TIDMHCM
Hutchison China Meditech Limited
17 September 2020
Press Release
Chi-Med Announces Second NDA Acceptance in China for Surufatinib
in Pancreatic Neuroendocrine Tumors
Hong Kong, Shanghai, & Florham Park, NJ: Thursday, September
17, 2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) today announces that its New Drug Application ("NDA") for
surufatinib for the treatment of patients with advanced pancreatic
neuroendocrine tumors ("NET") has been accepted for review by the
China National Medical Products Administration ("NMPA").
The NDA is supported by data from the successful SANET-p study,
a Phase III pivotal study of s urufatinib in a dvanced n
euroendocrine t umors - p ancreatic patients in China for whom
there is no effective therapy. The study was terminated early
following positive interim analysis completed in January 2020. The
positive results of the study demonstrating improvement in
progression free survival ("PFS") will be presented at the 2020
European Society for Medical Oncology Congress (" ESMO ") (Abstract
Number 1156O ) . This is the second NDA acceptance for surufatinib.
The first NDA for non-pancreatic NET was accepted by the NMPA in
November 2019 and was granted priority review status in December
2019.
Chi-Med currently retains all worldwide rights to surufatinib.
This drug candidate is under investigation in multiple solid tumors
in China and the U.S., both as a monotherapy and in combination
with immunotherapies.
In the U.S., the Food and Drug Administration ("FDA") granted
Fast Track Designation status to surufatinib for both the
non-pancreatic NET and pancreatic NET development programs in April
2020. Chi-Med has initiated preparatory work for the U.S. NDA and
intends to utilize a rolling submission, which is expected to start
in late 2020. In addition, the Marketing Authorization Application
("MAA") submission in Europe is planned for 2021.
About NET
NETs form in cells that interact with the nervous system or in
glands that produce hormones. They can originate in various parts
of the body, most often in the gut or the lungs and can be benign
or malignant. NET are typically classified as pancreatic NET or
non-pancreatic NET. Approved targeted therapies include Sutent(R)
and Afinitor(R) for pancreatic NET, or well-differentiated,
non-functional gastrointestinal or lung NET.
According to Frost and Sullivan, there were 19,000 newly
diagnosed cases of NET in the U.S. in 2018. Importantly, NETs are
associated with a relatively long duration of survival compared to
other tumors. As a result, there were approximately 141,000
estimated patients living with NET in the U.S. in 2018.
In China, there were approximately 67,600 newly diagnosed NET
patients in 2018 and, considering the current incidence to
prevalence ratio in China, potentially as many as 300,000 patients
living with the disease in the country.
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
vascular endothelial growth factor receptor (VEGFR) and fibroblast
growth factor receptor (FGFR), which both inhibit angiogenesis, and
colony stimulating factor-1 receptor (CSF-1R), which regulates
tumor-associated macrophages, promoting the body's immune response
against tumor cells. Its unique dual mechanism of action may be
very suitable for possible combinations with other immunotherapies,
where there may be synergistic anti-tumor effects.
Chi-Med currently retains all rights to surufatinib
worldwide.
About Surufatinib Development
NET in the U.S. and Europe: In the U.S., surufatinib was granted
Fast Track Designations for development in pancreatic and
non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan
Drug Designation for pancreatic NET in November 2019. A U.S. FDA
NDA submission is being prepared, to be followed by a MAA
submission to the EMA in Europe. The basis to support these filings
includes the completed SANET-ep and SANET-p studies, along with
existing data from surufatinib in U.S. non-pancreatic and
pancreatic NET patients (clinicaltrials.gov identifier:
NCT02549937).
Non-pancreatic NET in China: In November 2019, a NDA for
surufatinib for the treatment of patients with advanced
non-pancreatic NET was accepted for review by the NMPA and granted
Priority Review status in December 2019. The NDA is supported by
data from the successful SANET-ep study, a Phase III study of
surufatinib in patients with advanced non-pancreatic NET in China
for whom there is no effective therapy. A 198-patient interim
analysis was conducted in June 2019, leading the Independent Data
Monitoring Committee ("IDMC") to determine that the study met the
pre-defined primary endpoint of progression-free survival ("PFS")
and should be stopped early. The positive results of this trial
were highlighted in an oral presentation at ESMO 2019
(clinicaltrials.gov identifier: NCT02588170).
Pancreatic NET in China: In 2016, we initiated the SANET-p
study, which is a pivotal Phase III study in patients with low- or
intermediate-grade, advanced pancreatic NET in China. Following an
interim analysis review conducted in January 2020 by the IDMC that
recommended the registrational study be terminated early as the
pre-defined primary endpoint of PFS had already been met
(clinicaltrials.gov identifier: NCT02589821), leading to a second
NDA accepted by the China NMPA. The results of this study will be
presented at ESMO 2020.
Biliary tract cancer in China: In March 2019, we initiated a
Phase IIb/III study comparing surufatinib with capecitabine in
patients with advanced biliary tract cancer whose disease
progressed on first-line chemotherapy. The primary endpoint is
overall survival (OS) (clinicaltrials.gov identifier
NCT03873532).
Immunotherapy combinations: We have entered into collaboration
agreements to evaluate the safety, tolerability and efficacy of
surufatinib in combination with anti-PD-1 monoclonal antibodies,
including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.),
Tuoyi (R) (toripalimab, developed by Shanghai Junshi Biosciences
Co., Ltd.) and Tyvyt (R) (sintilimab, developed by Innovent
Biologics, Inc.), which are approved in China.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
biopharmaceutical company committed, over the past twenty years, to
the discovery and global development of targeted therapies and
immunotherapies for the treatment of cancer and immunological
diseases. It has a portfolio of nine cancer drug candidates
currently in clinical studies around the world and extensive
commercial infrastructure in its home market of China. For more
information, please visit: www.chi-med.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect Chi-Med's current expectations regarding future
events, including its expectations regarding the therapeutic
potential of surufatinib for the treatment of patients with
pancreatic NET, the further clinical development of surufatinib in
this and other indications, its expectations as to whether clinical
studies of surufatinib would meet their primary or secondary
endpoints, and its expectations as to the timing of the completion
and the release of results from such studies. Forward-looking
statements involve risks and uncertainties. Such risks and
uncertainties include, among other things, assumptions regarding
the sufficiency of its data to support NDA approval of surufatinib
for the treatment of patients with pancreatic NET in China, its
potential to gain expeditious approvals for surufatinib in other
jurisdictions such as the U.S., E.U. or Japan, the safety profile
of surufatinib, the potential for surufatinib to become a new
standard of care for pancreatic NET patients, its ability to
implement and complete its further clinical development plans for
surufatinib, its potential commercial launch of surufatinib in
China and other jurisdictions, the timing of these events, and the
impact of the COVID-19 pandemic on general economic, regulatory and
political conditions. Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. For further
discussion of these and other risks, see Chi-Med's filings with the
U.S. Securities and Exchange Commission and on AIM. Chi-Med
undertakes no obligation to update or revise the information
contained in this press release, whether as a result of new
information, future events or circumstances or otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
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