TIDMHCM
Hutchmed (China) Limited
20 May 2021
Press Release
HUTCHMED Highlights Clinical Data to be Presented at the
Upcoming ASCO21 Virtual Scientific Program
- HUTCHMED will review these highlights as part of its company
update audio call and webcast on Wednesday, May 26 at 9 a.m. EDT to
discuss data disclosures, its PD-1/L1 combination study strategy
and provide a corporate update -
Hong Kong, Shanghai & Florham Park, NJ - Thursday, May 20,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) today
announces that new analyses and updates on the ongoing studies of
savolitinib, surufatinib, fruquintinib and HMPL-306 will be
presented at the upcoming ASCO21 Virtual Scientific Program, taking
place on June 4-8, 2021.
Aspects of these clinical data disclosures, alongside its
PD-1/L1 combination study strategy and corporate update will be
discussed part of the previously announced call. For more details,
please visit: https://www.hutch-med.com/event/.
SAVOLITINIB
Title: Clinical activity of durvalumab and savolitinib in
MET-driven, metastatic papillary renal cancer
Lead Author: Cristina Suárez, MD, Hospital Univ. Vall D Hebron
General
Session: Poster Discussion Session: Genitourinary Cancer-Kidney
and Bladder
Abstract Number: 4511
SURUFATINIB
Title: Interim analysis results of surufatinib in U.S. patients
with neuroendocrine tumors (NETs).
Lead Author Scott Paulson, MD, Baylor Sammons Cancer Center
Session: Poster Session: Gastrointestinal Cancer-Gastroesophageal,
Pancreatic, and Hepatobiliary
Abstract Number: 4114
Title: Surufatinib in combination with toripalimab in patients
with advanced neuroendocrine carcinoma: results from
a multicenter, open-label, single-arm, phase II trial
Lead Author Lin Shen, MD, Peking University Cancer Hospital &
Institute
Session: Online publication only
Number: e16199
Title: Phase II trial of surufatinib plus toripalimab for
disease progression after first-line chemotherapy
with platinum and fluoropyrimidine in advanced gastric
or gastroesophageal junction adenocarcinoma
Lead Author Lin Shen, MD, Peking University Cancer Hospital &
Institute
Session: Online publication only
Number: e16040
Title: A single-arm, multi-center, open-label phase 2 trial
of surufatinib in patients with unresectable or metastatic
biliary tract cancer.
Lead Author Yuxian Bai, MD, PhD, Harbin Medical University Cancer
Hospital
Session: Online publication only
Number: e16123
Title: Subgroup analysis by Ki-67 and baseline CgA of the
randomized, placebo-controlled phase 3 study of surufatinib
in advanced well-differentiated pancreatic neuroendocrine
tumors (SANET-p)
Lead Author Xianjun Yu, MD, Fudan University Shanghai Cancer
Center
Session: Poster Session: Gastrointestinal Cancer-Gastroesophageal,
Pancreatic, and Hepatobiliary
Abstract Number: 4111
Title: An open-label phase 1b/2 study of surufatinib in
combination with tislelizumab in subjects with advanced
solid tumors
Lead Author Arvind Dasari, MD, MS, MD Anderson Cancer Center
Session: Poster Session: Developmental Therapeutics-Immunotherapy
Abstract Number: TPS2677
FRUQUINTINIB
Title: Preliminary results of a phase 1b study of fruquintinib
plus sintilimab in advanced colorectal cancer
Lead Author Ye Guo, MD, Shanghai East Hospital
Session: Poster Discussion Session: Gastrointestinal Cancer-Colorectal
and Anal
Abstract Number: 2514
Title: A phase Ib trial of assessing the safety and preliminary
efficacy of a combination therapy of Geptanolimab
(GB 226) plus Fruquintinib in patients with metastatic
colorectal cancer (mCRC)
Lead Author Yanzhi Cui, MD, Tumour Institute, Fourth Hospital
of Hebei Medical University
Session: Online publication only
Number: e15551
HMPL-306
Title: A multicenter open-label phase 1 study evaluating
the safety and tolerability of HMPL-306 in patients
with locally advanced or metastatic solid tumors
with IDH mutations.
Lead Author Filip Janku, MD, MD Anderson Cancer Center
Session: Poster Session: Developmental Therapeutics-Molecularly
Targeted Agents and Tumor Biology
Abstract Number: TPS3159
About Savolitinib
Savolitinib is an oral, potent, and highly selective small
molecule inhibitor of MET, a receptor tyrosine kinase which has
been shown to function abnormally in many types of solid tumors
promoting tumor growth, angiogenesis, and metastasis. Savolitinib
has been studied in over 1,100 patients to date. In clinical
studies, it has shown promising clinical efficacy in patients with
MET gene alterations in multiple tumor types with an acceptable
safety profile.
In 2011, HUTCHMED entered into a global licensing and joint
development and commercialization agreement with AstraZeneca PLC
(LSE/STO/NYSE: AZN) for savolitinib. Savolitinib's global
development plan includes non-small cell lung cancer (NSCLC) and
kidney cancer, and additional MET-driven tumors are being
explored.
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
vascular endothelial growth factor receptor ("VEGFR") and
fibroblast growth factor receptor (FGFR), which both inhibit
angiogenesis, and colony stimulating factor-1 receptor (CSF-1R),
which regulates tumor-associated macrophages, promoting the body's
immune response against tumor cells. Its unique dual mechanism of
action may be very suitable for possible combinations with other
immunotherapies, where there may be synergistic anti-tumor
effects.
HUTCHMED currently retains all rights to surufatinib
worldwide.
About Fruquintinib
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 HMPL-306
HMPL-306 is HUTCHMED's ninth innovative oncology drug candidate
that it has discovered that has entered clinical development and
the sixth to enter global clinical development. Cytoplasmic mutant
IDH1 and mitochondrial mutant IDH2 have been known to switch to the
other form when targeted by an inhibitor of IDH1 mutant alone or
IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations,
HMPL-306 could potentially provide therapeutic benefits in cancer
patients harboring either IDH mutation, and may address acquired
resistance to IDH inhibition through isoform switching.
HUTCHMED currently retains all rights to HMPL-306 worldwide.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech)
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 1,200 personnel has advanced ten cancer drug
candidates from in-house discovery into clinical studies around the
world, with its first two oncology drugs now approved and launched.
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,"
"estimates," "pipeline," "could," "potential," "first-in-class,"
"designed to," "objective," "guidance," "pursue," or similar terms,
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 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, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.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
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile) / +852 97 83 6894 (Mobile)
HUTCHMED@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
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