HUTCHMED Announces Continued Inclusion of ELUNATE® (fruquintinib) and SULANDA® (surufatinib) in the National Reimbursement Drug List in China at Current Terms
13 December 2023 - 3:30PM
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13)
today announces that under the 2023 simple renewal mechanism of the
China National Healthcare Security Administration (“NHSA”), on
January 1, 2024 the updated National Reimbursement Drug List
(“NRDL”) will continue to include ELUNATE® (fruquintinib) and
SULANDA® (surufatinib) at the same terms as the current two-year
agreement.
Mr Hong Chen, Senior Vice President and Chief
Commercial Officer (China) of HUTCHMED, said: “The NRDL has made it
possible for our innovative medicines to quickly reach more
patients in need across China. In the past few years, we have seen
an array of new measures adopted by the NHSA, including the NRDL
negotiation, the bidding process for non-exclusive medicines and
simplified renewal rules for already listed medicines. Those new
measures provided a solid foundation for the sustainable
development of the innovative pharmaceutical industry and
continuous improvement of patients’ access to innovative medicines,
allowing patients to truly benefit from healthcare
innovations.”
ELUNATE® 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 555,000 new cases
each year.1
SULANDA® was first included in the NRDL on
January 1, 2022, for the treatment of non-pancreatic and pancreatic
neuroendocrine tumors (“NETs”). 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
About the NRDL
The government in China has placed great
importance on improving the affordability of drug treatments for
the public. As of 2022, 1.35 billion people in China had basic
medical insurance coverage, representing around 95% of the entire
population. The NRDL is updated every year, and inclusion on the
list is subject to renewal every two years. The NHSA annually
convenes a broad network of experts in medicine, pharmacology,
pharmacoeconomics and actuarial valuation to identify innovative
medicines to consider for NRDL inclusion. Reimbursement of Category
B medicines, including novel oncology medicines, requires varying
degrees of copayment from patients, depending on their province or
type of NHSA insurance scheme enrollment.
About Fruquintinib
Fruquintinib is a selective oral inhibitor of
vascular endothelial growth factor receptors (“VEGFR”)-1, -2 and
-3. VEGFR inhibitors play a pivotal role in inhibiting tumor
angiogenesis. Fruquintinib was designed to have enhanced
selectivity that limits off-target kinase activity, allowing for
high drug exposure, sustained target inhibition, and flexibility
for the potential use as part of combination therapy. Fruquintinib
has demonstrated a manageable safety profile and is being
investigated in combinations with other anti-cancer therapies.
Fruquintinib is marketed in China by HUTCHMED
under the brand name ELUNATE® following its approval in September
2018, in partnership with Eli Lilly and Company. Fruquintinib is
marketed in the United States by its partner Takeda under the brand
name FRUZAQLA™, following its approval in November 2023.
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase
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. It is marketed in China by HUTCHMED
under the brand name SULANDA®.
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
approximately 5,000 personnel across all its companies, at the
center of which is a team of about 1,800 in oncology/immunology.
Since inception it has focused on bringing drug candidates from
in-house discovery to patients around the world, with its first
three medicines marketed in China, the first of which is also
marketed in the U.S. For more information, please visit:
www.hutch-med.com or follow us on LinkedIn.
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 HUTCHMED’s current expectations
regarding future events, including its expectations for the
commercialization of fruquintinib and surufatinib in China, the
potential benefits and further clinical development of fruquintinib
and surufatinib, its expectations as to whether further 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 and surufatinib, the impact of the inclusion of
fruquintinib and surufatinib on the NRDL on sales of the drug and
its pricing, 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
fruquintinib and surufatinib 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
osimertinib or durvalumab as combination therapeutics, such risks
and uncertainties include assumptions regarding their safety,
efficacy, supply and continued regulatory approval and the impact
of COVID-19 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, The Stock Exchange of Hong Kong Limited
and on AIM. HUTCHMED 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.
Medical Information
This press release contains information about
products that may not be available in all countries, or may be
available under different trademarks, for different indications, in
different dosages, or in different strengths. Nothing contained
herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under
development.
CONTACTS
Investor Enquiries |
+852 2121 8200 / +1 973 306 4490 /
ir@hutch-med.com |
|
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Media Enquiries |
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Ben Atwell / Alex Shaw,
FTI Consulting |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) /
HUTCHMED@fticonsulting.com |
Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com |
|
|
Nominated Advisor |
|
Atholl Tweedie / Freddy Crossley
/ Daphne Zhang, Panmure Gordon |
+44 (20) 7886 2500 |
1 The Global Cancer Observatory. Accessed
November 23, 2023.2 According to Frost & Sullivan. Report on
file.
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