TIDMHCM
Hutchison China Meditech Limited
10 August 2020
Press Release
Chi-Med Plans to Submit Marketing Authorization Application for
Surufatinib Following Scientific Advice from EMA's CHMP
Hong Kong, Shanghai, & Florham Park, NJ: Monday, August 10,
2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) today announces that it received scientific advice from the
European Medicines Agency's ("EMA") Committee for Medicinal
Products for Human Use ("CHMP") for surufatinib for the treatment
of patients with advanced neuroendocrine tumors ("NET"). Based on
the CHMP advice, we have concluded that the completed SANET-ep
(non-pancreatic NET) and SANET-p (pancreatic NET) studies, along
with existing data from surufatinib in U.S. non-pancreatic and
pancreatic NET patients, could form the basis to support a
marketing authorization application ("MAA"). Given that no filing
issues were identified, the MAA submission is planned for 2021,
following submission for the U.S. Food and Drug Administration
("FDA") new drug application ("NDA").
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,
where there may be synergistic anti-tumor effects.
Chi-Med currently retains all rights to surufatinib
worldwide.
About Surufatinib Development
NET in the U.S., Europe and Japan: In the U.S., surufatinib was
granted Fast Track Designations for development in pancreatic and
non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan
Drug Designation for pancreatic NET in November 2019. A U.S. FDA
NDA submission is being prepared, to be followed by a MAA
submission to the EMA in Europe. All such interactions are based on
the robust 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. that began in November 2015 (clinicaltrials.gov
identifier: NCT02549937).
Non-pancreatic NET in China: In November 2019, a 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") 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 surufatinib in
patients with advanced non-pancreatic NET 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 ("ESMO") (clinicaltrials.gov identifier:
NCT02588170).
Pancreatic NET 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. Following an
interim analysis review conducted in January 2020 by the IDMC that
recommended the registrational study be terminated early as the
pre-defined primary endpoint of PFS had already been met
(clinicaltrials.gov identifier: NCT02589821), we submitted our
second NDA to the China NMPA and are now waiting for formal
acceptance. The results of this study will be presented at ESMO
2020.
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: We have entered into collaboration
agreements to evaluate the safety, tolerability and efficacy of
surufatinib in combination with anti-PD-1 monoclonal antibodies,
including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.),
Tuoyi (R) (toripalimab, developed by Shanghai Junshi Biosciences
Co. Ltd.) and Tyvyt (R) (sintilimab, developed by Innovent
Biologics, Inc.), which are approved in China.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
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 nine 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 submission of an
EU MAA and U.S. NDA for surufatinib for the treatment of NET with
the EMA and FDArespectively, the timing of such submissions, the
therapeutic potential of surufatinib for the treatment of patients
with NET, the further clinical development of surufatinib in this
and other indications, 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 the E.U.,
U.S. and China or other jurisdictions such as the E.U. or Japan,
its potential to gain expeditious approvals from regulatory
authorities, the safety profile of surufatinib, its ability to
fund, implement and complete its further clinical development and
commercialization plans for surufatinib, the timing of these
events, and the impact of the COVID-19 pandemic on general
economic, regulatory and political conditions. In addition, as
certain studies rely on the use of capecitabine, tislelizumab,
Tuoyi(R) , and Tyvyt(R) as combination therapeutics with
surufatinib, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and continued regulatory
approval of these therapeutics. 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
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
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