RCS - Hutchmed China Ltd - Surufatinib MAA Submitted and Validated by the EMA

HUTCHMED (China)Announcement

16/07/2021 07:00

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RNS Number : 4257F  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 (https://www.hutch-med.com/) ") (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  (#_edn1) )) and
SANET‑ep 2  (#_edn2) , 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
(https://www.hutch-med.com/fda-accepts-surufatinib-nda-for-net/) 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  (#_edn3)
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  (#_edn4)

 

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 (https://www.hutch-med.com/fda-accepts-surufatinib-nda-for-net/) ,
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
(https://clinicaltrials.gov/ct2/show/NCT02549937) ). In the U.S., surufatinib
was granted Fast Track Designations
(https://www.hutch-med.com/surufatinib-granted-us-fda-fast-track-designations/)
for development in pNET and epNET in April 2020, and Orphan Drug Designation
(https://www.hutch-med.com/surufatinib-fda-orphan-drug-designation/) for pNET
in November 2019.

 

epNETs in China: On December 30, 2020, surufatinib was granted drug
registration approval
(https://www.hutch-med.com/chi-med-announces-the-nmpa-approval-of-surufatinib-sulanda-in-china-for-epnet/)
by the National Medical Products Administration of China ("NMPA") for the
treatment of epNET. Surufatinib is marketed in China under the brand name
Sulanda(®). The approval was based on results from the SANET-ep study, a
Phase III trial (clinicaltrials.gov identifier: NCT02588170
(https://clinicaltrials.gov/ct2/show/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 (https://www.hutch-med.com/2019-esmo-annual-meeting/) of this
trial were highlighted in an oral presentation at the 2019 ESMO Congress and
published (https://doi.org/10.1016/S1470-2045(20)30496-4) in The Lancet
Oncology in September 2020. 5  (#_edn5) 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
(https://www.hutch-med.com/nmpa-approval-of-surufatinib-for-advanced-pnet/) 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
(https://clinicaltrials.gov/ct2/show/NCT02589821) ) in patients with advanced
pNET in China. The pre-defined primary endpoint of PFS was met
(https://www.hutch-med.com/surufatinib-phase-iii-sanet-p-study-achieved-primary-endpoint/)
at a preplanned interim analysis, leading to a second NDA accepted
(https://www.hutch-med.com/chi-med-announces-second-nda-acceptance-in-china-for-surufatinib-in-pancreatic-net/)
by the NMPA in September 2020. The positive results of this study were
presented
(https://www.hutch-med.com/surufatinib-phase-iii-results-at-esmo-2020-and-publications-in-the-lancet-oncology/)
at the 2020 ESMO Virtual Congress and published
(https://doi.org/10.1016/S1470-2045(20)30493-9) simultaneously in The Lancet
Oncology(( 6  (#_edn6) )), 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
(https://clinicaltrials.gov/ct2/show/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
(https://www.hutch-med.com/chi-med-and-beigene-collaboration-to-evaluate-surufatinib-and-fruquintinib-with-tislelizumab-combinations/)
(BGB-A317), Tuoyi
(https://www.hutch-med.com/chi-med-initiates-a-phase-ii-trial-of-surufatinib-in-combination-with-tuoyi-in-patients-with-advanced-solid-tumors/)
(®
(https://www.hutch-med.com/chi-med-initiates-a-phase-ii-trial-of-surufatinib-in-combination-with-tuoyi-in-patients-with-advanced-solid-tumors/)
) (toripalimab) and Tyvyt
(https://www.hutch-med.com/innovent-and-chi-med-expand-global-collaboration-to-evaluate-the-combination-of-sintilimab-and-surufatinib-in-solid-tumors/)
(®
(https://www.hutch-med.com/innovent-and-chi-med-expand-global-collaboration-to-evaluate-the-combination-of-sintilimab-and-surufatinib-in-solid-tumors/)
) (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 (https://www.hutch-med.com/) or follow us on
LinkedIn (https://www.linkedin.com/company/hutchmed/) .

 

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(®), and Tyvyt(®) 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 (mailto: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 (mailto:HUTCHMED@fticonsulting.com)
 Asia - Joseph Chi Lo / Zhou Yi, Brunswick                       +852 9850 5033 (Mobile) / +852 9783 6894 (Mobile)

                                                                 HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited   +44 (20) 7886 2500

 

 

 

 1  (#_ednref1) Surufatinib in advanced neuroendocrine tumors - pancreatic.

 2  (#_ednref2) Surufatinib in advanced neuroendocrine tumors -
extra-pancreatic (non-pancreatic).

 3  (#_ednref3)  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
(https://doi.org/10.1530/ERC-13-0125) .

 4  (#_ednref4) 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  (#_ednref5) 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 (https://doi.org/10.1016/S1470-2045(20)30496-4)
.

 6  (#_ednref6) 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 (https://doi.org/10.1016/S1470-2045(20)30493-9)
.

 

 

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