argenx and Zai Lab Announce Strategic Collaboration for Efgartigimod in Greater China

Rhea-AI Summary

argenx and Zai Lab have announced an exclusive agreement for the development and commercialization of efgartigimod in Greater China. This collaboration enables argenx to expand its global reach and accelerate clinical development of autoimmune treatments. argenx will receive $175 million, including $75 million in Zai Lab equity and milestone payments. Efgartigimod targets conditions such as myasthenia gravis and has significant potential for changing treatment paradigms. Zai Lab will lead patient recruitment for global trials, enhancing access to this promising therapy for Chinese patients.

Positive

• Zai Lab gains exclusive rights to develop and commercialize efgartigimod in Greater China.
• Argentx receives $175 million in collaboration payments, including $75 million upfront.
• Potential to accelerate clinical development of multiple new autoimmune indications.

Negative

• None.

• 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 and SHANGHAI and SAN FRANCISCO, Jan. 06, 2021 (GLOBE NEWSWIRE) -- 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 indications.

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.

About Efgartigimod

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.

About argenx

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/.

About Zai Lab

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,

FAQ

What is the collaboration between argenx and Zai Lab about?

The collaboration focuses on the exclusive development and commercialization of efgartigimod in Greater China.

How much will argenx receive from Zai Lab?

Argentx will receive $175 million, which includes a $75 million upfront payment and milestone payments.

What are the potential diseases efgartigimod targets?

Efgartigimod targets autoimmune diseases, including myasthenia gravis, pemphigus vulgaris, and immune thrombocytopenia.

What is the significance of this deal for Zai Lab?

The deal significantly expands Zai Lab's pipeline in severe autoimmune diseases, addressing unmet medical needs.

Why is efgartigimod important for patients in Greater China?

Efgartigimod has the potential to change treatment paradigms for autoimmune diseases where few treatments are available.

When was the agreement between argenx and Zai Lab announced?

The agreement was announced on January 6, 2021.