TIDMHCM
Hutchison China Meditech Limited
10 October 2019
Press Release
Innovent and Chi-Med Expand Global Collaboration to Evaluate the
Combination of Sintilimab and Surufatinib in Solid Tumors
SUZHOU, CHINA and LONDON, UK, Thursday, October 10, 2019 -
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) and Hutchison
China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today
announced the expansion of their global collaboration agreement to
evaluate the safety and efficacy of Innovent's Tyvyt(R) (sintilimab
injection), a fully human anti-programmed cell death protein 1
(anti-PD-1) monoclonal antibody, in combination with Chi-Med's
surufatinib, a novel inhibitor of vascular endothelial growth
factor receptor (VEGFR), fibroblast growth factor receptor 1
(FGFR1) and colony stimulating factor-1 receptor (CSF-1R), in
patients with advanced solid tumors. The expansion builds on the
existing global collaboration agreement between the two companies
on sintilimab in combination with Chi-Med's highly selective VEGFR
inhibitor, fruquintinib.
The expansion of the global collaboration will allow Innovent
and Chi-Med to jointly explore the potential application of
Tyvyt(R) and surufatinib combination therapy in solid tumors with
global unmet medical needs. Clinical studies with this new
combination will be conducted both in the United States and in
China. The combination of Tyvyt(R) and surufatinib is expected to
have synergistic anti-tumor effects by simultaneously targeting
multiple cell types and signaling pathways in the tumor
microenvironment. Preclinical studies have suggested that
surufatinib is able to inhibit angiogenesis, block the accumulation
of tumor associated macrophages and promote infiltration of
effector T cells into tumors, all of which could contribute to
improve anti-tumor activity of Tyvyt(R) (sintilimab injection).
"Sintilimab, co-developed by Innovent and Eli Lilly and Company,
has gained broad recognition by the market, due to its profiles in
safety and efficacy. Through partnership with other companies, we
are exploring more sintilimab-based combination therapies. We
already saw some promising results out of such combinations," said
Dr. Michael Yu, Chairman and Chief Executive Officer of Innovent.
"We are excited to further collaborate with Chi-Med to develop the
combination therapy of sintilimab and surufatinib, hoping more
patients will benefit from this potential therapy globally."
"We believe that the future of oncology treatments increasingly
lies in combining therapies, utilizing multiple mechanisms of
action to greatly improve the treatment of solid tumors," said Mr.
Christian Hogg, Chief Executive Officer of Chi-Med. "Our unique
next-generation anti-angiogenesis VEGFR inhibitors, with high
selectivity and tolerability, make them ideal candidates for
combinations with immunotherapy agents such as PD-1/L1 monoclonal
antibodies. Our existing collaboration with Innovent on
fruquintinib is progressing well. We are excited to expand our
collaboration to include surufatinib and look forward to bringing
the benefits of these combined therapies to more patients in China
and around the world."
About Tyvyt(R) (Sintilimab Injection)
Tyvyt(R) (sintilimab injection) is an innovative drug jointly
developed in China by Innovent and Eli Lilly and Company. Innovent
is also conducting clinical studies of sintilimab injection in the
United States. Tyvyt(R) (sintilimab injection) is a type of
immunoglobulin G4 monoclonal antibody, which binds to PD-1
molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1
(PD-L1) pathway and reactivates T-cells to kill cancer cells.
Tyvyt(R) (sintilimab injection) is the only PD-1 antibody in China
branded by both a local biopharmaceutical company and a global
pharmaceutical company. Tyvyt(R) (sintilimab injection) has been
granted marketing approval by the National Medical Products
Administration (NMPA) for relapsed or refractory classical
Hodgkin's lymphoma (r/r cHL) and has been included in the 2019
Guidelines of Chinese Society of Clinical Oncology (CSCO) for
Lymphoid Malignancies. Innovent is currently conducting more than
20 clinical studies for sintilimab injection to evaluate its safety
and efficacy in a wide variety of cancer indications, including
eight registration or pivotal clinical trials.
