RCS - Hutchmed China Ltd - FRUZAQLA® Launched in Japan by Takeda

HUTCHMED (China)Announcement

22/11/2024 07:00

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RNS Number : 2166N  Hutchmed (China) Limited  22 November 2024

Press Release

 

HUTCHMED Announces Launch by Takeda of FRUZAQLA(®) (fruquintinib) in Japan

 

 

- Launch follows approval by Japanese Ministry of Health, Labour and Welfare
in September 2024 -

 

- Milestone payment to be made to HUTCHMED from Takeda -

 

- Fruquintinib already launched in several regions including the United
States, Europe and China -

 

Hong Kong, Shanghai & Florham Park, NJ - Friday, November 22, 2024:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that it will receive a milestone
payment following the pricing approval and launch of FRUZAQLA(®)
(fruquintinib) 1mg/5mg capsules in Japan by its partner Takeda
(https://www.takeda.com/) (TSE:4502/NYSE:TAK) for patients with previously
treated metastatic colorectal cancer ("CRC"). This follows approval for the
manufacturing and marketing of FRUZAQLA(®) by the Japanese Ministry of
Health, Labour and Welfare.

 

FRUZAQLA(®) is the first novel oral targeted therapy in Japan to be approved
for metastatic CRC, regardless of biomarker status, in over a decade.
FRUZAQLA(®) is indicated for the treatment of advanced or recurrent
colorectal cancer that is neither curable nor resectable, and that has
progressed after chemotherapy. CRC is the most prevalent type of cancer in
Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023,
according to statistics from the National Cancer Center. 1  (#_edn1)

 

On the launch of FRUZAQLA(®) in Japan by Takeda, Dr Weiguo Su, Chief
Executive Officer and Chief Scientific Officer of HUTCHMED, said: "The launch
of FRUZAQLA(®) in Japan highlights the continued progress of our partnership
with Takeda across the globe. Takeda is well positioned to build on more than
a decade of leadership in the treatment of metastatic CRC in Japan and bring a
differentiated treatment option in FRUZAQLA(®) to patients."

 

The launch of FRUZAQLA(®) in Japan follows its approval in September 2024,
primarily based on results from the Phase III FRESCO-2 trial conducted in the
US, Europe, Japan and Australia. Data from FRESCO-2 were published
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00772-9/fulltext)
in The Lancet in June 2023. Takeda has the exclusive worldwide license to
further develop, commercialize, and manufacture fruquintinib outside of
mainland China, Hong Kong and Macau, and markets under the FRUZAQLA(®) brand
name. It received approval in the US
(https://www.hutch-med.com/us-fda-approval-of-fruzaqla-fruquintinib/) in
November 2023, in the EU
(https://www.hutch-med.com/european-commission-approval-for-fruzaqla-fruquintinib/)
in June 2024, in Switzerland in August 2024, in Canada, Japan
(https://www.hutch-med.com/japan-approval-for-fruzaqla-fruquintinib/) and the
United Kingdom in September 2024 and in Argentina, Australia and Singapore in
October 2024. Regulatory applications are progressing in many other
jurisdictions.

 

About CRC

 

CRC is a cancer that starts in either the colon or rectum. According to the
International Agency for Research on Cancer/World Health Organization, CRC is
the third most prevalent cancer worldwide, associated with more than 1.9
million new cases and 900,000 deaths in 2022. In Japan, CRC was the most
common cancer, with an estimated 146,000 new cases and 60,000 deaths, in 2022.
In Europe, CRC was the second most common cancer in 2022, with approximately
538,000 new cases and 248,000 deaths. 2  (#_edn2) (, 3  (#_edn3) ) In the US,
it is estimated that 153,000 patients will be diagnosed with CRC and 53,000
deaths from the disease will occur in 2024. 4  (#_edn4) 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. 5  (#_edn5) (,) 6  (#_edn6) (,) 7  (#_edn7)
(,) 8  (#_edn8) (,) 9  (#_edn9)

 

About Fruquintinib

 

Fruquintinib is a selective oral inhibitor of all three VEGF receptors
(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 drug exposure that achieves
sustained target inhibition and flexibility for potential use as part of a
combination therapy.

