Vertex and Zai Lab Announce Strategic Agreement to Develop and Commercialize Povetacicept in Mainland China, Hong Kong SAR, Macau SAR, Taiwan Region and Singapore
- Exclusive collaboration and licensing agreement for povetacicept in the region -
- Zai Lab will leverage its local expertise and commercial footprint to accelerate development of povetacicept and bring the medicine to eligible patients in the region if approved -
Under the terms of the agreement, Vertex will receive an upfront payment, as well as certain regulatory milestone payments and tiered royalties, on net sales of pove in the region of focus for Zai Lab. Zai Lab will utilize its extensive research and development expertise to help advance clinical trials and make regulatory submissions in the licensed territory. Leveraging its large commercial footprint, Zai Lab will be responsible for all commercialization activities in the licensed territory once pove becomes an approved product.
“Zai Lab’s deep R&D and commercialization expertise, as well as infrastructure in the region, make them the ideal partner for Vertex as we work to bring pove to patients in
“Pove is an important expansion of our portfolio as we continue to solidify our leading position in immunology in China,” said Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “We are committed to bringing innovative therapies to patients in need, and we are excited about this collaboration with Vertex to make pove available for patients in
About Povetacicept
Povetacicept is a recombinant fusion protein therapeutic and a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation, and/or survival of B cells, T cells, and innate immune cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has higher binding affinity and greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and has demonstrated potential best-in-class efficacy in a clinical trial in patients with IgA nephropathy and primary membranous nephropathy. Povetacicept is also in development for multiple serious B cell-mediated diseases including other autoimmune kidney diseases and autoimmune cytopenias.
About IgA Nephropathy (IgAN)
IgAN is a serious, progressive, life-threatening, B cell-mediated chronic kidney disease that is the most common cause of primary (idiopathic) glomerulonephritis, affecting approximately 300,000 people in
About RAINIER
RAINIER is a global Phase 3 pivotal trial of povetacicept 80 mg vs. placebo on top of standard of care in approximately 480 people with IgAN. The study is designed to have a pre-planned interim analysis evaluating urine protein to creatinine ratio (UPCR) for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment. If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the
The Phase 3 clinical trial is underway in multiple regions, including the
About RUBY-3
RUBY-3 is an ongoing, multiple ascending dose, multi-cohort, open label, Phase 1/2 basket study of povetacicept in autoimmune glomerulonephritis, including IgAN, primary membranous nephropathy, lupus nephritis, and ANCA-associated vasculitis with glomerulonephritis where povetacicept is being administered subcutaneously for up to 104 weeks.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.
Vertex was founded in 1989 and has its global headquarters in
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in
Vertex Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Reshma Kewalramani, M.D., and Samantha Du in this press release, and statements regarding Vertex’s beliefs about the terms of and expectations for the collaboration with Zai Lab, statements regarding upfront, milestone and royalty payments to Vertex, statements regarding the future activities of the parties pursuant to the collaboration, including expectations that Zai Lab will help advance clinical trials, make regulatory submissions in the licensed territory and be responsible for commercialization activities once pove is approved, and the trial design of and expectations for the Phase 3 RAINIER clinical trial, including that an interim analysis may serve as a basis to seek accelerated approval in the
(VRTX-GEN)
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to Zai Lab’s future expectations, plans, and prospects, including, without limitation, statements regarding our prospects and plans for developing and commercializing pove in
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