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argenx SE

Regulatory Filings Sep 23, 2015

6221_iss_2015-09-23_2b074d2d-abf2-4b72-847a-e5a571964245.pdf

Regulatory Filings

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arGEN-X' Partner RuiYi, Inc. Announces First Human Dosing of Gerilimzumab, A Novel SIMPLE Antibody(TM) Against IL-6

Breda, the Netherlands / Ghent, Belgium, 23 September - arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today reports that its partner RuiYi, Inc., a company focused on the discovery and development of novel biologic therapies, has announced the first human dosing of Gerilimzumab, a novel monoclonal antibody neutralizing the IL-6 cytokine, for the treatment of autoimmune disorders including rheumatoid arthritis.

arGEN-X licensed the worldwide rights to develop and commercialize Gerilimzumab to RuiYi in late 2012. Gerilimzumab was originally generated by arGEN-X using its SIMPLE Antibody(TM) platform and has been further differentiated with NHance®, its novel, proprietary technology, which prolongs the circulation time and improves tissue distribution of antibodies.

The clinical trial initiated by RuiYi is a double-blind, placebo controlled study in healthy volunteers, with both single and multiple ascending dose protocols. The start of the trial triggers an undisclosed milestone payment by RuiYi to arGEN-X.

Positive results from this study will support advancing Gerilimzumab into trials in patients with autoimmune disorders, including moderate to severe rheumatoid arthritis in 2016.

"The first human dosing of Gerilimzumab marks significant progress for this exciting antibody product candidate," said Tim Van Hauwermeiren, CEO at arGEN-X. "RuiYi has been an excellent partner for arGEN-X and we've been impressed with how they have efficiently progressed Gerilimzumab, discovered with arGEN-X's SIMPLE Antibody(TM) platform, into clinical studies."

A copy of the RuiYi announcement can be accessed here.

About arGEN-X

arGEN-X combines the diversity of the llama immune system with antibody engineering to advance a clinical pipeline to treat patients with cancer and autoimmune diseases. Our platforms allow us to unlock novel and complex targets and develop antibody-based drugs designed for longer duration of effect and greater efficacy. The strength of our team, our deep understanding of the biology, and our committed collaborations with industry leaders contribute to the success of our journey.

arGEN-X is listed on the Euronext Brussels exchange under the symbol ARGX.

www.arGEN-X.com

SIMPLE Antibody(TM) and NHance® are trademarks of arGEN-X NV

For further information, please contact:

Joke Comijn, Corporate Communications Manager +32 (0)477 77 29 44 +32 (0)9 243 40 70 [email protected]

Mark Swallow/David Dible Citigate Dewe Rogerson +44 207 282 2948 [email protected]

Beth DelGiacco (US IR) Stern Investor Relations +1 212 362 1200 [email protected]

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", "estimates", "anticipates", "expects", "intends", "may", "will", or "should", and include statements arGEN-X makes concerning the intended results of its strategy. 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. arGEN-X' actual results may differ materially from those predicted by the forward-looking statements. arGEN-X undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

"Management's Discussion and Analysis of Financial Condition and Results of Operations"

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