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Hutchison China Meditech Limited
20 December 2019
Press Release
Chi-Med's New Drug Application for Surufatinib in Non-Pancreatic
Neuroendocrine Tumors Granted Priority Review in China
London: Friday, December 20, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that the
Center for Drug Evaluation (CDE) of China's National Medical
Products Administration ("NMPA") has granted Priority Review status
to the New Drug Application ("NDA") for surufatinib for the
treatment of patients with advanced non-pancreatic neuroendocrine
tumors ("NET").
"Surufatinib is our second drug to be granted priority review by
the NMPA," says Christian Hogg, Chief Executive Officer of Chi-Med.
"We are working closely with the NMPA as they review our NDA for
the treatment of non-pancreatic NET. Surufatinib being granted
priority review is a positive step forward in potentially bringing
this innovative drug to patients, who currently have very limited
treatment options."
In November 2019, the NDA for surufatinib for the treatment of
non-pancreatic NET was accepted for review by the NMPA, and the
U.S. Food and Drug Administration granted Orphan Drug designation
to surufatinib for the treatment of pancreatic NET.
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. In November 2019, the NDA was accepted
for review by the NMPA.
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 490 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 non-pancreatic NET, pancreatic NET 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 under priority review in
China and 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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