First and only NMPA-approved subcutaneous
injectable FcRn blocker for gMG patients in China
Consistent clinical benefit and safety profile of
efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC
study
July 16, 2024 6:30am CET
Amsterdam, the Netherlands—
argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited
(Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National
Medical Products Administration (NMPA) approved the Biologics
License Application (BLA) on July 16, 2024 for efgartigimod alfa
injection (subcutaneous injection) (efgartigimod SC), 1,000mg
(5.6ml)/vial indicated as an add on to standard therapy for the
treatment of adult patients with generalized myasthenia gravis
(gMG) who are anti-acetylcholine receptor (AChR) antibody
positive.
“The NMPA approval for efgartigimod SC is yet
another key milestone on our journey to expand into new patient
populations around the world with our transformative medicine.”
said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We
celebrate this achievement with our partner, Zai Lab, who shares
our mutual passion for bringing needed innovation to patients with
gMG in China. We are impressed by the team’s incredible launch
execution, bringing 2,700 new patients onto VYVGART IV treatment in
the first quarter of 2024, which underscores the high unmet need
that remains for gMG patients. The addition of a flexible
30-to-90second subcutaneous injection opens the door for new
patients in China, while taking into account personal preference
and convenience. We look forward to continuing our partnership and
expanding our footprint in one of the world’s fastest growing
markets to reach more people living with severe autoimmune
diseases.”
“We are pleased to receive NMPA approval for
efgartigimod SC, marking an important milestone as we bring another
first-in-class option to gMG patients in China,” said Rafael G.
Amado, M.D., President, Head of Global Research and Development at
Zai Lab. “The addition of a new treatment option for gMG patients
enhances flexibility for patients, potentially further simplifying
the regimen and making therapy more accessible within the
community. We appreciate the NMPA for their thorough assessment and
recognition of the therapy’s differentiated profile and the large
unmet medical need in China.”
“There are approximately 170,000 people living
with gMG in China1,” said Prof. Xueqiang Hu, M.D., Ph.D., Chief
Physician of Department of Neurology, the Third Affiliated Hospital
of Sun Yat-sen University. “Compared to fixed infusion schedules,
the availability of efgartigimod SC allows a more individualized
and flexible treatment approach based on patient needs without
sacrificing clinical benefit or safety. In the global Phase 3
ADAPT-SC study, efgartigimod SC demonstrated consistent benefit and
safety compared to the intravenous product. This is a meaningful
advancement for the patient community, and we are grateful to Zai
Lab for supporting patients who have been devastated by this
disease for so long.”
The BLA approval is supported by positive
results from the global Phase 3 ADAPT-SC study, a bridging study to
the Phase 3 ADAPT study, which formed the basis for approval of
intravenous VYVGART in adult gMG patients. In the ADAPT-SC study,
the primary endpoint of noninferiority was met (p< 0.0001), and
efgartigimod SC demonstrated mean total IgG reduction of 66.4% from
baseline at day 29, compared to 62.2% with efgartigimod IV.
Additional key secondary endpoints were also met, which were
consistent with efficacy measures from the ADAPT study identifying
the correlation between total IgG reduction and clinical benefit in
gMG.
The safety profile for efgartigimod SC was also
consistent with the ADAPT study. Efgartigimod SC was generally
well-tolerated; the most frequent adverse event being injection
site reactions (ISRs), commonly observed with biologics
administered subcutaneously. All ISRs were mild to moderate and
resolved over time.
Efgartigimod SC is also being evaluated for the
potential treatment of additional autoimmune disorders. In May
2024, the NMPA accepted a supplemental Biologics License
Application (sBLA) with priority review for efgartigimod SC in
chronic inflammatory demyelinating polyneuropathy (CIDP). The U.S.
Food and Drug Administration (FDA) approved efgartigimod SC in June
2024 for adults with CIDP.
About VYVGART® and Efgartigimod
SC
VYVGART (efgartigimod alfa injection) is a human
IgG1 antibody fragment that binds to the neonatal Fc receptor
(FcRn), resulting in the reduction of circulating IgG
autoantibodies. It is the first approved FcRn blocker for the
treatment of adults with generalized myasthenia gravis (gMG) who
are anti-AChR antibody positive.
