Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
China’s National Medical Products Administration (NMPA) has
accepted the Biologics License Application (BLA) for efgartigimod
alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial)
for the treatment of adult patients with generalized myasthenia
gravis (gMG).
“We are pleased to have the NMPA’s acceptance of the BLA for
efgartigimod alfa injection for subcutaneous use. We’re excited
about the potential of efgartigimod to offer patients multiple ways
to receive treatment through various administrations and an
individualized dosing schedule,” said Dr. Harald Reinhart,
President and Head of Global Development, Neuroscience, Autoimmune
& Infectious Diseases, Zai Lab. “As a company focused on
developing innovative medicines for diseases in need of more
effective treatment options, we look forward to bringing another
first-in-class option for gMG patients in Greater China.”
The BLA submission is supported by positive results from the
global Phase 3 ADAPT-SC study, demonstrating noninferior total IgG
reduction from baseline at day 29 with SC administered efgartigimod
compared to intravenous (IV) administered efgartigimod in adult
patients with gMG. Patients treated with efgartigimod SC achieved
mean total IgG reduction of 66.4% from baseline at day 29, compared
to 62.2% reduction with efgartigimod IV.
The safety profile for efgartigimod SC was also consistent with
the ADAPT study. It 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.
In June 2023, efgartigimod alfa injection (VYVGART®) for IV use
was approved by China’s NMPA as an add on to standard therapy for
the treatment of adult patients with gMG who are anti-acetylcholine
receptor (AChR) antibody positive.
In June 2023, VYVGART® Hytrulo (efgartigimod alfa and
hyaluronidase-qvfc) was approved by the U.S. Food and Drug
Administration (FDA) for SC use for the treatment of adult patients
with gMG who are anti-AChR antibody positive.
About Efgartigimod (brand name
VYVGART®)
Efgartigimod is a human IgG1 antibody fragment that binds to the
neonatal Fc receptor (FcRn), resulting in the reduction of
circulating IgG autoantibodies. It is being investigated in several
autoimmune diseases known to be mediated by disease-causing IgG
antibodies, including neuromuscular disorders, blood disorders, and
skin blistering diseases, in both an IV and SC formulation. SC
efgartigimod is co-formulated with recombinant human hyaluronidase
PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.
VYVGART 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.
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.
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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