TIDMHCM
Hutchmed (China) Limited
29 September 2023
Press Release
HUTCHMED Announces Submission of New Drug Application for
Fruquintinib for Previously Treated Metastatic Colorectal Cancer in
Japan
- Third major market authorization application based on data
from the FRESCO-2 global Phase III trial -
Hong Kong, Shanghai & Florham Park, NJ - Friday, September
29, 2023: 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(R) . 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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