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Hutchison China Meditech Limited
25 November 2019
Press Release
Chi-Med Announces Surufatinib Granted FDA Orphan Drug
Designation for Pancreatic Neuroendocrine Tumors
London: Monday, November 25, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that the U.S.
Food and Drug Administration ("FDA") has granted Orphan Drug
designation to surufatinib for the treatment of pancreatic
neuroendocrine tumors ("NET").
"NET is an area of significant unmet medical need. The current
treatment options are very limited," said Christian Hogg, CEO of
Chi-Med. "The FDA granting Orphan designation is a positive step
and continues to reinforce the importance of our research and
development in bringing surufatinib to more patients in need."
If approved by the FDA as an orphan treatment, surufatinib will
be entitled to seven years of market exclusivity for the approved
indication. Orphan Drug designation also affords certain
development cost benefits in the U.S.
Surufatinib is under investigation in multiple solid tumors in
China and the U.S., both as a monotherapy and in combination with
immunotherapies.
Surufatinib is the second novel oncology drug discovered by
Chi-Med to successfully complete a Phase III trial in China. A New
Drug Application ("NDA") for surufatinib for the treatment of
patients with advanced non-pancreatic NET was accepted for review
by the China National Medical Products Administration (NMPA) on
November 11, 2019.
About FDA Orphan Drug Designation
The FDA Orphan Drug Designation Program provides orphan status
to drugs and biologics which are defined as those intended for the
safe and effective treatment, diagnosis or prevention of rarer
diseases/disorders that affect fewer than 200,000 people in the
U.S., or that affect more than 200,000 persons but are not expected
to recover the costs of developing and marketing a treatment
drug.
About Surufatinib
Surufatinib (previously known as HMPL-012 or sulfatinib) 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.
Surufatinib is in several late-stage and proof-of-concept clinical
trials in China and proof-of-concept clinical trials in the
U.S.
According to Frost & Sullivan, the market for
anti-angiogenesis VEGF/VEGFR inhibitors in China has grown from
US$500 million in 2015 to over US$1.5 billion in 2019 and is
expected to reach US$5 billion by 2026.
Chi-Med currently retains all rights to surufatinib
worldwide.
Non-Pancreatic neuroendocrine tumors in China: In 2015, we
initiated the SANET-ep study, a Phase III study of surufatinib in
advanced neuroendocrine tumors - extra-pancreatic patients in China
for whom there is no effective therapy. In June 2019, a 198 patient
interim analysis was conducted, leading the independent data
monitoring committee to determine that the study met the
pre-defined primary endpoint of progression-free survival ("PFS")
and should be stopped early.
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 neuroendocrine
tumors in China. The primary endpoint is PFS. We expect an interim
analysis in the first half of 2020 and enrollment to complete in
2020 (clinicaltrials.gov identifier: NCT02589821).
Neuroendocrine tumors in the U.S. and Europe: We are planning a
U.S. registration study in neuroendocrine tumors patients based on
the encouraging data from the Phase II and Phase III studies of
surufatinib in neuroendocrine tumors in China (clinicaltrials.gov
identifier: NCT02267967), and the ongoing Phase Ib study in the
U.S. (clinicaltrials.gov identifier: NCT02549937).
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. It 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 (AIM/Nasdaq: HCM) is an innovative biopharmaceutical
company which researches, develops, manufactures and markets
pharmaceutical products. Its Innovation Platform, Hutchison
MediPharma, has about 470 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies in oncology and autoimmune diseases. It has a
portfolio of eight cancer drug candidates currently in clinical
studies around the world. Chi-Med's Commercial Platform
manufactures, markets, and distributes prescription drugs and
consumer health products, covering an extensive network of
hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the
AIM market of the London Stock Exchange and the Nasdaq Global
Select Market. 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 NDA approval and
launch of surufatinib for the treatment of patients with
non-pancreatic NET in China, 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 non-pancreatic NET
in China, its potential to gain expeditious approvals for
surufatinib in other jurisdictions such as the U.S. and EU, the
safety profile of surufatinib, the potential for surufatinib to
become a new standard of care for non-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 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
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
Media Enquiries
UK & Europe - Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China - Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
- Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China - Sam Shen, Edelman +86 136 7179 1029 (Mobile)
sam.shen@edelman.com
Nominated Advisor
Atholl Tweedie, Panmure Gordon (UK) Limited +44 (20) 7886 2500
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END
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