TIDMHCM
Hutchmed (China) Limited
01 July 2021
Press Release
U.S. FDA Accepts Filing of HUTCHMED's NDA for Surufatinib for
the Treatment of Advanced Neuroendocrine Tumors
- U.S. FDA has assigned a target action date of April 30 , 2022
-
- If approved, surufatinib would be HUTCHMED's first novel
oncology drug marketed outside of China -
Hong Kong, Shanghai & Florham Park, NJ - Thursday, July 1,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:
13) today announces that the U.S. Food and Drug Administration
("FDA") has accepted its filing of the New Drug Application ("NDA")
for surufatinib for the treatment of pancreatic and
extra-pancreatic (non-pancreatic) neuroendocrine tumors ("NETs").
The Prescription Drug User Fee Act (PDUFA) goal date assigned by
the FDA for this NDA is April 30 , 2022.
Surufatinib received fast track designation in April 2020 for
the treatment of pancreatic and extra-pancreatic NET. Orphan Drug
Designation for pancreatic NET was also granted in November
2019.
Dr. Marek Kania, Managing Director and Chief Medical Officer of
HUTCHMED International Corporation, said: "This NDA filing
acceptance of surufatinib in the U.S. is a significant achievement
for HUTCHMED as we expand our global operations and work to bring
our innovative oncology drugs to cancer patients worldwide. The
FDA's acceptance of the NDA highlights the clinical value of this
submission package and the importance of bringing more treatment
options to US NET patients."
The NDA is supported by data from 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), and a surufatinib study conducted
in the U.S.[3] The data package will also be used to file a
Marketing Authorization Application ("MAA") to the European
Medicines Agency ("EMA") imminently, based on scientific advice
from the EMA's Committee for Medicinal Products for Human Use.
HUTCHMED has initiated an Expanded Access Protocol (EAP) in the
U.S. to ensure patients with NET with 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).
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.[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: 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 completed in April 2021
, 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.[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 pNETs conducted in China. 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 ([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) (formerly Hutchison China
MediTech) 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. 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, the further clinical
development of surufatinib in this and other indications and
HUTCHMED's expansion of its global operations. 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 the Stock Exchange of Hong Kong. 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] ASCO 2021 J Clin Oncol 39, 2021 (suppl 15; abstr 4114)
[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. 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.
[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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