Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib for Treatment of Patients with NTRK-positive TKI-pretreated advanced solid tumors in China
August 30 2023 - 7:30AM
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the
Center for Drug Evaluation (CDE) of the National Medical Products
Administration (NMPA) granted Breakthrough Therapy Designation for
investigational repotrectinib for the treatment of patients with
advanced solid tumors that have an NTRK gene fusion who have
progressed following treatment with TRK tyrosine kinase inhibitors
(TKIs). The Breakthrough Therapy Designation for repotrectinib was
supported by data from both global and Chinese NTRK-positive
TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.
“We are excited to receive our fourth Breakthrough Therapy
Designation for repotrectinib in China. Today’s recognition further
supports repotrectinib as a potential first-in-class treatment for
patients with NTRK-positive, TKI-pretreated solid tumors in China,”
said Rafael G. Amado, M.D., President, Head of Global Oncology
Research and Development at Zai Lab. “NTRK is estimated to be an
oncogenic driver in approximately 0.5 percent of patients with a
variety of advanced solid tumors.1 There remains an unmet medical
need for NTRK-positive, TKI-pretreated advanced solid tumor
patients where there are no targeted therapies currently approved.
We look forward to working with regulatory authorities in China to
bring this important medicine to patients in need as soon as
possible.”
The Breakthrough Therapy Designation review policy is designed
to facilitate the development and expeditious review of novel
medicines that are intended for the prevention or treatment of
serious, life-threatening diseases or diseases that severely impact
the quality of life for which there is no existing treatment, or
where sufficient evidence indicates advantages of the novel drug
over currently available treatment options. Drugs granted
Breakthrough Therapy Designations receive priority communications
and guidance from the CDE to promote and expedite the drug
development process.
In June 2023, Zai Lab announced that the NMPA in China has
accepted its New Drug Application (NDA) for repotrectinib for the
treatment of adult patients with locally advanced or metastatic
ROS1-positive NSCLC, after granting priority review in May
2023.
1 NTRK fusion detection across multiple assays and 33,997 cases:
diagnostic implications and pitfalls, 2020.
About Repotrectinib
Repotrectinib is a next-generation tyrosine kinase inhibitor
targeting the ROS1 and NTRK oncogenic drivers of advanced solid
tumors, including NSCLC. Patients with tumor harboring ROS1 and
NTRK gene fusions treated with approved targeted therapies often
develop resistance mutations, eventually leading to tumor
progression. Repotrectinib is the first next-generation TKI for
ROS1- positive metastatic NSCLC and tumors with NTRK fusions,
uniquely designed to address key drivers of disease progression.
Zai Lab and Turning Point Therapeutics, Inc. (Turning Point,
acquired by Bristol Myers Squibb) are studying repotrectinib in
TRIDENT-1, a registrational Phase 1/2 study in adults, and CARE, a
Phase 1/2 study in pediatric patients. Repotrectinib has shown
robust antitumor activity and durable responses among TKI-naïve and
pre-treated patients. Zai Lab participated in the registrational
TRIDENT-1 study in Greater China (mainland China, Hong Kong,
Taiwan, and Macau), while Turning Point Therapeutics is enrolling
patients in other regions of the world.
In the United States, repotrectinib has been granted three
Breakthrough Therapy Designations from the U.S. Food and Drug
Administration (FDA) in: ROS1-positive metastatic NSCLC patients
who have not been treated with a ROS1 TKI; ROS1-positive metastatic
NSCLC patients who have previously been treated with a ROS1 TKI and
who have not received prior platinum-based chemotherapy; and
patients with advanced solid tumors that have an NTRK gene fusion
who have progressed following treatment with one or two prior TRK
TKIs, with or without prior chemotherapy, and have not had
satisfactory alternative treatments. Additionally, repotrectinib
was previously granted four Fast-Track Designations by the FDA in
ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve;
ROS1-positive advanced NSCLC patients who have been previously
treated with one prior line of platinum-based chemotherapy and one
prior ROS1 TKI; ROS1-positive advanced NSCLC patients pretreated
with one prior ROS1 TKI without prior platinum-based chemotherapy;
and NTRK-positive patients with advanced solid tumors who have
progressed following treatment with at least one prior line of
chemotherapy and one or two prior TRK TKIs and have not had
satisfactory alternative treatments. Repotrectinib was also granted
an Orphan Drug Designation by the FDA in 2017.
In China, repotrectinib has been granted three Breakthrough
Therapy Designations from the CDE of the NMPA in ROS1-positive
metastatic NSCLC patients who have not been treated with a ROS1
TKI; ROS1-positive metastatic NSCLC patients who have previously
been treated with a ROS1 TKI and who have not received prior
platinum-based chemotherapy; and ROS1-positive metastatic NSCLC
patients who have previously been treated with a ROS1 TKI and one
prior line of platinum-based chemotherapy.
Zai Lab has an exclusive license agreement with Turning Point to
develop and commercialize repotrectinib in Greater China.
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, 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
repotrectinib and the potential treatment of NTRK-positive solid
tumors in China. 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 our 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) risks
related to doing business in China, and (6) other factors
identified in our most recent annual and quarterly reports and in
other reports we have filed with the U.S. Securities and Exchange
Commission. 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
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