TIDMHCM
Hutchmed (China) Limited
13 December 2023
Press Release
HUTCHMED Announces Continued Inclusion of ELUNATE(R)
(fruquintinib) and SULANDA(R) (surufatinib) in the National
Reimbursement Drug List in China at Current Terms
Hong Kong, Shanghai & Florham Park, NJ - Wednesday, December
13, 2023: 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(R)
(fruquintinib) and SULANDA(R) (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(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 555,000 new cases each year. [1]
SULANDA(R) 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. Reimburse-ment 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(R) 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(TM), 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(R) .
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
Media Enquiries
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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END
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