This marks the first regulatory approval for
BRUKINSA in Russia
BRUKINSA is now approved for the treatment of
MCL in ten countries, following the U.S., China, Canada, Australia,
and others
BeiGene is committed to rapidly advancing the
global registration of BRUKINSA on its own and alongside strategic
collaborators
Under an exclusive distribution agreement,
Nanolek will commercialize BRUKINSA in Russia
BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven
biotechnology company focused on developing innovative and
affordable medicines to improve treatment outcomes and access for
patients worldwide, and Nanolek, a biopharmaceutical company
specializing in the production of import-substituting and
innovative drugs in Russia, today announced that BRUKINSA®
(zanubrutinib) has received approval from the Russia Ministry of
Health for the treatment of adult patients with mantle cell
lymphoma (MCL) who have received at least one prior therapy.
BeiGene and Nanolek entered into an exclusive distribution
agreement for Nanolek to commercialize BRUKINSA in the Russian
Federation.
“The registration of BRUKINSA (zanubrutinib), a next-generation
BTK inhibitor that demonstrated improved clinical benefit while
reducing the frequency of certain off-target side effects in MCL,
will give physicians and patients another treatment option.
BRUKINSA has the potential to give those impacted by MCL in Russia
an improved prognosis and a more tolerable therapeutic option,”
commented Irina Vladimirovna Poddubnaya, Professor, Academician of
Russian Academy of Sciences (RAS), and Head of Oncology Department
at the Russian Medical Academy of Postgraduate Education.
“This approval reinforces BRUKINSA’s potential as a
best-in-class BTK inhibitor for the treatment of hematological
malignancies, and we are pleased to make it available to MCL
patients in Russia,” said Jane Huang, M.D., Chief Medical Officer,
Hematology, BeiGene. “We are working to improve outcomes for
patients living with cancer, wherever they live, and this year have
secured 12 regulatory approvals for BRUKINSA in the United States,
Canada, Latin America, and the APAC and EMEA regions.”
“We look forward to collaborating with Nanolek to bring a much
needed new treatment option to MCL patients in Russia,” said Vitaly
Sokolinsky, Senior Director, New Market Development, Russia, at
BeiGene. “Today’s approval in MCL highlights our continued
expansion into Russia, greater Europe and beyond as we bring our
expertise to new markets around the world.”
“We’re proud of this significant achievement for patients and
look forward to contributing to BRUKINSA’s growing global footprint
through our strong collaboration with BeiGene,” added Vladimir
Khristenko, President of Nanolek. “Together, we are committed to
delivering innovative therapies for the benefit of people impacted
by cancer in Russia.”
Marketing approval for BRUKINSA for the treatment of MCL in
Russia is based on results from two single-arm clinical trials.
Across both trials, as assessed by independent review committee
(IRC) per 2014 Lugano Classification, BRUKINSA achieved an overall
response rate (ORR) of 83.7%, defined as the combined rate of
complete responses (CRs) and partial responses (PRs).
Of the 118 patients with MCL who received at least one prior
therapy and received BRUKINSA treatment, serious adverse reactions
occurred in 36 patients (31%), with the most frequent being
pneumonia (11%) and bleeding (5%). Eight patients (7%) discontinued
treatment due to adverse reactions in the trials, with the most
frequent being pneumonia (3.4%), and one patient (0.8%) experienced
an adverse reaction that led to dose reduction.
The recommended dose of BRUKINSA is either 160 mg twice daily or
320 mg once daily, taken orally with or without food. The dose may
be adjusted for adverse reactions and reduced for patients with
severe hepatic impairment and certain drug interactions.
About Mantle Cell Lymphoma (MCL)
MCL is rare form of non-Hodgkin lymphoma (NHL), representing
about 5% of all NHL cases.1 It develops in the outer edge of a
lymph node called the mantle zone.1 Mantle cell lymphoma occurs
more often in men than in women.1 It is usually diagnosed in people
in their early 60s.1 MCL has a poor prognosis, with a median
survival of three to four years, and is often diagnosed at a later
stage of disease.2 In Russia, there are more than 1,000 new cases
of MCL diagnosed each year.3
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. Because new BTK is continuously
synthesized, BRUKINSA was specifically designed to deliver complete
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 approved in the following indications and
regions:
- For the treatment of mantle cell lymphoma (MCL) in adult
patients who have received at least one prior therapy (United
States, November 2019)*;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (China, June 2020)**;
- For the treatment of chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL) in adult patients who have
received at least one prior therapy (China, June 2020)**;
- For the treatment of relapsed or refractory MCL (United Arab
Emirates, February 2021);
- For the treatment of Waldenstr�m’s macroglobulinemia (WM) in
adult patients (Canada, March 2021);
- For the treatment of adult patients with WM who have received
at least one prior therapy (China, June 2021)**;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (Canada, July 2021);
- For the treatment of MCL in adult patients who have received at
least one prior therapy (Chile, July 2021);
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Brazil, August 2021);
- For the treatment of adult patients with WM (United States,
August 2021);
- For the treatment of adult patients with marginal zone lymphoma
(MZL) who have received at least one anti-CD20-based regimen
(United States, September 2021)*;
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Singapore, October 2021);
- For the treatment of MCL in patients who have received at least
one prior therapy (Israel, October 2021);
- For the treatment of adult patients with WM who have received
at least one prior therapy, or in first line treatment for patients
unsuitable for chemo-immunotherapy (Australia, October 2021);
- For the treatment of adult patients with MCL who have received
at least one prior therapy (Australia, October 2021); and
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Russia, October 2021).
