Regulatory marketing applications for U.S. and
EU under review, with plans to expand TEVIMBRA commercial presence
worldwide
TEVIMBRA is the cornerstone of BeiGene’s solid
tumor portfolio, potentially pairing with more than 20 internal
investigational assets as part of a broad, flexible combination
strategy
Regaining global rights furthers Company’s
mission of bringing innovative, affordable medicines to more
patients and addressing areas of high unmet need
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced that it has entered into an
agreement with Novartis to regain worldwide rights to develop,
manufacture, and commercialize TEVIMBRA (tislelizumab).
“We are excited to regain the global rights to TEVIMBRA, which
enables us to build out our in-house solid tumor commercial
capabilities and complements our deep pipeline presented at our
recent R&D Day. With more than 12,000 patients enrolled in our
TEVIMBRA global clinical trial program, we plan to rapidly
accelerate our regulatory and development plans across a wider
range of tumor types,” said John V. Oyler, Co-Founder, Chairman and
CEO of BeiGene. “BeiGene will continue to work with Novartis on
development, regulatory and manufacturing priorities. Novartis will
manufacture TEVIMBRA for many markets worldwide and explore its
potential in combination with their oncology assets.”
BeiGene has launched more than 20 potentially
registration-enabling trials with TEVIMBRA, of which 10 Phase 3
randomized trials and four Phase 2 trials have already had positive
readouts. Through these trials, TEVIMBRA has demonstrated its
ability to safely deliver clinically meaningful improvements in
survival benefits and quality of life for hundreds of thousands of
cancer patients across a range of tumor types – in many cases,
regardless of PD-L1 status – both as a monotherapy and in
combination with other regimens. More than 750,000 patients have
been prescribed TEVIMBRA to-date.
“TEVIMBRA is the backbone of our diverse solid tumor development
pipeline focused on developing novel combination regimens with
precision medicine targets – such as OX40, HPK1, and LAG3 – in our
next wave immuno-oncology portfolio. It also nicely complements our
diversified research portfolio, which includes additional
modalities such as antibody drug conjugates and bispecific
antibodies, many of which have blockbuster potential,” said Mark
Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at
BeiGene. “We are eager to continue to explore TEVIMBRA’s full
potential to address unmet clinical needs around the world,
including in combination with our deep and diverse solid tumor
pipeline, which has over 20 immuno-oncology and targeted molecules
that could be paired with TEVIMBRA to help more patients.”
Terms of the Agreement The parties mutually agreed to
terminate the previous collaboration and license agreement entered
into on January 11, 2021, and, pursuant to the new agreement,
BeiGene regained full global rights to TEVIMBRA with no royalty
payments due to Novartis. In addition, Novartis will provide
transition services and support to BeiGene to enable key aspects of
the TEVIMBRA development and commercialization plan to proceed
without disruption, including manufacturing, regulatory, safety and
clinical support. BeiGene has agreed to provide Novartis with
ongoing clinical supply of TEVIMBRA to support its clinical
trials.
Under the previous agreement, BeiGene and Novartis were jointly
developing TEVIMBRA in the United States, Canada, Mexico, member
countries of the European Union, United Kingdom, Norway,
Switzerland, Iceland, Liechtenstein, Russia, and Japan. Under the
agreement, Novartis was responsible for regulatory submissions and
had the right to commercialize in these licensed countries
following regulatory approval.
About TEVIMBRA (tislelizumab) TEVIMBRA is a humanized
IgG4 anti-PD-1 monoclonal antibody specifically designed to
minimize binding to Fc-gamma (Fcγ) receptors on macrophages,
helping to aid the body’s immune cells to detect and fight tumors.
In pre-clinical studies, binding to Fcγ receptors on macrophages
has been shown to compromise the anti-tumor activity of PD-1
antibodies through activation of antibody-dependent
macrophage-mediated killing of T effector cells.
TEVIMBRA is currently under review by the U.S. Food and Drug
Administration and the European Medicines Agency (EMA) for advanced
or metastatic ESCC after prior chemotherapy. The EMA is reviewing a
marketing authorization application for TEVIMBRA as a treatment for
locally advanced or metastatic non-small cell lung cancer (NSCLC)
after prior chemotherapy, and in combination with chemotherapy for
previously untreated locally advanced or metastatic NSCLC.
Regulatory submissions for TEVIMBRA are also under review by
authorities in the U.K., Australia, China, New Zealand, Brazil,
Korea, Switzerland, Israel and Indonesia. Tislelizumab is approved
as a treatment in 11 indications in China and is the leading PD-1
inhibitor in the country.
The tislelizumab development program encompasses 21
registration-enabling clinical trials in more than 30 countries and
regions. To date, BeiGene has announced positive readouts from 10
Phase 3 pivotal studies across multiple tumor types and disease
settings such as NSCLC, small cell lung cancer, gastric cancer,
ESCC, hepatocellular cancer, and nasopharyngeal cancer. More
information on the clinical trial program for tislelizumab can be
found at:
https://www.beigene.com/en-us/science-and-product-portfolio/pipeline.
About BeiGene BeiGene is a global biotechnology company
that is discovering and developing innovative oncology treatments
that are more affordable and accessible to cancer patients
worldwide. With a broad portfolio, we are expediting development of
our diverse pipeline of novel therapeutics through our internal
capabilities and collaborations. We are committed to radically
improving access to medicines for far more patients who need them.
Our growing global team of more than 10,000 colleagues spans five
continents, with administrative offices in Basel, Beijing, and
Cambridge, U.S. To learn more about BeiGene, please visit
www.beigene.com and follow us on LinkedIn and X (formerly known as
Twitter).
Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and other federal
securities laws, including statements regarding BeiGene’s ability
to build out in-house solid tumor commercial capabilities;
BeiGene’s plan to rapidly accelerate regulatory and development
plans across a wider range of tumor types; the future development,
regulatory filing, approval and commercialization of TEVIMBRA; and
BeiGene’s plans, commitments, aspirations, and goals under the
heading “About BeiGene.” Actual results may differ materially from
those indicated in the forward-looking statements as a result of
various important factors, including BeiGene's ability to
demonstrate the efficacy and safety of its drug candidates; the
clinical results for its drug candidates, which may not support
further development or marketing approval; actions of regulatory
agencies, which may affect the initiation, timing, and progress of
clinical trials and marketing approval; BeiGene's ability to
achieve commercial success for its marketed medicines and drug
candidates, if approved; BeiGene's ability to obtain and maintain
protection of intellectual property for its medicines and
technology; BeiGene's reliance on third parties to conduct drug
development, manufacturing, commercialization, and other services;
BeiGene’s limited experience in obtaining regulatory approvals and
commercializing pharmaceutical products and its ability to obtain
additional funding for operations and to complete the development
of its drug candidates and achieve and maintain profitability; and
those risks more fully discussed in the section entitled “Risk
Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as
well as discussions of potential risks, uncertainties, and other
important factors in BeiGene's subsequent filings with the U.S.
Securities and Exchange Commission. All information in this press
release is as of the date of this press release, and BeiGene
undertakes no duty to update such information unless required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230919525395/en/
Investor: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: Kyle Blankenship +1 667-351-5176
media@beigene.com
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