Full Press Release Details
and Zai Lab Announce Approval of VYVGART (efgartigimod alfa injection) for
Generalized Myasthenia Gravis in China
Amsterdam, the Netherlands-June 30, 2023 -- argenx SE
(Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China's National Medical
Products Administration (NMPA) has approved the Biologics License Application (BLA) for VYVGART (efgartigimod alfa injection), a
first-in-class neonatal Fc receptor (FcRn) antagonist, 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. Zai Lab will now work with the National Healthcare
Security Administration (NHSA) for NRDL inclusion to enable broad access for patients.
approval by the NMPA for VYVGART, our sixth approval globally, is the first-and-only FcRn blocker available for people living with gMG
in China. This is another milestone on our path to redefine what well-controlled means for gMG patients and underscores our longstanding
commitment to the global gMG community," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "We celebrate this
achievement with our partner, Zai Lab, who shares our mutual passion to bring needed innovation to people with gMG in China. We look forward
to continuing our partnership as we further explore efgartigimod in other indications, expanding our global footprint in one of the world's
fastest growing markets to reach more people living with severe autoimmune diseases."
"We are pleased to have the NMPA's approval for VYVGART
for intravenous use. This important milestone brings forward a novel treatment for gMG patients who face many challenges living with this
complex and difficult-to-control autoimmune disease," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer
of Zai Lab. "We appreciate the NMPA for their thorough assessment of VYVGART, recognizing its differentiated profile and the large
unmet medical need in China. In addition to gMG, we are working with argenx on three registrational programs exploring other immunoglobulin
G (IgG)-related autoimmune indications and are looking forward to exploring even more indications over time."
"There are over 200,000 people living with myasthenia gravis
(MG) in China1. Despite the availability of current treatment options, there remains a significant unmet medical need. The
approval of VYVGART in China marks an important milestone for patients and provides physicians with a novel, safe and effective therapy
to help improve the quality of life for those in their care," said Dr. Chongbo Zhao, M.D., Ph.D., Deputy Director of Department
of Neurology, Huashan Hospital Affiliated to Fudan University, Director of Working Group of Huashan Rare Disease Center. "In clinical
studies, efgartigimod demonstrated outstanding characteristics in terms of onset of action, efficacy, and safety, helping to improve patients'
muscle strength and quality of life. VYVGART, the first-and-only approved FcRn antagonist for gMG patients in China, has the potential
to revolutionize the treatment landscape for gMG patients in China and we are grateful to Zai Lab for providing the support for these
patients who have been devastated by this disease for so long."
The global Phase 3 ADAPT trial met its primary endpoint, demonstrating
that significantly more anti-AChR antibody positive gMG patients were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL)
scale following treatment with efgartigimod compared with placebo (68% vs. 30%; p<0.0001). Responders were defined as having at least
a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle2.
There were also significantly more responders on the Quantitative Myasthenia
Gravis (QMG) scale following treatment with efgartigimod compared with placebo (63% vs. 14%; p<0.0001). Responders were defined as
having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.
VYVGART demonstrated a well-tolerated safety profile in the ADAPT clinical
trial. The most commonly reported adverse reactions that occurred more frequently with VYVGART than placebo were upper respiratory tract
infections (10.7% following treatment with efgartigimod vs. 4.8% of placebo) and urinary tract infections (9.5% vs. 4.8%).
VYVGART 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 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
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
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.
2 Howard JF et al. Lancet Neurol 2021;20(7):526-536.
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. The Company
is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its
Zai Lab (Nasdaq: ZLAB; HKEX:
9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. Zai Lab is 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. The Company's goal is to leverage our competencies
and resources to positively impact human health in China and worldwide.
For additional information about
Zai Lab, including their products, business activities and partnerships, research, and other events or developments, please visit www.zailaboratory.com
or follow them at www.twitter.com/ZaiLab_Global.
For further information, please contact:
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 "believes," "hope," "estimates,"
"anticipates," "expects," "intends," "may," "will," or "should"
and include statements argenx makes concerning the approval of VYVGART (efgartigimod alfa injection) for Generalized Myasthenia Gravis
(gMG) by China's National Medical Products Administration (NMPA); argenx's partnership with Zai Lab and Zai Lab's ability
to gain National Reimbursement Drug List (NRDL) inclusion for efgartigimod; the registrational programs exploring other immunoglobulin
G-related autoimmune indications and possibility of exploring additional indications; and the benefits and safety profile of VYVGART .
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. A further list and description of these risks, uncertainties and other risks can
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