New indication based on results from a global
Phase 3 trial demonstrating TEVIMBRA plus chemotherapy
significantly improved overall survival for patients with advanced
gastric cancers
Second FDA approval for TEVIMBRA in 2024
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company that intends to change its name to BeOne Medicines
Ltd., today announced the U.S. Food and Drug Administration (FDA)
has approved TEVIMBRA® (tislelizumab-jsgr), in combination with
platinum and fluoropyrimidine-based chemotherapy, for the
first-line treatment of unresectable or metastatic HER2-negative
gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in
adults whose tumors express PD-L1 (≥1).
“Today’s FDA approval of TEVIMBRA for the treatment of gastric
or gastroesophageal junction cancers in PD-L1 positive adult
patients marks a significant step forward in our mission to deliver
transformative therapies to patients with cancer,” said Mark
Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at
BeiGene. “This is the second U.S. approval for TEVIMBRA this year,
underscoring its potential to address critical needs in oncology.
We remain deeply grateful to the patients, clinicians, and
researchers whose commitment and courage have made this progress
possible—and we look forward to building on this momentum in
2025.”
The additional indication for first-line G/GEJ cancers is based
on results from BeiGene’s RATIONALE-305 (NCT03777657), a
randomized, double-blind, placebo-controlled, global Phase 3 trial
to evaluate the efficacy and safety of TEVIMBRA in combination with
chemotherapy as a first-line treatment for adult patients with
advanced unresectable or metastatic G/GEJ cancer. The study met its
primary endpoint and demonstrated a statistically significant and
clinically meaningful overall survival (OS) benefit with a median
OS of 15.0 months for patients treated with TEVIMBRA in combination
with the investigator’s choice of chemotherapy compared to 12.9
months for patients treated with placebo plus chemotherapy (n=997;
HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), resulting in a 20%
reduction in the risk of death.
The pooled safety data in the application included 1,972
patients who received TEVIMBRA monotherapy in two randomized
open-label, active-controlled studies (RATIONALE-302, BGB-A317-303)
and five open-label, single-arm studies (BGB-A317-208,
BGB-A317-204, BGB-A317-203, BGB-A317-102, BGB A317_Study_001),
which enrolled 307 patients with esophageal squamous cell carcinoma
and 1,665 patients with advanced or recurrent tumors. The most
common Grade 3 or 4 adverse reactions for TEVIMBRA given in
combination with chemotherapy were neutropenia, thrombocytopenia,
anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased
appetite, rash, lymphopenia, alanine aminotransferase increased,
aspartate aminotransferase increased, diarrhea, pneumonitis, and
hepatitis.
TEVIMBRA is also approved in the U.S. as monotherapy for the
treatment of adult patients with unresectable or metastatic
esophageal squamous cell carcinoma (ESCC) after prior systemic
chemotherapy that did not include a PD-(L)1 inhibitor. An
additional Biologics License Application (BLA) is under review at
the FDA for the first-line treatment of adult patients with locally
advanced unresectable or metastatic ESCC.
The Company recently announced its intent to change its name to
BeOne Medicines Ltd., reaffirming its commitment to develop
innovative medicines to eliminate cancer by partnering with the
global community to serve as many patients as possible.
About Gastric and Gastroesophageal Junction (G/GEJ)
Cancer
Gastric (stomach) cancer is the fifth most common cancer
worldwide and the fifth highest leading cause of cancer deaths.1
Nearly 1 million new patients were diagnosed with gastric cancer in
2022, and 660,000 deaths were reported globally. In the U.S., it is
estimated that there were approximately 27,000 patients diagnosed
with gastric cancer and 11,000 deaths from the disease in 2024.2
The five-year survival rate for gastric cancer in the U.S. is 36%.3
Gastroesophageal junction cancer occurs where the esophagus joins
the stomach, which is just beneath the diaphragm (the thin sheet of
breathing muscle under the lungs).4
About TEVIMBRA® (tislelizumab-jsgr)
TEVIMBRA is a uniquely designed humanized immunoglobulin G4
(IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal
antibody with high affinity and binding specificity against PD-1.
It is designed to minimize binding to Fc-gamma (Fcγ) receptors on
macrophages, helping the body’s immune cells detect and fight
tumors.
