at Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:Verdana" ALIGN="justify"><I>&#147;We are fueled by our focus on innovation and finding <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">best-in-class</FONT></FONT> solutions to help ease the burden of disease for patients. The IRAKLIA study results are a prime example of what&#146;s driving our scientific engine. Being able to possibly bring a novel option
that helps reduce time in a healthcare facility is driven by our patient and provider-centric mindset. We look forward to sharing full results and working to bring this new advancement to the multiple myeloma community.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing. The safety and efficacy of
Sarclisa SC and the enFuse device have not been evaluated by any regulatory authority outside of their approved indications. Regulatory submissions in the US and in the EU are planned during the first half of 2025. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><I>About the IRAKLIA study </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">IRAKLIA is a randomized, open-label, pivotal phase 3 study evaluating the <FONT STYLE="white-space:nowrap">non-inferiority</FONT> of Sarclisa SC
formulation administered at a fixed dose subcutaneously via an OBDS versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM. The study enrolled 531 patients across 252 global sites, who were equally randomized to
receive Sarclisa SC or IV in combination with Pd for <FONT STYLE="white-space:nowrap">28-day</FONT> cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever came
first. In the SC arm, Sarclisa was administered at a fixed dose SC weekly for four weeks during the first cycle and every two weeks for subsequent cycles. In the IV arm, Sarclisa was administered at a weight-based dose via IV infusion weekly for
four weeks during the first cycle and every two weeks for subsequent cycles. The study enrolled adult patients with MM who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The <FONT STYLE="white-space:nowrap">co-primary</FONT> outcomes being assessed are ORR, defined as the proportion of patients with stringent complete
response, complete response, VGPR, and partial response (PR) according to the 2016 IMWG criteria assessed by Independent Review Committee (IRC), and observed C trough at steady state, defined as observed Sarclisa plasma concentrations. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><I>About Enable Injections </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Based in the US (Cincinnati, Ohio), Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience
through the development and manufacturing of enFuse. enFuse is an innovative wearable drug delivery platform that is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of
improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7800e6"><U>https://enableinjections.com</U></FONT><FONT
STYLE="font-family:Verdana">. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><I>About Sarclisa </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor
activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for
antibody-based therapeutics such as Sarclisa. In the US, the <FONT STYLE="white-space:nowrap">non-proprietary</FONT> name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological
products guidance for industry issued by the US FDA. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Currently, Sarclisa is approved in more than 50 countries, including the US and EU, across
two indications; Sarclisa is approved under an additional indication in the US. Based on the <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> phase 3 study, Sarclisa is approved in combination with Pd for the treatment of patients with R/R MM who
have received <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>2 prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on last therapy. Based on the IKEMA phase 3 study, Sarclisa is also approved in 50
countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received 1&#150;3 prior lines of therapy and in the EU for patients with MM who have received at least 1 prior
therapy. In the US, Sarclisa is approved in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a front-line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem
cell transplant (ASCT), based on the IMROZ phase 3 study. On November&nbsp;14, 2024, the European Medicines Agency (EMA)&#146;s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of <FONT
STYLE="white-space:nowrap">Sarclisa-VRd</FONT> in this patient population. A final decision is expected in the coming months. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Sanofi continues to
advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. Further clinical studies evaluating a subcutaneous
administration method for Sarclisa are ongoing. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">In striving to become the number one immunoscience company globally, Sanofi remains committed to
advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">difficult-to-treat</FONT></FONT> often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as
well as gastrointestinal and lung cancers. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">For more information on Sarclisa clinical studies, please visit <FONT
STYLE="font-family:Verdana; font-size:10pt" COLOR="#7800e6"><U>www.clinicaltrials.gov</U></FONT><FONT STYLE="font-family:Verdana">. </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Verdana"><FONT COLOR="#7800e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">We are an
innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people&#146;s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into
the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><FONT
 COLOR="#7800e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Sandrine Guendoul</B><B></B>&nbsp;|&nbsp;+ 33 6 25 09 14 25 |&nbsp;<FONT
STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Evan Berland</B>
| +1 215 432 0234 | <FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>evan.berland@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Nicolas Obrist</B><B></B>&nbsp;|&nbsp;+ 33 6 77 21 27 55 | <FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>nicolas.obrist@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>L&eacute;o Le Bourhis</B> | + 33 6 75 06 43 81 |
<FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>leo.lebourhis@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Victor
Rouault</B><B></B>&nbsp;|&nbsp;+ 33 6 70 93 71 40 |&nbsp;<FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Timothy Gilbert</B><B></B>&nbsp;|&nbsp;+ 1 516 521 2929 | <FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><FONT COLOR="#7800e6"><I>Investor Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Thomas Kudsk Larsen</B> |+ 44 7545 513 693 | <FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>thomas.larsen@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Aliz&eacute; Kaisserian</B><B></B>&nbsp;|&nbsp;+ 33 6 47 04 12 11 | <FONT
STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>alize.kaisserian@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Felix
Lauscher</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;908&nbsp;612 7239 | <FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Keita Browne</B><B></B>&nbsp;|&nbsp;+ 1 781 249 1766 | <FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>keita.browne@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 |
<FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Tarik Elgoutni
</B>| + 1 617 710 3587 | <FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana"><B>Thibaud Ch&acirc;telet</B> | + 33 6 80 80 89 90 | <FONT STYLE="font-family:Verdana; font-size:9pt" COLOR="#7800e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&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:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify"><I>This press release
contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;,
&#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect
the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating
to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and
volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees
and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under &#147;Risk Factors&#148; and
&#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2023. Other than as required by applicable law, Sanofi
does not undertake any obligation to update or revise any forward-looking information or statements. </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><I>All trademarks mentioned in this press release are the
property of the Sanofi group. </I></P>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><I>Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or
refractory multiple myeloma </I></FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Approval based on positive pivotal <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> phase 3 study using the
China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa and the standard treatment Pd, improved responses and long-term outcomes compared to Pd alone in R/R MM patients<SUP STYLE="font-size:75%; vertical-align:top">
</SUP> </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt"><FONT STYLE="white-space:nowrap">Sarclisa-Pd</FONT> is currently recommended by the Chinese Society of Clinical
Oncology (CCSCO) and Chinese Anti-Cancer Association (CACA) treatment guidelines for this patient population </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><B>Paris,
January</B><B></B><B>&nbsp;13, 2025</B>. The National Medical Products Administration (NMPA) in China has approved Sarclisa, an anti-CD38 medicine, in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with
multiple myeloma (MM)&nbsp;who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">This approval
is based on results from the pivotal <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> phase 3 study, using the China-based IsaFiRsT real-world study as bridging data. The <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> study demonstrated Sarclisa
in combination with Pd significantly reduced the risk of disease progression or death by 40% (HR 0.596, 95% CI <FONT STYLE="white-space:nowrap">0.44-0.81,</FONT> p=0.001), and resulted in a clinically meaningful,
<FONT STYLE="white-space:nowrap">6.9-month</FONT> improvement in overall survival (OS) (HR=0.78; <FONT STYLE="white-space:nowrap">log-rank</FONT> <FONT STYLE="white-space:nowrap">1-sided</FONT> P=0.0319), compared to Pd alone. Additionally, the
IsaFiRsT study, which is the first real-world study for the registration of an anti-CD38 therapy in combination with Pd in China, showed an overall response rate (ORR) of 82.6% among relapsed or refractory multiple myeloma (R/R MM) adult patients.
</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><B><I>Olivier Nataf </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify">Global Head, Oncology </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify"><I>&#147;This approval marks an important milestone for Sanofi in China. The results of the
<FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> phase 3 study, coupled with the real-world IsaFiRsT study, highlight the benefit of Sarclisa for patients living with multiple myeloma and the importance of innovative regulatory pathways for timely
access to different treatments. We look forward to continuing to build strong partnerships with the medical community, local companies, and authorities in China as we work to bring more innovative treatments to patients.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Through the Lecheng Pilot for real-world data application, the NMPA has increasingly used real-world evidence (RWE) to help accelerate the review and
approval of innovative therapies and medical devices in China. Sarclisa was one of the first three treatments authorized for real-world studies as part of the pilot program and is the first blood cancer treatment approved based on RWE, in addition
to clinical data. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">In addition to the NMPA approval, the Chinese Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer Association (CACA)
guidelines include <FONT STYLE="white-space:nowrap">Sarclisa-Pd</FONT> as a &#147;Category I Recommendation&#148; and the &#147;Preferred Option&#148; for the treatment of patients with first-relapsed MM. Beyond R/R MM, a regulatory submission for
Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) in adult patients not eligible for autologous stem cell transplant, is also under review in China with a final decision
expected in the coming months. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">As one of the first multinational companies to enter China in 1982, Sanofi is committed to accelerating the
introduction of innovative medicines and vaccines into China, aiming to transform the practice of medicine for the benefit of more Chinese people. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><I>About the <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> study
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> was a pivotal phase 3 randomized, open-label, multi-center trial evaluating Sarclisa
in combination with Pd versus Pd alone in patients with R/R MM. The study enrolled 307 patients with R/R MM across 96 centers spanning 24 countries. Overall, patients had received a median of three prior lines of anti-myeloma therapies, including at
least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">During the trial, Sarclisa was
administered by intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for <FONT STYLE="white-space:nowrap">28-day</FONT> cycles in combination with standard doses of Pd for the duration of treatment. The primary
endpoint of <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> was progression-free survival (PFS). Key secondary endpoints included ORR and OS. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><FONT
