ROCKVILLE, Md. and
SUZHOU, China, July 7, 2024
/PRNewswire/ -- Ascentage Pharma (6855.HK), a global
biopharmaceutical company engaged in discovering, developing and
commercializing both first- and best-in-class therapies for
hematological malignancies, announced today that its novel BCR-ABL1 tyrosine
kinase inhibitor (TKI), olverembatinib, has been approved by the
Pharmaceutical Administration Bureau (ISAF) of the Macau
Special Administrative Region (SAR) of the People's Republic of China for the
treatment of adult patients with tyrosine kinase inhibitors
(TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or
accelerated-phase CML (CML-AP) harboring the T315I mutation;
and adult patients with CML-CP resistant to and/or intolerant of
first-and second-generation TKIs. This approval marks another major
milestone for olverembatinib following initial approvals granted to
the drug in the Chinese mainland for the above indications.
Olverembatinib, a novel drug developed by Ascentage Pharma with
support from the National Major New Drug Development program, is
the first third-generation BCR-ABL1 inhibitor approved by
China's National Medical Products
Administration (NMPA). As a potential global best-in-class drug
that can effectively target BCR-ABL1 and a spectrum of BCR-ABL1
mutants, including the T315I mutation, clinical trial
results of olverembatinib have already been included in the
National Comprehensive Cancer Network (NCCN) guidelines for the
management of CML.[1] Olverembatinib is being jointly
commercialized in China by
Ascentage Pharma and Innovent Biologics. All lead drug candidates
are being studied as they are an investigational drug and not
approved in the US.
"Olverembatinib has the potential to be a global best-in-class
drug. We are glad that the drug is set to benefit patients with CML
in Macau, China, with the approval marking another major
milestone in the clinical development of olverembatinib," said
Dr. Dajun Yang, Chairman and CEO of
Ascentage Pharma. "Since its inception, Ascentage Pharma has
steadfastly committed to its mission of addressing unmet clinical
needs in China and around the
world. We are confident that over time, olverembatinib and our
other investigational drugs will bring greater benefits to more
patients globally."
Reference:
1. Shah N, Bhatia R, Altman JK et
al. NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) Chronic Myeloid Leukemia Version
2.2024 (December 5, 2023).
Available from:
https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf.
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a fully integrated global
biopharmaceutical company engaged in discovering, developing and
commercializing both first-in-class and best-in-class therapies to
address global unmet medical needs primarily in hematological
malignancies. On October 28, 2019,
Ascentage Pharma was listed on the Main Board of the Stock Exchange
of Hong Kong Limited with the stock code 6855.HK.
The company has built a pipeline of 9 clinical-stage drug
candidates, including novel, highly potent Bcl-2 and dual
Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and
MDM2-p53 pathways, and next-generation TKIs. Ascentage Pharma is
also the only company in the world with active clinical programs
targeting all three known classes of key apoptosis regulators. The
company is conducting more than 40 clinical trials, including 6
global registrational Phase III studies, in the US, Australia, Europe, and China.
Olverembatinib, the company's first lead asset developed for the
treatment of drug-resistant chronic myeloid leukemia (CML) and the
company's first approved product in China, has been granted Priority Review
Designations and Breakthrough Therapy Designations by the Center
for Drug Evaluation (CDE) of China National Medical Products
Administration (NMPA). To date, the drug had been included into the
China National Reimbursement Drug List (NRDL). Furthermore,
olverembatinib has been granted Orphan Drug Designations (ODDs) and
a Fast Track Designation (FTD) by the US FDA, and an Orphan
Designation by the EMA of the EU.
To date, Ascentage Pharma has obtained a total of 16 ODDs from
the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of
the company's investigational drug candidates. Leveraging its
robust R&D capabilities, Ascentage Pharma has built a portfolio
of global intellectual property rights and entered into global
partnerships with numerous leveraging its robust R&D
capabilities, Ascentage Pharma has built a portfolio of global
intellectual property rights and entered into global partnerships
with numerous leading biotechnology and pharmaceutical companies
such as Takeda, AstraZeneca, Merck, Pfizer and Innovent ; and
research and development relationships with leading research
institutions such as Dana-Farber Cancer Institute, Mayo Clinic, MD
Anderson Cancer Center, National Cancer Institute and the
University of Michigan.
The company has built a talented team with global experience in
the discovery and development of innovative drugs and is setting up
its world-class commercial manufacturing and Sales & Marketing
teams. One pivotal aim of Ascentage Pharma is to continuously
strengthen its R&D capabilities and accelerate its clinical
development programs, in order to fulfil its mission of addressing
unmet clinical needs in China and
around the world for the benefit of more patients.
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, Ascentage
Pharma undertakes 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 and expectations or those of any of
our Directors or our Company are made as of the date of this
article. Any of these intentions and expectations may alter in
light of future development.
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SOURCE Ascentage Pharma