REG - Hutchmed China Ltd - Updated NRDL to include ELUNATE and SULANDA

HUTCHMED (China)Announcement

03/12/2021 07:00

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RNS Number : 4993U  Hutchmed (China) Limited  03 December 2021

HUTCHMED Announces Agreement with NHSA for Continued Inclusion of ELUNATE(®) and Addition of SULANDA(®) in the National Reimbursement Drug List in China

 

 

Hong Kong, Shanghai & Florham Park, NJ - Friday, December 3, 2021:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM; HKEX:13) today announces that, following the 2021
negotiations with the China National Healthcare Security Administration
("NHSA"), on January 1, 2022 the updated National Reimbursement Drug List
("NRDL") will continue to include ELUNATE(®) (fruquintinib) and will now
include SULANDA(®) (surufatinib).

 

Christian Hogg, Chief Executive Officer of HUTCHMED, said, "We welcome the
addition of SULANDA(®) into the NRDL, along with the renewal of ELUNATE(®).
The NRDL has made it possible for novel therapies to gain wide reach across
the country for diseases with large patient populations."

 

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
450,000 to 550,000 new cases each year. 1 

 

SULANDA(®) was approved in China for the treatment of advanced non-pancreatic
neuroendocrine tumors ("NETs") in December 2020 and for advanced pancreatic
NETs in June 2021. 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 

 

HUTCHMED's third oncology drug, ORPATHYS(®) (savolitinib), is the first and
only approved MET inhibitor in China for the treatment of patients with
non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alterations. It
was also included in the 2021 negotiations with the NHSA, however HUTCHMED and
AstraZeneca, its partner on ORPATHYS(®), declined inclusion in the NRDL for
2022. This position will be reassessed next year ahead of the next NRDL
update. In China, there was an estimated 13,000 newly diagnosed NSCLC patients
with MET exon 14 skipping alterations each year.(1)

 

About the NRDL

 

In recent years, the government in China has placed great importance on
improving the public affordability of drug use. The NHSA regularly convenes a
broad network of experts in medicine, pharmacology and pharmaco-economics to
identify innovative drugs to be considered for inclusion in the NRDL. This has
led to expansion of reimbursement of Category B drugs, which increasingly
include novel oncology drugs. Reimburse-ment of Category B drugs requires
varying degrees of copayment from patients, depending on their province of
residence or type of NHSA insurance scheme enrollment. Agreements for all
included drugs are generally renewed every two years.

 

In this latest update of the NRDL, the NHSA is adding or renewing over 30
Category B oncology drugs, including ELUNATE(®) and SULANDA(®). Effective
January 1, 2022, included NRDL drugs are expected to be made available in all
state-run hospital pharmacies in China and reimbursement will commence for
patients included in NHSA insurance schemes.

 

About fruquintinib (ELUNATE(®) in China)

 

Fruquintinib is a highly selective and potent oral inhibitor of vascular
endothelial growth factor receptors ("VEGFRs") -1, -2 and -3. VEGFR inhibitors
play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed
to improve kinase selectivity to minimize off-target toxicities, improve
tolerability and provide more consistent target coverage. The generally good
tolerability in patients to date, along with fruquintinib's low potential for
drug-drug interaction based on preclinical assessment, suggests that it may
also be highly suitable for combinations with other anti-cancer therapies.

 

Fruquintinib is marketed in China under the brand name ELUNATE(® )for the
treatment of metastatic CRC. It is currently under clinical development for
the treatment of gastric cancer and metastatic breast cancer, and in
combination with PD-1 monoclonal antibodies, including with tislelizumab
(BGB-A317, developed by BeiGene, Ltd.) and sintilimab (TYVYT(®) in China,
IBI308, developed by Innovent Biologics, Inc.). The U.S. Food and Drug
Administration ("FDA") granted Fast Track Designation for the development of
fruquintinib for treating metastatic CRC in June 2020
(https://www.hutch-med.com/fruquintinib-granted-us-fda-fast-track-designation-for-mcrc/)
. A Phase III registration study of fruquintinib in metastatic CRC, FRESCO-2,
is currently underway in the U.S., Europe, Japan and Australia.

