Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the
first patient has been treated in the mainland China portion of the
global registrational, Phase 3 FORTITUDE-101 study for
bemarituzumab, a potential first-in-class Fc-optimized monoclonal
antibody that is designed to block fibroblast growth factors from
binding and activating Fibroblast Growth Factor Receptor 2b
(FGFR2b), inhibiting several downstream pro-tumor signaling
pathways and potentially slowing tumor proliferation. FORTITUDE-101
is a global trial of bemarituzumab in first-line gastric cancer
sponsored by Amgen.
The FORTITUDE-101 study is a double-blind, placebo-controlled
Phase 3 trial in patients with untreated, unresectable locally
advanced or metastatic gastric or gastroesophageal junction (GEJ)
adenocarcinoma not amenable to curative therapy. Adult patients
with FGFR2b overexpression will be randomized to bemarituzumab plus
chemotherapy (mFOLFOX6), versus placebo plus chemotherapy
(mFOLFOX6).
“Approximately 30 percent of advanced HER2-negative gastric
cancer patients are estimated to have FGFR2b overexpression, and
currently, there are no approved treatments targeting FGFR2b in
gastric cancer,” said Rafael G. Amado, M.D., President, Head of
Global Oncology Research and Development at Zai Lab. “We are
focused on expanding treatment options to patients with advanced
cancer, and we look forward to our continued partnership with Amgen
to advance this global Phase 3 study and gain a greater
understanding of the potential of bemarituzumab to impact gastric
cancer treatment.”
Previously, Zai Lab collaborated with Five Prime Therapeutics, a
company later acquired by Amgen, to evaluate bemarituzumab plus
chemotherapy (modified FOLFOX6) as a frontline targeted treatment
for FGFR2b+ gastric and GEJ cancers in the Phase 2 FIGHT study.
In early 2024, Zai Lab will join the Amgen-sponsored global
Phase 3 FORTITUDE-102 study in first-line gastric cancer. This
study is evaluating bemarituzumab plus chemotherapy and nivolumab,
versus placebo plus chemotherapy and nivolumab for untreated
advanced gastric and GEJ cancer with FGFR2b overexpression.
About Bemarituzumab
Bemarituzumab (anti-FGFR2b) is a potential first-in-class
targeted antibody that is designed to block fibroblast growth
factors (FGFs) from binding and activating FGFR2b, inhibiting
several downstream pro-tumor signaling pathways and potentially
slowing cancer progression. Bemarituzumab is not currently approved
for marketing; it is being developed in gastric and GEJ cancers as
a targeted therapy for tumors that overexpress FGFR2b. It is also
being developed in other solid tumors with FGFR2b overexpression,
including squamous non-small cell lung cancer.
Bemarituzumab has been granted Breakthrough Therapy Designations
by both the U.S. Food and Drug Administration and China Center for
Drug Evaluation of the National Medical Products
Administration.
Zai Lab has an exclusive license to develop and commercialize
bemarituzumab in Greater China (mainland China, Hong Kong, Taiwan,
and Macau).
About Gastric Cancer in China
Gastric cancer is the second most common cancer in China
(478,508 newly diagnosed cases in 2020, which was 18 times higher
than newly diagnosed cases in the United States), and is the third
leading cause of cancer deaths in China (373,789 deaths in 2020).1
The 5-year overall survival rate of metastatic gastric cancer is
only 5.5%.2 Current therapies include surgery, radiotherapy,
chemotherapy, immuno-oncology, and targeted therapy. Nearly 88% of
patients with advanced gastric and GEJ cancers are HER2-negative,
and approximately 30% of these patients present with FGFR2b
overexpression.3
1 Globocan 2020.2 Rui-Hua Xu, et al. Lancet Gastroenterol
Hepatol 2021, Published Online October 6, 2021.3 Data on file. Five
Prime Therapeutics; 2020; Cancer assessed by local and central
laboratories: Chinese results of the HER EAGLE Study; HER2 status
in gastric cancers: a retrospective analysis from four Chinese
representative clinical centers and assessment of its prognostic
significance, 2013.
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, autoimmune disorders, infectious diseases, and
neuroscience. Our goal is to leverage our competencies and
resources to positively impact human health in China and
worldwide.
For additional information about Zai Lab, including our
products, business activities and partnerships, research, and other
events or developments, please visit www.zailaboratory.com or
follow us at www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements about
future expectations, plans and prospects for Zai Lab, including,
without limitation, statements regarding the prospects of and plans
for developing bemarituzumab in Greater China and related clinical
trials and the potential treatment of patients with gastric and GEJ
cancers. 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 but not limited to (1) our ability to
successfully commercialize and generate revenue from our approved
products, (2) our ability to obtain funding for our operations and
business initiatives, (3) the results of clinical and pre-clinical
development of our product candidates, (4) the content and timing
of decisions made by the relevant regulatory authorities regarding
regulatory approvals of our product candidates, (5) the effects of
the novel coronavirus (COVID-19) pandemic on our business and
results of operations, (6) risks related to doing business in
China, and (7) other factors discussed in our most recent annual
and quarterly reports and in other reports we have filed with the
U.S. Securities and Exchange Commission (SEC). We anticipate that
subsequent events and developments will cause our expectations and
assumptions to change, and 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.
Our SEC filings can be found on our website at
www.zailaboratory.com and on the SEC’s website at www.SEC.gov.
For more information, please contact:
Investor Relations: Christine
Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257
6943christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com
Media: Shaun Maccoun / Xiaoyu Chen+1 (415)
317-7255/+86 185 0015
5011shaun.maccoun@zailaboratory.com/xiaoyu.chen@zailaboratory.com
Source: Zai Lab Limited
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