REG - Hutchmed China Ltd - HUTCHMED Announces Strategy Update

HUTCHMED (China)Announcement

15/11/2022 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:20221115:nRSO3752Ga&default-theme=true

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 (https://www.hutch-med.com/) ")
(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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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
                                       (mailto: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
                                       (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

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. 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/)
.

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  UPDBKQBPBBDBQDD