Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext
& Nasdaq: ARGX) today announced that China’s National Medical
Products Administration (NMPA) has approved the Biologics License
Application (BLA) for VYVGART® (efgartigimod alfa injection), a
first-in-class neonatal Fc receptor (FcRn) antagonist, 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. Zai Lab will now work with the
National Healthcare Security Administration (NHSA) for NRDL
inclusion to enable broad access for patients.
“We are pleased to have the NMPA’s approval for VYVGART for
intravenous use. This important milestone brings forward a novel
treatment for gMG patients who face many challenges living with
this complex and difficult-to-control autoimmune disease,” said Dr.
Samantha Du, Founder, Chairperson, and Chief Executive Officer of
Zai Lab. “We appreciate the NMPA for their thorough assessment of
VYVGART, recognizing its differentiated profile and the large unmet
medical need in China. In addition to gMG, we are working with
argenx on three registrational programs exploring other
immunoglobulin G (IgG)-related autoimmune indications and are
looking forward to exploring even more indications over time.”
“This approval by the NMPA for VYVGART, our sixth approval
globally, is the first-and-only FcRn blocker available for people
living with gMG in China. This is another milestone on our path to
redefine what well-controlled means for gMG patients and
underscores our longstanding commitment to the global gMG
community,” said Tim Van Hauwermeiren, Chief Executive Officer of
argenx. “We celebrate this achievement with our partner, Zai Lab,
who shares our mutual passion to bring needed innovation to people
with gMG in China. We look forward to continuing our partnership as
we further explore efgartigimod in other indications, expanding our
global footprint in one of the world’s fastest growing markets to
reach more people living with severe autoimmune diseases.”
“There are over 200,000 people living with myasthenia gravis
(MG) in China1. Despite the availability of current treatment
options, there remains a significant unmet medical need. The
approval of VYVGART in China marks an important milestone for
patients and provides physicians with a novel, safe and effective
therapy to help improve the quality of life for those in their
care,” said Dr. Chongbo Zhao, M.D., Ph.D., Deputy Director of
Department of Neurology, Huashan Hospital Affiliated to Fudan
University, Director of Working Group of Huashan Rare Disease
Center. “In clinical studies, efgartigimod demonstrated outstanding
characteristics in terms of onset of action, efficacy, and safety,
helping to improve patients' muscle strength and quality of life.
VYVGART, the first-and-only approved FcRn antagonist for gMG
patients in China, has the potential to revolutionize the treatment
landscape for gMG patients in China and we are grateful to Zai Lab
for providing the support for these patients who have been
devastated by this disease for so long.”
The global Phase 3 ADAPT trial met its primary endpoint,
demonstrating that significantly more anti-AChR antibody positive
gMG patients were responders on the Myasthenia Gravis Activities of
Daily Living (MG-ADL) scale following treatment with efgartigimod
compared with placebo (68% vs. 30%; p<0.0001). Responders were
defined as having at least a two-point reduction on the MG-ADL
scale sustained for four or more consecutive weeks during the first
treatment cycle2.
There were also significantly more responders on the
Quantitative Myasthenia Gravis (QMG) scale following treatment with
efgartigimod compared with placebo (63% vs. 14%; p<0.0001).
Responders were defined as having at least a three-point reduction
on the QMG scale sustained for four or more consecutive weeks
during the first treatment cycle.
VYVGART demonstrated a well-tolerated safety profile in the
ADAPT clinical trial. The most commonly reported adverse reactions
that occurred more frequently with VYVGART than placebo were upper
respiratory tract infections (10.7% following treatment with
efgartigimod vs. 4.8% of placebo) and urinary tract infections
(9.5% vs. 4.8%).
About VYVGART
VYVGART 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 in the United States, EU and China for the treatment of
adults with generalized myasthenia gravis (gMG) who are
anti-acetylcholine receptor (AChR) antibody positive, and in Japan
for the treatment of adults with gMG who do not have sufficient
response to steroids or non-steroidal immunosuppressive therapies
(ISTs).
Zai Lab has an exclusive license agreement with argenx to
develop and commercialize efgartigimod in mainland China, Hong
Kong, Macau, and Taiwan (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 200,000 people in China
living with the disease1. More than 85% of people with MG progress
to gMG within 18 months; 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. However, there is a lack of high-level
evidence-based recommendations for the treatment of MG,
representing significant unmet needs.
1 Nationwide population-based epidemiological study of
myasthenia gravis in Taiwan, 2010.
2 Howard JF et al. Lancet Neurol 2021;20(7):526-536.
About Zai Lab
Zai Lab (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 diseases, 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, including our
products, business activities and partnerships, research, and other
events or developments, please visit www.zailaboratory.com or
follow us at www.twitter.com/ZaiLab_Global.
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. 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.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements about
future expectations, plans, and prospects for Zai Lab, including,
without limitation, statements regarding the prospects of and plans
for development and commercialization of efgartigimod in Greater
China, the safety and efficacy of efgartigimod, and the potential
treatment of patients with myasthenia gravis in Greater China.
These forward-looking statements may contain words such as “aim,”
“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,”
“goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,”
“would,” and other similar expressions. 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 or guarantees or
assurances of future performance. Forward-looking statements are
based on our 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) our ability to successfully commercialize and
generate revenue from our approved products, (2) our ability to
obtain funding for our operations and business initiatives, (3) the
results of clinical and pre-clinical development of our product
candidates, (4) the content and timing of decisions made by the
relevant regulatory authorities regarding regulatory approvals of
our product candidates, (5) the effects of the novel coronavirus
(COVID-19) pandemic on our business and results of operations, (6)
risks related to doing business in China, and (7) other factors
identified in our most recent annual and quarterly reports and in
other reports we have filed with the U.S. Securities and Exchange
Commission (SEC). We anticipate that subsequent events and
developments will cause our expectations and assumptions to change,
and we undertake no obligation to 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 our views as of any date subsequent to the date of
this press release.
Our SEC filings can be found on our website at
www.zailaboratory.com and the SEC’s website at www.sec.gov.
For more information, please contact:
Investor Relations:Christine Chiou / Lina
Zhang+1 (917) 886-6929 / +86 136 8257
6943christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media:Shaun Maccoun / Xiaoyu Chen+1 (415)
317-7255 / +86 185 0015 5011shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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