 

HUTCHMED retains all rights to fruquintinib outside of China. In China,
HUTCHMED is partnered with Eli Lilly and Company. Since October 2021, HUTCHMED
has been responsible for development and execution of all on-the-ground
medical detailing, promotion and local and regional marketing.

 

About surufatinib (SULANDA(®) in China)

 

Surufatinib is a novel, oral 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.

 

Surufatinib is marketed in China under the brand name SULANDA(®) for the
treatment of patients with advanced NETs. It is currently under clinical
development in combination with anti-PD-1 monoclonal antibodies, including
with tislelizumab and toripalimab (TUOYI(®), developed by Shanghai Junshi
Biosciences Co., Ltd.). A U.S. FDA New Drug Application (NDA) submission was
accepted in June 2021
(https://www.hutch-med.com/fda-accepts-surufatinib-nda-for-net/) , followed by
a Marketing Authorisation Application (MAA) submission to the European
Medicines Agency (EMA) validated in July 2021. In the U.S., surufatinib was
granted Fast Track Designations
(https://www.hutch-med.com/surufatinib-granted-us-fda-fast-track-designations/)
for development in pancreatic and non-pancreatic NETs in April 2020, and
Orphan Drug Designation
(https://www.hutch-med.com/surufatinib-fda-orphan-drug-designation/) for
pancreatic NETs in November 2019.

 

HUTCHMED currently retains all rights to surufatinib worldwide.

 

About savolitinib (ORPATHYS(®) in China)

 

Savolitinib is an oral, potent, and highly selective MET 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) or
gene amplification.

 

Savolitinib is marketed
(https://www.hutch-med.com/first-commercial-sale-of-orpathys-milestone-payment/)
in China under the brand name ORPATHYS(®) 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 currently
under clinical development for multiple tumor types, including lung, kidney,
and gastric cancers, as a single treatment and in combination with other
medicines.

 

In 2011, following its discovery and initial development by HUTCHMED,
AstraZeneca and HUTCHMED entered a global licensing agreement to jointly
develop and commercialize savolitinib. Joint development in China is led by
HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is
responsible for the marketing authorization, manufacturing and supply of
savolitinib in China. AstraZeneca is responsible for the commercialization of
savolitinib in China and worldwide. Sales of savolitinib are recognized by
AstraZeneca.

 

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 more than 4,500
personnel across all its companies, at the center of which is a team of over
1,400 in oncology/immunology. Since inception it has advanced eleven cancer
drug candidates from in-house discovery into clinical studies around the
world, with its first three oncology drugs now approved and marketed in China.
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 announcement 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, surufatinib and savolitinib in China, their
potential benefits, their further clinical development, plans to initiate
further clinical studies, its expectations as to whether such 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, surufatinib and savolitinib, the
ability of NRDL inclusion of fruquintinib and surufatinib to broaden their
availability and patient access, 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 drug candidates fruquintinib,
surufatinib and savolitinib, including as combination therapies, to meet the
primary or secondary endpoints of a study, 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 tislelizumab, paclitaxel,
sintilimab or toripalimab as combination therapeutics, such risks and
uncertainties include assumptions regarding their safety, efficacy, supply and
continued regulatory approval and the impact of the COVID-19 pandemic 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, on AIM and with The Stock Exchange of
Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the
information contained in this announcement, whether as a result of new
information, future events or circumstances or otherwise.

 

Inside Information

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in
the European Union (Withdrawal) Act 2018).

 

CONTACTS

 

 Investor Enquiries
 Mark Lee, Senior Vice President    +852 2121 8200
 Annie Cheng, Vice President        +1 (973) 567 3786

 Media Enquiries
 Americas - Brad Miles,             +1 (917) 570 7340 (Mobile)

Solebury Trout
bmiles@troutgroup.com (mailto:bmiles@troutgroup.com)
 Europe - Ben Atwell / Alex Shaw,   +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)

FTI Consulting
HUTCHMED@fticonsulting.com (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick

                                    HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley,  +44 (20) 7886 2500

Panmure Gordon (UK) Limited

 

 

 1  According to Frost & Sullivan. Report on file.

 2  According to Frost & Sullivan. The current incidence to prevalence
ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due
to lower access to treatment options. Report on file.

 

 

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