TEVIMBRA is the foundational asset of BeiGene’s solid tumor
portfolio and has shown potential across multiple tumor types and
disease settings. The global TEVIMBRA clinical development program
includes almost 14,000 patients enrolled to date in 34 counties and
regions across 66 trials, including 20 registration-enabling
studies. TEVIMBRA is approved in more than 42 countries, and more
than 1.3 million patients have been treated globally.
U.S. Indication and Important Safety Information for TEVIMBRA
(tislelizumab-jsgr)
IMPORTANT SAFETY
INFORMATION
WARNINGS AND PRECAUTIONS
Severe and Fatal Immune-Mediated Adverse Reactions
TEVIMBRA is a monoclonal antibody that belongs to a class of
drugs that bind to either the programmed death receptor-1 (PD-1) or
PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby
removing inhibition of the immune response, potentially breaking
peripheral tolerance and inducing immune-mediated adverse
reactions.
Immune-mediated adverse reactions, which may be severe or fatal,
can occur in any organ system or tissue. Immune-mediated adverse
reactions can occur at any time after starting treatment with a
PD-1/PD-L1 blocking antibody. While immune-mediated adverse
reactions usually manifest during treatment with PD-1/PD-L1
blocking antibodies, immune-mediated adverse reactions can also
manifest after discontinuation of PD-1/PD-L1 blocking antibodies.
Important immune-mediated adverse reactions listed here may not
include all possible severe and fatal immune-mediated
reactions.
Early identification and management of immune-mediated adverse
reactions are essential to ensure safe use of PD-1/PD-L1 blocking
antibodies. Monitor patients closely for symptoms and signs that
may be clinical manifestations of underlying immune-mediated
adverse reactions. Evaluate liver enzymes, creatinine, and thyroid
function at baseline and periodically during treatment. In cases of
suspected immune-mediated adverse reactions, initiate appropriate
workup to exclude alternative etiologies, including infection.
Institute medical management promptly, including specialty
consultation as appropriate.
Withhold or permanently discontinue TEVIMBRA depending on
severity. In general, if TEVIMBRA requires interruption or
discontinuation, administer systemic corticosteroid therapy (1 to 2
mg/kg/day prednisone or equivalent) until improvement to Grade 1 or
less. Upon improvement to Grade 1 or less, initiate corticosteroid
taper and continue to taper over at least 1 month. Consider
administration of other systemic immunosuppressants in patients
whose immune-mediated adverse reactions are not controlled with
corticosteroids.
Immune-Mediated Pneumonitis
TEVIMBRA can cause immune-mediated pneumonitis, which can be
fatal. In patients treated with other PD-1/PD-L1 blocking
antibodies, the incidence of pneumonitis is higher in patients who
have received prior thoracic radiation.
Immune-mediated pneumonitis occurred in 4.9% (96/1972) of
patients receiving TEVIMBRA, including fatal (0.1%), Grade 4
(0.3%), Grade 3 (1.6%) and Grade 2 (1.9%) adverse reactions.
Pneumonitis led to permanent discontinuation of TEVIMBRA in 38
(1.9%) patients and withholding of TEVIMBRA in 32 (1.6%)
patients.
Seventy-four (77.1%) of the 96 patients received systemic
corticosteroids. Sixty-five (67.7%) of the 96 patients received
high-dose systemic corticosteroids. Immune-mediated pneumonitis
resolved in 50% of the 96 patients. Of the 32 patients in whom
TEVIMBRA was withheld for pneumonitis, 20 (62.5%) reinitiated
TEVIMBRA after symptom improvement; of these, 2 (10%) patients had
recurrence of pneumonitis.
Immune-Mediated Colitis
TEVIMBRA can cause immune-mediated colitis, which can be fatal.
Cytomegalovirus (CMV) infection/reactivation has been reported in
patients with corticosteroid-refractory immune-mediated colitis
treated with PD-1/PD-L1 blocking antibodies. In cases of
corticosteroid-refractory colitis, consider repeating infectious
workup to exclude alternative etiologies.
