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Hutchison China Meditech Limited
26 November 2018
Press Release
Chi-Med Announces First Commercial Launch of Fruquintinib
Capsules (Elunate(R) )
London: Monday, November 26, 2018: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces the first
commercial launch of fruquintinib capsules (Elunate(R) ) with the
initiation of product sales in China. Elunate(R) is for the
treatment of patients with metastatic colorectal cancer ("CRC")
that have been previously treated with fluoropyrimidine,
oxaliplatin and irinotecan, including those who have previously
received or are unsuitable for anti-vascular endothelial growth
factor (VEGF) therapy and/or anti-epidermal growth factor receptor
(EGFR) therapy (Ras wild type).
CRC is the second most common cancer type in China[1], with
about 380,000 new cases per year[2]. The market launch of
Elunate(R) in China is being conducted through collaboration with
Chi-Med's partner Eli Lilly and Company ("Lilly").
"This launch is a major milestone for Chi-Med," said Simon To,
Chairman of Chi-Med. "We are very proud to have brought
fruquintinib from its initial discovery through to its first sale,
and now look forward to seeing patients in China benefit from this
important new therapy." He added, "This achievement reinforces
Chi-Med's position as a fast emerging biotech company, and
illustrates China's capability to emerge as an important global
force in oncology innovation."
Fruquintinib was first approved by the National Medical Products
Administration of China ("NMPA") in September 2018 for the
treatment of advanced CRC, becoming the first China-discovered and
-developed pharmaceutical for a mainstream oncology indication to
be unconditionally approved in China. Chi-Med has established a
manufacturing facility in Suzhou, China to produce
fruquintinib.
Dr. Wang Li, Senior Vice President, Head of Lilly China Drug
Development & Medical Affairs Center, said, "We look forward to
working with Chi-Med to bring this novel medicine to patients,
addressing the significant unmet need in colorectal cancer in
China."
Given the broad relevance of anti-angiogenesis therapies in
cancer biology and the observed effects in various cancers to date,
Chi-Med is developing fruquintinib in multiple further indications,
including in combination with other cancer therapies.
About Other Fruquintinib Development Programs
Global Development
Phase I monotherapy in the U.S.: In December 2017, Chi-Med
initiated a multi-center, open-label, Phase I clinical study to
evaluate the safety, tolerability and pharmacokinetics of
fruquintinib in U.S. patients with advanced solid tumors
(clinicaltrials.gov identifier NCT03251378). This study is almost
complete, and proof-of-concept ("POC") studies are expected to
begin in 2019.
China Development
Colorectal cancer in China: The NMPA approved the first NDA for
fruquintinib for the treatment of patients with advanced CRC in
September 2018. The NDA is supported by data from the successful
FRESCO study, a Phase III pivotal registration trial of
fruquintinib in 416 patients with CRC in China, which was
highlighted in an oral presentation at the American Society of
Clinical Oncology Annual Meeting held on June 5, 2017 and was
published in The Journal of the American Medical Association, JAMA,
in June 2018 (clinicaltrials.gov identifier NCT02314819).
Gastric cancer in China: In October 2017, Chi-Med initiated a
pivotal Phase III clinical trial of fruquintinib in combination
with Taxol(R) (paclitaxel), known as the FRUTIGA study, in
approximately 500 patients with advanced gastric or
gastroesophageal junction (GEJ) adenocarcinoma who have progressed
after first-line standard chemotherapy (clinicaltrials.gov
identifier NCT03223376). An interim analysis on FRUTIGA, to
establish POC, is anticipated during the first half of 2019 and if
successful could trigger a POC milestone payment from Lilly. The
FRUTIGA study followed a Phase I/II clinical trial in 34 patients
with gastric cancer that demonstrated that combination therapy of
fruquintinib and Taxol(R) was generally well-tolerated with
promising tumor response (clinicaltrials.gov identifier
NCT02415023).
Lung cancer in China: The FALUCA trial is a randomized,
double-blind, placebo-controlled, multi-center, Phase III
registration study targeted at treating patients with advanced
non-squamous non-small cell lung cancer ("NSCLC"), who have failed
two lines of systemic chemotherapy. 527 patients were randomized at
a 2:1 ratio to receive either: 5mg of fruquintinib orally once per
day, on a three-weeks-on / one-week-off cycle, plus best supportive
care ("BSC"); or placebo plus BSC. On November 16, 2018, Chi-Med
announced that FALUCA did not meet the primary endpoint to
demonstrate a statistically significant increase in overall
survival compared to placebo, however the data did show
statistically significant improvement in all secondary endpoints
including progression-free survival, objective response rate,
disease control rate and duration of response as compared to the
placebo. The safety profile of the trial was in line with that
observed in prior clinical studies. Full detailed results are
expected to be disclosed at an upcoming scientific meeting.
Additional details about this study can be found at
clinicaltrials.gov, using identifier NCT02691299.