 COLOR="#7800e6"><I>About the IsaFiRsT study </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The IsaFiRsT study was a <FONT STYLE="white-space:nowrap">single-arm,</FONT>
observational, prospective, real-world study evaluating Sarclisa in combination with Pd in patients with R/R MM. The study enrolled 24 patients with R/R MM at one site in China. Overall, patients received a median of three prior lines of therapy,
including lenalidomide and a proteasome inhibitor, and had measurable serum or urine <FONT STYLE="white-space:nowrap">M-protein.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">During
the trial, Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for <FONT STYLE="white-space:nowrap">28-day</FONT> cycles in combination with standard doses of Pd for the
duration of treatment. Treatment continued until disease progression or unacceptable toxicity. The primary endpoint of IsaFiRsT was ORR. Key secondary endpoints included PFS, OS, duration of response (DOR) and safety. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><FONT COLOR="#7800e6"><I>About Sarclisa </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor
activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for
antibody-based therapeutics such as Sarclisa. In the US, the <FONT STYLE="white-space:nowrap">non-proprietary</FONT> name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological
products guidance for industry issued by the US FDA. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Currently, Sarclisa is approved in more than 50 countries, including the US and EU, across
two indications; Sarclisa is approved under an additional indication in the US. Based on the <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> phase 3 study, Sarclisa is approved in combination with Pd for the treatment of patients with R/R MM who
have received <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>2 prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on last therapy. Based on the IKEMA phase 3 study, Sarclisa is also approved in 50
countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received 1&#150;3 prior lines of therapy and in the EU for patients with MM who have received at least 1 prior
therapy. In the US, Sarclisa is approved in combination with VRd as a front-line treatment option for adult patients with NDMM not eligible for transplant based on the IMROZ phase 3 study. On November&nbsp;14, 2024, the European Medicines Agency
(EMA)&#146;s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of <FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT> in this patient population. A final decision is expected in the coming
months. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase
3 studies across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous administration method for Sarclisa in clinical studies. The safety and efficacy of Sarclisa has not been evaluated
by any regulatory authority outside of its approved indications and methods of delivery. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">In striving to become the number one immunoscience
company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered
on <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">difficult-to-treat</FONT></FONT> often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid
leukemia, certain types of lymphomas, as well as gastrointestinal and lung cancers. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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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:Verdana" ALIGN="justify">For more information on Sarclisa clinical studies, please visit <FONT
STYLE="font-family:Verdana; font-size:10pt" COLOR="#7800e6"><U>www.clinicaltrials.gov</U></FONT><FONT STYLE="font-family:Verdana">. </FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #b7b7b7">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana"><FONT COLOR="#7800e6"><I>About Sanofi </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people&#146;s lives. Our team, across the world, is
dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting
sustainability and social responsibility at the center of our ambitions. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana"><FONT COLOR="#7800e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Sandrine
Guendoul</B><B></B>&nbsp;|&nbsp;+33 6 25 09 14 25 |&nbsp;<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Evan Berland</B> | +1 215 432 0234 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>evan.berland@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Nicolas Obrist</B><B></B>&nbsp;|&nbsp;+33 6 77 21 27 55 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>nicolas.obrist@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;o Le
Bourhis</B> | +33 6 75 06 43 81 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>leo.lebourhis@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Victor Rouault</B><B></B>&nbsp;|&nbsp;+33 6 70 93 71 40
|&nbsp;<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Timothy
Gilbert</B><B></B>&nbsp;|&nbsp;+1 516 521 2929 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana"><FONT COLOR="#7800e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thomas Kudsk
Larsen</B> |+44 7545 513 693 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>thomas.larsen@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Aliz&eacute; Kaisserian</B><B></B>&nbsp;|&nbsp;+33 6 47 04 12 11 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>alize.kaisserian@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Felix
Lauscher</B><B></B>&nbsp;|&nbsp;+1&nbsp;908&nbsp;612 7239 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Keita Browne</B><B></B>&nbsp;|&nbsp;+1 781 249 1766 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>keita.browne@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+33 7 85 93 30 17 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Tarik Elgoutni
</B>| +1 617 710 3587 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7800e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&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:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify"><I>This press release
contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;,
&#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect
the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating
to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and
volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees
and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under &#147;Risk Factors&#148; and
&#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2023. Other than as required by applicable law, Sanofi
does not undertake any obligation to update or revise any forward-looking information or statements. </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><I>All trademarks mentioned in this press release are the
property of the Sanofi group. </I></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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