Press Release: Sanofi and Innovent Biologics enter strategic
collaboration to accelerate development of oncology medicines and
expand presence in China
Sanofi and Innovent Biologics enter strategic collaboration to
accelerate development of oncology medicines and expand presence in
China
- Collaboration to accelerate the
development and access of oncology medicines for cancer patients in
China
- Clinical trial programs combining two of Sanofi’s prioritized
oncology assets with sintilimab, the leading checkpoint inhibitor
in China, to address some of the most prevalent solid tumors in
China
- Sanofi to make an initial equity investment of €300 million in
Innovent in addition to the strategic multi-product
collaboration
- This strategic partnership demonstrates Sanofi and Innovent’s
commitment to bringing high quality oncology medicines to patients
in China
Paris,
August 4, 2022. Sanofi and
Innovent Biologics (HKEX: 1801.HK, “Innovent”) announced a
collaboration to bring innovative medicines to patients in China
with difficult-to-treat cancers. Innovent is a leading
biopharmaceutical company with strong clinical development
capabilities and a broad commercial footprint in China. Both
companies are committed to accelerating the development and
commercialization of two Sanofi key clinical stage oncology assets:
Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5
antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2),
combining with sintilimab, the leading checkpoint inhibitor in
China.
In addition to the collaboration and license
agreement, Sanofi will invest €300 million in Innovent through
subscription of new common shares.
John Reed, M.D., Ph.D. Global Head of
Research and Development at Sanofi
“This strategic collaboration with Innovent will
not only accelerate the development, market access and future
commercialization of two of our key oncology medicines in selected
combinations with sintilimab, but also bolster our overall presence
in oncology in China. We look forward to a successful partnership
with Innovent, one of the most innovative companies in China, and
to leveraging their development capabilities and market leadership
in the country.”
Michael Yu, Ph.D. Founder, Chairman and
CEO of Innovent
“This strategic collaboration with Sanofi, a
leading global pharmaceutical company, opens the pathway to great
synergy for accelerating the pace of innovation. This pioneering
partnership will leverage the synergy between Sanofi and Innovent’s
pipeline and R&D resources with the mutual aim to address major
unmet medical needs for cancer patients. We hope this agreement
will be a great start of the two parties’ long-term partnership,
and we look forward to bringing more innovative therapies to
patients.”
Clinical development and commercialization of
tusamitamab ravtansine
SAR408701 (tusamitamab ravtansine) is a
potential first-in-class antibody-drug conjugate (ADC) targeting
CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule
5), a cell-surface glycoprotein that is highly expressed in
non-small cell lung cancer (NSCLC), gastric cancer and other
cancers. SAR408701 is currently in a Phase 3 study for 2L NSCLC
globally including China, and global Phase 2 studies in additional
indications including 1L NSCLC, gastric cancers and other solid
tumors.
According to the agreement, Innovent will be
responsible for developing and exclusively commercializing
tusamitamab in multiple oncology-based indications in China. Sanofi
will be entitled to receive up to €80 million development milestone
payment and royalties on the net sales of the product in China upon
approval.
Clinical development and commercialization of
SAR444245
SAR444245 is a potential first-in-class
reprogrammed, site-directed, single PEGylated, recombinant human
IL-2 (rIL-2) variant with extended half-life that specifically
binds to the low-affinity IL-2 receptor but lacks binding affinity
for the αlpha chain of the high-affinity IL-2 receptor.
SAR444245(IL-2) is currently under global Phase 2 studies for skin
cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and
neck tumors, and lymphoma.
Innovent and Sanofi will jointly explore the
development of SAR444245 in China in various cancer types, where
Innovent will lead the clinical development. Sanofi remains the
sole Marketing Authorization holder for both assets and will be
fully responsible for SAR245 commercialization. Innovent will be
entitled to receive up to €60 million development milestone
payments and royalties on the net sales of the product in China
upon approval.
Sanofi’s initial strategic equity investment in
Innovent for €300 million
In addition to the strategic multi-product
collaboration and license agreement, Sanofi, subject to conditions
precedent including regulatory approval and customary closing
conditions, will invest in new common shares issued by Innovent for
€300 million, at a price of HK $42.42 per share, representing a 20%
premium to the Innovent 30-trading-day average share price as of
August 3, 2022, one day prior to the signing of the agreements.
Subject to mutual agreement of both parties in
the future, Sanofi will have the right to acquire additional
Innovent new common shares for €300 million, at a subscription
price that represents 20% premium to Innovent 30-trading-day
average share price as the date of the separate agreement that may
be entered into by both parties.