To date, more than 30 marketing authorization applications in
multiple indications have been submitted in the United States,
China, the European Union, and more than 20 other countries or
regions.
* This indication was approved under accelerated approval based
on overall response rate. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
** This indication was approved under conditional approval.
Complete approval for this indication may be contingent upon
results from ongoing randomized, controlled confirmatory clinical
trials.
IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA
(ZANUBRUTINIB)
Warnings and Precautions
Hemorrhage
Fatal and serious hemorrhagic events have occurred in patients
with hematological malignancies treated with BRUKINSA monotherapy.
Grade 3 or higher hemorrhage including intracranial and
gastrointestinal hemorrhage, hematuria and hemothorax have been
reported in 3.4% of patients treated with BRUKINSA monotherapy.
Hemorrhage events of any grade occurred in 35% of patients treated
with BRUKINSA monotherapy.
Bleeding events have occurred in patients with and without
concomitant antiplatelet or anticoagulation therapy.
Co-administration of BRUKINSA with antiplatelet or anticoagulant
medications may further increase the risk of hemorrhage.
Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA
if intracranial hemorrhage of any grade occurs. Consider the
benefit-risk of withholding BRUKINSA for 3-7 days pre- and
post-surgery depending upon the type of surgery and the risk of
bleeding.
Infections
Fatal and serious infections (including bacterial, viral, or
fungal) and opportunistic infections have occurred in patients with
hematological malignancies treated with BRUKINSA monotherapy. Grade
3 or higher infections occurred in 27% of patients, most commonly
pneumonia. Infections due to hepatitis B virus (HBV) reactivation
have occurred.
Consider prophylaxis for herpes simplex virus, pneumocystis
jiroveci pneumonia and other infections according to standard of
care in patients who are at increased risk for infections. Monitor
and evaluate patients for fever or other signs and symptoms of
infection and treat appropriately.
Cytopenias
Grade 3 or 4 cytopenias, including neutropenia (26%),
thrombocytopenia (11%) and anemia (8%) based on laboratory
measurements, developed in patients treated with BRUKINSA
monotherapy. Grade 4 neutropenia occurred in 13% of patients, and
Grade 4 thrombocytopenia occurred in 3.6% of patients.
Monitor complete blood counts regularly during treatment and
interrupt treatment, reduce the dose, or discontinue treatment as
warranted. Treat using growth factor or transfusions, as
needed.
Second Primary Malignancies
Second primary malignancies, including non-skin carcinoma, have
occurred in 14% of patients treated with BRUKINSA monotherapy. The
most frequent second primary malignancy was non-melanoma skin
cancer, reported in 8% of patients. Other second primary
malignancies included malignant solid tumors (4.0%), melanoma
(1.7%) and hematologic malignancies (1.2%). Advise patients to use
sun protection and monitor patients for the development of second
primary malignancies.
Cardiac Arrhythmias
Atrial fibrillation and atrial flutter were reported in 3.2% of
patients treated with BRUKINSA monotherapy. Patients with cardiac
risk factors, hypertension, and acute infections may be at
increased risk. Grade 3 or higher events were reported in 1.1% of
patients treated with BRUKINSA monotherapy. Monitor signs and
symptoms for atrial fibrillation and atrial flutter and manage as
appropriate.
Embryo-Fetal Toxicity
Based on findings in animals, BRUKINSA can cause fetal harm when
administered to a pregnant woman. Administration of zanubrutinib to
pregnant rats during the period of organogenesis caused
embryo-fetal toxicity including malformations at exposures that
were 5 times higher than those reported in patients at the
recommended dose of 160 mg twice daily. Advise women to avoid
becoming pregnant while taking BRUKINSA and for 1 week after the
last dose. Advise men to avoid fathering a child during treatment
and for 1 week after the last dose.
If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential hazard to a fetus.
