RCS - Hutchmed China Ltd - Continued Inclusion of ORPATHYS in China NRDL

HUTCHMED (China)Announcement

28/11/2024 10:45

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RNS Number : 0452O  Hutchmed (China) Limited  28 November 2024

Press Release

 

HUTCHMED Announces Continued Inclusion of ORPATHYS(®) (savolitinib) in the National Reimbursement Drug List in China at Current Terms

 

Hong Kong, Shanghai & Florham Park, NJ - Thursday, November 28, 2024:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that following the contract renewal
with the China National Healthcare Security Administration ("NHSA"), the
updated National Reimbursement Drug List ("NRDL") effective on January 1, 2025
will continue to include ORPATHYS(®) (savolitinib) at the same terms as the
current two-year agreement.

 

ORPATHYS(®) is an oral, potent, and highly selective MET tyrosine kinase
inhibitor ("TKI"). It received conditional approval in China in June 2021 for
the treatment of certain patients with non-small cell lung cancer ("NSCLC")
with MET exon 14 skipping alterations. More than a third of the world's lung
cancer patients are in China and, among those with NSCLC globally,
approximately 2-3% have tumors with MET exon 14 skipping alterations.

 

ORPATHYS(®) was first included in the NRDL on March 1, 2023. The government
in China has placed great importance on improving the affordability of drug
treatments for the public. As of end of 2023, 1.33 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
provinces or types of NHSA insurance scheme enrollment.

 

About ORPATHYS(®)

ORPATHYS(®) (savolitinib) is an oral, potent, and highly selective MET TKI
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), gene amplification or protein overexpression.

 

ORPATHYS(®) is jointly developed by HUTCHMED and AstraZeneca and
commercialized by AstraZeneca. It is approved in China 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
the first selective MET inhibitor approved in China and the first in the NRDL.
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.

 

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
cancer 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
approved in the US, Europe and Japan. 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 savolitinib in China, the potential benefits and further
clinical development of savolitinib, 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 savolitinib, the impact of the inclusion of
savolitinib 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
savolitinib to obtain regulatory approval for a targeted indication in
different jurisdictions and the sufficiency of funding. 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
US 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 / 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 / Rupert Dearden, Panmure Liberum      +44 (20) 7886 2500

 

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