About Surufatinib
Discovered and developed solely by Chi-Med, surufatinib
(previously known as HMPL-012 or sulfatinib) is a novel, oral drug
candidate that selectively inhibits the tyrosine kinase activity
associated with VEGFR and FGFR, which both inhibit angiogenesis, as
well as CSF-1R, which regulates tumor-associated macrophages,
promoting the body's immune response against tumor cells.
Surufatinib's unique dual mechanism of action may be very suitable
for possible combinations with other immunotherapies.
Surufatinib is in several late-stage and proof-of-concept
clinical trials in China, for indications such as neuroendocrine
tumors and biliary tract cancer. In June 2019, an interim analysis
of a Phase III study in patients with non-pancreatic neuroendocrine
tumors in China confirmed that the study had met its primary
endpoint early. Detailed results from this study were orally
presented at the 2019 European Society for Medical Oncology
Congress on September 29, 2019, and preparations are underway for a
New Drug Application submission in China.
Surufatinib is also in proof-of-concept clinical trials in the
United States. Chi-Med currently retains all rights to surufatinib
worldwide.
About Innovent
Inspired by the spirit of "Start with Integrity, Succeed through
Action," Innovent's mission is to develop and commercialize high
quality biopharmaceutical products that are affordable to ordinary
people. Established in 2011, Innovent is committed to developing,
manufacturing and commercializing high quality innovative medicines
for the treatment of oncology, autoimmune, metabolic and other
major diseases. On October 31, 2018, Innovent was listed on the
Main Board of the Stock Exchange of Hong Kong Limited with the
stock code: 01801.HK.
Since it was founded, Innovent has developed a fully-integrated
platform which includes R&D, CMC (Chemistry, Manufacturing, and
Controls), clinical development and commercialization capabilities.
Leveraging the platform, the company has built a robust pipeline of
21 innovative assets in the fields of oncology, autoimmune,
metabolic diseases and other major therapeutic areas. 16 have
entered into clinical development, four have entered Phase III
clinical trials, three monoclonal antibodies have their New Drug
Application (NDA) under review and three of them have been granted
with priority review status, and one, Tyvyt(R) (sintilimab
injection), is now approved for relapsed or refractory classical
Hodgkin's lymphoma (r/r cHL).
Innovent has built an international team of advanced talents in
high-end biological drug development and commercialization,
including many overseas experts. The company has also entered into
strategic collaborations with Eli Lilly and Company, Adimab,
Incyte, Hanmi and other international pharmaceutical companies.
Innovent strives to work with all relevant parties to help advance
China's biopharmaceutical industry, improve drug availability to
ordinary people and enhance the quality of the patients' lives. For
more information, please visit: www.innoventbio.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 470 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies 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.
Chi-Med is headquartered in Hong Kong and is dual-listed on the
AIM market of the London Stock Exchange and the Nasdaq Global
Select Market. 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 clinical development of
surufatinib and fruquintinib, including in combinations with
sintilimab, plans to initiate further clinical studies for
surufatinib and fruquintinib as monotherapies or in combinations,
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 surufatinib and fruquintinib as monotherapies or in
combinations 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 surufatinib and fruquintinib for a targeted
indication and the sufficiency of funding. In addition, as the
combination studies rely on the use of sintilimab as a combination
therapeutic with surufatinib and fruquintinib, such risks and
uncertainties include assumptions regarding the safety, efficacy,
supply and regulatory approval of sintilimab. 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.
Innovent Contacts
Media:
pr@innoventbio.com
+86 512-6956 6088
Investors:
ir@innoventbio.com
+86 512-6956 6088
Chi-Med Contacts
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
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
Atholl Tweedie, Panmure Gordon (UK) Limited +44 (20) 7886 2500
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRAEAXEEFLDNFEF
(END) Dow Jones Newswires
October 10, 2019 04:00 ET (08:00 GMT)
Hutchison China Meditech (LSE:0J7G)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Hutchison China Meditech (LSE:0J7G)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024