BRUKINSA now approved in Brazil for three
indications
BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE:
688235), a global biotechnology, today announced BRUKINSA
(zanubrutinib) has been approved in Brazil for the treatment of
adult patients with Waldenstr�m’s macroglobulinemia (WM) and adult
patients with relapsed/refractory (R/R) marginal zone lymphoma
(MZL) who have received at least one anti-CD20-based regimen.
BRUKINSA was previously approved as a treatment in Brazil for adult
patients with mantle cell lymphoma (MCL) who have received at least
one prior therapy. BeiGene is focused on developing innovative and
affordable oncology medicines to improve treatment outcomes and
access for patients worldwide.
“We have carried out an expansive and global clinical
development program for our innovative BTK inhibitor, BRUKINSA,
which has led to approval for the treatment of WM, MZL, and MCL in
Brazil. These approvals demonstrate our commitment to accelerate
development and broaden access to innovative medicines around the
globe,” said Alex Carvalho, Country General Manager, Brazil, at
BeiGene. “I’m proud to bring this potentially best-in-class
medicine to Brazil and look forward to working with our partner,
Adium on commercialization activities.”
About BRUKINSA
BRUKINSA (zanubrutinib) is a small-molecule inhibitor of
Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists
that is currently being evaluated globally in a broad clinical
program as a monotherapy and in combination with other therapies to
treat various B-cell malignancies. BRUKINSA was specifically
designed to deliver targeted and sustained inhibition of the BTK
protein by optimizing bioavailability, half-life, and selectivity.
With differentiated pharmacokinetics compared to other approved BTK
inhibitors, BRUKINSA has been demonstrated to inhibit the
proliferation of malignant B cells within a number of
disease-relevant tissues.
BRUKINSA is supported by a broad clinical program which includes
more than 4,700 subjects in 35 trials in more than 25 countries and
regions. To date, BRUKINSA is approved in 58 markets, including the
United States, China, the European Union Great Britain, Canada,
Australia, South Korea, Switzerland and additional international
markets.
BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class
clinical candidates internally or with like-minded partners to
develop impactful and affordable medicines for patients across the
globe. We have a growing R&D and medical affairs team of more
than 3,500 colleagues dedicated to advancing more than 100 clinical
trials that have involved more than 20,000 subjects. Our expansive
portfolio is directed predominantly by our internal colleagues
supporting clinical trials in more than 45 countries and regions.
Hematology-oncology, and solid tumor targeted therapies, and
immuno-oncology are key focus areas for the Company, with both
monotherapies and combination therapies prioritized in our research
and development. BeiGene currently has three licensed medicines
discovered and developed in our own labs: BTK inhibitor BRUKINSA®
in the U.S., China, the European Union, Great Britain, Canada,
Australia, South Korea, Switzerland, and additional international
markets; and the non-FC-gamma receptor binding anti-PD-1 antibody
tislelizumab as well as the poly adenosine diphosphate-ribose
polymerase (PARP) inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including Mirati Therapeutics, Seagen, and
Zymeworks.
In January 2021 BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD-1 antibody tislelizumab in North
America, Europe, and Japan. Building upon this productive
collaboration, BeiGene and Novartis announced an option,
collaboration, and license agreement in December 2021 for BeiGene’s
TIGIT inhibitor ociperlimab that is in Phase 3 development.
Novartis and BeiGene also entered into a strategic commercial
agreement through which BeiGene will promote five approved Novartis
oncology products across designated regions of China.
About BeiGene
BeiGene is a global biotechnology company that is developing and
commercializing innovative and affordable oncology medicines to
improve treatment outcomes and access for far more 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 9,000 colleagues spans five
continents, with administrative offices in Beijing, China;
Cambridge, U.S.; and Basel, Switzerland. To learn more about
BeiGene, please visit www.beigene.com and follow us on Twitter at
@BeiGeneGlobal.
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
the potential for BRUKINSA to provide clinical benefit to patients
with B-cell malignancies, the future development, regulatory filing
and approval, commercialization, and market access of BRUKINSA in
Brazil and other markets, the potential commercial opportunity for
BRUKINSA, and BeiGene’s plans, commitments, aspirations, and goals
under the headings “BeiGene Oncology” and “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, 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 and commercialization of its drug candidates and
achieve and maintain profitability; and the impact of the COVID-19
pandemic on BeiGene’s clinical development, regulatory, commercial,
manufacturing, and other operations, as well as 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.
About Adium
Adium is a private pharmaceutical company based in Montevideo,
Uruguay. Adium distributes its products in 18 Latin American &
Caribbean countries including Brazil, Mexico and Colombia. Adium
has been distributing products from leading international companies
in the field of Oncology, Urology, Hematology and Rare Diseases,
for more than 20 years. Adium provides its partners a full set of
local capabilities including commercial, market access, regulatory
and pharmacovigilance.
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version on businesswire.com: https://www.businesswire.com/news/home/20221110005458/en/
Investor Contact Kevin Mannix +1 240-410-0129 ir@beigene.com
Media Contact Kathleen Cuca +1 551 222 6790
media@beigene.com
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