TIDMHCM
RNS Number : 1621K
Hutchison China Meditech Limited
30 December 2020
Chi-Med Announces the NMPA Approval of Surufatinib (Sulanda(R)
in China) for Non-Pancreatic Neuroendocrine Tumors
- Sulanda(R) is Chi-Med's first oncology drug brought to market
without a partnership and the company's second oncology drug
approved in China -
- The pivotal Phase III SANET-ep trial demonstrated surufatinib
reduced risk of progression or death by 67%, extending PFS in all
subgroups of non-pancreatic NET patients with an acceptable
risk/benefit ratio -
- 400-strong oncology commercial team in place to bring
Sulanda(R) to patients in China -
Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, December
30, 2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) today announces that surufatinib has been granted approval for
drug registration by the National Medical Products Administration
of China ("NMPA") for the treatment of non-pancreatic
neuroendocrine tumors ("NETs"). Surufatinib will be marketed in
China under the brand name Sulanda(R) . Surufatinib is Chi-Med's
first self-discovered oncology drug to be approved in China without
the support of a development partner, and follows the approval of
Chi-Med's first oncology drug, Elunate(R) (fruquintinib capsules),
in 2018.
Christian Hogg, Chief Executive Officer of Chi-Med commented,
"We are very pleased to have achieved this major milestone for
Chi-Med. The approval of surufatinib, our first un-partnered
oncology drug, is a strong testament to our in-house research and
development capability."
"Today's approval also marks an important development for NET
patients, for whom there are currently limited treatment options.
Compared with other NET therapies available in the market,
surufatinib has a unique mode of action by both inhibiting
angiogenesis and promoting the body's immune response against tumor
cells. If our second new drug application ("NDA") in pancreatic NET
is successful, this therapy would be approved in China to address
all NET patients regardless of the tumor origin."
"We look forward to making this unique therapy available to
patients as quickly and broadly as possible through our own
expanded oncology commercial team."
Chi-Med has established an oncology commercial team that today
covers more than 2,000 hospitals across China. The team is led by a
leadership team highly experienced in oncology products
commercialization in China with deep knowhow in the field of
NETs.
The NMPA approval of Sulanda(R) was based on results from the
SANET-ep[1] study, a Phase III trial (clinicaltrials.gov
identifier: NCT02588170 ) in patients with advanced non -pancreatic
NETs conducted in China. The study met the pre-defined primary
endpoint of progression-free survival (" PFS") at a preplanned
interim analysis. The positive results of this trial were
highlighted in an oral presentation at the 2019 ESMO Congress ) and
published in The Lancet Oncology in September 2020.[2] Median PFS
was significantly longer for patients treated with surufatinib at
9.2 months, compared to 3.8 months for patients in the placebo
group (HR 0.334; 95% CI: 0.223-0.499; p <0.0001). Surufatinib
had an acceptable safety profile, with the most common
treatment-related adverse events of grade 3 or worse being
hypertension (36% of surufatinib patients vs. 13% of placebo
patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).
In China, there were an estimated 67,600 newly diagnosed NET
patients in 2018. Considering the current incidence to prevalence
ratio, there may be as many as 300,000 patients living with the
disease. [3]
About NETs
NETs form in cells that interact with the nervous system or in
glands that produce hormones. They can originate in various parts
of the body, most often in the gut or the lungs and can be benign
or malignant. NETs are typically classified as pancreatic NET
("pNET") or non-pancreatic NET ("epNET"). Approved targeted
therapies include Sutent(R) (for pNET only) and Afinitor(R) for
pNET and well-differentiated, non-functional gastrointestinal or
lung NET.
According to Frost and Sullivan, there were 19,000 newly
diagnosed cases of NETs in the U.S. in 2018. Importantly, NETs are
associated with a relatively long duration of survival compared to
other tumors. As a result, there were approximately 141,000
estimated patients living with NETs in the U.S. in 2018.
About Surufatinib (Sulanda(R) in China)
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.
Chi-Med currently retains all rights to surufatinib
worldwide.