Along with FALUCA, fruquintinib is concurrently being studied in
a Phase II study in combination with Iressa(R) (gefitinib) in
patients with untreated advanced or metastatic NSCLC
(clinicaltrials.gov identifier NCT02976116). Preliminary results
were highlighted in an oral presentation at the 18(th) World
Conference on Lung Cancer on October 16, 2017.
Programmed cell death protein-1 ("PD-1") checkpoint inhibitor
combination: It is an important part of Chi-Med's strategy to
explore the potential synergies of its drug candidates in
combination with other anti-cancer treatments in several solid
tumor settings. In October 2018, Chi-Med entered into a further
collaboration in China to evaluate the combination of fruquintinib
with genolimzumab (GB226), a PD-1 inhibitor being developed by
Genor Biopharma Company Limited.
About Fruquintinib
Fruquintinib (brand name: Elunate(R) ) is a small molecule,
selective and highly potent inhibitor of VEGFR 1, 2 and 3. VEGFR
inhibitors play a pivotal role in tumor-related angiogenesis,
cutting off the blood supply that a tumor needs to grow rapidly.
The global market for anti-angiogenesis therapies was estimated at
over US$18 billion in 2017, including both monoclonal antibodies
and small molecules approved in around 30 tumor settings. During
the discovery research process, which began at Chi-Med in 2007,
fruquintinib was successfully designed to be differentiated by
improving kinase selectivity in comparison to other approved small
molecule tyrosine kinase inhibitors (TKIs), to minimize off-target
toxicities, improve tolerability and provide more consistent target
coverage, resulting in better clinical efficacy. The superior
tolerability, along with fruquintinib's low potential for drug-drug
interaction based on preclinical assessment, suggests that it may
be highly suitable for innovative combinations with other
anti-cancer therapies.
In October 2013, Chi-Med entered into a licensing,
co-development and commercialization agreement in China with Lilly
for fruquintinib. Under the terms of the agreement, the costs of
development of fruquintinib, carried out by Chi-Med, are shared;
Chi-Med has received upfront payments and development and
regulatory approval milestone payments; and upon commercialization
in China, Chi-Med would receive royalties. Chi-Med and Lilly agreed
to develop fruquintinib in three initial solid tumor indications,
including CRC, NSCLC and gastric cancer.
The most common adverse reactions included hypertension,
hand-foot syndrome and proteinuria. Clinically effective management
of these adverse effects is feasible. For important safety
information about fruquintinib, please see www.chi-med.com.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical
company which researches, develops, manufactures and markets
pharmaceutical products. Its Innovation Platform, Hutchison
MediPharma, has about 400 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
in oncology and autoimmune diseases. It has a portfolio of eight
cancer drug candidates currently in clinical studies around the
world. Chi-Med's Commercial Platform manufactures, markets, and
distributes prescription drugs and consumer health products,
covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and
the Nasdaq Global Select Market, Chi-Med is headquartered in Hong
Kong and majority owned by the multinational conglomerate CK
Hutchison Holdings Limited (SEHK: 1). For more information, please
visit: www.chi-med.com.
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 reflect Chi-Med's current expectations regarding future
events, including its expectations for the ability of fruquintinib
to gain commercial acceptance in China, the potential market of
fruquintinib for patients with metastatic CRC who have failed two
prior treatments in China, the ability for Chi-Med to quickly
provide fruquintinib to patients by year end, and the clinical
development of fruquintinib in other indications. Forward-looking
statements involve risks and uncertainties. Such risks and
uncertainties include, among other things, assumptions regarding
Chi-Med's ability to obtain regulatory approval in different
jurisdictions, to commercialize fruquintinib, that the benefits
obtained from fruquintinib during clinical trials will be the same
for all patients who are prescribed fruquintinib, that no
unidentified side effects will occur which could result in the NMPA
pulling
fruquintinib from the market and the sufficiency of funding to
support commercialization of fruquintinib in metastatic CRC and the
development of fruquintinib in other indications. In addition, as
certain studies rely on the use of Iressa(R) (gefitinib), Taxol(R)
(paclitaxel), or genolimzumab (GB226) as combination therapeutics
with fruquintinib, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and continued regulatory
approval of Iressa(R) , Taxol(R) , and genolimzumab. 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 press release, whether as a
result of new information, future events or circumstances or
otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President, Corporate Finance & Development +852 2121 8200
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
Media Enquiries
UK & Europe - Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China - Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
- Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China - Sam Shen, Edelman +86 136 7179 1029 (Mobile)
sam.shen@edelman.com
Nominated Advisor
Richard Gray / Andrew Potts, Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] R. Zheng, H. Zeng et al, Cancer Lett. 2016 Jan
1;370(1):33-8. National estimates of cancer prevalence in China,
2011. doi:10.1016/j.canlet.2015.10.003. Epub 2015 Oct 13.
[2] W. Chen, R. Zheng et al, CA Cancer J Clin. 2016
Mar-Apr;66(2):115-32. Cancer Statistics in China, 2015.
doi:10.3322/caac.21338. Epub 2016 Jan 25.
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END
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