RCS - Hutchmed China Ltd - HUTCHMED Receives Marketing Approval in Hong Kong

HUTCHMED (China)Announcement

30/01/2024 07:15

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RNS Number : 3508B  Hutchmed (China) Limited  30 January 2024

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
(https://www.hutch-med.com/) ") 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
(https://www.hutch-med.com/us-fda-approval-of-fruzaqla-fruquintinib/) 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  (#_edn1)
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  (#_edn2) (, 3  (#_edn3)
, 4  (#_edn4) , 5  (#_edn5) , 6  (#_edn6) )

 

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
(https://jamanetwork.com/journals/jama/fullarticle/2685988) 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
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00772-9/fulltext)
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
(http://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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 (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 / Daphne Zhang, Panmure Gordon   +44 (20) 7886 2500

 

 1  (#_ednref1) Hong Kong Cancer Registry, Hospital Authority. Colorectal
Cancer in 2021. Available at
https://www3.ha.org.hk/cancereg/pdf/factsheet/2021/colorectum_2021.pdf

 2  (#_ednref2) 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  (#_ednref3) 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  (#_ednref4) 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  (#_ednref5) 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  (#_ednref6) 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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