Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
China’s National Medical Products Administration (NMPA) has
accepted the New Drug Application (NDA) for KarXT for the treatment
of schizophrenia in adults.
“There are more than 8 million patients living with
schizophrenia in China who face significant unmet needs due to the
limited efficacy and undesirable side effects of current treatment
options,” said Dr. Rafael Amado, M.D., President, Head of Global
Research and Development at Zai Lab. “In clinical trials, KarXT
demonstrated statistically significant reductions of schizophrenia
symptoms along with a tolerable safety profile. If approved, KarXT
has the potential to redefine the treatment landscape.”
“KarXT is the first new class of treatment for patients with
schizophrenia in several decades,” said Gang Wang, M.D., Dean of
Beijing Anding Hospital, Capital Medical University and the leading
principal investigator for the Phase 3 China study. “We are excited
about this potentially transformative treatment option in clinical
settings to benefit these patients as early as possible.”
The NDA submission is supported by the results from a Phase 1
China Pharmacokinetics (PK) study, the Phase 3 China study
(ZL-2701-001) and data from the global EMERGENT clinical
programs.
The China Phase 3 study met its primary endpoint, with KarXT
demonstrating a statistically significant 9.2-point difference from
placebo in the reduction in the Positive and Negative Syndrome
Scale (PANSS) total score from baseline at Week 5 (-16.9 KarXT vs.
-7.7 placebo, p=0.0014). The study also met all key secondary
efficacy endpoints, demonstrating a significant improvement in
PANSS positive symptom subscale score, PANSS negative symptom
subscale score, PANSS negative Marder factor score, the Clinical
Global Impression-Severity (CGI-S) scale at week five and
percentage of PANSS responders at week five compared to placebo.
There were no safety signals that were new or unexpected in
comparison with prior KarXT trials in schizophrenia. Similar to the
global program, the common treatment emergent adverse events in the
treatment arm include vomiting, tachycardia, nausea, systemic
hypertension, dizziness and diarrhea.
In the global Phase 3 EMERGENT-2 and EMERGENT-3 trials, KarXT
met its primary endpoint, demonstrating statistically significant
reductions of schizophrenia symptoms compared to placebo. The
safety and tolerability profile of KarXT has been established
across acute and long-term trials.
In September 2024, the U.S. Food and Drug Administration (FDA)
approved COBENFY™ (xanomeline and trospium chloride) for the
treatment of schizophrenia in adults. COBENFY does not have
atypical antipsychotic class warnings and precautions and does not
have a boxed warning.
About KarXT
KarXT (xanomeline and trospium chloride) is a combination of an
oral M1/M4-preferring muscarinic acetylcholine receptor agonist and
a muscarinic acetylcholine receptor antagonist. This combination is
in development for the treatment of psychiatric conditions,
including schizophrenia and Alzheimer's-related psychosis.
Xanomeline stimulates muscarinic receptors in the central nervous
system implicated in these conditions, as compared to current
antipsychotic medicines, which mostly target dopamine or serotonin
receptors.
Zai Lab has an exclusive license from Karuna Therapeutics, Inc.,
a company acquired by Bristol Myers Squibb, to develop,
manufacture, and commercialize KarXT in Greater China (mainland
China, Hong Kong, Macau, and Taiwan, collectively).
About Schizophrenia
Schizophrenia is a persistent and often disabling mental illness
affecting how a person thinks, feels, and behaves. It is
characterized by positive symptoms (e.g., hallucinations and
delusions), negative symptoms (e.g., difficulty enjoying life and
withdrawal from others), and cognitive impairment (e.g., deficits
in memory, concentration, and decision-making) – all of which can
severely impact functioning, with only 10% of patients gainfully
employed and many struggling to meet adult milestones, such as
living independently. The life expectancy of people living with
schizophrenia is reduced by 10-20 years compared to the general
population. Schizophrenia affects nearly 24 million people
worldwide and is most commonly treated with antipsychotics.
Unfortunately, many people with schizophrenia continue to
experience limited efficacy or problematic side effects while on
current antipsychotic therapy, and approximately 75% of patients
discontinue medication before 18 months. When schizophrenia
treatment is discontinued, it can lead to impacts on health
including relapse, hospitalization, and longer time to
remission.
More than 8 million people in China are living with
schizophrenia, yet fewer than half are receiving treatment, and
even fewer are obtaining adequate symptom improvement using the
current treatment of antipsychotics. Like patients globally, there
is a significant need for more effective therapies with improved
safety to treat patients with schizophrenia 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, immunology, neuroscience and infectious disease. Our goal
is to leverage our competencies and resources to positively impact
human health 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 relating
to our future expectations, plans, and prospects, including,
without limitation, statements regarding the prospects of and plans
for developing and commercializing KarXT, the potential benefits of
KarXT, and the potential treatment of schizophrenia and other
psychiatric and neurological conditions including
Alzheimer’s-related psychosis. 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 decisions, (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 the SEC’s website at www.sec.gov.
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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 (857) 270-8854 /
+86 185 0015 5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
Zai Lab (NASDAQ:ZLAB)
過去 株価チャート
から 12 2024 まで 1 2025
Zai Lab (NASDAQ:ZLAB)
過去 株価チャート
から 1 2024 まで 1 2025
