REG - Hutchmed China Ltd - Expanded NRDL Coverage + CIDL Inclusion in China

HUTCHMED (China)Announcement

08/12/2025 07:00

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RNS Number : 5466K  Hutchmed (China) Limited  08 December 2025

Press Release

 

HUTCHMED Announces Expanded Coverage on National Reimbursement Drug List and
Inclusion in the First Commercial Insurance Drug List in China

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, December 8, 2025:
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, 2026
will continue to include ELUNATE(®), ORPATHYS(®) and  SULANDA(®). In
addition, TAZVERIK(®) will be included in the first edition of the National
Commercial Health Insurance Innovative Drug List ("Commercial Insurance Drug
List").

 

ELUNATE(®) (fruquintinib) is included for the treatment of patients with
advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that
have failed prior systemic therapy and are not candidates for curative surgery
or radiation, in combination with TYVYT(®) (sintilimab injection). It is also
renewed for the treatment of patients with metastatic colorectal cancer who
have previously received fluoropyrimidine, oxaliplatin and irinotecan-based
chemotherapy, and those who have previously received or are not suitable for
receiving anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR)
therapy (RAS wild-type).

 

ORPATHYS(®) (savolitinib) is included for treatment of adult patients with
locally advanced or metastatic non-small cell lung cancer with MET exon 14
skipping alteration.

 

SULANDA(®) (surufatinib) is renewed for the treatment of patients with
unresectable; locally advanced or metastatic; progressive non-functional,
well-differentiated (G1 or G2) pancreatic and non-pancreatic neuroendocrine
tumors.

 

TAZVERIK(®) (tazemetostat) is included in the Commercial Insurance Drug List
for the treatment of adult patients with relapsed or refractory follicular
lymphoma with EZH2 mutation who have received at least two prior systemic
therapies. In July 2025, the NHSA issued the 2025 Adjustment Work Plan for the
NRDL and the Commercial Health Insurance Innovative Drug List, announcing the
establishment of the new Commercial Insurance Drug List. This list, together
with the NRDL, forms a key component of China's multi-level medical insurance
system. This new list focuses on medicines with high innovation and
significant clinical value that fall beyond the scope of basic medical
insurance, including certain high-cost oncology drugs, gene therapies, and
rare disease therapies, enabling reimbursement through commercial health
insurance products such as high-limit medical insurance, inclusive health
plans ("Huiminbao") and group health insurance. This multi-layered
reimbursement framework enhances patient access to breakthrough treatments
while supporting the sustainable development of China's innovative
pharmaceutical sector.

 

About NRDL

The government in China has placed great importance on improving the
affordability of drug treatments for the public. As of end of 2024, 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 Fruquintinib

Fruquintinib is a selective oral inhibitor of all three vascular endothelial
growth factor receptors ("VEGFR") -1, ‑2 and -3. Fruquintinib is
co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and
Company under the brand name ELUNATE(®). Takeda holds the exclusive worldwide
license to further develop, commercialize, and manufacture fruquintinib
outside mainland China, Hong Kong and Macau, marketing it under the brand name
FRUZAQLA(®).

 

About Savolitinib

Savolitinib is an oral, potent and highly selective MET tyrosine kinase
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), gene amplification or protein overexpression.
Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and
commercialized by AstraZeneca under the brand name ORPATHYS(®).

 

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively
inhibits the tyrosine kinase activity associated with VEGFRs 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.
Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA(®).
HUTCHMED currently retains all rights to surufatinib worldwide.

 

About Tazemetostat

Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed
by Epizyme, an Ipsen company. HUTCHMED entered into a strategic collaboration
with Epizyme to research, develop, manufacture and commercialize tazemetostat
in Chinese Mainland, Hong Kong, Macau and Taiwan.

 

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. 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 approved around the world including in the US, Europe and Japan.
For more information, please visit: www.hutch‑med.com
(https://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, savolitinib, surufatinib and tazemetostat
in China, the potential benefits and further clinical development of
fruquintinib, savolitinib, surufatinib and tazemetostat, 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, savolitinib,
surufatinib and tazemetostat, the impact of the inclusion of fruquintinib,
savolitinib and surufatinib on the NRDL and tazemetostat on the Commercial
Health Insurance Innovative Drug List 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, savolitinib, surufatinib and tazemetostat 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
other drug products such as sintilimab as combination therapeutics, such
risks and uncertainties include assumptions regarding their safety, efficacy,
supply and continued regulatory approval. 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
 FTI Consulting -                                    +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                     (mailto:HUTCHMED@fticonsulting.com)
    Ben Atwell / Tim Stamper                            +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)
 Brunswick - Zhou Yi                                 +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                     (mailto:HUTCHMED@brunswickgroup.com)

 Panmure Liberum                                     Nominated Advisor and Joint Broker
 Atholl Tweedie / Emma Earl / Rupert Dearden         +44 20 7886 2500

 Cavendish                                           Joint Broker
 Geoff Nash / Nigel Birks                            +44 20 7220 0500

 Deutsche Numis                                      Joint Broker
 Freddie Barnfield / Jeffrey Wong / Duncan Monteith  +44 20 7260 1000

 

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