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RNS Number : 3226A
Hutchison China Meditech Limited
20 January 2020
Chi-Med Announces that Surufatinib Phase III SANET-p Study Has
Already Achieved its Primary Endpoint in Advanced Pancreatic
Neuroendocrine Tumors in China and Will Stop Early
London: Monday, January 20, 2020: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that the
independent Data Monitoring Committee ("IDMC") of the Phase III
pivotal study of surufatinib in advanced neuroendocrine tumors -
pancreatic ("SANET-p") has completed a pre-planned interim
analysis. The IDMC recommended that the study stops early as the
pre-defined primary endpoint of progression free survival ("PFS")
had already been met.
Following the early success of this study, Chi-Med now plans to
arrange a pre-New Drug Application ("NDA") meeting with the China
National Medical Products Administration ("NMPA") to discuss the
preparation of the NDA for surufatinib for this indication. Chi-Med
intends to submit the results of the SANET-p study for presentation
at an upcoming scientific conference.
Christian Hogg, Chief Executive Officer of Chi-Med, said, "This
positive data is a further important milestone for Chi-Med.
Following surufatinib's NDA submission for the treatment of
non-pancreatic neuroendocrine tumors, these positive results for
pancreatic neuroendocrine tumors reinforce that surufatinib has the
unique opportunity to address all advanced neuroendocrine tumors.
We believe that no targeted therapies are approved in China or
globally for such a broad spectrum of neuroendocrine tumor
disease."
In November 2019, the U.S. Food and Drug Administration ("FDA")
granted Orphan Drug designation to surufatinib for the treatment of
pancreatic neuroendocrine tumors. The China NDA for surufatinib for
the treatment of advanced non-pancreatic neuroendocrine tumors was
accepted for review by the NMPA, and was subsequently granted
Priority Review status in December. Currently Chi-Med is building
an oncology-focused sales and marketing team to launch surufatinib
if approved in China.
About SANET-p
SANET-p is a Phase III study in China of surufatinib in patients
with low-grade or intermediate-grade advanced pancreatic
neuroendocrine tumor patients for whom there is no effective
therapy. In this study, patients are randomized at a 2:1 ratio to
receive either 300 mg of surufatinib orally daily or placebo, on a
28-day treatment cycle. The primary endpoint of the study is to
evaluate the PFS, with secondary endpoints including objective
response rate (ORR), disease control rate (DCR), time to response
(TTR), duration of response (DoR), overall survival (OS), safety,
and tolerability. Additional details may be found at
clinicaltrials.gov, using identifier NCT02589821.
About Neuroendocrine Tumors
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([1]) . It
is estimated that approximately 80% of the patients living with
neuroendocrine tumors in China are non-pancreatic neuroendocrine
tumor patients.
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 November 2019,
an NDA for surufatinib for the treatment of patients with advanced
non-pancreatic neuroendocrine tumors was accepted for review by the
China NMPA. The NDA is supported by data from the successful
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. A 198-patient interim analysis was
conducted in June 2019, leading the IDMC to determine that the
study met the pre-defined primary endpoint of 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 on September 29, 2019. (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 neuroendocrine
tumors in China. The primary endpoint is PFS (clinicaltrials.gov
identifier: NCT02589821).
Pancreatic neuroendocrine tumors in the U.S. and Europe: We are
planning a U.S. registration study in neuroendocrine tumor 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).
This program was granted Orphan Drug designation by the U.S.
FDA.
Biliary tract cancer in China: In March 2019, we initiated a
Phase IIb/III study comparing surufatinib (HMPL-012 or sulfatinib)
with capecitabine in patients with advanced biliary tract cancer
whose disease progressed on first-line chemotherapy. The primary
endpoint is 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 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 500 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies for the treatment of cancer 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 announcement 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 pancreatic
or non-pancreatic NET in China, the further clinical development of
surufatinib in these 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 or
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 pancreatic or
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 announcement, whether
as a result of new information, future events or circumstances or
otherwise.
Inside Information
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014.
[1] 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.
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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