RCS - Hutchmed China Ltd - Closing of Fruquintinib License to Takeda

HUTCHMED (China)Announcement

14/03/2023 13:30

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RNS Number : 9468S  Hutchmed (China) Limited  14 March 2023

Press Release

 

HUTCHMED Announces Closing of Fruquintinib License to Takeda Outside China

 

 

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, March 14, 2023:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM, HKEX:13) today announces that, further to its announcement on
January 23, 2023
(https://www.hutch-med.com/fruquintinib-outside-china-partnership-with-takeda/)
and following the completion of customary closing conditions including
antitrust regulatory reviews, the exclusive license agreement with a
subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502, NYSE:TAK) to
further the global development, commercialization and manufacture of
fruquintinib outside China has closed.

 

With a strong preclinical and clinical profile, fruquintinib offers a
potential new treatment option for patients with refractory metastatic
colorectal cancer ("CRC"), supporting the shared goal of Takeda and HUTCHMED
to improve the lives of those living with cancer worldwide. Takeda is now
responsible for the development, commercialization and manufacture of
fruquintinib in all included territories worldwide excluding mainland China,
Hong Kong and Macau, where it is marketed by HUTCHMED.

 

Following the closing of the exclusive license agreement, HUTCHMED Limited
will receive US$400 million shortly, and is eligible to receive up to US$730
million in additional potential payments relating to regulatory, development
and commercial sales milestones, as well as royalties on net sales. Marketing
authorization submissions in the U.S., Europe and Japan are planned to
complete in 2023, with the rolling submission to the U.S. Food and Drug
Administration ("FDA") initiated in December 2022.

 

About Fruquintinib

Fruquintinib is a highly selective and potent inhibitor of vascular
endothelial growth factor receptors ("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.

 

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 more than 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/) .

 

Takeda's Commitment to Oncology

At Takeda Oncology, we are united by our aspiration to cure cancer and
motivated every day to work harder for patients with limited or ineffective
treatment options. Our agile structure and deep in-house expertise are
complemented by a network of partnerships that optimize our ability to
research, develop and deliver transformative medicines to people living with
cancer. Building on decades of leadership in oncology and a portfolio of
approved medicines for hematologic cancers and solid tumors, we are advancing
a cutting-edge pipeline focused on the power of innate immunity. With
inspiration from patients and innovation from everywhere, our goal is to
introduce new classes of immunotherapies that can lead to deep, durable
responses so that more patients can benefit from - and have access to -
innovative medicines.

 

For more information, visit www.takedaoncology.com
(http://www.takedaoncology.com/) .

 

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
submission of a New Drug Application ("NDA") for fruquintinib for the
treatment of CRC with the FDA and the timing of such submission, 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 the U.S. or other jurisdictions such as Europe or Japan,
its potential to gain approvals from regulatory authorities on an expedited
basis or at all; the efficacy and 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; 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 and commercialize
fruquintinib; 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 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 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.

 

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

 Media Enquiries
 Americas - Brad Miles, Solebury Trout             +1 (917) 570 7340 (Mobile) / bmiles@soleburystrat.com
                                                   (mailto:bmiles@soleburystrat.com)
 Europe - 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)
 Asia - Zhou Yi, Brunswick                         +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                   (mailto:HUTCHMED@brunswickgroup.com)

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

Panmure Gordon (UK) Limited

 

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