- XPOVIO® is the first and only approved XPO1
inhibitor in Thailand.
- XPOVIO® has been approved for multiple
indications in nine markets across the APAC region. Antengene has
submitted a new drug application (NDA) for XPOVIO® in
Indonesia with approval expected
in the second half of 2024.
- XPOVIO® has been approved for health insurance
coverage in the mainland of China,
Australia, Singapore and South
Korea.
SHANGHAI and HONG
KONG, Sept. 23, 2024 /PRNewswire/ --
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK),
a leading innovative, commercial-stage global biopharmaceutical
company dedicated to discovering, developing and commercializing
first-in-class and/or best-in-class medicines for cancer, today
announced that the Thailand Food and Drug Administration
has approved a New Drug Application (NDA) for XPOVIO® (selinexor) for two
indications: (1) In combination with bortezomib and
dexamethasone for the treatment of adult patients with multiple
myeloma(MM) who have received at least one prior therapy;
and (2) in combination with dexamethasone for the
treatment of adult patients with MM who have received at least four
prior therapies and whose disease is refractory to at least two
proteasome inhibitors, two immunomodulatory agents and an anti-CD38
monoclonal antibody, and who have demonstrated disease progression
on the last therapy.
With a novel mechanism of action, XPOVIO® is the world's first approved
orally-available, selective XPO1 inhibitor, which has already been
approved in nine markets in APAC. This successful approval for
XPOVIO® in Thailand will introduce novel therapies to the
clinical management of patients with MM in Thailand, benefiting many patients and their
families in the country. To date, XPOVIO® has also been included in national
health insurance or reimbursement schemes in the mainland of
China, Australia, Singapore and South
Korea.
The ASEAN region, with its steady economic growth and a
population exceeding 600 million, has become a significant
potential market for global biomedical development. The
accelerating aging population in ASEAN has increased the overall
disease burden on patients and local communities, leading to a
growing demand for novel therapeutics. Fulfilling its commitment to
enhancing the health and well-being of the ASEAN population,
Antengene has successfully obtained NDA approvals for
XPOVIO® in
Malaysia in August and very
recently in Thailand, and expects
XPOVIO® to be approved
in Indonesia in the second half of
2024. Looking ahead, the company aims to introduce more innovative
medicines to the ASEAN market, bringing improved healthcare to more
patients in the region.
While bringing XPOVIO® to more APAC markets, Antengene
is also striving to expand the indications of XPOVIO®. Leveraging the drug's novel
mechanism of action, Antengene is currently developing multiple
combination regimens of XPOVIO® for the treatment of various
indications including myelofibrosis (MF), and endometrial
cancer.
About XPOVIO® (selinexor)
XPOVIO® is the
world's first approved orally-available, selective inhibitor of the
nuclear export protein XPO1. It offers a novel mechanism of
action, synergistic effects in combination regimens, fast onset of
action, and durable responses.
By blocking the nuclear export protein XPO1,
XPOVIO® can promote
the intranuclear accumulation and activation of tumor suppressor
proteins and growth regulating proteins, and down-regulate the
levels of multiple oncogenic proteins. XPOVIO® delivers its
antitumor effects through three mechanistic pathways: 1) exerting
antitumor effects by inducing the intranuclear accumulation of
tumor suppressor proteins; 2) reducing the level of oncogenic
proteins in the cytoplasm by inducing the intranuclear accumulation
of oncogenic mRNAs; 3) restoring hormone sensitivity by activating
the glucocorticoid receptors (GR) pathway. To utilize its unique
mechanism of actions, XPOVIO® is being evaluated for use in
multiple combination regimens in a range of indications. At
present, Antengene is conducting multiple clinical studies of
XPOVIO® in the
mainland of China for the
treatment of relapsed/refractory hematologic malignancies and solid
tumors (3 of these studies are being jointly conducted by Antengene
and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]).
About Antengene
Antengene Corporation Limited ("Antengene", SEHK:
6996.HK) is a leading commercial-stage R&D-driven global
biopharmaceutical company focused on the discovery, development,
manufacturing and commercialization of innovative
first-in-class/best-in-class therapeutics for the treatment of
hematologic malignancies and solid tumors, in realizing its vision
of "Treating Patients Beyond Borders".
Since 2017, Antengene has built a pipeline of 9 oncology assets
at various stages going from clinical to commercial, including 6
with global rights, and 3 with rights for the APAC region. To date,
Antengene has obtained 29 investigational new drug (IND) approvals
in the U.S. and Asia, and
submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for
XPOVIO® (selinexor)
already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, and Australia.
Forward-looking statements
The forward-looking statements made in this article relate only
to the events or information as of the date on which the statements
are made in this article. Except as required by law, we undertake
no obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise, after the date on which the statements are made or to
reflect the occurrence of unanticipated events. You should read
this article completely and with the understanding that our actual
future results or performance may be materially different from what
we expect. In this article, statements of, or references to, our
intentions or those of any of our Directors or our Company are made
as of the date of this article. Any of these intentions may alter
in light of future development. For a further discussion of these
and other factors that could cause future results to differ
materially from any forward-looking statement, please see the other
risks and uncertainties described in the Company's Annual Report
for the year ended December 31, 2023,
and the documents subsequently submitted to the Hong Kong Stock
Exchange.
For more information, please contact:
Investor Contacts:
Donald Lung
E-mail: Donald.Lung@antengene.com
Mobile: +86 18420672158
PR Contacts:
Peter Qian
E-mail: Peter.Qian@antengene.com
Mobile: +86 13062747000
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SOURCE Antengene Corporation Limited