UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of November 2024
Commission File Number: 001-38097
ARGENX SE
(Translation of registrant’s name into English)
Laarderhoogtweg 25
1101 EB Amsterdam, the Netherlands
(Address of principal executive offices)
Indicate by check
mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x
Form 40-F ¨
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
EXPLANATORY
NOTE
On November 11, 2024, argenx SE (the “Company”)
issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information contained in this Current
Report on Form 6-K, including Exhibit 99.1, shall be deemed
to be incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-258251) and S-8 (File
Nos. 333-225375, 333-258253, and 333-274721), and to be part thereof from the date on which this Current Report on Form 6-K
is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ARGENX SE |
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| Date: November 12, 2024 |
By: |
/s/ Hemamalini
(Malini) Moorthy |
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Name: Hemamalini (Malini) Moorthy |
| |
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Title: General Counsel |
Exhibit 99.1
argenx
and Zai Lab Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in
China
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 Petok
bpetok@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 press release, including any forward-looking statements, except as may be required by law.
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