First and only NMPA-approved treatment for
patients with CIDP in China
Second VYVGART Hytrulo indication approved in
China
November 11, 2024 – 7:30am ET
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 supplemental
Biologics License Application (sBLA) for VYVGART Hytrulo 1,000mg
(5.6ml)/vial [efgartigimod alfa injection (subcutaneous injection)]
for the treatment of adult patients with chronic inflammatory
demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved
for CIDP as a once weekly 30-to-90 second subcutaneous injection.
It is the first and only therapy approved in China for the
treatment of CIDP, a debilitating, often progressive,
immune-mediated neuromuscular disorder of the peripheral nervous
system.
“VYVGART Hytrulo is a precision therapy for
patients living with CIDP, many of whom have been waiting for a new
treatment innovation,” said Tim Van Hauwermeiren, Chief Executive
Officer of argenx. “We are grateful to our partners at Zai Lab for
collaborating with argenx to reach CIDP patients in China, and to
the NMPA for approving VYVGART Hytrulo for CIDP. Zai has a strong
record of impeccable execution and a shared value of doing all that
we can, together, for patients in need. We look forward to
continuing our partnership with Zai as argenx continues to reach
more patients in one of the world’s fastest growing markets.”
“We are pleased to receive NMPA approval for
VYVGART Hytrulo, marking a groundbreaking milestone for CIDP
patients in China,” said Rafael G. Amado, M.D., President, Head of
Global Research and Development at Zai Lab. “This approval brings a
much-needed treatment option to patients who have been suffering
from CIDP for far too long. We appreciate the NMPA for their
thorough assessment and recognition of the therapy’s differentiated
profile and the large unmet patient medical need in China. We will
continue to work with argenx to explore the potential in other
immunoglobulin G (IgG)-mediated autoimmune indications.”
“CIDP is a serious and debilitating disease with
approximately 50,000 diagnosed patients in China1, with only a
small fraction of patients able to achieve remission on
corticosteroids and plasma-derived therapies, the current standard
of care.” said Prof. Ting Chang, M.D., Deputy Chief Physician and
Associate Professor, Department of Neurology, Tangdu Hospital. “In
addition, existing treatment options are problematic and
challenging for some patients. VYVGART Hytrulo provides a new, safe
and effective treatment option that can meaningfully improve and
stabilize disease symptoms and potentially lessen the burden of
treatment for these patients. This is an important advancement for
the patient community, and we are grateful to Zai Lab for their
work supporting patients who have been devastated by this disease
for so long.”
The NMPA approval is supported by the positive
results from the ADHERE (NCT04281472) study, a multicenter,
randomized, double-blind, placebo-controlled trial evaluating
VYVGART Hytrulo for the treatment of CIDP. The ADHERE study
included an open-label period to identify responders who then
entered a randomized-withdrawal, double-blinded period. 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 the risk of relapse with VYVGART
Hytrulo compared to placebo. In addition, 78% of Chinese
participants treated in the open-label period of the study
demonstrated evidence of clinical improvement, further confirming
the role IgG autoantibodies play in the underlying biology of CIDP.
The favorable safety and tolerability profile of VYVGART Hytrulo,
dosed weekly in the Chinese patient cohort was consistent with what
was shown in global trial participants.
In May 2024, Zai Lab announced that the Centre
for Drug Evaluation (CDE) accepted the sBLA with priority review
designation for VYVGART Hytrulo for CIDP in China. The CDE granted
the Breakthrough Therapy Designation for the treatment of patients
with CIDP in September 2023.
About VYVGART Hytrulo
VYVGART Hytrulo is a subcutaneous product that
consists of efgartigimod alfa, 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 a single subcutaneous injection (1,000 mg
fixed dose) delivered over 30-to-90 seconds and given weekly.
VYVGART Hytrulo can be administered by a healthcare professional or
at home by the patient or caregiver after adequate training in the
subcutaneous injection technique. It is approved in the United
States (marketed as VYVGART® Hytrulo for generalized myasthenia
gravis (gMG) and CIDP), EU (marketed as VYVGART® SC for gMG), Japan
(marketed as VYVDURA® for gMG) and China (marketed as VYVGART
Hytrulo® for gMG and CIDP).
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 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
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 the U.S.,
Japan, Israel, the EU, the UK, Canada and China. 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, X/Twitter, Instagram, Facebook, and
YouTube.
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, immunology, neuroscience, and infectious
disease. 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 Lab Investor Relations: Christine
Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257
6943 christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Zai Lab Media: Shaun Maccoun / Xiaoyu
Chen +1 (415) 317-7255 / +86 185 0015
5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@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 the
continued partnership between argenx and Zai Lab; its ability to
reach more patients in China; the growth and expansion of the
Chinese market; 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. argenx’s actual results may differ materially from
those predicted by the forward-looking statements as a result of
various important factors, 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 parties suppliers,
service provides and manufacturing; inflation and deflation and the
corresponding fluctuations in interest rates; and regional
instability and conflicts. 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
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