- XPOVIO® is the first and only approved XPO1
inhibitor in Malaysia.
- XPOVIO® has been approved for multiple
indications in eight markets across the APAC region. Antengene has
submitted new drug applications (NDAs) for XPOVIO® in
other ASEAN markets including Thailand and Indonesia with approvals 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, Aug. 5, 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 Malaysian National Pharmaceutical Regulatory
Agency 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 eight markets in APAC. This
successful approval for XPOVIO® in Malaysia will introduce novel therapies to the
clinical management of patients with MM in Malaysia, 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. Antengene, in efforts to
fulfill its commitment to enhancing the health and well-being of
the ASEAN population, has submitted NDAs for XPOVIO® in
Thailand and Indonesia, with approvals expected 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), T-cell non-Hodgkin's
lymphoma (T-NHL), 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 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