TIDMHCM
RNS Number : 4993U
Hutchmed (China) Limited
03 December 2021
HUTCHMED Announces Agreement with NHSA for Continued Inclusion
of ELUNATE(R) and Addition of SULANDA(R) in the National
Reimbursement Drug List in China
Hong Kong, Shanghai & Florham Park, NJ - Fri day, December 3
, 2021: HUTCHMED (China) Limited (" HUTCHMED ") (Nasdaq/AIM: HCM;
HKEX:13) today announces that, following the 2021 negotiations with
the China National Healthcare Security Administration ("NHSA"), on
January 1, 2022 the updated National Reimbursement Drug List
("NRDL") will continue to include ELUNATE(R) (fruquintinib) and
will now include SULANDA(R) (surufatinib).
Christian Hogg, Chief Executive Officer of HUTCHMED, said, "We
welcome the addition of SULANDA(R) into the NRDL, along with the
renewal of ELUNATE(R) . The NRDL has made it possible for novel
therapies to gain wide reach across the country for diseases with
large patient populations."
ELUNATE(R) was first included in the NRDL on January 1, 2020,
for the treatment of metastatic colorectal cancer ("CRC") . CRC was
the third most diagnosed form of cancer by incidence in China in
2020, with an estimated 450,000 to 550,000 new cases each
year.[1]
SULANDA(R) was approved in China for the treatment of advanced
non-pancreatic neuroendocrine tumors ("NETs") in December 2020 and
for advanced pancreatic NETs in June 2021. In China, there were an
estimated 71,300 newly diagnosed NET patients in 2020, with
potentially up to 300,000 patients living with the disease.[2]
HUTCHMED's third oncology drug, ORPATHYS (R) (savolitinib), is
the first and only approved MET inhibitor in China for the
treatment of patients with non-small cell lung cancer ("NSCLC")
with MET exon 14 skipping alterations. It was also included in the
2021 negotiations with the NHSA, however HUTCHMED and AstraZeneca,
its partner on ORPATHYS (R) , declined inclusion in the NRDL for
2022. This position will be reassessed next year ahead of the next
NRDL update. In China, there was an estimated 13,000 newly
diagnosed NSCLC patients with MET exon 14 skipping alterations each
year.(1)
About the NRDL
In recent years, the government in China has placed great
importance on improving the public affordability of drug use. The
NHSA regularly convenes a broad network of experts in medicine,
pharmacology and pharmaco-economics to identify innovative drugs to
be considered for inclusion in the NRDL. This has led to expansion
of reimbursement of Category B drugs, which increasingly include
novel oncology drugs. Reimburse-ment of Category B drugs requires
varying degrees of copayment from patients, depending on their
province of residence or type of NHSA insurance scheme enrollment.
Agreements for all included drugs are generally renewed every two
years.
In this latest update of the NRDL, the NHSA is adding or
renewing over 30 Category B oncology drugs, including ELUNATE(R)
and SULANDA(R) . Effective January 1, 2022, included NRDL drugs are
expected to be made available in all state-run hospital pharmacies
in China and reimbursement will commence for patients included in
NHSA insurance schemes.
About fruquintinib (ELUNATE(R) in China)
Fruquintinib is a highly selective and potent oral inhibitor of
vascular endothelial growth factor receptors ("VEGFRs") -1, -2 and
-3. VEGFR inhibitors play a pivotal role in blocking tumor
angiogenesis. Fruquintinib was designed to improve kinase
selectivity to minimize off-target toxicities, improve tolerability
and provide more consistent target coverage. The generally good
tolerability in patients to date, along with fruquintinib's low
potential for drug-drug interaction based on preclinical
assessment, suggests that it may also be highly suitable for
combinations with other anti-cancer therapies.
Fruquintinib is marketed in China under the brand name ELUNATE
(R) for the treatment of metastatic CRC. It is currently under
clinical development for the treatment of gastric cancer and
metastatic breast cancer, and in combination with PD-1 monoclonal
antibodies, including with tislelizumab (BGB-A317, developed by
BeiGene, Ltd.) and sintilimab (TYVYT(R) in China, IBI308, developed
by Innovent Biologics, Inc.). The U.S. Food and Drug Administration
("FDA") granted Fast Track Designation for the development of
fruquintinib for treating metastatic CRC in June 2020 . A Phase III
registration study of fruquintinib in metastatic CRC, FRESCO-2, is
currently underway in the U.S., Europe, Japan and Australia.
