TIDMHCM
RNS Number : 3752G
Hutchmed (China) Limited
15 November 2022
HUTCHMED Announces Strategy to Focus on Late-Stage Pipeline
Regulatory Approvals
Reprioritization accelerating path to profitability
Evaluation of partnership opportunities for select late-stage
assets
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, November
15, 2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today provides a corporate and strategic update, following
an in-depth evaluation of the business.
In response to the challenging market conditions currently
affecting the global biopharmaceutical sector, HUTCHMED has taken a
number of decisions aimed at accelerating HUTCHMED's path to
profitability and establishing a long-term sustainable
business.
HUTCHMED is proactively making a strategic shift to focus on the
most advanced assets from its internal developed pipeline, that are
most likely to drive near-term value. Accordingly:
-- HUTCHMED will prioritize its late-stage and registrational
studies, to focus on bringing these assets through regulatory
approval in particular the global registration of fruquintinib.
-- Selected early-stage studies will not be prioritized for
internal development, and others will be considered as candidates
for out-licensing opportunities, enabling the company to focus
resources on its later-stage assets. As some related clinical
trials wind down, HUTCHMED remains committed to ethical practices
and patient care will continue to be our top priority.
-- HUTCHMED will seek potential partnerships to commercialize
its assets outside of China, to accelerate the availability of
innovative medicines for patients globally.
HUTCHMED will provide updates in due course with detailed
decisions regarding specific programs and progress to streamline
the organization, redeploying key talent in support of
registrational studies and regulatory submissions.
In light of this strategic shift in focus, Dr. Michael Shi,
currently Executive Vice President, Head of Research and
Development and Chief Medical Officer, China, will become
responsible for clinical development globally. Under Dr. Shi's
leadership, HUTCHMED will remain highly focused on the regulatory
submission and further development for fruquintinib, its lead
international asset, following the successful multi-regional
clinical trial results achieved in August 2022 from FRESCO-2,
including its upcoming U.S. FDA New Drug Application filing. As
part of this change in strategic focus, Dr. Marek Kania, Executive
Vice President, Managing Director and Chief Medical Officer,
International, will be transitioning out from his role with
HUTCHMED.
Dr. Weiguo Su, Executive Director, Chief Executive Officer and
Chief Scientific Officer of HUTCHMED, said:
"We believe that these prudent actions will ensure that we
accelerate our path to profitability and therefore establish a
sustainable business to support our future success. The challenging
market conditions affecting biopharmaceutical companies across the
globe require companies to be disciplined in their approach and,
like many other companies, we have decided to make adjustments now
to enable us to focus on the development of the products in our
late-stage pipeline.
"On behalf of the Board and management team, I would like to
recognize the contributions of everyone affected by our decisions
and I remain grateful to our global team for their continued work
towards HUTCHMED's success. I would also like to thank Marek for
his contribution to HUTCHMED, his role in establishing our presence
internationally, and building a strong leadership team to
accelerate the clinical development of several major programs.
"Our vision of becoming a global biopharmaceutical company
remains unchanged, but we expect to fulfill this strategy by
commercialization outside China primarily through partnerships.
Regardless, we will continue to invest in global development to
reach our goal of bringing innovative medicines to patients
worldwide."
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 4,900 personnel across all
its companies, at the center of which is a team of about 1,800 in
oncology/immunology. Since inception HUTCHMED has been 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 announcement 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 implementation and
results of its corporate strategy and its ability to successfully
enter into partnerships to commercialize its assets outside of
China. Forward-looking statements involve risks and uncertainties.
Such risks and uncertainties include, among other things,
assumptions regarding the potential benefits, safety and efficacy
or progress of the drug candidates in HUTCHMED's pipeline, the
number and timing of advancement of drug candidates into clinical
development, the plans of collaborative partners and the impact of
those collaborations on product development activities and
financial resources, the potential to gain approvals from
regulatory authorities by HUTCHMED or its partners on an expedited
basis or at all, the availability of sufficient funding to enable
HUTCHMED to continue executing on its strategy and achieve
profitability, the timing of these events, and the impact of the
COVID-19 pandemic on general economic, regulatory and political
conditions. 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 announcement, whether as a result
of new information, future events or circumstances or
otherwise.
Inside Information
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 (as it forms part of
retained EU law as defined in the European Union (Withdrawal) Act
2018).
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, Solebury +1 (917) 570 7340 (Mobile) | bmiles@soleburystrat.com
Europe - Ben Atwell / Alex Shaw, FTI +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) |
HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile) | HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
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