Chi-Med Submits New Drug Application to CFDA for Fruquintinib in Advanced Colorectal Cancer
June 12 2017 - 1:14AM
Business Wire
– Application accepted by CFDA for technical
review by the Center for Drug Evaluation –
– Triggers RMB30.8 million milestone payment
from Eli Lilly and Company (“Lilly”) –
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM)
today announces that the China Food and Drug Administration
(“CFDA”) has acknowledged acceptance of the New Drug Application
(“NDA”) for fruquintinib for the treatment of patients with
advanced colorectal cancer, which triggers a milestone payment of
RMB30.8 million (US$4.5 million) from Lilly to Chi-Med. The NDA is
supported by data from the successful FRESCO study, a Phase III
pivotal registration trial of fruquintinib in 416 patients with
locally advanced or metastatic colorectal cancer (“CRC”) in China,
which was highlighted in an oral presentation at the American
Society of Clinical Oncology Annual Meeting on June 5, 2017.
About CRC
CRC is the second most common cancer type in China, with about
380,000 new cases per year, according to National Central Cancer
Registry of China. There were approximately 1.5 million new CRC
cases globally in 2015 which are expected to increase to
approximately 1.7 million new cases per year by 2020, according to
Frost & Sullivan.
About Fruquintinib
Fruquintinib is a highly selective small molecule drug candidate
that has been shown to inhibit vascular endothelial growth factor
receptor (“VEGFR”) 24 hours a day via an oral dose, with lower
off-target toxicities compared to other targeted therapies. Its
tolerability, along with its clean drug-drug interaction profile
demonstrated to date, may enable rational combination with other
cancer therapies such as in our ongoing clinical trials of
fruquintinib in combination with chemotherapy and targeted
therapy.
At an advanced stage, tumors secrete large amounts of VEGF, a
protein ligand, to stimulate formation of excessive vasculature
(angiogenesis) around the tumor to provide greater blood flow,
oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal
roles in tumor-related angiogenesis, and fruquintinib inhibits the
VEGF/VEGFR pathway. This represents an important therapeutic
strategy in blocking the development of new blood vessels essential
for tumors to grow and invade.
Fruquintinib is currently under joint development in China by
Chi-Med and its partner Lilly. Chi-Med and Lilly jointly announced
top-line results from the FRESCO CRC trial on March 3, 2017. In
addition, fruquintinib is being studied in China in a Phase III
pivotal trial in non-small cell lung cancer (“NSCLC”), known as
FALUCA; and a Phase II study using fruquintinib combined with
Iressa® (gefitinib) in the first-line setting for patients with
advanced or metastatic NSCLC. Other studies currently being
planned, and soon to be initiated, include a Phase III study in
gastric cancer in combination with paclitaxel in China, new studies
in the United States, and certain exploratory studies in
combination with other oncology agents.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which
researches, develops, manufactures and sells pharmaceuticals and
healthcare products. Its Innovation Platform, Hutchison MediPharma
Limited, focuses on discovering and developing innovative
therapeutics in oncology and autoimmune diseases for the global
market. Its Commercial Platform manufactures, markets, and
distributes prescription drugs and consumer health products in
China.
Chi-Med is majority owned by the multinational conglomerate CK
Hutchison Holdings Limited (SEHK: 0001). For more information,
please visit: www.chi-med.com.
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 Chi-Med’s current expectations regarding future
events, including its expectations for the clinical development of
fruquintinib, plans to initiate clinical studies for fruquintinib,
its expectations as to whether such studies would meet their
primary or secondary endpoints, and its expectations as to the
timing of the completion and the release of results from such
studies. Forward-looking statements involve risks and
uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding enrollment rates, timing and
availability of subjects meeting a study’s inclusion and exclusion
criteria, changes to clinical protocols or regulatory requirements,
unexpected adverse events or safety issues, the ability of drug
candidate fruquintinib to meet the primary or secondary endpoint of
a study, to obtain regulatory approval in different jurisdictions,
to gain commercial acceptance after obtaining regulatory approval,
the potential market of fruquintinib for a targeted indication and
the sufficiency of funding. 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 Chi-Med’s filings with the
U.S. Securities and Exchange Commission and on AIM. Chi-Med
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 Christian Hogg, CEO +852 2121 8200
U.K. & International Media Enquiries Anthony Carlisle,
Citigate Dewe Rogerson +44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries Brad Miles, BMC
Communications +1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com Susan Duffy, BMC Communications +1
(917) 499 8887 (Mobile) sduffy@bmccommunications.com
Investor Relations Matt Beck, The Trout Group +1 (917) 415
1750 (Mobile) mbeck@troutgroup.com David Dible, Citigate Dewe
Rogerson +44 7967 566 919 (Mobile) david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited Richard Gray / Andrew
Potts +44 (20) 7886 2500
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version on businesswire.com: http://www.businesswire.com/news/home/20170611005094/en/
Chi-MedInvestor EnquiriesChristian Hogg, CEO+852 2121 8200orU.K.
& International Media EnquiriesCitigate Dewe RogersonAnthony
Carlisle+44 7973 611 888
(Mobile)anthony.carlisle@cdrconsultancy.co.ukorU.S. Based Media
EnquiriesBMC CommunicationsBrad Miles+1 (917) 570 7340
(Mobile)bmiles@bmccommunications.comorSusan Duffy+1 (917) 499 8887
(Mobile)sduffy@bmccommunications.comorThe Trout GroupInvestor
RelationsMatt Beck, +1 (917) 415 1750 (Mobile)
mbeck@troutgroup.comorCitigate Dewe RogersonDavid Dible, +44 7967
566 919 (Mobile) david.dible@citigatedr.co.ukorPanmure Gordon (UK)
LimitedRichard Gray / Andrew Potts +44 (20) 7886 2500
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