Efgartigimod SC is a subcutaneous product
including efgartigimod alfa injection, a human IgG1 antibody
fragment, and recombinant human hyaluronidase PH20 (rHuPH20),
Halozyme’s ENHANZE® drug delivery technology to facilitate
subcutaneous delivery of biologics. The product is to be
administered subcutaneously as a single injection (1,000 mg fixed
dose) over 30-to-90 seconds in cycles of once weekly injections for
four weeks. Efgartigimod SC is approved in the United States
(marketed as VYVGART® Hytrulo), EU (marketed as VYVGART® SC) and
Japan (marketed as VYVDURA®).
Efgartigimod has the potential to address a
multitude of severe autoimmune diseases where pathogenic IgGs are
believed to be mediators of disease and is being evaluated in
several autoimmune indications.Zai Lab has an exclusive license
agreement with argenx to develop and commercialize efgartigimod in
mainland China, Hong Kong, Macau, and Taiwan (collectively, Greater
China).
About Myasthenia Gravis in
China
Myasthenia gravis (MG) is a chronic autoimmune
disease, characterized by debilitating and potentially
life-threatening muscle weakness. There are approximately 170,000
people in China living with gMG1, and of those patients, 85% are
estimated to have confirmed AChR antibodies; in this generalized
form of the disease, skeletal muscles throughout the body may be
affected, resulting in weakness and early fatigue. Difficulties
with double vision, facial expression, speech, swallowing, and
ambulation are frequent and difficult to manage for patients and
treating physicians. In more life-threatening cases, gMG can affect
the muscles responsible for breathing, which can be fatal.
Acetylcholinesterase (AChE) inhibitors, steroids,
immunosuppressants, and IVIg are the mainstay of treatment in
China. These drugs often achieve only partial restoration of
strength.
1 The growing burden of generalized myasthenia
gravis: a population-based retrospective cohort study
in Taiwan, 2023.
About argenx
argenx is a global immunology company committed
to improving the lives of people suffering from severe autoimmune
diseases. 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 developed and is commercializing
the first approved neonatal Fc receptor (FcRn) blocker in China,
the U.S., Japan, Israel, the EU, the UK, and Canada. The Company is
evaluating efgartigimod in multiple serious autoimmune diseases and
advancing several earlier stage experimental medicines within its
therapeutic franchises. For more information, visit www.argenx.com
and follow us on LinkedIn, Twitter, and Instagram.
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an
innovative, research-based, commercial-stage biopharmaceutical
company based in China and the United States. We are focused on
discovering, developing, and commercializing innovative products
that address medical conditions with significant unmet needs in the
areas of oncology, autoimmune disorders, infectious disease, and
neuroscience. Our goal is to leverage our competencies and
resources to positively impact human health in China and
worldwide.
For additional information about Zai Lab, please
visit www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
For further information, please
contact:
argenx Media:
Ben Petokbpetok@argenx.com
argenx Investors:
Alexandra Roy (US)ARoy@argenx.com
Lynn Elton (EU)LElton@argenx.com
Zai Media:
Shaun Maccoun / Xiaoyu Chenshaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
Zai Investors:
Christine Chiou / Lina Zhangchristine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.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 “aims,”
or “continues,” and include statements argenx makes concerning its
goal to expand into new patient populations around the world; the
remaining unmet need for gMG patients; its partnership with Zai
Lab; its future expansion in China and globally; its ability to
gain new patients in China; the potential approval of efgartigimod
SC in other regions and its potential for treatment of additional
autoimmune disorders; and its goal of translating immunology
breakthroughs into a world-class portfolio of novel antibody-based
medicines. 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, including the results of argenx's clinical trials;
expectations regarding the inherent uncertainties associated with
the development of novel drug therapies; preclinical and clinical
trial and product development activities and regulatory approval
requirements in products and product candidates; the acceptance of
argenx's products and product candidates by patients as safe,
effective and cost-effective; the impact of governmental laws and
regulations on our business; disruptions caused on our reliance of
third-party suppliers, service providers and manufacturers;
inflation and deflation and the corresponding fluctuations in
interest rates; and regional instability and conflicts. argenx’s
actual results may differ materially from those predicted by the
forward-looking statements as a result of various important
factors. 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.
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