About SAR408701
SAR408701 (tusamitamab ravtansine) is a
potential first-in-class antibody-drug conjugate (ADC) targeting
CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule
5), a cell-surface glycoprotein that is highly expressed in
non-small cell lung cancer (NSCLC), gastric cancer and other
cancers. Tusamitamab ravtansine is currently in a Phase 3 study for
second-line NSCLC globally including China, and global Phase 2
studies in additional indications including first-line NSCLC,
gastric cancers and other solid tumors. About
SAR444245SAR444245 is a potential first-in-class recombinant human
IL-2 (rIL-2) variant that includes a site-directed single PEG
moiety/chain that prevents it from binding to the α chain of the
IL-2 receptor while retaining near-native affinity for the
beta/gamma subunits.
SAR444245 is currently being investigated in
global Phase 2 studies for the treatment of skin cancers,
gastrointestinal cancer, NSCLC / mesothelioma, head and neck
tumors, and lymphoma.
About Sintilimab (TYVYT®)Sintilimab, marketed as
TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4
monoclonal antibody jointly developed by Innovent and Eli Lilly and
Company. Innovent is currently conducting more than 20 clinical
studies of sintilimab to evaluate its safety and efficacy in a wide
variety of cancer indications, including more than 10
registrational or pivotal clinical trials. In China, sintilimab has
been approved for six indications including relapsed or refractory
classic Hodgkin’s lymphoma, first-line treatment of non-squamous
NSCLC, first-line treatment of squamous NSCLC, first-line treatment
of hepatocellular carcinoma, first-line treatment of esophageal
squamous cell carcinoma, and first-line treatment of gastric or
gastroesophageal junction adenocarcinoma, of which the first four
indications have been included in the National Reimbursement Drug
List (NRDL).
Note:SAR408701 and SAR444245 are not approved products in
China
About Sanofi We are an innovative
global healthcare company, driven by one purpose: we chase the
miracles of science to improve people’s lives. Our team, across
some 100 countries, 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. Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
About Innovent
Inspired by the spirit of "Start with Integrity,
Succeed through Action,” Innovent’s mission is to develop,
manufacture and commercialize high-quality biopharmaceutical
products that are affordable to ordinary people. Established in
2011, Innovent has developed a fully integrated multi-functional
platform which includes R&D, CMC (Chemistry, Manufacturing, and
Controls), clinical development and commercialization capabilities.
Leveraging the platform, the company has built a robust pipeline of
34 valuable assets in the fields of cancer, autoimmune, metabolic,
ophthalmology and other major therapeutic areas. On October 31,
2018, Innovent was listed on the Main Board of the Stock Exchange
of Hong Kong Limited with the stock code: 01801.HK.
For more information, please visit: www.innoventbio.com. and
www.linkedin.com/company/innovent-biologics/.
SanofiMedia Relations Sandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.com Sally Bain | +
1 617 834 6026 | sally.bain@sanofi.com Kate
Conway | + 1 508 364 4931
| kate.conway@sanofi.com
Investor Relations Eva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.com Arnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.com Corentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.com Felix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.com Priya
Nanduri | +1 617 764 6418 | priya.nanduri@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
InnoventMedia | +86 512-6956
6088 | pr@innoventbio.comInvestors | +86 512-6956
6088 | ir@innoventbio.com
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expectations with respect to future financial results, events,
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things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
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rates, volatile economic and market conditions, cost containment
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foregoing could also adversely impact us. This situation is
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AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in
Sanofi’s annual report on Form 20-F for the year ended December 31,
2021. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.
Innovent Forward-Looking
StatementsThis news release may contain certain
forward-looking statements that are, by their nature, subject to
significant risks and uncertainties. The words "anticipate",
"believe", "estimate", "expect", "intend" and similar expressions,
as they relate to Innovent Biologics, Inc. (“Innovent” or
“Company”) , are intended to identify certain of such
forward-looking statements. The Company does not intend to update
these forward-looking statements regularly.
These forward-looking statements are based on the existing
beliefs, assumptions, expectations, estimates, projections and
understandings of the management of the Company with respect to
future events at the time these statements are made. These
statements are not a guarantee of future developments and are
subject to risks, uncertainties and other factors, some of which
are beyond the Company's control and are difficult to predict.
Consequently, actual results may differ materially from information
contained in the forward-looking statements as a result of future
changes or developments in our business, the Company's competitive
environment and political, economic, legal and social
conditions.
The Company, the Directors and the employees of the Company
assume (a) no obligation to correct or update the forward-looking
statements contained in this site; and (b) no liability in the
event that any of the forward-looking statements does not
materialise or turn out to be incorrect.
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