sBLA submission based on positive results from
the ADHERE trial, the first positive global neonatal FC receptor
(FcRn) pivotal study for CIDP
There are currently no approved therapies
available in China for this serious autoimmune disease
Milestone underscores Zai Lab’s operational
capabilities and deep expertise developing and commercializing
innovative treatments in China across a broad range of diseases
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
the Center for Drug Evaluation (CDE) of the China National Medical
Products Administration (NMPA) has accepted the supplemental
Biologics License Application (sBLA) for efgartigimod alfa
injection (subcutaneous injection) (efgartigimod SC) for the
treatment of chronic inflammatory demyelinating polyneuropathy
(CIDP). The CDE granted priority review on May 11, 2024 and
Breakthrough Therapy Designation for efgartigimod SC for the
treatment of patients with CIDP on September 18, 2023.
“The sBLA acceptance with priority review designation brings us
one step closer to providing a treatment option for patients with
CIDP in China, a serious disease that affects approximately 50,000
diagnosed patients, with only a small fraction of patients able to
achieve remission on corticosteroids and intravenous immunoglobulin
(IVIg) treatment, the current standard of care. Achieving this
milestone helps demonstrate our capabilities and commitment to
develop and deliver meaningful and differentiated therapies to
patients in China with our partner argenx,” said Dr. Harald
Reinhart, President and Head of Global Development, Neuroscience,
Autoimmune & Infectious Diseases, Zai Lab. “Our collaboration
with argenx is generating a robust pipeline of indications with the
potential to improve care for many patients who live with
autoimmune diseases, including CIDP.”
The sBLA application is based on the ADHERE (NCT04281472) study,
a multicenter, randomized, double-blind, placebo-controlled trial
evaluating efgartigimod SC for the treatment of CIDP. Zai Lab
enrolled patients into the ADHERE trial in Greater China and
treatment response in these participants was consistent with global
study outcomes. Subgroup analysis of Chinese participants
demonstrated a 69% reduction in relapse rates with efgartigimod SC
compared to placebo. In addition, 78% of Chinese participants
treated in the open-label portion of the study demonstrated
evidence of clinical improvement (ECI), further confirming the role
IgG autoantibodies play in the underlying biology of CIDP. The
favorable safety and tolerability profile of efgartigimod SC weekly
dosing (up to 1 year) in the Chinese patient cohort was consistent
with global trial participants.
In September 2023, Zai Lab launched VYVGART® (efgartigimod alfa
injection) for generalized myasthenia gravis (gMG) in mainland
China, with VYVGART becoming the first and only approved FcRn
antagonist for these gMG patients.
In July 2023, Zai Lab announced that the CDE has accepted the
BLA for efgartigimod SC for gMG in China.
About CIDP in China
There are an estimated 50,000 patients diagnosed with CIDP in
mainland China.1 Current treatment options are primarily
corticosteroids and intravenous immunoglobulin (IVIg), with plasma
exchange (PLEX) generally reserved for refractory patients. There
is limited access to PLEX or IVIg in many parts of the world,
including China. Because most patients require treatment for an
extended period, there remains a significant unmet need for
alternative treatment options that are effective, well-tolerated,
and convenient for patients with CIDP in China.
1 Chronic inflammatory demyelinating polyneuropathy and
diabetes, 2020.
About ADHERE Trial Design
The ADHERE trial, sponsored by argenx, was a multicenter,
randomized, double-blind, placebo-controlled trial evaluating
efgartigimod SC for the treatment of CIDP. ADHERE enrolled 322
adult patients with CIDP who were treatment-naïve (not on active
treatment for ≥6 months) or being treated with immunoglobulin
therapy or corticosteroids. Zai Lab enrolled patients in the ADHERE
trial in Greater China (mainland China, Hong Kong, Taiwan and
Macau). The trial consisted of an open-label Stage A followed by a
randomized, placebo-controlled Stage B. In order to enter Stage A
and receive efgartigimod SC the diagnosis of CIDP was confirmed by
an independent panel of experts. Patients entered a run-in stage,
where any ongoing CIDP treatment was stopped and they had to
demonstrate active disease, with clinically meaningful worsening on
at least one CIDP clinical assessment tool, including INCAT,
I-RODS, or mean grip strength. Treatment naïve patients were able
to skip the run-in period with proof of recent worsening. To
advance to Stage B, patients needed to demonstrate ECI to
efgartigimod SC. ECI was achieved through improvement of INCAT
score, or improvement on I-RODS or mean grip strength if those
scales had demonstrated worsening during the run-in period. In
Stage B, patients were randomized to either efgartigimod SC or
placebo for up to 48 weeks. The primary endpoint was based on the
hazard ratio for the time to first adjusted INCAT deterioration
(i.e. relapse). After Stage B, all patients had the option to
roll-over to an open-label extension study to receive efgartigimod
SC.
About VYVGART® Hytrulo
VYVGART Hytrulo is a subcutaneous combination of efgartigimod
alfa, a human IgG1 antibody fragment marketed for intravenous use
as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20),
Halozyme’s ENHANZE® drug delivery technology to facilitate
subcutaneous injection delivery of biologics. In binding to the
neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the
reduction of circulating IgG. It is the first-and-only approved
FcRn blocker administered by subcutaneous injection. VYVGART
Hytrulo is the proprietary name in the U.S. for subcutaneous
efgartigimod alfa and recombinant human hyaluronidase PH20. It may
be marketed under different proprietary names following approval in
other regions.
Zai Lab has an exclusive license agreement with argenx to
develop and commercialize efgartigimod in Greater China (mainland
China, Hong Kong, Macau, and Taiwan) for numerous autoimmune
indications where there is significant unmet patient need.
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 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.
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 chronic inflammatory demyelinating
polyneuropathy. 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) risks related
to doing business in China, and (6) 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240514659787/en/
Investor Relations: Christine Chiou / Lina Zhang +1 (917)
886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media: Jennifer Chang / Xiaoyu Chen +1 (857) 270-8985 /
+86 185 0015 5011 jennifer.chang@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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