Immune-mediated colitis occurred in 0.8% (16/1972) of patients
receiving TEVIMBRA, including Grade 3 (0.3%) and Grade 2 (0.4%)
adverse reactions. Colitis led to permanent discontinuation of
TEVIMBRA in 4 (0.2%) patients and withholding of TEVIMBRA in 5
(0.3%) patients. Twelve (75%) of the 16 patients received systemic
corticosteroids. Eight (50%) of the 16 patients received high-dose
systemic corticosteroids. Two (12.5%) of the 16 patients received
immunosuppressive treatment. Immune-mediated colitis resolved in
93.8% of the 16 patients. All 5 patients in whom TEVIMBRA was
withheld for colitis reinitiated TEVIMBRA after symptom
improvement; of these, none of the patients had recurrence of
colitis.
Immune-Mediated Hepatitis
TEVIMBRA can cause immune-mediated hepatitis, which can be
fatal.
Immune-mediated hepatitis occurred in 1.2% (24/1972) of patients
receiving TEVIMBRA, including fatal (0.1%), Grade 4 (0.2%), Grade 3
(0.5%) and Grade 2 (0.4%) adverse reactions. Immune-mediated
hepatitis led to permanent discontinuation in 3 (0.2%) patients and
withholding of TEVIMBRA in 13 (0.7%) patients. Eighteen (75%) of
the 24 patients received systemic corticosteroids. Thirteen (54.2%)
of the 24 patients received high-dose systemic corticosteroids. Two
patients (8.3%) of the 24 patients received immunosuppressive
treatment. Immune-mediated hepatitis resolved in 70.8% of the 24
patients. Of the 13 patients in whom TEVIMBRA was withheld for
hepatitis, 7 (53.8%) reinitiated TEVIMBRA after symptom
improvement; of these, none of the patients had recurrence of
hepatitis.
Immune-Mediated
Endocrinopathies
Adrenal Insufficiency
TEVIMBRA can cause immune-mediated adrenal insufficiency. For
Grade 2 or higher adrenal insufficiency, initiate symptomatic
treatment, including hormone replacement as clinically indicated.
Withhold TEVIMBRA depending on severity.
Immune-mediated adrenal insufficiency occurred in 0.4% (8/1972)
of patients receiving TEVIMBRA, including Grade 4 (0.1%), Grade 3
(0.1%) and Grade 2 (0.3%) adverse reactions. Adrenal insufficiency
did not lead to permanent discontinuation of TEVIMBRA. TEVIMBRA was
withheld in 7 (0.4%) patients. All 8 patients received systemic
corticosteroids. Three (37.5%) of the 8 patients received high-dose
systemic corticosteroids. Adrenal insufficiency resolved in 25% of
the 8 patients. Of the 7 patients in whom TEVIMBRA was withheld for
adrenal insufficiency, 5 (71.4%) reinitiated TEVIMBRA after symptom
improvement; of these, none of the patients had recurrence of
adrenal insufficiency.
Hypophysitis
TEVIMBRA can cause immune-mediated hypophysitis. Hypophysitis
can present with acute symptoms associated with mass effect such as
headache, photophobia, or visual field defects. Hypophysitis can
cause hypopituitarism. Initiate hormone replacement as clinically
indicated. Withhold or permanently discontinue TEVIMBRA depending
on severity.
Hypophysitis/hypopituitarism occurred in 0.2% (4/1972) of
patients receiving TEVIMBRA, including a Grade 2 (0.2%) adverse
reaction. No TEVIMBRA treatment discontinuation was required, while
treatment was withheld in 1 (0.1%) patient. Three (75%) of the 4
patients received systemic corticosteroids. One (25%) of the 4
patients received high-dose systemic corticosteroids.
Hypophysitis/hypopituitarism did not resolve in the 4 patients. For
the 1 patient where TEVIMBRA was withheld for
hypophysitis/hypopituitarism, there was no recurrence of
hypophysitis/hypopituitarism.
Thyroid Disorders
TEVIMBRA can cause immune-mediated thyroid disorders.
Thyroiditis can present with or without endocrinopathy.
Hypothyroidism can follow hyperthyroidism. Initiate hormone
replacement for hypothyroidism or institute medical management of
hyperthyroidism as clinically indicated. Withhold or permanently
discontinue TEVIMBRA depending on severity.
Thyroiditis: Immune-mediated thyroiditis occurred in 1.2%
(24/1972) of patients receiving TEVIMBRA, including Grade 2 (0.5%)
adverse reactions. Thyroiditis did not lead to permanent
discontinuation of TEVIMBRA. TEVIMBRA was withheld in 3 (0.2%)
patients. Two (8.3%) of the 24 patients received systemic
corticosteroids. Thyroiditis resolved in 41.7% of the 24 patients.