HUTCHMED retains all rights to fruquintinib outside of China. In
China, HUTCHMED is partnered with Eli Lilly and Company. Since
October 2021, HUTCHMED has been responsible for development and
execution of all on-the-ground medical detailing, promotion and
local and regional marketing.
About surufatinib (SULANDA(R) in China)
Surufatinib is a novel, oral inhibitor that selectively inhibits
the tyrosine kinase activity associated with 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.
Surufatinib is marketed in China under the brand name SULANDA(R)
for the treatment of patients with advanced NETs. It is currently
under clinical development in combination with anti-PD-1 monoclonal
antibodies, including with tislelizumab and toripalimab (TUOYI(R) ,
developed by Shanghai Junshi Biosciences Co., Ltd.). A U.S. FDA New
Drug Application (NDA) submission was accepted in June 2021,
followed by a Marketing Authorisation Application (MAA) submission
to the European Medicines Agency (EMA) validated in July 2021. In
the U.S., surufatinib was granted Fast Track Designations for
development in pancreatic and non-pancreatic NETs in April 2020,
and Orphan Drug Designation for pancreatic NETs in November
2019.
HUTCHMED currently retains all rights to surufatinib
worldwide.
About savolitinib (ORPATHYS(R) in China)
Savolitinib is an oral, potent, and highly selective MET
inhibitor that has demonstrated clinical activity in advanced solid
tumors. It blocks atypical activation of the MET receptor tyrosine
kinase pathway that occurs because of mutations (such as exon 14
skipping alterations or other point mutations) or gene
amplification.
Savolitinib is marketed in China under the brand name
ORPATHYS(R) for the treatment of patients with NSCLC with MET exon
14 skipping alterations who have progressed following prior
systemic therapy or are unable to receive chemotherapy. It is
currently under clinical development for multiple tumor types,
including lung, kidney, and gastric cancers, as a single treatment
and in combination with other medicines.
In 2011, following its discovery and initial development by
HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing
agreement to jointly develop and commercialize savolitinib. Joint
development in China is led by HUTCHMED, while AstraZeneca leads
development outside of China. HUTCHMED is responsible for the
marketing authorization, manufacturing and supply of savolitinib in
China. AstraZeneca is responsible for the commercialization of
savolitinib in China and worldwide. Sales of savolitinib are
recognized by AstraZeneca.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery and global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. It has more than 4,500 personnel across all
its companies, at the center of which is a team of over 1,400 in
oncology/immunology. Since inception it has advanced eleven cancer
drug candidates from in-house discovery into clinical studies
around the world, with its first three oncology drugs now approved
and marketed in China. For more information, please visit:
www.hutch-med.com or follow us on LinkedIn .
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 HUTCHMED's current expectations regarding future
events, including its expectations for the commercialization of
fruquintinib, surufatinib and savolitinib in China, their potential
benefits, their further clinical development, plans to initiate
further clinical studies, its expectations as to whether such
studies 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 commercial acceptance of
fruquintinib, surufatinib and savolitinib, the ability of NRDL
inclusion of fruquintinib and surufatinib to broaden their
availability and patient access, clinical trial enrollment rates,
timing and availability of subjects meeting a study's inclusion and
exclusion criteria, changes to clinical protocols or regulatory
requirements, unexpected adverse events or safety issues, the
ability of drug candidates fruquintinib, surufatinib and
savolitinib, including as combination therapies, to meet the
primary or secondary endpoints of a study, to obtain regulatory
approval for a targeted indication in different jurisdictions and
the sufficiency of funding. In addition, as certain studies rely on
the use of tislelizumab, paclitaxel, sintilimab or toripalimab as
combination therapeutics, such risks and uncertainties include
assumptions regarding their safety, efficacy, supply and continued
regulatory approval and the impact of the COVID-19 pandemic on
general economic, regulatory and political conditions. 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 HUTCHMED's filings with
the U.S. Securities and Exchange Commission, on AIM and with The
Stock Exchange of Hong Kong Limited. HUTCHMED 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 (as it forms part of
retained EU law as defined in the European Union (Withdrawal) Act
2018).
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] According to Frost & Sullivan. Report on file.
[2] According to Frost & Sullivan. 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. Report
on file.
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END
MSCUOONRAOUURRA
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