TIDMHCM
Hutchison China Meditech Limited
11 November 2019
Chi-Med Announces NDA Acceptance in China for Surufatinib in
Non-Pancreatic Neuroendocrine Tumors
London: Monday, November 11, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that its New
Drug Application ("NDA") for surufatinib for the treatment of
patients with advanced non-pancreatic neuroendocrine tumors ("NET")
has been accepted for review by the China National Medical Products
Administration.
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. 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.
Christian Hogg, Chief Executive Officer of Chi-Med commented,
"This NDA filing puts us on track for the potential approval and
launch of surufatinib in China, an important development for NET
patients with limited treatment options. In order to maximize
patient access to surufatinib upon regulatory approval, we are now
building our own dedicated commercial oncology organization and
expect to be ready to cover all relevant hospitals and clinics in
China at the time of launch."
"We believe surufatinib has robust efficacy, tolerability and
combinability with a dual angio-immuno kinase inhibition profile,
which may make it an attractive treatment in China," Mr. Hogg
added.
Chi-Med currently retains all worldwide rights to surufatinib.
Surufatinib is under investigation in multiple solid tumors in
China, the U.S. and Europe, both as a monotherapy and in
combination with immunotherapies.
Surufatinib is Chi-Med's second in-house discovered novel
oncology drug to reach NDA submission in China, following the
launch of fruquintinib last year for colorectal cancer under the
brand name Elunate(R) .
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 other
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 SANET-ep
SANET-ep is a randomized, double-blind, placebo-controlled,
multi-center, Phase III study comparing surufatinib orally daily
with placebo in patients with low- or intermediate-grade advanced
extra-pancreatic neuroendocrine tumors for whom there is no
effective therapy. In June 2019, a 198 patient interim analysis was
conducted, 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. 84%
of the patients in the study had disease with pathological grade 2.
41% of patients had disease originating outside of the
gastrointestinal (GI) tract and the lung or with unknown
origin.
Surufatinib reduced the risk of progression or death by 67%.
Median PFS per investigator assessment was 9.2 months for patients
treated with surufatinib, as compared to 3.8 months for patients in
the placebo group (hazard ratio [HR] 0.334; 95% confidence interval
[CI] 0.223-0.499; p<0.0001). The efficacy of surufatinib was
seen across all subgroups, and supported by statistically
significant improvement as measured by secondary efficacy endpoints
including objective response rate (ORR), disease control rate
(DCR), time to response (TTR), duration of response (DoR), safety,
and tolerability. Efficacy was also supported by Blinded
Independent Image Review Committee (BIIRC) assessment. Overall
survival (OS) data was not mature, with only 18.7% OS events at
data cut-off. The safety profile was consistent with observations
in prior clinical studies. Additional details may be found at
clinicaltrials.gov, using identifier NCT02588170.
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 receptors ("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 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.
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: 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), have led us to decide
to proceed with planning a registration study in neuroendocrine
tumors patients.
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 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 over 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 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
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 announcement,
whether as a result of new information, future events or
circumstances or otherwise.
Inside Information
This announcement contains inside information for the purpose of
Article 7 of Regulation (EU) No 596/2014.
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
[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. Current Prevalence to Incidence
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRAFFWSIFFUSEIF
(END) Dow Jones Newswires
November 11, 2019 02:00 ET (07:00 GMT)
Hutchison China Meditech (LSE:0J7G)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Hutchison China Meditech (LSE:0J7G)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024