All three patients in whom TEVIMBRA was withheld for thyroiditis
reinitiated TEVIMBRA after symptom improvement; of these, none of
the patients had recurrence of thyroiditis.
Hyperthyroidism: Immune-mediated hyperthyroidism occurred in
4.8% (95/1972) of patients receiving TEVIMBRA, including Grade 3
(0.1%) and Grade 2 (0.9%) adverse reactions. Hyperthyroidism led to
the permanent discontinuation of TEVIMBRA in 1 (0.1%) patient and
withholding of TEVIMBRA in 4 (0.2%) patients. One (1.1%) of the 95
patients received systemic corticosteroids. Hyperthyroidism
resolved in 75.8% of the 95 patients. Of the 4 patients in whom
TEVIMBRA was withheld for hyperthyroidism, 3 (75%) reinitiated
TEVIMBRA after symptom improvement; of these, none of the patients
had recurrence of hyperthyroidism.
Hypothyroidism: Immune-mediated hypothyroidism occurred in 12.7%
(250/1972) of patients receiving TEVIMBRA, including Grade 4 (0.1%)
and Grade 2 (6.8%) adverse reactions. TEVIMBRA was not permanently
discontinued in any patient, while treatment was withheld in 7
(0.4%) patients. Two (0.8%) of the 250 patients received systemic
corticosteroids and 158 patients (63.2%) received hormone
replacement therapy. Hypothyroidism resolved in 31.6% of the 250
patients. The majority (51.6%) of patients with hypothyroidism
required long-term thyroid hormone replacement. Of the 7 patients
in whom TEVIMBRA was withheld for hypothyroidism, 6 (85.7%)
reinitiated TEVIMBRA after symptom improvement; of these, none of
the patients had recurrence of hypothyroidism.
Type 1 Diabetes Mellitus, which can present with Diabetic
Ketoacidosis
Type 1 diabetes mellitus has been reported with PD-1/PD-L1
blocking antibodies. Monitor patients for hyperglycemia or other
signs and symptoms of diabetes. Initiate treatment with insulin as
clinically indicated. Withhold or permanently discontinue TEVIMBRA
depending on severity.
Type 1 diabetes mellitus occurred in 0.9% (18/1972) of patients
receiving TEVIMBRA, including Grade 4 (0.1%), Grade 3 (0.4%) and
Grade 2 (0.4%) adverse reactions. TEVIMBRA was permanently
discontinued in 3 (0.2%) patients and TEVIMBRA treatment was
withheld in 3 (0.2%) patients. Twelve (66.7%) patients received
insulin therapy for Type 1 diabetes mellitus. Type 1 diabetes
mellitus resolved in 27.8% of the 18 patients. Of the 3 patients in
whom TEVIMBRA was withheld for type 1 diabetes mellitus, none of
the patients reinitiated TEVIMBRA after symptom improvement.
Immune-Mediated Nephritis with Renal
Dysfunction
TEVIMBRA can cause immune-mediated nephritis, which can be
fatal.
Immune-mediated nephritis with renal dysfunction occurred in
0.3% (5/1972) of patients receiving TEVIMBRA, including Grade 3
(0.1%) and Grade 2 (0.2%) adverse reactions. TEVIMBRA was
permanently discontinued in 1 (0.1%) patient and treatment was
withheld in 3 (0.2%) patients. Three (60%) of the 5 patients
received systemic corticosteroids. All 3 (60%) of the 5 patients
received high-dose systemic corticosteroids. Nephritis with renal
dysfunction resolved in 40.0% of the 5 patients. Of the 3 patients
in whom TEVIMBRA was withheld for nephritis, 2 (66.7%) reinitiated
TEVIMBRA after symptom improvement and one (50%) patient had
recurrence of nephritis.
Immune-Mediated Dermatologic Adverse
Reactions
TEVIMBRA can cause immune-mediated rash or dermatitis. Cases of
severe cutaneous adverse reactions (SCARs), including exfoliative
dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal
necrolysis (TEN), have been reported, some with fatal outcome.
Topical emollients and/or topical corticosteroids may be adequate
to treat mild to moderate non-exfoliative rashes. Withhold or
permanently discontinue TEVIMBRA depending on severity.
