EQS-News / 29/04/2021 / 11:36 UTC+8
Antengene Announces XPO1 Inhibitor Selinexor Prescribed for the First Time in the Pilot Zone of Hainan Province and
Authorized to be Expanded Beyond the Pilot Zone for Outpatient Treatment
With the official release and implementation of the Overall Plan for the Construction of Hainan Free Trade Port,
patient can now access global innovative medicines in mainland China. Recently, the global first-in-class selective
inhibitor of nuclear export (SINE) compound, selinexor (XPOVIO(R)), was prescribed for the first time in mainland China
at the Boao Super Hospital in Boao Lecheng Pilot Zone and has been authorized to be expanded beyond the Pilot Zone for
the outpatient treatment of relapsed or refractory multiple myeloma (rrMM). Prescribing selinexor for the first time in
China is a significant milestone in changing the hematological cancer treatment landscape in the country as it allows
Chinese patients access to this novel antitumor therapy, similar to patients in other parts of the world.
Numerous media outlets including People's Daily, The Paper, and Hainan News of Hainan TV have reported on the first
prescription and the Name Patient Program (NPP) inclusion of selinexor, in recognition of the clinical significance of
having this novel therapy accessible to patients in China. Among these media outlets, People.cn stated: "the first
patient with rrMM treated with selinexor in the Pilot Zone responded well to the therapy with his condition already
stabilized. Selinexor achieves its antitumor effects by precision targeting the underlying oncogenic pathways, and has
a special mechanism of action compared to other approved therapies. Through the rapid clinical adoption of selinexor in
Lecheng, Boao, a much-needed new treatment option has been made available to patients with MM in China."
Previously, Antengene initiated a Named Patient Program (NPP) in Hong Kong for dozens of patients with rrMM and
relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). After being prescribed at the Boao Super Hospital for
the first time, the use of selinexor in such patients will now be a part of real-world research in China.
The First Prescription of selinexor
Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma (DLBCL) are two of the common types of hematological
malignancies in the world. MM is a kind of plasma cell hematologic cancer. In recent years, with the availability of
autologous stem cell transplantations and introductions of newer therapies such as lenalidomide, the conventional
treatment of MM continues to evolve. Although significant progress has been made in treatment, MM is still incurable,
mainly due to primary drug resistance and disease recurrence. In China, patients with MM face a range of challenges
including late or missed diagnosis, as well as lack of effective treatment options for relapsed patients to improve
overall survival. DLBCL is an aggressive hematologic malignancy that accounts for around 50%-60% of all lymphoma
incidences. About half of patients with DLBCL fail to reach complete remission after receiving first-line treatments,
and approximately 60% of patients with rrDLBCL lack effective treatment options.
As a first-in-class SINE compound XPO1 inhibitor, selinexor has been approved by U.S. food and drug administration
(FDA) for the treatment of rrMM and rrDLBCL, and was included into five recommended regimens by the National
Comprehensive Cancer Network (NCCN(R)) Guidelines for the treatment of hematological malignancies. Being an oral drug
requiring low dosing frequency, selinexor has the advantages of ease of use and high patient compliance. Enabled by the
Interim Provisions on the Administration of Imported Drugs of Urgent Need in Boao Lecheng International Medical Tourism
Pilot Zone of Hainan Province, selinexor has successfully entered into clinical application in mainland China, and
became the world's first XPO1 inhibitor accessible to patients both inside and outside the country, while being
authorized to be used beyond the Pilot Zone for outpatient treatment. As the company that initiated this introduction
of selinexor through a collaboration with the Boao Super Hospital and Hainan Chengmei Medicine Co., Ltd., Antengene has
provided patients in mainland China a reliable and convenient program to access an urgently needed therapy.
Hongxia Yao, Director of Hematological Lymphoma Department of Hainan Cancer Hospital, said: "This prescription marks
the first clinical application of selinexor at the Boao Super Hospital. It is a testament to a clinical breakthrough
made possible by the supporting policies of the Boao Lecheng International Medical Tourism Pilot Zone, and benefit it
brings to patients. This patient with rrMM has received multiple lines of therapy, and unfortunately failed all of the
approved therapies in mainland China. The special policy in Hainan has brought renewed hope to this patient, giving him
the early access to a novel therapy that has already been approved abroad and the possibility of bringing the drug's
use beyond the Pilot Zone for outpatient treatment."
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical
company focused on innovative medicines for oncology and other life-threatening diseases. Antengene aims to provide the
most advanced anti-cancer medicines to patients in the Asia Pacific Region and around the world. Since its
establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets
through partnerships as well as in-house drug discovery, and obtained 13 investigational new drug (IND) approvals and
submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients
Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering,
developing and commercializing first-in-class/best-in-class therapeutics.
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.
*XPOVIO(R)is a registered trade mark of KaryopharmTherapeutics Inc.;
*NCCN(R) is a registered trademark of National Comprehensive Cancer Network.
File: Antengene Announces XPO1 Inhibitor Selinexor Prescribed for the First Time in the Pilot Zone of Hainan Province
and Authorized to be Expanded Beyond the Pilot Zone for Outpatient Treatment
29/04/2021 Dissemination of a Financial Press Release, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
Media archive at www.todayir.com
Image link:
https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=show_t_gif&application_id=1190267&application_name=news(END) Dow Jones Newswires
April 28, 2021 23:37 ET (03:37 GMT)
