Full Press Release Details
argenx and Zai Lab Announce Strategic
Collaboration for Efgartigimod in Greater China
| Collaboration to expand and accelerate global development of efgartigimod; expected to allow argenx to more rapidly advance new potential indications into clinical development each year | ||
| Zai Lab granted exclusive rights to develop and commercialize efgartigimod in Greater China | ||
| argenx to receive $75 million in upfront Zai Lab equity and $100 million in near-term milestone and other payments |
Regulated Information/Inside Information
Breda, the Netherlands, Shanghai and San Francisco -
Jan. 6, 2021 - argenx SE (Euronext & NASDAQ: ARGX), a global immunology company committed to improving the lives
of people suffering from severe autoimmune diseases and cancer, and Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage
biopharmaceutical company, today announced an exclusive license agreement for the development and commercialization of efgartigimod
in Greater China, including mainland China, Hong
Kong, Taiwan and Macau.
"Through this collaboration with Zai Lab, we are expanding
our global footprint in one of the world's fastest growing markets and reaching more people living with severe autoimmune
diseases. By leveraging Zai Lab's strong local expertise within Greater China and proven development capabilities, we aim
to provide broad access to efgartigimod in these important markets as well as accelerate the number of autoimmune indications in
clinical development," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "We believe that Zai Lab is the
ideal partner for us ahead of our first potential approval of efgartigimod in generalized myasthenia gravis (gMG) in the U.S. and
we are aligned in our mutual passion to bring potential innovative immunology therapies to patients in need."
"argenx is building a leading immunology company and we
are excited to collaborate with them during this important time. Efgartigimod is being evaluated in a broad range of autoimmune
diseases and we look forward to bringing this potentially first-in-class product to patients in Greater China," said Dr.
Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "This collaboration also significantly expands
and strengthens our pipeline in severe autoimmune diseases, where there is an urgent and serious need for new therapeutic options."
"There are an estimated 200,000 people living with MG
in China," said Dr. Harald Reinhart, Chief Medical Officer for Autoimmune and Infectious Diseases, Zai Lab. "The unmet
medical need is significant for these patients, with very limited treatment options. We believe efgartigimod has a promising profile
that, if approved, can potentially change the treatment paradigm not only of gMG but of other autoimmune diseases."
Under the terms of the agreement, Zai
Lab obtains the exclusive right to develop and commercialize efgartigimod in Greater China. Zai Lab will recruit Chinese
patients to argenx's global registrational trials for the development of efgartigimod. Additionally, this agreement is expected
to allow argenx to accelerate efgartigimod development by initiating multiple Phase 2 proof-of-concept trials in new autoimmune
argenx will receive $175 million in collaboration
payments, comprised of a $75 million upfront payment in the form of 568,182 newly issued Zai Lab shares calculated
at a price of $132.00 per share, $75 million
as a guaranteed non-creditable, non-refundable development cost-sharing payment, and an additional $25 million milestone
payment upon approval of efgartigimod in the U.S. argenx is also eligible to receive tiered royalties (mid-teen to
low-twenties on a percentage basis) based on annual net sales of efgartigimod in Greater China.
Efgartigimod is an investigational antibody fragment designed
to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal
Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation.
Blocking FcRn reduces IgG antibody levels, representing a logical potential therapeutic approach for several autoimmune diseases
known to be driven by disease-causing IgG antibodies, including: myasthenia gravis (MG), a chronic disease that causes muscle weakness;
pemphigus vulgaris (PV), a chronic disease characterized by severe blistering of the skin; immune thrombocytopenia (ITP), a chronic
bruising and bleeding disease; and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disease leading to
impaired motor function.
argenx is a global immunology company committed to improving
the lives of people suffering from severe autoimmune diseases and cancer. 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 is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological
cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic
franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit www.argenx.com and follow
us on LinkedIn at https://www.linkedin.com/company/argenx/.
Zai Lab (NASDAQ:ZLAB; HKEX: 9688) is an innovative commercial-stage
biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients
in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical
market. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to
generate a broad pipeline of innovative marketed products and drug candidates. We have also built an in-house team with strong
drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global
rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing
our portfolio in order to impact human health worldwide.
For additional information about the company, please visit
Media: Ryo Imai / Robert Flamm, Ph.D.
Burns McClellan, on behalf of Zai Lab
212-213-0006 ext. 315 / 364
Investors: Mike Zanoni
Endurance Advisors, on behalf of Zai Lab
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, estimates, anticipates, expects, intends, may, will, or should, and include statements
argenx makes concerning the therapeutic potential of its product candidates; the intended results of its strategy; the expected
benefits of the collaboration with Zai Lab; its and its collaboration partners' clinical development and regulatory plans,
including the timing, design and outcome of ongoing and planned clinical trials and the timing and outcome of regulatory filings
and approvals; and the timing and progress of commercialization activities. 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 effects of the COVID-19 pandemic, the inherent uncertainties associated with preclinical and clinical
trial and product development activities and regulatory approval requirements; argenx's reliance on collaborations with third
parties; estimating the commercial potential of argenx's product candidates; argenx's ability to obtain and maintain
protection of intellectual property for its technologies and drugs; argenx's limited operating history; and argenx's
ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates.
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.
Zai Lab Forward-Looking Statements
This press release contains statements about future expectations,
plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for commercializing
efgartigimod in Greater China. 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 nor are they guarantees or assurances
of future performance. Forward-looking statements are based on Zai Lab's 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) Zai Lab's ability to obtain additional future