Immune-mediated dermatologic adverse reactions occurred in 15.3%
(301/1972) of patients receiving TEVIMBRA, including Grade 4
(0.1%), Grade 3 (0.9%) and Grade 2 (3.5%) adverse reactions.
Dermatologic adverse reactions led to permanent discontinuation of
TEVIMBRA in 2 (0.1%) patients and withholding of TEVIMBRA in 18
(0.9%) patients. Thirty (10.0%) of the 301 patients received
systemic corticosteroids. Thirteen (4.3%) of the 301 patients
received high-dose systemic corticosteroids. Immune-mediated skin
reactions resolved in 190 (63.1%) of the 301 patients. Of the 18
patients in whom TEVIMBRA was withheld for dermatologic adverse
reactions, 15 (83.3%) reinitiated TEVIMBRA after symptom
improvement; of these, 1 (6.7%) patient had recurrence of
immune-mediated dermatologic adverse reactions.
Other Immune-Mediated Adverse
Reactions
The following clinically significant immune-mediated adverse
reactions occurred at an incidence of less than 1% each in 1972
patients who received TEVIMBRA: myositis, myocarditis, arthritis,
polymyalgia rheumatica, and pericarditis.
The following additional clinically significant immune-mediated
adverse reactions have been reported with other PD-1/PD-L1 blocking
antibodies, including severe or fatal cases.
Cardiac/Vascular: Vasculitis
Nervous System: Meningitis, encephalitis, myelitis and
demyelination, myasthenic syndrome/myasthenia gravis (including
exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune
neuropathy.
Ocular: Uveitis, iritis, and other ocular inflammatory
toxicities can occur. Some cases can be associated with retinal
detachment. Various grades of visual impairment, including
blindness, can occur. If uveitis occurs in combination with other
immune-mediated adverse reactions, consider a
Vogt-Koyanagi-Harada-like syndrome, as this may require treatment
with systemic steroids to reduce the risk of permanent vision
loss.
Gastrointestinal: Pancreatitis including increases in serum
amylase and lipase levels, gastritis, duodenitis
Musculoskeletal and Connective Tissue: Polymyositis,
rhabdomyolysis and associated sequelae including renal failure
Endocrine: Hypoparathyroidism
Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia,
hemophagocytic lymphohistiocytosis, systemic inflammatory response
syndrome, histiocytic necrotizing lymphadenitis (Kikuchi
lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid
organ transplant rejection, other transplant (including corneal
graft) rejection.
Infusion-Related Reactions
TEVIMBRA can cause severe or life-threatening infusion-related
reactions. Infusion-related reactions occurred in 5% (99/1972)
patients receiving TEVIMBRA, including Grade 3 or higher (0.2%)
reactions. Monitor patients for signs and symptoms of
infusion-related reactions.
Slow the rate of infusion for mild (Grade 1) and interrupt the
infusion for moderate (Grade 2) infusion-related reactions. For
severe (Grade 3) or life-threatening (Grade 4) infusion-related
reactions, stop infusion and permanently discontinue TEVIMBRA.
Complications of Allogeneic HSCT
Fatal and other serious complications can occur in patients who
receive allogeneic hematopoietic stem cell transplantation (HSCT)
before or after being treated with a PD-1/PD-L1 blocking antibody.
Transplant-related complications include hyperacute
graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic
veno-occlusive disease after reduced intensity conditioning, and
steroid-requiring febrile syndrome (without an identified
infectious cause). These complications may occur despite
intervening therapy between PD-1/PD-L1 blockade and allogeneic
HSCT.
Follow patients closely for evidence of transplant-related
complications and intervene promptly. Consider the benefit versus
risks of treatment with a PD-1/PD-L1 blocking antibody prior to or
after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action, TEVIMBRA can cause fetal harm
when administered to a pregnant woman. Animal studies have
demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to
increased risk of immune-mediated rejection of the developing fetus
resulting in fetal death. Advise women of the potential risk to a
fetus. Advise females of reproductive potential to use effective
contraception during treatment with TEVIMBRA and for 4 months after
the last dose.
