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Hutchmed (China) Limited
16 July 2021
Press Release
HUTCHMED's Marketing Authorization Application for Surufatinib
Submitted and Validated by the European Medicines Agency
- EMA commences review of surufatinib for the treatment of
advanced neuroendocrine tumors -
- Expands potential global reach of surufatinib, in addition to
China where it is already launched, and in the U.S. where it is
under review for marketing approval -
Hong Kong, Shanghai & Florham Park, NJ - Friday, July 16,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:
13) today announces that the European Medicines Agency ("EMA") has
validated and accepted its marketing authorization application
("MAA") for surufatinib for the treatment of pancreatic and
extra-pancreatic (non-pancreatic) neuroendocrine tumors ("NETs").
The EMA's validation confirms that the submission is sufficiently
complete and that it is ready to commence the formal review
process.
The submission follows scientific advice from the EMA's
Committee for Medicinal Products for Human Use ("CHMP"), from which
it was concluded that the two positive Phase III studies of
surufatinib in patients with pancreatic and extra-pancreatic NET in
China (SANET -- p ([1]) and SANET -- ep [2] , both previously
reported in The Lancet Oncology), along with existing data from
surufatinib in U.S. extra-pancreatic and pancreatic NET patients,
could form the basis to support a MAA. The submission follows the
acceptance of a new drug application ("NDA") with the U.S. Food and
Drug Administration ("FDA"), as announced on July 1, 2021.
Dr. Marek Kania, Managing Director and Chief Medical Officer of
HUTCHMED International Corporation, said, "HUTCHMED's novel
oncology pipeline is making important progress globally and the
EMA's validation of surufatinib's MAA, which we believe recognizes
the scientific value of this submission package, follows the recent
acceptance of the U.S. NDA by the FDA. With its launch earlier this
year in China, surufatinib has given NET patients an important new
therapeutic option and we now hope to soon be able to bring this
important treatment to patients across the U.S. and Europe."
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 extra-pancreatic (non-pancreatic) NET ("epNET").
According to Frost & Sullivan, there were 19,000 newly
diagnosed cases of NET in the U.S. in 2020. Rates across the
European Union (E.U.) appear largely similar to the U.S.. This is
supported by an analysis of global epidemiologic trends, which also
show growth in the incidence of NETs worldwide. [3] Importantly,
NETs are associated with a relatively long duration of survival
compared to other tumors. As a result, there were approximately
140,000 estimated patients living with NET in France, Germany,
Italy, Spain, and the United Kingdom in 2020. [4]
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
vascular endothelial growth factor receptors (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.
HUTCHMED currently retains all rights to surufatinib
worldwide.
About Surufatinib Development
NETs in the U.S. and Europe: A U.S. FDA NDA submission was
accepted in June 2021, followed by a MAA submission to the EMA in
Europe validated in July 2021. The basis to support these filings
includes the completed SANET-ep and SANET-p studies, along with
existing data from surufatinib in U.S. epNET and pNET patients
(clinicaltrials.gov identifier: NCT02549937). 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.
epNETs in China: On December 30, 2020, surufatinib was granted
drug registration approval by the National Medical Products
Administration of China ("NMPA") for the treatment of epNET.
Surufatinib is marketed in China under the brand name Sulanda(R) .
The approval was based on results from the SANET-ep study, a Phase
III trial (clinicaltrials.gov identifier: NCT02588170 ) in patients
with advanced epNETs 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.
[5] 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%).
pNETs in China: On June 18, 2021, surufatinib was granted drug
registration approval by the NMPA for the treatment of pNET. The
approval was based on results from the SANET-p study, a Phase III
trial (clinicaltrials.gov identifier: NCT02589821 ) in patients
with advanced pNET in China. The pre-defined primary endpoint of
PFS was met at a preplanned interim analysis, leading to a second
NDA accepted by the NMPA in September 2020. The positive results of
this study were presented at the 2020 ESMO Virtual Congress and
published simultaneously in The Lancet Oncology ([6]) ,
demonstrating that surufatinib reduces the risk of disease
progression or death by 51% in patients, with a median PFS of 10.9
months compared to 3.7 months on placebo (HR 0.491; 95% CI:
0.391-0.755; p=0.0011). The safety profile of surufatinib was
manageable and consistent with observations in prior studies.
Biliary tract cancer in China: In March 2019, HUTCHMED initiated
a Phase IIb/III study 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: HUTCHMED 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), Tuoyi (R) (toripalimab) and
Tyvyt (R) (sintilimab), which are approved as monotherapies in
China.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery, 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
three oncology drugs now approved and marketed. For more
information, please visit: www.hutch--med.com or follow us on
LinkedIn.
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 HUTCHMED's current expectations regarding future
events, including its expectations regarding the review of an MAA
for surufatinib for the treatment of NET with the EMA and the
timing of such review, the therapeutic potential of surufatinib for
the treatment of patients with NET and the further clinical
development of surufatinib in this and other indications.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding the sufficiency of clinical data to support NDA approval
of surufatinib for the treatment of patients with NET in the U.S.,
China and other jurisdictions such as the E.U., its potential to
gain expeditious approvals from regulatory authorities, the safety
profile of surufatinib, HUTCHMED'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 HUTCHMED's filings with the U.S. Securities and Exchange
Commission, on AIM and on The Stock Exchange of Hong Kong Limited.
HUTCHMED 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 +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
Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
[1] Surufatinib in advanced neuroendocrine tumors -
pancreatic.
[2] Surufatinib in advanced neuroendocrine tumors -
extra-pancreatic (non-pancreatic).
[3] Fraenkel M, Kim M, Faggiano A, de Herder WW, Valk GD; Knowledge NETwork. Incidence of gastroenteropancreatic neuroendocrine tumours: a systematic review of the literature. Endocr Relat Cancer. 2014;21(3):R153-R163. Published 2014 May 6. doi: 10.1530/ERC-13-0125 .
[4] According to Frost & Sullivan, in 2020, there were
19,000 newly diagnosed cases of NETs in the U.S. and an estimated
143,000 patients living with NETs.
[5] 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 .
[6] 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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