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Hutchison China Meditech Limited
17 April 2020
Press Release
Chi-Med Announces Surufatinib Granted U.S. FDA Fast Track
Designations for the Treatment of Both Pancreatic and
Non-Pancreatic Neuroendocrine Tumors
London: Friday, April 17, 2020: Hutchison China MediTech Limited
("Chi-Med") (Nasdaq/AIM: HCM) today announces that the U.S. Food
and Drug Administration ("FDA") has granted two Fast Track
Designations for the development of surufatinib, for the treatment
of both advanced and progressive pancreatic neuroendocrine tumors
("NET") and extra-pancreatic (non-pancreatic) NET in patients who
are not amenable for surgery.
The FDA Fast Track Designation is one of several approaches
utilized by the U.S. FDA to expedite development and review of
potential medicines for serious conditions and that fulfill unmet
medical needs. A potential new medicine may fill an unmet medical
need by being the first therapy to address a specific serious
condition, offer clinically significant advantages over available
therapies, act via a different mechanism of action than available
therapies, or have a benefit in patients who are unresponsive to or
intolerant of available therapies. Programs that receive Fast Track
Designation are entitled to more frequent interactions with the
U.S. FDA on drug development plan, as well as eligibility for
accelerated approval, priority review, and rolling review.(1)
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.
Chi-Med currently retains all rights to surufatinib
worldwide.
Neuroendocrine tumors in the U.S., Europe and Japan: We are
preparing for regulatory interactions in the U.S., Europe and Japan
to confirm clinical development and path to registration, based on
the encouraging data from the two positive Phase III studies of
surufatinib in NET in China, and the ongoing multi-cohort Phase Ib
study in the U.S. (clinicaltrials.gov identifier: NCT02549937). In
addition to the aforementioned grants of Fast Track Designation in
pancreatic and non-pancreatic NET in the U.S., surufatinib was
granted Orphan Drug Designation for pancreatic NET in November
2019.
Non-pancreatic neuroendocrine tumors in China : In November
2019, an NDA for surufatinib for the treatment of patients with
advanced extra-pancreatic (non-pancreatic) neuroendocrine tumors
was accepted for review by the China 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 s urufatinib in
a dvanced n euro e ndocrine t umors - e xtra- p ancreatic patients
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 the 2019
European Society for Medical Oncology Congress (clinicaltrials.gov
identifier: NCT02588170).
Pancreatic neuroendocrine tumors 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.
A second NDA for surufatinib for the treatment of patients with
advanced pancreatic NET is being prepared for submission, following
an interim analysis review conducted in January 2020 by the IDMC
that recommended that registrational study be terminated early as
the pre-defined primary endpoint of PFS had already been met
(clinicaltrials.gov identifier: NCT02589821). Study results will be
submitted for presentation at an upcoming scientific
conference.
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: In November 2018 and September 2019,
we entered into collaboration agreements to evaluate the safety,
tolerability and efficacy of surufatinib in combination with
anti-programmed cell death protein 1 (PD-1) monoclonal antibodies.
This included global collaborations to evaluate the combination of
surufatinib with Tuoyi (R) , approved in China by Shanghai Junshi
Biosciences Co. Ltd, and with Tyvyt(R) , approved in China by
Innovent Biologics, Inc.
About Neuroendocrine Tumors (NET)
Neuroendocrine tumors 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. Neuroendocrine tumors are
typically classified as pancreatic neuroendocrine tumors or
non-pancreatic neuroendocrine tumors. Approved targeted therapies
include Sutent(R) and Afinitor(R) for pancreatic neuroendocrine
tumors, or well-differentiated, non-functional gastrointestinal or
lung neuroendocrine tumors.
According to Frost and Sullivan, there were 19,000 newly
diagnosed cases of neuroendocrine tumors in the U.S. in 2018.
Importantly, neuroendocrine tumors 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
neuroendocrine tumors in the U.S. in 2018 of which over 90%, or
approximately 132,000, were non-pancreatic neuroendocrine tumor
patients.
In China, there were approximately 67,600 newly diagnosed
neuroendocrine tumor 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(2) . I t is
estimated that approximately 80% of the patients living with
neuroendocrine tumors in China are non-pancreatic neuroendocrine
tumor patients.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative 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 eight 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 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 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 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 and the timing of
these events. 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
(1) Source: Food and Drug Administration, "Expedited Programs
for Serious Conditions - Drugs and Biologics":
https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf
(2) According to Frost & Sullivan, in 2018, there were
19,000 newly diagnosed cases of NETs in the U.S and an estimated
141,000 patients living with NETs. The current incidence to
prevalence ratio in China is estimated at 4.4, lower than the 7.4
ratio in the U.S. due to lower access to treatment options.
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END
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