ADVERSE REACTIONS
Esophageal squamous cell carcinoma
after prior systemic chemotherapy
Permanent discontinuation of TEVIMBRA due to an adverse reaction
occurred in 19% of patients. Adverse reactions which resulted in
permanent discontinuation in ≥ 1% of patients were hemorrhage,
pneumonitis (including pneumonitis and immune-mediated
pneumonitis), and pneumonia.
Dosage interruptions of TEVIMBRA due to an adverse reaction
occurred in 23% of patients. Adverse reactions which required
dosage interruptions in ≥ 2% of patients were pneumonia,
pneumonitis, and fatigue.
The most common (≥ 20%) adverse reactions, including laboratory
abnormalities, were increased glucose, decreased hemoglobin,
decreased lymphocytes, decreased sodium, decreased albumin,
increased alkaline phosphatase, anemia, fatigue, increased AST,
musculoskeletal pain, decreased weight, increased ALT, and
cough.
Treatment of Previously Untreated
Unresectable or Metastatic Gastric or Gastroesophageal Junction
Adenocarcinoma (G/GEJ)
Permanent discontinuation of TEVIMBRA in TEVIMBRA plus
chemotherapy arm due to an adverse drug reaction occurred in 16% of
patients. Adverse drug reactions which resulted in permanent
discontinuation in ≥1% of patients were pneumonitis and death.
Dosage interruption of TEVIMBRA in the TEVIMBRA plus
chemotherapy arm due to an adverse drug reaction occurred in 49% of
patients. Adverse drug reactions which required dosage
modifications in ≥2% of patients were, platelet count decreased
(12%), neutrophil count decreased (10%), neutropenia (6%), white
blood cell count decreased (6%), increased AST (4.8%), increased
ALT (3.8%), increased blood bilirubin (3%), COVID-19 (3%),
thrombocytopenia (2.8%), leukopenia (2.6%), pneumonitis (2.2%), and
pneumonia (2%) .
The most common (≥20%) adverse reactions, including laboratory
abnormalities, for TEVIMBRA in combination with chemotherapy were
nausea, fatigue, decreased appetite, anemia, peripheral sensory
neuropathy, vomiting, decreased platelet count, decreased
neutrophil count, increased aspartate aminotransferase, diarrhea,
abdominal pain, increased alanine aminotransferase, decreased white
blood cell count, decreased weight, and pyrexia.
INDICATIONS
TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking
antibody indicated:
Esophageal Cancer
As a single agent, for the treatment of adult patients with
unresectable or metastatic esophageal squamous cell carcinoma after
prior systemic chemotherapy that did not include a PD-(L)1
inhibitor.
Gastric Cancer
In combination with platinum and fluoropyrimidine-based
chemotherapy for the treatment of adult patients with unresectable
or metastatic HER2-negative gastric or gastroesophageal junction
adenocarcinoma whose tumors express PD-L1 (≥1).
Please see full U.S. Prescribing Information
including the U.S. Medication Guide.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd.,
is a global oncology company that is discovering and developing
innovative 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 nearly
11,000 colleagues spans five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn, X
(formerly known as Twitter), Facebook and Instagram.
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 deliver transformative therapies to patients
with cancer; TEVIMBRA’s ability to address critical needs in
oncology; the future potential of and approvals for 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; BeiGene’s 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.
To access BeiGene media resources, please visit our News
& Media site.
___________________________ 1 Ferlay J, Ervik M, Lam F,
Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram
I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon,
France: International Agency for Research on Cancer. Available
from: https://gco.iarc.who.int/today. 2 American Cancer Society.
Cancer Facts & Figures 2024.
https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts-figures.html.
Accessed October 28, 2024. 3 National Cancer Institute.
Surveillance, Epidemiology, and End Results Program. Cancer stat
facts: stomach cancer. Available at
https://seer.cancer.gov/statfacts/html/stomach.html. Accessed
October 28, 2024. 4 American Cancer Society. What Is Stomach
Cancer?
https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html.
Accessed October 28, 2024.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241227403101/en/
Investor Contact: Liza Heapes +1 857-302-5663
ir@beigene.com
Media Contact: Kim Bencker +1 610-256-8932
media@beigene.com
BeiGene (NASDAQ:BGNE)
Historical Stock Chart
From Nov 2024 to Dec 2024
BeiGene (NASDAQ:BGNE)
Historical Stock Chart
From Dec 2023 to Dec 2024