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 |
+852 2121 8200 /
ir@hutch-med.com |
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Media Enquiries |
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Ben Atwell / Alex Shaw, FTI Consulting |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) /
HUTCHMED@fticonsulting.com |
Zhou Yi, Brunswick |
+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 |
+44 (20) 7886 2500 |
1 Hong Kong Cancer Registry, Hospital Authority.
Colorectal Cancer in 2021. Available at
https://www3.ha.org.hk/cancereg/pdf/factsheet/2021/colorectum_2021.pdf2
Bando H, et al. Therapeutic landscape and future direction of
metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol 2023;
20(5)306-322. doi:10.1038/s41575-022-00736-1.3 D’Haene N, et al.
Clinical application of targeted next-generation sequencing for
colorectal cancer patients: a multicentric Belgian experience.
Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17.
doi:10.18632/oncotarget.25099.4 Venderbosch, et al. Mismatch repair
status and braf mutation status in metastatic colorectal cancer
patients: A pooled analysis of the Cairo, Cairo2, coin, and Focus
Studies. Clinical Cancer Res.,2014; 20(20):5322–5330.
doi:10.1158/1078-0432.ccr-14-0332.5 Koopman, M., et al. Deficient
mismatch repair system in patients with sporadic advanced
colorectal cancer. Br J Cancer. 209;100(2), 266–273.
doi:10.1038/sj.bjc.6604867.6 Ahcene Djaballah S, et al. HER2 in
Colorectal Cancer: The Long and Winding Road From Negative
Predictive Factor to Positive Actionable Target. Am Soc Clin Oncol
Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354.
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