RCS - Hutchmed China Ltd - Inclusion in National Reimbursement Drug List

HUTCHMED (China)Announcement

13/12/2023 07:15

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RNS Number : 6193W  Hutchmed (China) Limited  13 December 2023

Press Release

 

HUTCHMED Announces Continued Inclusion of ELUNATE(®) (fruquintinib) and SULANDA(®) (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 (https://www.hutch-med.com/) ")
(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  (#_edn1)

 

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  (#_edn2)

 

 

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(®)
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
(http://www.hutch-med.com) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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
                                                                   (mailto: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
                                                                   (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi, Brunswick                                                +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                   (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon   +44 (20) 7886 2500

 

 

 1  The Global Cancer Observatory (https://gco.iarc.fr/) . Accessed November
23, 2023.

 2  (#_ednref2) According to Frost & Sullivan. Report on file.

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