TIDMHCM
Hutchison China Meditech Limited
04 May 2021
Press Release
HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for
Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
- First NDA submission by HUTCHMED in the U.S.; product launch
preparations underway -
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, May 4,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) today
announces that it completed the rolling submission of a New Drug
Application ("NDA") to the U.S. Food and Drug Administration
("FDA") for surufatinib for the treatment of pancreatic and
extra-pancreatic (non-pancreatic) neuroendocrine tumors
("NETs").
Dr. Marek Kania, Managing Director and Chief Medical Officer of
HUTCHMED International Corporation, said, "HUTCHMED is developing
six novel oncology drug candidates internationally and this
surufatinib NDA represents our first ever in the United States.
Having successfully launched surufatinib in China early this year,
we are now looking forward, subject to its approval, to being able
to provide access to this important new therapeutic option for NETs
patients in the U.S. and beyond. Our surufatinib NDA submission to
the FDA was completed by our rapidly expanding international team
of over 70 personnel based mainly in the U.S., working side by side
with our discovery and development colleagues in China."
The NDA is supported by data from two positive Phase III studies
of surufatinib in NET in China (SANET-p ([1]) and SANET-ep[2]), and
by data from a surufatinib study conducted in the U.S. in patients
with pancreatic and extra-pancreatic NET. HUTCHMED previously
announced that it had reached an agreement with the FDA during a
pre-NDA meeting, whereby these studies may serve as the basis to
support an NDA submission. Fast Track Designations granted in April
2020 by the FDA have permitted HUTCHMED to submit sections of the
NDA on a rolling basis. Filing acceptance of the NDA is subject to
the FDA's review of the complete application. The data package will
also be used to file a Marketing Authorization Application ("MAA")
to the European Medicines Agency ("EMA") in 2021, based on
scientific advice from the EMA's Committee for Medicinal Products
for Human Use.
HUTCHMED initiated an Expanded Access Protocol (EAP) in the U.S.
to ensure patients with NET and limited therapeutic options have
access to this treatment. Regulatory clearance of this protocol has
been granted by the FDA and this program is open for site
activation (clinicaltrials.gov identifier: NCT04814732).
In addition to the two Fast Track Designations for surufatinib
development in pancreatic and extra-pancreatic NET granted by the
FDA in April 2020, Orphan Drug Designation for pancreatic NET was
also granted in November 2019.
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 NET ("epNET").
According to Frost & Sullivan, there were 19,000 newly
diagnosed cases of NET in the U.S. in 2020. Importantly, NETs are
associated with a relatively long duration of survival compared to
other tumors. As a result, there were approximately 143,000
estimated patients living with NET in the U.S. in 2020.[3]
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: 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 MAA submission to the EMA in Europe. 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
).
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.[4]
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: In 2016, we initiated the SANET-p study, which
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 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 ([5]) , demonstrating that surufatinib reduces
the risk of disease progression or death by 51% in patients, with
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, we 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: We have 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) (formerly Hutchison China MediTech
Limited) is an innovative, commercial-stage, biopharmaceutical
company. It is committed to the discovery and global development
and commercialization of targeted therapies and immunotherapies for
the treatment of cancer and immunological diseases. A dedicated
organization of over 1,200 personnel has advanced ten cancer drug
candidates from in-house discovery into clinical studies around the
world, with its first two oncology drugs now approved and launched.
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 submission of an
NDA for surufatinib for the treatment of NET with the FDA and the
timing of such submission, 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 and on AIM. 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
Freddy Crossley / Atholl Tweedie, 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] 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. 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] 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 .
[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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