argenx SE (Euronext & NASDAQ: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases and cancer, and Zai Lab Limited (NASDAQ:
ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical
company, today announced an exclusive license agreement for the
development and commercialization of efgartigimod in Greater China,
including mainland China, Hong
Kong, Taiwan and Macau.
“Through this collaboration with Zai Lab, we are expanding our
global footprint in one of the world’s fastest growing markets and
reaching more people living with severe autoimmune diseases. By
leveraging Zai Lab’s strong local expertise within Greater China
and proven development capabilities, we aim to provide broad access
to efgartigimod in these important markets as well as accelerate
the number of autoimmune indications in clinical development,” said
Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We
believe that Zai Lab is the ideal partner for us ahead of our first
potential approval of efgartigimod in generalized myasthenia gravis
(gMG) in the U.S. and we are aligned in our mutual passion to bring
potential innovative immunology therapies to patients in need.”
“argenx is building a leading immunology company and we are
excited to collaborate with them during this important time.
Efgartigimod is being evaluated in a broad range of autoimmune
diseases and we look forward to bringing this potentially
first-in-class product to patients in Greater China,” said Dr.
Samantha Du, Founder, Chairperson and Chief Executive Officer of
Zai Lab. “This collaboration also significantly expands and
strengthens our pipeline in severe autoimmune diseases, where there
is an urgent and serious need for new therapeutic options.”
“There are an estimated 200,000 people living with MG in China,”
said Dr. Harald Reinhart, Chief Medical Officer for Autoimmune and
Infectious Diseases, Zai Lab. “The unmet medical need is
significant for these patients, with very limited treatment
options. We believe efgartigimod has a promising profile that, if
approved, can potentially change the treatment paradigm not only of
gMG but of other autoimmune diseases.”
Under the terms of the agreement, Zai Lab obtains the exclusive
right to develop and commercialize efgartigimod in Greater
China. Zai Lab will recruit Chinese patients to argenx’s
global registrational trials for the development of efgartigimod.
Additionally, this agreement is expected to allow argenx to
accelerate efgartigimod development by initiating multiple Phase 2
proof-of-concept trials in new autoimmune indications.
argenx will receive $175 million in collaboration payments,
comprised of a $75 million upfront payment in the form of 568,182
newly issued Zai Lab shares calculated at a price of $132.00 per
share, $75 million as a guaranteed non-creditable, non-refundable
development cost-sharing payment, and an additional $25 million
milestone payment upon approval of efgartigimod in the U.S. argenx
is also eligible to receive tiered royalties (mid-teen to
low-twenties on a percentage basis) based on annual net sales of
efgartigimod in Greater China.
About Efgartigimod
Efgartigimod is an investigational antibody fragment designed to
reduce disease-causing immunoglobulin G (IgG) antibodies and block
the IgG recycling process. Efgartigimod binds to the neonatal Fc
receptor (FcRn), which is widely expressed throughout the body and
plays a central role in rescuing IgG antibodies from degradation.
Blocking FcRn reduces IgG antibody levels, representing a logical
potential therapeutic approach for several autoimmune diseases
known to be driven by disease-causing IgG antibodies, including:
myasthenia gravis (MG), a chronic disease that causes muscle
weakness; pemphigus vulgaris (PV), a chronic disease characterized
by severe blistering of the skin; immune thrombocytopenia (ITP), a
chronic bruising and bleeding disease; and chronic inflammatory
demyelinating polyneuropathy (CIDP), a neurological disease leading
to impaired motor function.
About argenx
argenx is a global immunology company committed to improving the
lives of people suffering from severe autoimmune diseases and
cancer. Partnering with leading academic researchers through its
Immunology Innovation Program (IIP), argenx aims to translate
immunology breakthroughs into a world-class portfolio of novel
antibody-based medicines. argenx is evaluating efgartigimod in
multiple serious autoimmune diseases, and cusatuzumab in
hematological cancers in collaboration with Janssen. argenx is also
advancing several earlier stage experimental medicines within its
therapeutic franchises. argenx has offices in Belgium, the United
States, and Japan. For more information, visit www.argenx.com and
follow us on LinkedIn at
https://www.linkedin.com/company/argenx/.