About Surufatinib Development
NETs in the U.S. and Europe: In the U.S., surufatinib was
granted Fast Track Designations for development in pNET and epNET
in April 2020, and Orphan Drug Designation for pNET in November
2019. A U.S. FDA NDA rolling submission was initiated in December
2020, to be followed by a marketing authorization application (MAA)
submission to the European Medicines Agency (EMA) in Europe. The
basis to support these filings includes the completed SANET-ep and
SANET-p[4] studies, along with existing data from surufatinib in
U.S. non-pancreatic and pancreatic NET patients (clinicaltrials.gov
identifier: NCT02549937).
Pancreatic NETs in China: The SANET-p study is a pivotal Phase
III study in patients with low- or intermediate-grade, advanced
pNET in China. It was terminated early as the pre-defined primary
endpoint of PFS was met (clinicaltrials.gov identifier:
NCT02589821) at an preplanned interim analysis, leading to a second
NDA accepted by the China NMPA in September 2020. The results of
this study were presented at the ESMO Virtual Congress 2020 and
published simultaneously in The Lancet Oncology. [5]
Biliary tract cancer in China: A Phase IIb/III study was
initiated in March 2019, comparing surufatinib with capecitabine in
patients with advanced biliary tract cancer whose disease
progressed on first-line chemotherapy. The primary endpoint is
overall survival (OS) (clinicaltrials.gov identifier
NCT03873532).
Immunotherapy combinations: Chi-Med has entered into
collaboration agreements to evaluate the safety, tolerability and
efficacy of surufatinib in combination with anti-PD-1 monoclonal
antibodies, including with tislelizumab (BGB-A317, developed by
BeiGene, Ltd.), Tuoyi (R) (toripalimab, developed by Shanghai
Junshi Biosciences Co. Ltd.) and Tyvyt (R) (sintilimab, developed
by Innovent Biologics, Inc.), which are approved as monotherapies
in China.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
biopharmaceutical company committed, over the past twenty years, to
the discovery and global development of targeted therapies and
immunotherapies for the treatment of cancer and immunological
diseases. It has a portfolio of nine cancer drug candidates
currently in clinical studies around the world and extensive
commercial infrastructure in its home market of China. 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 regarding the commercial launch
of surufatinib in China, the ability of its in-house oncology sales
team to distribute surufatinib quickly and broadly, the potential
market for surufatinib in non-pancreatic NET patients China, the
potential approval of surufatinib in pancreatic NET, and the
further clinical development for surufatinib in these and other
indications 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 Chi-Med's ability to commercialize surufatinib, the
benefits obtained from surufatinib during clinical trials being the
same for all patients who are prescribed surufatinib, no
unidentified side effects occurring which could result in the NMPA
pulling surufatinib from the market, Chi-Med's ability to fund,
implement and complete its further clinical development and
commercialization plans for surufatinib, 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 capecitabine, tislelizumab,
Tuoyi(R) , and Tyvyt(R) as combination therapeutics with
surufatinib, 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 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
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)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
[1] Surufatinib in advanced neuroendocrine tumors -
extra-pancreatic (non-pancreatic).
[2] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced
extrapancreatic neuroendocrine tumours (SANET-ep): a randomised,
double-blind, placebo-controlled, phase 3 study [published online
ahead of print, 2020 Sep 20]. Lancet Oncol. 2020;
S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4 .
[3] According to Frost & Sullivan. In 2018, there were
19,000 newly diagnosed cases of NETs in the U.S and an estimated
141,000 patients living with NETs. The current incidence to
prevalence ratio in China is estimated at 4.4, lower than the 7.4
ratio in the U.S. due to lower access to treatment options.
[4] Surufatinib in advanced neuroendocrine tumors -
pancreatic.
[5] Xu J, Shen L, Bai C, et al. Surufatinib in advanced
pancreatic neuroendocrine tumours (SANET-p): a randomised,
double-blind, placebo-controlled, phase 3 study [published online
ahead of print, 2020 Sep 20].
Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9 .
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