RCS - Hutchmed China Ltd - NDA Acceptance in China for Fruquintinib

HUTCHMED (China)Announcement

18/04/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230418:nRSR4548Wa&default-theme=true

RNS Number : 4548W  Hutchmed (China) Limited  18 April 2023

Press Release

 

HUTCHMED Announces NDA Acceptance in China for Fruquintinib in Second-Line Gastric Cancer

 

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, April 18, 2023: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that its New Drug Application ("NDA") for
fruquintinib in combination with paclitaxel for the treatment of second-line
advanced gastric or gastroesophageal junction adenocarcinoma in China has been
accepted for review by the China National Medical Products Administration
("NMPA").

 

Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED said,
"The NMPA acceptance of our NDA for fruquintinib is a positive step towards
addressing the significant unmet medical need for gastric cancer patients.
Gastric cancer is one of the most common cancers globally, with the highest
incidence and mortality rates found in Asian populations. China alone accounts
for over 40% of all new gastric cancer cases in the world. Despite recent
advancement in the first line setting, there are few treatments available for
patients whose disease progressed on initial therapy. Fruquintinib has
demonstrated clinically meaningful benefit for patients in the Phase III
FRUTIGA study, and we are excited by the possibility of providing a potential
new oral treatment option for patients in China."

 

The NDA is supported by data from the FRUTIGA study, a randomized,
double-blind, Phase III study in China to evaluate fruquintinib combined with
paclitaxel compared with paclitaxel monotherapy, for second-line treatment of
advanced gastric cancer.

 

In China, fruquintinib is approved under the brand name ELUNATE(®) and is
included in the China National Reimbursement Drug List ("NRDL"). HUTCHMED
markets fruquintinib in China in partnership with Eli Lilly and Company.

 

In March 2023, HUTCHMED and Takeda Pharmaceutical Company Limited (TSE:4502,
NYSE:TAK) closed
(https://www.hutch-med.com/closing-of-fruquintinib-license-to-takeda-outside-china/)
an exclusive license agreement to further the global development,
commercialization and manufacture of fruquintinib outside China.

 

About the Phase III FRUTIGA Trial

FRUTIGA is a randomized, double-blind, Phase III study in China to evaluate
fruquintinib combined with paclitaxel compared with paclitaxel monotherapy,
for second-line treatment of advanced gastric cancer. The study enrolled
approximately 700 patients. Its dual-primary endpoints were progression-free
survival ("PFS") and overall survival ("OS"). The trial met the PFS endpoint
at a statistically and clinically meaningful level. While there was an
improvement in median OS, the OS endpoint was not statistically significant
per the pre-specified statistical plan. Fruquintinib also demonstrated a
statistically significant improvement in secondary endpoints including
objective response rate (ORR), disease control rate (DCR) and duration of
response (DoR). The safety profile of fruquintinib in FRUTIGA was consistent
with previously reported studies. Additional details may be found at
clinicaltrials.gov, using identifier NCT03223376
(https://clinicaltrials.gov/ct2/show/NCT03223376) .

 

About Gastric Cancer

Gastric cancer is a cancer that starts in the stomach. It is the fifth most
common cancer worldwide, estimated to have caused approximately 770,000 deaths
in 2020. 1  In China, an estimated 478,000 people were diagnosed with gastric
cancer and 373,000 people will have died from gastric cancer in 2020. 2 

 

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of vascular
endothelial growth factor receptor ("VEGFR") -1, -2 and -3. VEGFR inhibitors
play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed
to improve kinase selectivity with the intention of minimizing off-target
toxicities, improving tolerability and providing more consistent target
coverage. Fruquintinib has been generally well tolerated in patients to date
and is being investigated in combinations with other anti-cancer therapies.

 

Fruquintinib was approved for marketing by the NMPA in September 2018 and
commercially launched in China in November 2018 under the brand name
ELUNATE(®) for the treatment of patients with metastatic colorectal cancer
("CRC") who have been previously treated with fluoropyrimidine, oxaliplatin
and irinotecan, including those who have previously received anti-VEGF therapy
and/or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type).
It has been included in the NRDL since January 2020.

 

The safety and efficacy of fruquintinib for the following investigational uses
have not been established and there is no guarantee that it will receive
health authority approval or become commercially available in any country for
the uses being investigated.

 

Filing of a rolling submission of NDA to the U.S. Food and Drug Administration
("FDA") was completed
(https://www.hutch-med.com/rolling-submission-of-us-nda-for-fruquintinib-mcrc-completed/)
in March 2023. Submissions to the European Medicines Agency (EMA) and the
Japan Pharmaceuticals and Medical Devices Agency (PMDA) are expected to be
completed in 2023. The submission to the FDA is supported by positive results
from FRESCO-2 study, a global double-blind, placebo-controlled, Phase III
study in 691 patients with refractory metastatic CRC. 3   Additional details
of the study may be found at clinicaltrials.gov, using identifier NCT04322539
(https://clinicaltrials.gov/ct2/show/NCT04322539) .

 

HUTCHMED is also developing fruquintinib for the treatment of multiple solid
tumor cancers in combination with PD-1 monoclonal antibodies for the treatment
of endometrial and other solid tumors.

 

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
(https://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
advanced gastric cancer 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 NDA approval
of fruquintinib for the treatment of patients with advanced gastric cancer in
China, the U.S., Europe, Japan, Australia or other jurisdictions, its
potential to gain expeditious approvals from regulatory authorities, the
safety profile of fruquintinib, HUTCHMED's ability to fund, implement and
complete its further clinical development and commercialization plans for
fruquintinib, the timing of these events, and the impact of the COVID-19
pandemic on general economic, regulatory and political conditions. In
addition, as certain studies rely on the use of other drug products such as
paclitaxel, tislelizumab and sintilimab 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 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.

 

CONTACTS
 Investor Enquiries
 Mark Lee, Senior Vice President                   +852 2121 8200
 Annie Cheng, Vice President                       +1 (973) 306-4490

 Media Enquiries
 Americas - Brad Miles,                            +1 (917) 570 7340 (Mobile) / bmiles@s (mailto:bmiles@soleburystrat.com)

Solebury Strategic Communications                oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                   (mailto:bmiles@soleburystrat.com)
 Europe - Ben Atwell / Alex Shaw,                  +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                                   +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
                                                   (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick                         +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                   (mailto:HUTCHMED@brunswickgroup.com)

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

 

 1  The Global Cancer Observatory (https://gco.iarc.fr/) , Stomach Cancer Fact
Sheet
(https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf)
.  Accessed April 6, 2023.

 2  The Global Cancer Observatory (https://gco.iarc.fr/) , China Fact Sheet
(https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf)
. Accessed April 6, 2023.

 3  Dasari NA, Lonardi S, 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. 10.1016/annonc/annonc1089.

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAGPUMUCUPWGGM