-- 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
Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced an
exclusive collaboration and license agreement for the development
and commercialization of Vertex’s povetacicept (pove) in mainland
China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore (the
licensed territory). Pove is a recombinant fusion protein
therapeutic and dual antagonist of BAFF (B cell activating factor)
and APRIL (a proliferation inducing ligand) with best-in-class
potential being studied for the treatment of Immunoglobulin A
nephropathy (IgAN) and other B cell-mediated diseases.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20250110688135/en/
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 China and the
broader area,” said Reshma Kewalramani, M.D., Chief Executive
Officer and President of Vertex. “We are excited about this
collaboration with Zai Lab, which will accelerate our ability to
bring this potential best-in-class therapy to patients who are
waiting.”
“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 China and
beyond.”
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 the United States and Europe. It is estimated
that there are three to five million patients with IgAN in China,
including approximately 750,000 people who are already diagnosed
with the disease. IgAN results from deposition of circulating
immune complexes consisting of immunoglobulins and
galactose-deficient immunoglobulin A (Gd-IgA1) in the renal
glomerular mesangium, triggering kidney injury and fibrosis. A high
percentage of people with IgAN progress to end-stage renal disease.
There are no approved therapies that specifically target the
underlying cause of IgAN.
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 U.S. Final analysis will occur at two years of
treatment, with a primary endpoint of total eGFR slope through Week
104.
The Phase 3 clinical trial is underway in multiple regions,
including the U.S., EU and Asia. Specifically, Chinese regulatory
authorities have approved the Clinical Trial Application (CTA) for
RAINIER, where the Phase 3 trial is underway.
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
Boston, with international headquarters in London. Additionally,
the company has research and development sites and commercial
offices in North America, Europe, Australia, Latin America and the
Middle East. Vertex is consistently recognized as one of the
industry's top places to work, including 15 consecutive years on
Science magazine's Top Employers list and one of Fortune’s 100 Best
Companies to Work For. For company updates and to learn more about
Vertex's history of innovation, visit www.vrtx.com or follow us on
LinkedIn, Facebook, Instagram, YouTube and X.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative,
research-based, commercial-stage biopharmaceutical company based in
China and the United States. We are focused on discovering,
developing, and commercializing innovative products that address
medical conditions with significant unmet needs in the areas of
oncology, immunology, neuroscience, and infectious disease. Our
goal is to leverage our competencies and resources to positively
impact human health in China and worldwide. For additional
information about Zai Lab, please visit www.zailaboratory.com or
follow us at www.X.com/ZaiLab_Global.
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 U.S. While Vertex believes the forward-looking
statements contained in this press release are accurate, these
forward-looking statements represent the company's beliefs only as
of the date of this press release and there are a number of risks
and uncertainties that could cause actual events or results to
differ materially from those expressed or implied by such
forward-looking statements. Those risks and uncertainties include,
among other things, that the anticipated benefits and potential of
Vertex’s collaboration with Zai Lab may not be achieved on the
anticipated timeline, or at all, that data from Vertex’s clinical
programs may not support registration or further development of its
compounds due to safety, efficacy or other reasons, and other risks
listed under the heading “Risk Factors” in Vertex's most recent
annual report and subsequent quarterly reports filed with the
Securities and Exchange Commission at www.sec.gov and available
through the company's website at www.vrtx.com. You should not place
undue reliance on these statements. Vertex disclaims any obligation
to update the information contained in this press release as new
information becomes available.
(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 Greater China and
Singapore, the potential benefits of pove; and the potential
treatment of IgAN and other B-cell mediated diseases. These
forward-looking statements may contain words such as “aim,”
“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,”
“goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,”
“would,” and other similar expressions. 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 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 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
those identified in our most recent annual and quarterly reports
and in other reports we have filed with the U.S. Securities and
Exchange Commission (SEC), which can be found on our website at
www.zailaboratory.com and on the SEC’s website at www.sec.gov. We
undertake no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise, except as may be required by law. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250110688135/en/
For more information, please contact: Zai Lab Investor
Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86
136 8257 6943 christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu
Chen +1 (857) 270-8854 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Vertex Pharmaceuticals Incorporated Investors:
InvestorInfo@vrtx.com Media: mediainfo@vrtx.com or
International: +44 20 3204 5275 or U.S.: 617-341-6992 or Heather
Nichols: +1 617-839-3607
Zai Lab (NASDAQ:ZLAB)
Graphique Historique de l'Action
De Déc 2024 à Jan 2025
Zai Lab (NASDAQ:ZLAB)
Graphique Historique de l'Action
De Jan 2024 à Jan 2025
