BRUKINSA® received Marketing Authorization as a treatment
for rare blood cancers in six countries in Central and South
America
BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company focused on developing innovative and
affordable oncology medicines to improve treatment outcomes and
access for patients worldwide, today announced significant progress
in efforts to unlock global opportunities for BRUKINSA®
(zanubrutinib) with recent regulatory approvals in six Latin
American countries:
- Argentina Relapsed/refractory (r/r) mantle cell lymphoma
(MCL)
- Chile r/r marginal zone lymphoma (MZL) and Waldenstr�m’s
macroglobulinemia (WM)
- Ecuador r/r MZL and WM
- El Salvador r/r MCL, r/r MZL, and WM
- Mexico r/r MCL
- Paraguay r/r MCL
“It has only been one year since the first approval for BRUKINSA
in Latin America and these approvals, including the most recent in
Argentina, demonstrate our drive to accomplish our mission and
broaden access to innovative medicines,” said Eduardo Molinari,
Senior Director of New Market Development in Latin America at
BeiGene. “I look forward to collaborating with our partner, Adium,
on commercialization activities to provide this important treatment
option to people living with MCL, MZL, and WM in Latin
America.”
Dr. Maria Silvana Cugliari, Head of Hematology, Angel Roffo
Institute of Oncology University of Buenos Aires, Argentina
commented, “BTK inhibition has proven to be a highly effective
treatment strategy for a number of indolent B-cell malignancies and
BeiGene’s expansive clinical development program for BRUKINSA in
multiple indications has provided evidence of strong efficacy and
durable response rates, along with a consistent safety
profile.”
The announcement of regulatory approvals for BRUKINSA in Latin
America follows a recent positive CHMP Opinion for BRUKINSA as a
treatment for chronic lymphocytic leukemia (CLL) in the European
Union.
About BRUKINSA
BRUKINSA 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 4,500 subjects in 35 trials across 28 markets. To date,
BRUKINSA has received approvals covering more than 55 countries and
regions, including the United States, China, the EU, Switzerland,
Great Britain, Canada, Australia, 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
approximately 3,300 colleagues dedicated to advancing more than 100
clinical trials that have involved more than 16,000 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, Switzerland, Great Britain,
Canada, Australia, 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 Latin America 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/20221026005423/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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