Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
the 2024 National Reimbursement Drug List (NRDL) released by
China’s National Healthcare Security Administration (NHSA) has been
updated to include the following medicines and indications:
- AUGTYRO® (repotrectinib) is included in the NRDL for the
treatment of adult patients with locally advanced or metastatic
ROS1-positive non-small cell lung cancer (NSCLC);
- NUZYRA® (omadacycline) is renewed for its intravenous
(IV) formulation for the treatment of adults with
community-acquired bacterial pneumonia (CABP) and acute bacterial
skin and skin structure infections (ABSSSI); and
- QINLOCK® (ripretinib) is renewed for advanced
gastrointestinal stromal tumor (GIST) patients who have received
prior treatment with three or more kinase inhibitors in the
all-comer setting.
“The NRDL inclusion of AUGTYRO significantly expands access to
patients living with ROS1+ NSCLC in China to a new treatment option
with promising durability. We look forward to launching AUGTYRO by
the end of 2024,” said Andrew Zhu, Chief Commercial Officer of Zai
Lab. “The addition of AUGTYRO, as well as the renewals of NUZYRA
and QINLOCK, further support patient access to these important
medications throughout China at more affordable treatment costs for
patients and their families.”
“A key part of Zai Lab’s mission is to bring innovative
medicines to patients with significant unmet medical needs,” said
Josh Smiley, President and Chief Operating Officer of Zai Lab. “We
are pleased that we now have six products included in the NRDL, and
we will continue our efforts to broaden patient access to our
innovative treatments across China. We look forward to continuing
to work with the NHSA to improve affordability and accessibility
for differentiated innovative treatments in China, with the goal of
improving patient lives.”
About ROS1+ NSCLC in China
Lung cancer is the most commonly diagnosed cancer type and the
leading cause of cancer death in China. There were approximately
1,060,600 new cases and 733,300 cases of deaths from lung cancer in
China in 2022.1 NSCLC accounts for approximately 85% of lung
cancer, and approximately 70% of NSCLC is locally advanced or
metastatic at initial diagnosis. In China, ROS1 rearrangements
occur in approximately 2% of patients with advanced NSCLC.2
1 Bingfeng Han, et al. Cancer incidence and mortality in China,
2022. 2 Zhang, et al. Prevalence of ROS1 fusion in Chinese patients
with non-small cell lung cancer, Thoracic Cancer January 2019.
About AUGTYRO
AUGTYRO (repotrectinib) is a next-generation tyrosine kinase
inhibitor (TKI) that targets ROS1 and NTRK oncogenic drivers.
Patients with solid tumors, including NSCLC, harboring ROS1 or NTRK
gene fusions treated with approved targeted therapies often develop
resistance mutations that limit binding of drugs to their target.
Ultimately, this leads to shortened duration of response and tumor
progression. AUGTYRO is the first next-generation TKI that targets
ROS1 oncogenic fusions in NSCLC and provides improved durability of
benefit, including in metastases to the brain.
In November 2023, AUGTYRO was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of adult patients with
locally advanced or metastatic ROS1-positive NSCLC. In May 2024,
AUGTYRO was approved by China’s National Medical Products
Administration (NMPA) for the same indications. Additionally, in
August 2023, the NMPA granted AUGTYRO Breakthrough Therapy
Designation for the treatment of patients with advanced solid
tumors harboring a NTRK gene fusion.
Zai Lab has an exclusive license agreement with Turning Point
Therapeutics, Inc. (a Bristol Myers Squibb company) to develop and
commercialize AUGTYRO in Greater China (mainland China, Hong Kong,
Taiwan, and Macau, collectively). Zai Lab expects to commercially
launch AUGTYRO in mainland China by the end of 2024.
About CABP and ABSSSI in China
CABP is the most common type of pneumonia that is acquired
outside of the hospital. It is one of the most common infectious
diseases and is a significant cause of mortality and morbidity
worldwide. ABSSSI are bacterial infections of skin and associated
soft tissues, such as loose connective tissue and mucous membranes.
ABSSSI are common and encompass a variety of disease presentations
and degrees of severity. In 2020, the estimated incidence of CABP
in mainland China was approximately 10 million patients3, and in
2015, the estimated incidence of ABSSSI was 2.8 million patients4.
There are significant unmet needs for broad-spectrum antibiotics
addressing multi-drug resistance infections with a favorable safety
profile.
3 Incidence of community-acquired pneumonia in urban China: A
national population-based study, 2020. 4 2015 estimates, Zai Lab
analysis.
About NUZYRA
NUZYRA (omadacycline), a novel tetracycline-class antibacterial
with both oral and IV formulations, is active across a broad
spectrum of bacterial infections, such as those caused by
Gram-positive, Gram-negative, atypical, and many other
pathogens.
The NMPA approved NUZYRA as a Category 1 innovative drug for
both oral and IV formulations for the treatment of CABP and ABSSSI
in adult patients, and Zai Lab launched NUZYRA in mainland China
for these indications in December 2021. It was included in the NRDL
for the treatment of adult patients with CABP and ABSSSI in January
2023 for its IV formulation and in January 2024 for its oral
formulation.
Zai Lab has an exclusive license from Paratek Pharmaceuticals,
Inc. (acquired by Novo Holdings A/S) to develop, manufacture, and
commercialize NUZYRA in Greater China.
About GIST in China
It is estimated that approximately 30,000 GIST patients are
newly diagnosed each year in China. Treatment of GIST remains an
important unmet medical need in China as many GIST patients, who
initially respond to traditional TKIs, ultimately develop tumor
progression due to secondary mutations.
About QINLOCK
QINLOCK (ripretinib) is an orally administered switch-control
TKI that inhibits KIT and PDGFRA kinases, including wild-type and
forms with multiple primary and secondary mutations, by using a
dual mechanism of action that regulates the kinase switch pocket
and activation loop.
The NMPA approved QINLOCK in March 2021 for the treatment of
adult patients with advanced GIST who have received prior treatment
with three or more kinase inhibitors, including imatinib, and Zai
Lab launched QINLOCK in mainland China for this indication in 2021.
It was included in the NRDL in January 2023 for the treatment for
GIST patients who have received prior treatment with three or more
kinase inhibitors in the all-comer setting.
Zai Lab has an exclusive license agreement with Deciphera
Pharmaceuticals, Inc. (a member of ONO Pharmaceutical) for the
development and commercialization of QINLOCK in Greater China.
About Zai Lab
Zai Lab Limited (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.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 relating to the benefits and
potential of AUGTYRO (repotrectinib), NUZYRA (omadacycline), and
QINLOCK (ripretinib) and the treatment of ROS1+ NSCLC, CAPB, ABSSSI
and GIST in Greater 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241127265030/en/
For more information, please contact:
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 (415) 317-7255 / +86 185
0015 5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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