First and only NMPA-approved treatment for
patients with CIDP in China
Third approval for efgartigimod franchise in
China demonstrating Zai Lab’s deep expertise developing innovative
treatments across a broad range of diseases
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext
& Nasdaq: ARGX) 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.
“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.”
“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.”
“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 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.
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.
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 CIDP and other autoimmune disorders 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) 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/20241111503151/en/
For more information, please contact:
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 Media:
Ben Petok bpetok@argenx.com
argenx Investor Relations:
Alexandra Roy (US) ARoy@argenx.com Lynn Elton (EU)
LElton@argenx.com
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