LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced that CAMZYOS® (mavacamten) has
received marketing approval for the treatment of adults with
symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the
Pharmaceutical Administration Bureau of the Macau SAR.
“Hypertrophic cardiomyopathy is a cardiovascular
disease that significantly impacts the quality of life of
patients,” said Dr. Xiuhua Feng, Consultant of Cardiology at Kiang
Wu Hospital. “We are very pleased to see the approval of mavacamten
in Macau, as it will bring hope to local patients living with this
chronic and debilitating condition.”
"Macau marks mavacamten’s first approval in
LianBio’s licensed territories,” said Yizhe Wang, Ph.D., Chief
Executive Officer of LianBio. “This approval is a major milestone
for patients in the region and demonstrates LianBio’s commitment to
accelerating patient access throughout Asia to innovative new
treatments.”
In April 2023, the China National Medical Products
Administration (NMPA) accepted with Priority Review the New Drug
Application for mavacamten for the treatment of adults with
symptomatic oHCM.
In April 2023, LianBio announced positive topline
results from the Phase 3 EXPLORER-CN trial investigating mavacamten
for the treatment of Chinese patients with symptomatic oHCM.
EXPLORER-CN met its primary endpoint, demonstrating a statistically
significant and clinically meaningful improvement in Valsalva left
ventricular outflow tract (LVOT) gradient from baseline to week 30
compared to placebo (p<0.001). Additionally, mavacamten
demonstrated clinically important improvements for all secondary
endpoints, including change from baseline to week 30 in resting
LVOT peak gradient, proportion of participants achieving a Valsalva
LVOT peak gradient <30 mmHg at week 30, proportion of
participants achieving a Valsalva LVOT peak gradient <50 mmHg at
week 30, proportion of participants with at least one NYHA class
improvement from baseline to week 30, change from baseline to week
30 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical
Summary Score (CSS), and change from baseline to week 30 in left
ventricular mass index evaluated by cardiac magnetic resonance
imaging. Safety results in the trial were consistent with previous
studies of mavacamten in symptomatic oHCM, and no new safety
signals were reported.
About MavacamtenCAMZYOS
(mavacamten) is the first and only cardiac myosin inhibitor
approved by the U.S. FDA indicated for the treatment of adults with
symptomatic New York Heart Association (NYHA) class II-III oHCM to
improve functional capacity and symptoms. It has also received
regulatory approvals in Australia, Canada, Brazil, Switzerland and
Macau. CAMZYOS is an allosteric and reversible inhibitor selective
for cardiac myosin. CAMZYOS modulates the number of myosin heads
that can enter “on actin” (power generating) states, thus reducing
the probability of force producing (systolic) and residual
(diastolic) cross-bridge formation. Excess myosin actin cross
bridge formation and dysregulation of the super relaxed state are
mechanistic hallmarks of HCM. CAMZYOS shifts the overall myosin
population towards an energy sparing, recruitable, super relaxed
state. In HCM patients, myosin inhibition with CAMZYOS reduces
dynamic left ventricular outflow tract (LVOT) obstruction and
improves cardiac filling pressures.
LianBio licensed rights from MyoKardia, now a
wholly owned subsidiary of Bristol Myers Squibb, in August 2020 for
the development and commercialization of mavacamten in Mainland
China, Hong Kong, Macau, Taiwan, Thailand and Singapore. Mavacamten
was granted Breakthrough Therapy Designation in China for the
treatment of patients with oHCM in February 2022.
About EXPLORER-CN The EXPLORER-CN
Phase 3 trial enrolled a total of 81 patients in China with
symptomatic (NYHA Class II or III) oHCM. All participants had one
measurable LVOT gradient (resting or provoked) >50 mmHg during
screening. Patients were randomized 2:1 to mavacamten or
placebo.
The primary endpoint for EXPLORER-CN is the change
from baseline to week 30 in Valsalva LVOT gradient. Secondary
endpoints include changes from baseline to week 30 in resting LVOT
gradient, proportion of participants achieving a Valsalva LVOT peak
gradient <30 mmHg at week 30, proportion of participants
achieving a Valsalva LVOT peak gradient <50 mmHg at week 30,
proportion of participants with at least one NYHA class improvement
from baseline to week 30, change from baseline to week 30 in Kansas
City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
(CSS), change from baseline to week 30 in N-terminal pro B-type
Natriuretic Peptide (NT-proBNP), change from baseline to week 30 in
cardiac troponin, and change from baseline to week 30 in left
ventricular mass index evaluated by cardiac magnetic resonance
imaging.
About Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a chronic, progressive disease
in which excessive contraction of the heart muscle and reduced
ability of the left ventricle to fill can lead to the development
of debilitating symptoms and cardiac dysfunction. HCM is estimated
to affect one in every 500 people globally. The most frequent cause
of HCM is mutations in the heart muscle proteins of the sarcomere.
In both obstructive and non-obstructive HCM patients, exertion can
result in fatigue or shortness of breath, interfering with a
patient’s ability to participate in activities of daily living. HCM
has also been associated with increased risks of atrial
fibrillation, stroke, heart failure and sudden cardiac death.
In China, there are an estimated 1.1 million to
2.8 million patients with HCM.
About LianBio LianBio is a
cross-border biotechnology company on a mission to bring
transformative medicines to historically underserved patients in
China and other Asian markets. Through partnerships with highly
innovative biopharmaceutical companies around the world, LianBio is
advancing a diversified portfolio of clinically validated product
candidates with the potential to drive new standards of care across
cardiovascular, oncology, ophthalmology, and inflammatory disease.
LianBio is establishing an international infrastructure to position
the company as a partner of choice with a platform to provide
access to China and other Asian markets. For more information,
please visit www.lianbio.com.
Cautionary Note Regarding Forward-Looking
Statements Statements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
forward-looking statements. The words “expect,” “believe,”
“continue,” “estimate,” “potential,” “will” and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Forward-looking statements in this press release include, but are
not limited to, statements regarding the LianBio’s beliefs
regarding LianBio’s ability to accelerate patient access to
innovative medicines. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including: LianBio’s ability to
successfully initiate and conduct its planned clinical trials and
complete such clinical trials and obtain results on its expected
timelines, or at all; LianBio’s plans to leverage data generated in
its partners’ global registrational trials and clinical development
programs to obtain regulatory approval and maximize patient reach
for its product candidates; LianBio’s ability to identify new
product candidates and successfully acquire such product candidates
from third parties; competition from other biotechnology and
pharmaceutical companies; general market conditions; the impact of
changing laws and regulations and those risks and uncertainties
described in LianBio’s filings with the U.S. Securities and
Exchange Commission (SEC), including LianBio’s Annual Report on
Form 10-K for the year ended December 31, 2022 and subsequent
filings with the SEC.
Any forward-looking statements contained in this
press release speak only as of the date hereof, and LianBio
specifically disclaims any obligation to update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Readers should not rely upon this information as current
or accurate after its publication date.
For investor inquiries, please
contact: Elizabeth Anderson, VP Communications and
Investor Relations E:
elizabeth.anderson@lianbio.com T: +1 646 655
8390
For media inquiries, please
contact: Josh Xu, Director of
Communications E: josh.xu@lianbio.com
T: +86 136 6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: +1 619 849 5378
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