Submission seeks marketing authorization for
first-line treatment of unresectable or metastatic hepatocellular
carcinoma
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company announced that the Center for Drug Evaluation
(CDE) of the China National Medical Products Administration (NMPA)
has accepted a supplemental biologics license application (sBLA)
for tislelizumab in patients with first-line unresectable or
metastatic hepatocellular carcinoma (HCC).
Hepatocellular carcinoma is the most common type of primary
liver cancer worldwide and is associated with a very poor
prognosis.1 New cases and deaths due to HCC in China account for
half of the global numbers and the 5-year survival rate for
patients with HCC in China is only 14%.2
“While the incidence of HCC is increasing in China, the
treatment landscape has not advanced accordingly; survival benefits
with newer treatments are modest and multi-kinase inhibitors have
sub-optimal tolerability,” said Lai Wang, Ph.D., Global Head of
R&D at BeiGene. “We believe the evidence from our rigorously
conducted global clinical development program for tislelizumab in
HCC support the efficacy and favorable tolerability profile and
look forward to working with NMPA on this submission and bringing a
new treatment option to patients with HCC in China.”
The sBLA is supported by data from the RATIONALE 301 clinical
trial (NCT03412773) that enrolled 674 patients from research
centers across Asia, Europe, and the United States. RATIONALE 301
results were presented as a late-breaking oral presentation at the
2022 European Society for Medical Oncology (ESMO) Congress in
Paris.
Tislelizumab was approved by the China NMPA as a treatment for
nine indications, including conditional approval ‘for the treatment
of patients with hepatocellular carcinoma (HCC) who have been
previously treated with at least one systemic therapy’. Additional
tislelizumab’s sBLAs under review at CDE include: combination with
chemotherapy as a first-line treatment for patients with advanced
or metastatic gastric or gastroesophageal junction adenocarcinoma
whose tumors express PD-L1; combination with chemotherapy as
first-line treatment in patients with unresectable locally
advanced, recurrent or metastatic esophageal squamous cell
carcinoma. Tislelizumab is not approved for use outside of
China.
About Tislelizumab
Tislelizumab 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.
Tislelizumab is the first investigational medicine from
BeiGene’s immuno-oncology biologics program and is being evaluated
in solid tumor and hematologic malignancies, as monotherapy and in
combination.
The global tislelizumab clinical development program includes
more than 11,500 subjects enrolled to-date in 21
registration-enabling trials, from more than 30 countries and
regions.
About RATIONALE 301
RATIONALE 301 (NCT03412773) is a global, Phase 3, randomized,
open-label study of tislelizumab compared with sorafenib as a
first-line treatment in adult patients with unresectable HCC. The
primary endpoint of the study is non-inferiority of Overall
Survival between the two treatment groups. The key secondary
endpoint is Overall Response Rate, as assessed by Blinded
Independent Review Committee (BIRC) per RECIST v1.1. Other
secondary endpoints include other efficacy assessments such as
Progression Free Survival, Duration of Response, and Time to
Progression per BIRC, as well as measures of health-related quality
of life, and safety and tolerability.
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 Cambridge, U.S., &
Basel, Switzerland & Beijing, China. 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 tislelizumab to treat patients with HCC, plans
for regulatory approvals for tislelizumab in HCC, BeiGene's
advancement of anticipated clinical development, regulatory
milestones and commercialization of tislelizumab, 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 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 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.
1 Sung, H, Ferlay, J, Siegel, RL, Laversanne, M, Soerjomataram,
I, Jemal, A, Bray, F. Global cancer statistics 2020: GLOBOCAN
estimates of incidence and mortality worldwide for 36 cancers in
185 countries. CA Cancer J Clin. 2021: 71: 209- 249.
https://doi.org/10.3322/caac.21660 2 Zheng R, Qu C, Zhang S, Zeng
H, Sun K, Gu X, Xia C, Yang Z, Li H, Wei W, Chen W, He J. Liver
cancer incidence and mortality in China: Temporal trends and
projections to 2030. Chin J Cancer Res. 2018 Dec;30(6):571-579.
https://doi.org/10.21147/j.issn.1000-9604.2018.06.01.
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version on businesswire.com: https://www.businesswire.com/news/home/20221230005150/en/
Investor: Kevin Mannix +1 240-410-0129 ir@beigene.com
Media: Kyle Blankenship +1 667- 351-5176
media@beigene.com
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