Press Release
HUTCHMED Receives ELUNATE® (fruquintinib)
Marketing Approval in Hong Kong for Treatment of Metastatic
Colorectal Cancer
- First medicine approved under new "1+" mechanism by
HKSAR Government, providing an important treatment option to
patients in Hong Kong -
- ELUNATE® is the first oral targeted
therapy approved in Hong Kong for metastatic colorectal cancer
regardless of biomarker status or prior types of therapies in
almost a decade -
- Fruquintinib already approved in mainland China,
Macau SAR and the United States -
Hong Kong, Shanghai
& Florham Park, NJ - Tuesday, January 30, 2024: HUTCHMED
(China) Limited (Nasdaq/AIM:HCM, HKEX:13) ("HUTCHMED") today announces that
the marketing approval of ELUNATE® (fruquintinib) by the
Pharmacy and Poisons Board of Hong Kong for the treatment of adult
patients with previously treated metastatic colorectal cancer
("CRC"). ELUNATE® is a selective oral inhibitor of
vascular endothelial growth factor ("VEGF") receptors -1, -2 and
-3, which play a pivotal role in blocking tumor angiogenesis.
This marks the first medicine to be approved under
the new mechanism for registration of new drugs ("1+" mechanism)
announced by the Government of the Hong Kong Special Administrative
Region ("SAR") in October last year. The mechanism officially
commenced on November 1, 2023. It allows drugs which are beneficial
for treatment of life-threatening or severely debilitating diseases
to apply for registration for use in Hong Kong, if they have
supporting local clinical data and recognition from relevant
experts, when they have been approved by only one reference drug
regulatory authority (instead of two otherwise). HUTCHMED submitted
the application based on the approval of ELUNATE® from
the China National Medical Products Administration ("NMPA")
supported with local clinical data. Fruquintinib was also
approved by the U.S. Food and Drug Administration ("FDA") in
November 2023.
"We have made it a priority to do everything we can
to bring the benefits of our innovative medicines to Hong Kong, our
Company's birthplace, and are excited to have our first medicine
now approved here," said Dr Karen
Atkin, Executive Vice President and Chief Operating Officer
of HUTCHMED. "We appreciate the streamlined drug registration
process, showing the efficiency and commitment of the Hong Kong
government to accelerate patient access to novel therapies. As we
advance our pipeline of drug candidates in other cancer types and
immunological diseases, we look forward to bringing additional
therapies to benefit patients in Hong Kong."
This approval indication is for patients with
metastatic CRC 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).
"CRC is the second most common cancer type in Hong
Kong with limited effective treatment options available, especially
for previously treated metastatic CRC patients," said Dr Caron Li, Vice President, Oncology and
Immunology, Hong Kong and Regional Markets of HUTCHMED.
"Fruquintinib, as a third-line treatment administered orally,
demonstrated clinically meaningful benefits and a consistent safety
profile in global clinical trials. We are honored to be the first
through the "1+" mechanism and look forward to bringing this
important treatment option to patients in Hong Kong as quickly as
possible.
Dr Stephen Chan, an
academic and a specialist in Medical Oncology, said, "Cancer
remains to be a major challenge for the patients, their families
and us as healthcare providers, with a rising trend in incidence
over the past decades. The complex nature of cancer has made it
particularly arduous for researchers to bring new advancements to
the treatment. It is truly encouraging to see homegrown innovations
taking on an increasingly active role to address the global unmet
medical needs. We are excited to bring such meaningful treatment
options to the cancer patients in Hong Kong."
Fruquintinib will be sold and marketed in Hong Kong
by HUTCHMED under the brand name ELUNATE®. It has been
developed and commercialized in mainland China in partnership with
Eli Lilly & Company. Takeda has the exclusive worldwide license
to fruquintinib outside of mainland China, Hong Kong and Macau.
Takeda markets fruquintinib in the United States under the brand
name FRUZAQLA™. Fruquintinib was added to the National
Comprehensive Cancer Network Clinical Practice Guidelines in
Oncology (NCCN Guidelines) shortly after FDA approval.
About CRC in Hong Kong
CRC is a cancer that starts in either the colon or
rectum. It was the second most common cancer in Hong Kong in 2021,
with about 5,900 new patients diagnosed with CRC, and associated
with about 2,300 deaths.[1] Although
early-stage CRC can be surgically resected, metastatic CRC remains
an area of high unmet need with poor outcomes and limited treatment
options. Some patients with metastatic CRC may benefit from
personalized therapeutic strategies based on molecular
characteristics; however, most patients have tumors that do not
harbor actionable mutations.[2],[3],[4],[5],[6]
About Fruquintinib
Fruquintinib is a selective oral inhibitor of VEGF
receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal
role in blocking 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 combination with other anti-cancer
therapies.
About Fruquintinib Approval in
China
Fruquintinib was approved for marketing in
China in September 2018, where it is co-marketed by HUTCHMED and
Lilly under the brand name ELUNATE®. It was included in
the China National Reimbursement Drug List (NRDL) in January 2020.
The approval was based on data from the FRESCO study, a Phase III
pivotal registration trial of fruquintinib in 416 patients with
metastatic CRC in China, which were published
in The Journal of the American Medical Association, JAMA.
Since its launch in China, fruquintinib has benefited more than
80,000 colorectal cancer patients as of mid-2023.
About Fruquintinib Approval in the United
States
Fruquintinib received approval in the United
States in November 2023, where it is marketed by Takeda under the
brand name FRUZAQLA™. The approval was based on data from two large
Phase III trials: the multi-regional FRESCO-2 trial, data from
which were
published in The Lancet, along
with the FRESCO trial conducted in China. The trials investigated
fruquintinib plus best supportive care versus placebo plus best
supportive care in patients with previously treated mCRC. Both
FRESCO and FRESCO-2 met their primary and key secondary efficacy
endpoints and showed consistent benefit among a total of 734
patients treated with fruquintinib. Safety profiles were consistent
across trials.
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 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 regarding the
therapeutic potential of fruquintinib for the treatment of patients
with CRC and the further clinical development of fruquintinib in
this and other indications. Forward-looking statements involve
risks and uncertainties. Such risks and uncertainties include,
among other things, assumptions regarding the efficacy and safety
profile of fruquintinib; HUTCHMED and/or its licensees' ability to
fund, implement and complete its further clinical development and
commercialization plans for fruquintinib; the timing of these
events; HUTCHMED and its licensees' ability to satisfy their
obligations; actions of regulatory agencies, which may affect the
initiation, timing and progress of clinical trials or the
regulatory pathway for fruquintinib; HUTCHMED and its licensees'
ability to successfully develop, manufacture and commercialize
fruquintinib; and the impact of COVID-19 on general economic,
regulatory and political conditions. In addition, as certain
studies rely on the use of other drug products as combination
therapeutics with fruquintinib, such risks and uncertainties
include assumptions regarding the safety, efficacy, supply and
continued regulatory approval of these therapeutics. Such
forward-looking statements include, without limitation, statements
regarding the plan to develop, manufacture and commercialize
fruquintinib; and HUTCHMED's strategy, goals and anticipated
milestones, business plans and focus. 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 on The Stock Exchange of Hong Kong Limited. 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
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+852 2121 8200 /
ir@hutch-med.com
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Media Enquiries
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Ben Atwell / Alex Shaw,
FTI Consulting
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+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
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Zhou Yi, Brunswick
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+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com
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Nominated Advisor
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Atholl Tweedie / Freddy Crossley /
Daphne Zhang, Panmure Gordon
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+44 (20) 7886 2500
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