About Zai Lab
Zai Lab (NASDAQ:ZLAB; HKEX: 9688) is an innovative
commercial-stage biopharmaceutical company focused on bringing
transformative medicines for cancer and infectious and autoimmune
diseases to patients in China and around the world. We aim to
address significant unmet medical needs in large, fast-growing
segments of the pharmaceutical market. To that end, our experienced
team has secured partnerships with leading global biopharmaceutical
companies in order to generate a broad pipeline of innovative
marketed products and drug candidates. We have also built an
in-house team with strong drug discovery and translational research
capabilities and are establishing a pipeline of proprietary drug
candidates with global rights. Our vision is to become a leading
global biopharmaceutical company, discovering, developing,
manufacturing and commercializing our portfolio in order to impact
human health worldwide.
For additional information about the company, please visit
www.zailaboratory.com or follow us on Linkedin at
https://www.linkedin.com/company/zai-lab/mycompany/ and Twitter at
www.twitter.com/ZaiLab_Global.
argenx Contacts
Media:
Kelsey KirkKKirk@argenx.com
Investors:
Beth DelGiacco bdelgiacco@argenx.com
Joke Comijn (EU)jcomijn@argenx.com
Zai Lab Contacts
Billy Cho, CFO+86 137 6151 2501 billy.cho@zailaboratory.com
Media: Ryo Imai / Robert Flamm, Ph.D.Burns
McClellan, on behalf of Zai Lab212-213-0006 ext. 315 /
364rimai@burnsmc.com / rflamm@burnsmc.com
Investors: Mike ZanoniEndurance Advisors, on
behalf of Zai Lab610-442-8570mzanoni@enduranceadvisors.com
argenx Forward-looking Statements
The contents of this announcement include statements that are,
or may be deemed to be, forward-looking statements. These
forward-looking statements can be identified by the use of
forward-looking terminology, including the terms believes,
estimates, anticipates, expects, intends, may, will, or should, and
include statements argenx makes concerning the therapeutic
potential of its product candidates; the intended results of its
strategy; the expected benefits of the collaboration with Zai Lab;
its and its collaboration partners’ clinical development and
regulatory plans, including the timing, design and outcome of
ongoing and planned clinical trials and the timing and outcome of
regulatory filings and approvals; and the timing and progress of
commercialization activities. By their nature, forward-looking
statements involve risks and uncertainties and readers are
cautioned that any such forward-looking statements are not
guarantees of future performance. argenx’s actual results may
differ materially from those predicted by the forward-looking
statements as a result of various important factors, including the
effects of the COVID-19 pandemic, the inherent uncertainties
associated with preclinical and clinical trial and product
development activities and regulatory approval requirements;
argenx’s reliance on collaborations with third parties; estimating
the commercial potential of argenx’s product candidates; argenx’s
ability to obtain and maintain protection of intellectual property
for its technologies and drugs; argenx’s limited operating history;
and argenx’s ability to obtain additional funding for operations
and to complete the development and commercialization of its
product candidates. A further list and description of these risks,
uncertainties and other risks can be found in argenx’s U.S.
Securities and Exchange Commission (SEC) filings and reports,
including in argenx’s most recent annual report on Form 20-F filed
with the SEC as well as subsequent filings and reports filed by
argenx with the SEC. Given these uncertainties, the reader is
advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. argenx undertakes no
obligation to publicly update or revise the information in this
press release, including any forward-looking statements, except as
may be required by law.
Zai Lab Forward-Looking Statements
This press release contains statements about future
expectations, plans and prospects for Zai Lab, including, without
limitation, statements regarding the prospects of and plans for
commercializing efgartigimod in Greater China. Such statements
constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements are not statements of historical fact nor are they
guarantees or assurances of future performance. Forward-looking
statements are based on Zai Lab's expectations and assumptions as
of the date of this press release and are subject to inherent
uncertainties, risks and changes in circumstances that may differ
materially from those contemplated by the forward-looking
statements. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including but not limited to (1) Zai Lab’s
ability to obtain additional future funding, (2) Zai Lab’s results
of clinical and pre-clinical development of its drug candidates,
(3) the content and timing of decisions made by the relevant
regulatory authorities regarding regulatory approvals of Zai Lab’s
drug candidates, (4) Zai Lab’s ability to generate revenue from its
drug candidates, (5) the effects of the novel coronavirus
(COVID-19) pandemic on general economic, regulatory and political
conditions and (6) other factors discussed in Zai Lab's Annual
Report on Form 20-F for the fiscal year ended December 31, 2019,
filed on April 29, 2020, and its other filings with the Securities
and Exchange Commission. Zai Lab anticipates that subsequent events
and developments will cause Zai Lab’s expectations and assumptions
to change and undertakes no obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as may be required
by law. These forward-looking statements should not be relied upon
as representing Zai Lab’s views as of any date subsequent to the
date of this press release.
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