HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”)
today announced that Takeda (TSE:4502/NYSE:TAK) has submitted a
New Drug Application (“NDA”) to the Ministry of Health, Labour and
Welfare (“MHLW”) in Japan for the approval of fruquintinib for the
treatment of adult patients with previously treated metastatic
colorectal cancer (“CRC”). Fruquintinib is a selective inhibitor of
vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and
-3, which play a pivotal role in blocking tumor angiogenesis. CRC
has the highest incidence and second highest mortality rate among
both men and women in Japan.1
The NDA for fruquintinib is based on results
from FRESCO-2, a global Phase III multi-regional clinical trial
(MRCT) conducted in the U.S., Europe, Japan and Australia, as well
as data from the Phase III FRESCO clinical trial conducted in
China. The FRESCO-2 and FRESCO clinical trials compared
fruquintinib plus best supportive care (“BSC”) with placebo plus
BSC in patients with previously treated metastatic CRC. Both trials
met their primary and key secondary endpoints, showing a
statistically significant and clinically meaningful improvement in
overall survival (“OS”) and progression-free survival (“PFS”).
Fruquintinib has been generally well tolerated by patients.
“Alongside our partner Takeda, we are pleased to
take this key step towards bringing fruquintinib to patients in
Japan,” said Dr. Michael Shi, Head of R&D and Chief Medical
Officer of HUTCHMED. “Supported by a strong clinical data set, and
its success in China, we believe that fruquintinib is an important
option for these patients and are optimistic about the impact it
will have if approved in Japan. There is now real regulatory
momentum behind fruquintinib, and we are excited to see this drug
take to the global stage.”
This submission follows prior submissions for
fruquintinib in the U.S. and Europe for the same indication. The
U.S. Food and Drug Administration (“FDA”) granted Priority Review
and assigned a Prescription Drug User Fee Act (PDUFA) goal date of
November 30, 2023. The FDA review is progressing and the inspection
of HUTCHMED’s manufacturing facility in Suzhou, China has been
completed. A Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) was validated and accepted for
regulatory review in June 2023. Data from the global registrational
FRESCO-2 clinical trial was published in The Lancet, also in June
2023 (NCT04322539).2
Takeda has the exclusive worldwide license to
further develop, commercialize, and manufacture fruquintinib
outside of China. Fruquintinib is developed and marketed in China
by HUTCHMED, under the brand name ELUNATE®. Approval in China was
based on the results of the FRESCO study, a Phase III pivotal
registration trial of fruquintinib in 416 patients with metastatic
CRC in China, published in The Journal of the American Medical
Association, JAMA (NCT02314819).3
About Fruquintinib
Fruquintinib is a selective oral inhibitor of
VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in
inhibiting 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 been shown to be generally well tolerated in
patients to date.
About FRESCO-2
The FRESCO-2 study is a multi-regional clinical
trial conducted in the U.S., Europe, Japan and Australia
investigating fruquintinib plus BSC vs placebo plus BSC in patients
with previously treated metastatic CRC. As previously disclosed,
the 691-patient study met its primary endpoint of OS in patients
with metastatic CRC who had progressed on standard chemotherapy and
relevant biologic agents and who had progressed on, or were
intolerant to, TAS-102 and/or regorafenib. In addition to OS, a
statistically significant improvement in PFS, a key secondary
endpoint, was observed. Fruquintinib has been generally well
tolerated in patients to date. Results were presented at the
European Society for Medical Oncology (ESMO) Congress in September
2022 and subsequently published in The Lancet.4 Additional details
of the study may be found at clinicaltrials.gov, using
identifier NCT04322539.
About CRC
CRC is a cancer that starts in either the colon
or rectum. According to the International Agency for Research on
Cancer, CRC is the third most prevalent cancer worldwide,
associated with more than 935,000 deaths in 2020.5 In the U.S., it
is estimated that 153,000 patients will be diagnosed with CRC and
53,000 deaths from the disease will occur in 2023.6 In Europe, CRC
was the second most common cancer in 2020 with approximately
520,000 new cases and 245,000 deaths. In Japan, CRC was the most
common cancer with an estimated 148,000 new cases and 60,000 deaths
in 2020.5 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.7,8,9,10,11
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 oncology drugs now approved and marketed in China. 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
approval of a NDA for fruquintinib for the treatment of CRC with
the FDA, EMA and the MHLW and the timing of such approvals, 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 timing and outcome of
clinical studies and the sufficiency of clinical data to support
NDA approval of fruquintinib for the treatment of patients with CRC
or other indications in Japan or other jurisdictions such as the
U.S. or the E.U., its potential to gain approvals from regulatory
authorities on an expedited basis or at all; the efficacy and
safety profile of fruquintinib; HUTCHMED and/or Takeda’s ability to
fund, implement and complete its further clinical development and
commercialization plans for fruquintinib; the timing of these
events; each party’s ability to satisfy the terms and conditions
under the license agreement; actions of regulatory agencies, which
may affect the initiation, timing and progress of clinical trials
or the regulatory pathway for fruquintinib; Takeda’s 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 such as paclitaxel 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 under the license agreement; potential payments under
the license agreement, including the upfront payment and any
milestone or royalty payments; potential benefits of the license
agreement; 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 / +1 973 306 4490 /
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 |
Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com |
|
|
Nominated Advisor |
|
Atholl Tweedie / Freddy Crossley / Daphne Zhang,
Panmure Gordon |
+44 (20) 7886 2500 |
_____________________________
1 Cancer Statistics. Cancer Information Service,
National Cancer Center, Japan (Vital Statistics of Japan, Ministry
of Health, Labour and Welfare).
https://ganjoho.jp/public/qa_links/report/statistics/2023_jp.html.2
Dasari NA, et al. Fruquintinib versus placebo in patients with
refractory metastatic colorectal cancer (FRESCO-2): an
international, multicentre, randomised, double-blind, phase 3 study
[published online ahead of print, 2023 Jun 15]. Lancet. 2023. DOI:
10.1016/S0140-6736(23)00772-9.3 Li J, et al. Effect of Fruquintinib
vs Placebo on Overall Survival in Patients With Previously Treated
Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial.
JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.4 Dasari
NA, et al. LBA25 – FRESCO-2: A global phase III multiregional
clinical trial (MRCT) evaluating the efficacy and safety of
fruquintinib in patients with refractory metastatic colorectal
cancer. Ann Oncol. 2022 Sep;33(suppl_7): S808-S869.
doi:10.1016/annonc/annonc1089.5 Sung H, et al. Global Cancer
Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality
Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin.
2021;71(3):209-249. doi:10.3322/caac.21660.6 Siegel RL, et al.
Colorectal cancer statistics, 2023 [published online ahead of
print, 2023 Mar 1]. CA Cancer J Clin. 2023; 73(3):233-254.
doi:10.3322/caac.21772.7 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/s41575-022-00736-1.8 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.25099.9 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. 10 Koopman, M., et al. Deficient
mismatch repair system in patients with sporadic advanced
colorectal cancer. Br J Cancer. 2009;100(2):266–273.
doi:10.1038/sj.bjc.6604867.11 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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