 

About Fruquintinib Approvals

 

Global regulatory submissions are based on data from two large, randomized,
controlled Phase III trials, the global, multi-regional FRESCO-2 trial and the
FRESCO trial conducted in China, showing consistent benefit among a total of
734 patients treated with fruquintinib. Safety profiles were consistent across
trials. Results from the FRESCO-2 trial were published
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00772-9/fulltext)
in The Lancet in June 2023, 10  (#_edn10) while results from the FRESCO trial
were published (https://jamanetwork.com/journals/jama/fullarticle/2685988) in
The Journal of the American Medical Association, JAMA. 11  (#_edn11)

 

In mainland China, Hong Kong and Macau, fruquintinib is co-marketed by
HUTCHMED and Eli Lilly and Company under the brand name ELUNATE(®). It was
included in the China National Reimbursement Drug List (NRDL) in January 2020.
Since its launch in China, over 100,000 patients with colorectal cancer have
been treated with fruquintinib.

 

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
approved in the US, Europe and Japan. For more information, please visit
www.hutch-med.com (http://www.hutch-med.com) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

JAPAN IMPORTANT SAFETY INFORMATION

 

Please consult the FRUZAQLA (fruquintinib) Japan package insert (J-PI) before
prescribing.

 

WARNING: FRUZAQLA should be administered only to patients for whom the use of
FRUZAQLA is considered appropriate under the supervision of a physician with
sufficient knowledge of and experience in cancer chemotherapy at a medical
institution where adequate emergency care can be provided. Prior to treatment
initiation, the efficacy and risks should be fully explained to the patient
and/or his/her family and informed consent should be obtained; Severe
gastrointestinal hemorrhage, including fatal cases, has been reported.
Patients should be carefully monitored, and if any abnormalities are observed,
administration of FRUZAQLA should be withheld and appropriate measures should
be taken. If severe hemorrhage occurs, FRUZAQLA should not be re-administered;
Gastrointestinal perforation has been reported with some fatal cases. Patients
should be carefully monitored, and if any abnormalities are observed,
administration of FRUZAQLA should be withheld and appropriate measures should
be taken. If gastrointestinal perforation occurs, FRUZAQLA should not be
re-administered.

 

CONTRAINDICATIONS: Patients with a history of hypersensitivity to any of the
ingredients of FRUZAQLA.

 

IMPORTANT PRECAUTIONS: Hypertension, including hypertensive crisis, may occur.
Blood pressure should be measured prior to the initiation of FRUZAQLA
treatment and periodically during this treatment; Proteinuria may occur.
Urinary protein should be monitored prior to the initiation of FRUZAQLA
treatment and periodically during this treatment; If a surgical procedure is
to be performed, patients are recommended to withhold FRUZAQLA before the
surgery because wound healing may be delayed. Treatment resumption after the
surgical procedure should be determined depending on the patient's condition
upon confirmation of adequate wound healing.

 

PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS: Patients with
hyper-ten-sion: Hypertension may worsen; Patients with bleeding diathesis or
abnormal coagulation system: Hemorrhagic events may occur; Patients with
hemorrhage such as gastrointestinal hemorrhage: Hemorrhage may be enhanced;
Patients with a complication of intra-abdominal inflammation in the
gastrointestinal tract, etc.: Gastrointestinal perforation may occur; Patients
with current or a history of thromboembolism: Transient ischaemic attack,
thrombotic microangiopathy, pulmonary embolism, portal vein thrombosis, deep
vein thrombosis, etc. may occur; Patients with severe hepatic impairment
(Child-Pugh Class C): Since FRUZAQLA is metabolized mainly in the liver, blood
concentrations may be increased. There have been no clinical studies conducted
in patients with severe hepatic impairment; Patients with Reproductive
Potential: Women of childbearing potential should be advised to use adequate
contraception during treatment with FRUZAQLA and for 2 weeks after the last
dose; Pregnant Women: FRUZAQLA can be administered to women who are or may be
pregnant only if the expected therapeutic benefits outweigh the possible risks
associated with this treatment. In a rat embryo-fetal toxicity study, fetal
abnormalities and teratogenic effects consisting of fetal external, visceral,
and skeletal malformations and visceral and skeletal variations were observed
at exposure levels approximately 0.05 times the exposure level (AUC) of
FRUZAQLA at the maximum clinical dose (5 mg/day); Breast-feeding Women: It is
advisable not to breastfeed. FRUZAQLA may pass into breast milk, and infants
may experience serious adverse reactions if they are ingested through breast
milk; Pediatric Use: There have been no clinical studies conducted in
pediatric patients.

