TIDMHCM
Hutchmed (China) Limited
07 September 2021
Press Release
HUTCHMED Highlights Clinical Data to be Presented at the
Upcoming 2021 ESMO Virtual Conference
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, September
7, 2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM,
HKEX: 13) today announces that new analyses and updates on the
ongoing studies of amdizalisib (PI3K inhibitor HMPL -689),
savolitinib (ORPATHYS(R) in China) and fruquintinib (ELUNATE(R) in
China) will be presented at the upcoming 2021 European Society for
Medical Oncology ("ESMO") Virtual Congress taking place on
September 16-21, 2021.
AMDIZALISIB (also known as HMPL-689)
Title: A phase Ib study result of HMPL-689, a PI3K inhibitor,
in Chinese patients with relapsed/refractory lymphoma
Lead Author: Junning Cao, MD, Fudan University Shanghai Cancer
Center
Session: Proffered Paper - Haematological Malignancies
Presentation Number: 833O
Date & Time: Monday, September 20, 2021 2:10 pm CEST
Location: Channel 3
SAVOLITINIB
Title: ORCHARD osimertinib + savolitinib interim analysis:
A biomarker-directed phase II platform study in patients
with advanced non-small cell lung cancer (NSCLC)
whose disease has progressed on first-line (1L) osimertinib
Lead Author: Helena Yu, MD, Memorial Sloan Kettering Cancer Center
and Weill Cornell Medical College
Session: ePoster
Presentation Number: 1239P
Date available: Monday, September 13, 2021
FRUQUINTINIB
Title: An open-label, phase Ib/II study to evaluate the
safety and efficacy of fruquintinib in combination
with tislelizumab in patients with advanced triple
negative breast cancer
Lead Author: Debu Tripathy, MD, The University of Texas MD Anderson
Cancer Center
Session: ePoster
Presentation Number: 337TiP
Date available: Monday, September 13, 2021
About Amdizalisib
Amdizalisib (HMPL-689) is a novel, selective and potent oral
inhibitor targeting the isoform PI3K . Amdizalisib's
pharmacokinetics ("PK") properties are favorable with good oral
absorption, moderate tissue distribution and low clearance in
preclinical PK studies, suggesting a low risk of drug accumulation
and drug-to-drug interaction. Because of its high target
selectivity and optimal PK profile, amdizalisib has the potential
to demonstrate an optimal benefit-risk profile in this class.
HUTCHMED has initiated an extensive, globally-focused clinical
development pathway for amdizalisib. In addition to the currently
Phase II trial and the supportive Phase I trial in China,
amdizalisib is also being evaluated in an ongoing Phase I/Ib study
in the U.S. and Europe in patients with relapsed or refractory
non-Hodgkin's lymphoma (NHL).
HUTCHMED currently retains all rights to amdizalisib
worldwide.
About Savolitinib (ORPATHYS(R) in China)
Savolitinib is an oral, potent, and highly selective mesenchymal
epithelial transition receptor (MET) tyrosine kinase inhibitor
(TKI) that has demonstrated clinical activity in advanced solid
tumors. It blocks atypical activation of the MET receptor tyrosine
kinase pathway that occurs because of mutations (such as exon 14
skipping alterations or other point mutations) or gene
amplification.
Savolitinib is marketed in China under the brand name
ORPATHYS(R) for the treatment of patients with non-small cell lung
cancer (NSCLC) with MET exon 14 skipping alterations who have
progressed following prior systemic therapy or are unable to
receive chemotherapy. It is currently under clinical development
for multiple tumor types, including lung, kidney, and gastric
cancers, as a single treatment and in combination with other
medicines.
In 2011, following its discovery and initial development by
HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing
agreement to jointly develop and commercialize savolitinib. Joint
development in China is led by HUTCHMED, while AstraZeneca leads
development outside of China. HUTCHMED is responsible for the
marketing authorization, manufacturing and supply of savolitinib in
China. AstraZeneca is responsible for the commercialization of
savolitinib in China and worldwide. Sales of savolitinib will be
recognized by AstraZeneca.
About Fruquintinib (ELUNATE(R) in China)
Fruquintinib is a highly selective and potent oral inhibitor of
VEGFRs -1, -2 and -3. VEGFR inhibitors play a pivotal role in
blocking tumor angiogenesis. Fruquintinib was designed to improve
kinase selectivity to minimize off-target toxicities, improve
tolerability and provide more consistent target coverage. The
generally good tolerability in patients to date, along with
fruquintinib's low potential for drug-drug interaction based on
preclinical assessment, suggests that it may also be highly
suitable for combinations with other anti-cancer therapies.
HUTCHMED retains all rights to fruquintinib outside of China. In
China, HUTCHMED is partnered with Eli Lilly and Company and is
responsible for development and execution of all on-the-ground
medical detailing, promotion and local and regional marketing.
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. A dedicated organization of over 1,400
personnel has advanced eleven cancer drug candidates from in-house
discovery into clinical studies around the world, with its first
three oncology drugs now approved and marketed. For more
information, please visit: www.hutch-med.com or follow us on
LinkedIn.
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 can be identified by words like "will," "expects,"
"anticipates," "future," "intends," "plans," "believes,"
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or by express or implied discussions regarding potential drug
candidates, potential indications for drug candidates or by
discussions of strategy, plans, expectations or intentions. You
should not place undue reliance on these statements. Such
forward-looking statements are based on the current beliefs and
expectations of management regarding future events, and are subject
to significant known and unknown risks and uncertainties. Should
one or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements.
There can be no guarantee that any of our drug candidates will be
approved for sale in any market, or that any approvals which are
obtained will be obtained at any particular time, or that any such
drug candidates will achieve any particular revenue or net income
levels. In particular, management's expectations could be affected
by, among other things: unexpected regulatory actions or delays or
government regulation generally; the uncertainties inherent in
research and development, including the inability to meet our key
study assumptions regarding enrollment rates, timing and
availability of subjects meeting a study's inclusion and exclusion
criteria and funding requirements, changes to clinical protocols,
unexpected adverse events or safety, quality or manufacturing
issues; the inability of a drug candidate to meet the primary or
secondary endpoint of a study; the inability of a drug candidate to
obtain regulatory approval in different jurisdictions or gain
commercial acceptance after obtaining regulatory approval; global
trends toward health care cost containment, including ongoing
pricing pressures; uncertainties regarding actual or potential
legal proceedings, including, among others, actual or potential
product liability litigation, litigation and investigations
regarding sales and marketing practices, intellectual property
disputes, and government investigations generally; the impact of
the COVID-19 pandemic or other health crises in China or globally
on general economic, regulatory and political conditions; and
general economic and industry conditions, including uncertainties
regarding the effects of the persistently weak economic and
financial environment in many countries and uncertainties regarding
future global exchange rates. For further discussion of these and
other risks, see HUTCHMED's filings with the U.S. Securities and
Exchange Commission, The Stock Exchange of Hong Kong Limited and on
AIM. HUTCHMED is providing the information in this press release as
of this date and does not undertake any obligation to update any
forward-looking statements as a result of new information, future
events or otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
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