First and only NMPA-approved subcutaneous (SC)
injectable providing additional flexibility and optionality for gMG
patients in China
Consistent clinical benefit and safety profile
of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC
study
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext
& Nasdaq: ARGX) today announced that China’s National Medical
Products Administration (NMPA) approved the Biologics License
Application (BLA) for efgartigimod alfa injection (subcutaneous
injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated 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.
“We are pleased to receive NMPA approval for efgartigimod SC,
marking an important milestone as we bring another first-in-class
option to gMG patients in China,” said Rafael G. Amado, M.D.,
President, Head of Global Research and Development at Zai Lab. “The
addition of a new treatment option for gMG patients enhances
flexibility for patients, potentially further simplifying the
regimen and making therapy more accessible within the community. We
appreciate the NMPA for their thorough assessment and recognition
of the therapy’s differentiated profile and the large unmet medical
need in China.”
“The NMPA approval for efgartigimod SC is yet another key
milestone on our journey to expand into new patient populations
around the world with our transformative medicine,” said Tim Van
Hauwermeiren, Chief Executive Officer of argenx. “We celebrate this
achievement with our partner, Zai Lab, who shares our mutual
passion for bringing needed innovation to patients with gMG in
China. We are impressed by the team’s incredible launch execution,
bringing 2,700 new patients onto VYVGART IV treatment in the first
quarter of 2024, which only underscores the high unmet need that
remains for gMG patients. The addition of a flexible 30-to-90
second subcutaneous injection opens the door for new patients in
China, while taking into account personal preference and
convenience. We look forward to continuing our partnership and
expanding our footprint in one of the world’s fastest growing
markets to reach more people living with severe autoimmune
diseases.”
“There are approximately 170,000 people living with gMG in
China1,” said Prof. Xueqiang Hu, M.D., Ph.D., Chief Physician of
Department of Neurology, the Third Affiliated Hospital of Sun
Yat-sen University. “Compared to fixed infusion schedules, the
availability of efgartigimod SC allows a more individualized and
flexible treatment approach based on patient needs without
sacrificing clinical benefit or safety. In the global Phase 3
ADAPT-SC study, efgartigimod SC demonstrated consistent benefit and
safety compared to the intravenous product. This is a meaningful
advancement for the patient community, and we are grateful to Zai
Lab for supporting patients who have been devastated by this
disease for so long.”
The BLA approval is supported by positive results from the
global Phase 3 ADAPT-SC study, a bridging study to the Phase 3
ADAPT study, which formed the basis for approval of intravenous
VYVGART in adult gMG patients. In the ADAPT-SC study, the primary
endpoint of noninferiority was met (p< 0.0001), and efgartigimod
SC demonstrated mean total IgG reduction of 66.4% from baseline at
day 29, compared to 62.2% with efgartigimod IV. Additional key
secondary endpoints were also met, which were consistent with
efficacy measures from the ADAPT study identifying the correlation
between total IgG reduction and clinical benefit in gMG.
The safety profile for efgartigimod SC was also consistent with
the ADAPT study. Efgartigimod SC 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.
Efgartigimod SC is also being evaluated for the potential
treatment of additional autoimmune disorders. In May 2024, the NMPA
accepted a supplemental Biologics License Application (sBLA) with
priority review for efgartigimod SC in chronic inflammatory
demyelinating polyneuropathy (CIDP). The U.S. Food and Drug
Administration (FDA) approved efgartigimod SC in June 2024 for
adults with CIDP.
About VYVGART® and efgartigimod SC
VYVGART (efgartigimod alfa injection) (efgartigimod IV) 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 for the
treatment of adults with generalized myasthenia gravis (gMG) who
are anti-AChR antibody positive.
Efgartigimod SC is a subcutaneous product including efgartigimod
alfa injection, 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 to be administered subcutaneously as a
single injection (1,000 mg fixed dose) over 30-to-90 seconds in
cycles of once weekly injections for four weeks. Efgartigimod SC is
approved in the United States (marketed as VYVGART® Hytrulo), EU
(marketed as VYVGART® SC) and Japan (marketed as VYVDURA®).
Efgartigimod has the potential to address a multitude of severe
autoimmune diseases where pathogenic IgGs are believed to be
mediators of disease and is being evaluated in several autoimmune
indications.
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 Myasthenia Gravis in China
Myasthenia gravis (MG) is a chronic autoimmune disease,
characterized by debilitating and potentially life-threatening
muscle weakness. There are approximately 170,000 people in China
living with gMG1, and of those patients, 85% are estimated to have
confirmed AChR antibodies; 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. These drugs often achieve only partial
restoration of strength.
1 The growing burden of generalized myasthenia gravis: a
population-based retrospective cohort study in Taiwan, 2023.
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, 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.
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 China, the U.S.,
Japan, Israel, the EU, the UK, and Canada. 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 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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For more information, please contact: Investor Relations:
Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943
christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media: Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 /
+86 185 0015 5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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