Zai Lab Announces First Patient Assayed in Greater China in Global Registration Clinical Trial … | Nation / World


SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., November 16, 2021 (GLOBE NEWSWIRE) – Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative, patient-centric, commercial-stage global biopharmaceutical company, today announced that the first patient had received a dose in the Greater China portion of the ADHERE global registration study of efgartigimod in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

The ADHERE trial is a prospective, multi-center, registry study to evaluate the safety and efficacy of weekly subcutaneous (SC) efgartigimod in adult patients with CIDP. The trial consists of an open-label stage A followed by a randomized, placebo-controlled stage B. The diagnosis of CIDP will be confirmed by a panel of independent experts prior to enrollment in stage A. At stage B, patients are randomized to either of the SC groups. efgartigimod or placebo for up to 48 weeks. The primary endpoint is event-driven and based on the Inflammatory Neuropathy-Adjusted Global Disability Score for Cause and Treatment (INCAT).

“CIDP is a chronic, progressive disease characterized by progressive weakness and impaired sensory function of the legs and arms for which there are limited effective and well-tolerated treatment options,” said Harald Reinhart, MD, physician. Head, Autoimmune and Infectious Diseases at Zai Laboratoire. “Due to the side effects of corticosteroids and the limited access to intravenous immunoglobulin (IVIg) therapy in China, we are excited about the therapeutic potential of efgartigimod in CIDP and look forward to advancing the Chinese side of this. recording study. “

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a serious autoimmune disease of the peripheral nervous system. Although confirmation of the pathophysiology of the disease is still emerging, there is growing evidence that IgG antibodies play a key role in damage to peripheral nerves. People with CIDP experience fatigue, muscle weakness, and loss of sensation in the arms and legs that may get worse over time or may come and go. These symptoms can significantly affect a person’s ability to function in their daily life. Without treatment, a third of people living with CIDP will need a wheelchair.

About the CIDP in China

The prevalence of CIDP in China is estimated at 50,000 patients. Current treatment options are primarily corticosteroids and intravenous immunoglobulins (IVIG). Plasmapheresis (plasma exchange) is an option if first-line treatment fails. However, access to plasmapheresis or IVIG is limited in many parts of the world, including China. As most patients require treatment for a fairly extended period of time, there remains a significant unmet need for effective, well-tolerated and practical alternative treatment options for patients with CIDP in China.

About Efgartigimod

Efgartigimod is an experimental antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the recycling process of IgG. Efgartigimod is being studied in several autoimmune diseases known to be mediated by pathogenic IgG antibodies, including neuromuscular disorders, blood disorders and skin blisters. These diseases include myasthenia gravis (MG), leafy pemphigus vulgaris (PV and PF), immune thrombocytopenia (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), bullous pemphigoid, and idiopathic inflammatory myopathy (myositis).

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, patient-focused, commercial-stage global biopharmaceutical company focused on the development and commercialization of therapies that address medical conditions with unmet need in oncology , autoimmune diseases, infectious diseases and neuroscience. To this end, our experienced team has partnered with leading global biopharmaceutical companies to generate a broad portfolio of commercialized products and innovative product candidates. We have also assembled an in-house team with strong product discovery and translational research capabilities and are in the process of establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and marketing our portfolio to impact human health around the world.

For more information about the company, please visit www.zailaboratory.com or follow us on www.twitter.com/ZaiLab_Global.

Zai Lab forward-looking statements

This press release contains statements about future expectations, plans and prospects, including, without limitation, statements regarding the possible benefits, safety and efficacy of efgartigimod, the identification and the treatment of chronic inflammatory demyelinating polyneuropathy, and the risks and uncertainties associated with the development and marketing of drugs. . These statements can be identified by words such as “aim”, “anticipate”, “believe”, “could”, “estimate”, “expect”, “foresee”, “aim”, “intend” , “May”, “” plan “,” possible “,” potential “,” will “,” would “and other similar expressions. These 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 or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances which may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements due to various important factors including, but not limited to (1) our ability to successfully market and generate income from our approved products; (2) our ability to fund our operations and business initiatives and to obtain funding for such activities, (3) the results of clinical and preclinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities authorities regarding regulatory approvals of our product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory and political conditions and (6) risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the United States Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change and we assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. , unless required by law. . These forward-looking statements should not be taken as representing our views as of any date subsequent to the date of this press release.

For more information please contact:

ZAI LAB CONTACTS:

Investor Relations: Ron Aldridge / Lina Zhang

+1 (781) 434-8465 / +86 136 8257 6943

[email protected] / [email protected]

Media: Danielle Halstrom / Xiaoyu Chen

+1 (215) 280-3898 / +86 185 0015 5011

[email protected] / [email protected]

Zai Laboratory Limited

Copyright 2021 GlobeNewswire, Inc.



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