 

ADVERSE REACTIONS:

Any of the adverse reactions listed below may occur. Patients should be
closely monitored, and if any such abnormalities are observed, appropriate
measures should be taken, including treatment discontinuation. Clinically
Significant Adverse Reactions are as follows.

 

Hypertension: Hypertension or hypertensive crisis may occur. If an increase in
blood pressure is observed, appropriate treatment such as antihypertensive
drug administration should be given as necessary, and if necessary, the dose
of fruquintinib should be reduced, or fruquintinib administration should be
interrupted. If severe or persistent hypertension, or hypertension that cannot
be controlled by routine antihypertensive therapy occurs or if a hypertensive
crisis occurs, fruquintinib administration should be discontinued; Skin
disorder: Skin disorder including palmar-plantar erythrodysesthesia syndrome
and rash may occur; Hemorrhage: Hemorrhage including epistaxis, hematuria,
gastrointestinal hemorrhage and hemoptysis may occur. Fatal outcomes have been
reported; Gastrointestinal perforation: Fatal outcomes have been reported;
Arterial thromboembolic events: Arterial thromboembolic events including
transient ischemic attack and thrombotic microangiopathy may occur; Venous
thromboembolism events: Venous thromboembolism such as pulmonary embolism,
portal vein thrombosis, and deep vein thrombosis may occur; Posterior
reversible encephalopathy syndrome: If headaches, convulsions, lethargy,
confusion, changes in mental function, blindness or other visual disturbances,
or neurological impairment are observed, fruquintinib administration should be
discontinued, and appropriate measures should be taken, including blood
pressure control; Arterial dissection: Arterial dissection including aortic
dissection may occur.

 

For US Prescribing Information:

https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing-information.pdf
(https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing-information.pdf)

 

For European Union Summary of Product Characteristics:

https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla
(https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla)

 

Forward-Looking Statements

 

This press release contains forward‑looking statements within the meaning of
the "safe harbor" provisions of the US Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect HUTCHMED's current
expectations regarding future events, including but not limited to, its
expectations regarding the receipt of the milestone payment, the therapeutic
potential of fruquintinib for the treatment of such 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
sufficiency of clinical data to support approval of fruquintinib for the
treatment of patients with CRC or other indications in other jurisdictions
such as Japan, its potential to gain approvals from regulatory authorities,
the 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; and Takeda's
ability to successfully develop and commercialize fruquintinib. 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. 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 US 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 (mailto: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
                                                                         (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi, Brunswick                                                      +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                         (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum      +44 (20) 7886 2500

 

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 3  (#_ednref3)    Ferlay J, et al. Global Cancer Observatory: Cancer Today.
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 4  (#_ednref4)     American Cancer Society. Cancer Facts & Figures
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 7  (#_ednref7)     Venderbosch S, et al. Mismatch repair status and BRAF
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 8  (#_ednref8)     Koopman M, et al. Deficient mismatch repair system in
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 9  (#_ednref9)     Ahcene Djaballah S, et al. HER2 in Colorectal Cancer:
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 10  (#_ednref10)   Dasari NA, et al. Fruquintinib versus placebo in patients
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 11  (#_ednref11)   Li J, et al. Effect of Fruquintinib vs Placebo on Overall
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