TIDMHCM
RNS Number : 7652C
Hutchmed (China) Limited
22 June 2021
HUTCHMED announces savolitinib approved in China for patients
with lung cancer with MET exon 14 skipping alterations
- First selective MET inhibitor approval in China in this
setting -
- First regulatory approval for the oral, potent and selective
MET tyrosine kinase inhibitor -
Hong Kong, Shanghai & Florham Park, NJ -Tuesday, June 22,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) today
announces that AstraZeneca PLC ("AstraZeneca") and HUTCHMED's
savolitinib has been granted conditional approval in China 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. This
approval follows a priority review designation by China's National
Medical Products Administration ("NMPA") and marks the first
regulatory approval globally for this oral, potent and selective
MET tyrosine kinase inhibitor ("TKI").
Approximately 2-3% of newly diagnosed NSCLC patients have MET
exon skipping 14 alterations, a specific genetic mutation.
The approval by the NMPA was based on positive results from a
Phase II trial conducted in China in patients with NSCLC with this
mutation, including patients with the more aggressive pulmonary
sarcomatoid carcinoma subtype. Savolitinib demonstrated effective
anti-tumor activity based on an independent review of objective
response rate ("ORR") and disease control rate ("DCR"). The
approval is conditional upon successful completion of a
confirmatory study in this patient population.
Christian Hogg, Chief Executive Officer of HUTCHMED, said: "It
is with great pleasure that today we announce the first regulatory
approval of savolitinib globally , HUTCHMED's third self-discovered
oncology drug to be commercialized. Our collaboration with
AstraZeneca in 2011 has been an important driver in the development
of this novel targeted oncology drug, involving both a China-based
biotech and a global pharma company. This approval is a testament
to the perseverance and scientific ingenuity of this long-standing
alliance, and we are hopeful that this is only the beginning of the
progress we can achieve for patients with MET-altered tumors."
Dave Fredrickson, Executive Vice President, Oncology Business
Unit of AstraZeneca, said: "This approval makes savolitinib the
only targeted medicine approved for these biomarker-selected
patients in China, and it adds another novel medicine to our
already diverse lung cancer portfolio. We are proud that this
first-ever regulatory approval of savolitinib is in China, where we
have a long-standing commitment to improving patient outcomes and
working with the right partners to achieve that goal. Alongside
HUTCHMED, we look forward to the continued development of this
medicine across a range of cancers where MET alterations and
amplification are drivers of tumor growth and treatment
resistance."
About savolitinib
Savolitinib is an oral, potent and selective MET 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).
Savolitinib is currently under development for multiple tumor
types, including lung, kidney and gastric cancers, as a single
treatment and in combination with other medicines.
HUTCHMED and AstraZeneca collaboration
In 2011, HUTCHMED and AstraZeneca entered a global licensing
agreement with respect to the development and commercialization of
savolitinib. HUTCHMED is responsible for the manufacturing and
supply of savolitinib, and AstraZeneca is responsible for its
commercialization in China and 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 1,300 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.
About AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer
to cure through the detection and treatment of early-stage disease,
while also pushing the boundaries of science to improve outcomes in
the resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit most.
AstraZeneca 's comprehensive portfolio includes leading lung
cancer medicines and the next wave of innovations including
TAGRISSO (R) (osimertinib) and IRESSA (R) (gefitinib); IMFINZI (R)
(durvalumab) and tremelimumab; ENHERTU (R) (trastuzumab deruxtecan)
and datopotamab deruxtecan in collaboration with Daiichi Sankyo;
savolitinib in collaboration with HUTCHMED; as well as a pipeline
of potential new medicines and combinations across diverse
mechanisms of action.
AstraZeneca is a founding member of the Lung Ambition Alliance,
a global coalition working to accelerate innovation and deliver
meaningful improvements for people with lung cancer including and
beyond treatment.
About AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
AstraZeneca's focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyze changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialization of prescription medicines in
Oncology and BioPharmaceuticals, including Cardiovascular, Renal
& Metabolism, and Respiratory & Immunology. Based in
Cambridge, UK, AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com and follow the company on Twitter
@AstraZeneca.
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 commercial launch
of savolitinib in China, our ability to manufacture and supply
savolitinib, the ability of its partner AstraZeneca to distribute
savolitinib quickly and broadly, the potential market for
savolitinib in non-small cell lung cancer patients China, and the
further clinical development for savolitinib in these and other
indications and in combination with other medicines in China, the
United States and other jurisdictions. Forward-looking statements
involve risks and uncertainties. Such risks and uncertainties
include, among other things, assumptions regarding AstraZeneca's
ability to effectively commercialize savolitinib, the benefits
obtained from savolitinib during clinical trials being the same for
all patients who are prescribed savolitinib, no unidentified side
effects occurring which could result in the NMPA pulling
savolitinib from the market, AstraZeneca and HUTCHMED's ability to
fund, implement and complete further clinical development and
commercialization plans for savolitinib, the timing of these
events, 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 TAGRISSO(R) and IMFINZI(R) as
combination therapeutics with savolitinib, such risks and
uncertainties include assumptions regarding the safety, efficacy,
supply and continued regulatory approval of these therapeutics.
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 and on AIM. 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.
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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