Adverse reactions
The most common adverse reactions, including laboratory
abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847)
included decreased neutrophil count (54%), upper respiratory tract
infection (47%), decreased platelet count (41%), hemorrhage (35%),
decreased lymphocyte count (31%), rash (31%) and musculoskeletal
pain (30%).
Drug Interactions
CYP3A Inhibitors: When BRUKINSA is co-administered with a
strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily.
For coadministration with a moderate CYP3A inhibitor, reduce
BRUKINSA dose to 80 mg twice daily.
CYP3A Inducers: Avoid coadministration with moderate or
strong CYP3A inducers.
Specific Populations
Hepatic Impairment: The recommended dose of BRUKINSA for
patients with severe hepatic impairment is 80 mg orally twice
daily.
Please see full U.S. Prescribing Information at
www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at
www.beigene.com/PDF/BRUKINSAUSPPI.pdf.
BeiGene Oncology
BeiGene is committed to advancing hematology, immuno-oncology
and targeted therapies in order to bring impactful and affordable
medicines to patients across the globe. We have a growing R&D
team of approximately 2,300 colleagues dedicated to advancing more
than 90 clinical trials involving more than 13,000 patients and
healthy subjects. Our expansive portfolio is directed by a
predominantly internalized clinical development team supporting
trials in more than 40 countries or regions. We currently market
three medicines discovered and developed in our labs: BTK inhibitor
BRUKINSA in the United States, China, Canada, Australia and
additional international markets; and non-FC-gamma receptor binding
anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in
China. BeiGene has a high quality, innovative science and medicine
organization and is a leader in China with a large oncology focused
commercial team.
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 and Bristol Myers Squibb. We also plan to address greater
areas of unmet need globally through our collaborations including
with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen,
and Zymeworks. BeiGene has also entered into a collaboration with
Novartis granting Novartis rights to develop, manufacture, and
commercialize tislelizumab in North America, Europe, and Japan.
About BeiGene
BeiGene is a global, science-driven biotechnology company
focused on developing innovative and affordable medicines to
improve treatment outcomes and access for patients worldwide. With
a broad portfolio of more than 40 clinical candidates, we are
expediting development of our diverse pipeline of novel
therapeutics through our own capabilities and collaborations. We
are committed to radically improving access to medicines for two
billion more people by 2030. BeiGene has a growing global team of
over 7,000 colleagues across five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on Twitter at
@BeiGeneGlobal.
About Nanolek
Nanolek is a Russian biopharmaceutical company founded in 2011
by Vladimir Khristenko and Mikhail Nekrasov, specializing in the
production of import-substituting and innovative drugs, both
developed in-house and created with international partners. It is
one of the leaders in the production of pediatric vaccines in
Russia. A total of 20 medicines are now in the Nanolek’s portfolio,
with 35 more at various stages of preparation for release and will
hit the market within the next five years. The company's plant in
the Kirov region that opened in 2014 was built with an eye on the
best international practices and technologies. The production
facility is GMP-certified and besides regularly passes quality
audits performed by major international pharmaceutical
corporations: Nanolek plant produces drugs in cooperation with such
companies as Sanofi, Janssen, Merck, and Aspen.
Nanolek supports scientific educational initiatives through
active collaboration with RSOH (Russian Society of
Oncohematologists).The company contributes to the development of a
further educational program for hematologists on future clinical
indications: CLL, Waldenstr�m’s macroglobulinemia and marginal zone
cell lymphoma. www.nanolek.ru.
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
plans for development and commercialization of BRUKINSA in Russia
and other markets, the potential commercial opportunity for
BRUKINSA, plans for making BRUKINSA accessible to patients in
Russia, the potential for BRUKINSA to be a best-in-class BTK
inhibitor and to provide improved clinical benefits to patients,
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; the impact of the COVID-19 pandemic on the
BeiGene’s clinical development, regulatory, commercial, 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.
References:
1 Lymphoma Research Foundation. Understanding Mantle Cell
Lymphoma. Available at
https://lymphoma.org/wp-content/uploads/2018/10/MantleCellLymphomaFact-Sheet.pdf
Accessed October 2021.
2 Philip J. Bierman, James O. Armitage, in Goldman's Cecil
Medicine (Twenty Fourth Edition), 2012.
3
https://glavonco.ru/cancer_register/%D0%9F%D0%BE%D0%BC%D0%BE%D1%89%D1%8C%202019.pdf.
Accessed October 2021.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211020005166/en/
BeiGene Investor Contact Gabrielle Zhou +86 10-5895-8058
ir@beigene.com
Media Contact Emily Collins +1 201-201-4570
media@beigene.com
Nanolek Press Office Anna Karabash +7 929 602-61-04
prnanolek@gmail.com
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